Considerations for LGBTQ+ Inclusion in Clinical Research

Diversity, equity, and inclusion in clinical research starts with awareness of the perceptions of different communities. Repairing and reducing mistrust within underrepresented communities means learning how to recognize the obstacles and increase sensitivity for inclusion.

This Report:

  • Shares healthcare experiences of individuals in the LGTBQ+ community, as well as relationships and interactions with healthcare providers
  • An assessment of awareness of clinical research and drivers for participation and retention, as well as highlights and lowlights of past trial experiences
  • Identifies ways to raise awareness among and better engage the LGBTQ+ community in clinical research
Read the Industry Report Here

About the Report:

CISCRP and Teckro partnered to organize and facilitate a virtual advisory meeting among LGBTQ+ patients and community members. The purpose of this initiative was primarily to help inform clinical study staff and industry on considerations and best practices when engaging with the LGTBQ+ community, ultimately optimizing clinical trial experiences in the future. This article was originally written and published by Teckro, available here.

Additional Resources:

Read Broadening the Lens of Diversity for More Inclusion in Clinical Research | Written by Malia Lewin, Teckro

Read Improving LGBTQ+ Inclusivity in Ovarian Cancer Care | Written by Clara MacKay, World Ovarian Cancer Coalition

Download CISCRP’s infographic: Healthcare Provider Best Practices to Improve Experiences for LGBTQ+ Patients

To search for medical conditions in a specific location, visit our Search Clinical Trials page.

To stay informed about clinical trials, visit our Resources page.

Volunteer opportunities with CISCRP, visit our Volunteer page.

Inclusive Clinical Trials Could Improve Health Outcomes

In the U.S., Black people are twice as likely than white people to get Alzheimer’s disease, according to data from the National Institute on Aging. Yet one study that began in 2016 to develop a drug to treat Alzheimer’s had almost no Black participants.

This is not unique to Alzheimer’s research. While 30% of all U.S. prostate cancer deaths are among Black men, they make up only 3% of participants in cancer clinical trials.

Health experts say this lack of representation leads to widening health disparities and ballooning health care costs. An upcoming event in Indianapolis aims to increase awareness about the importance of diversity in clinical research. 

Journey to Better Health | AWARE for All – Indianapolis will take place from 5-8 p.m. Sept. 14 at the Ivy Tech Community College Culinary and Conference Center. The event is free and organized by the nonprofit Center for Information and Study on Clinical Research Participation.

Panelists will answer questions like what to expect as a clinical trial participant and the benefits and risks of participation.

One of the panelists will be Lena Harvey, a 37-year-old Indianapolis woman who lives with sickle cell disease. Harvey will discuss her experience as a participant in clinical trials.

While there are many reasons for lack of representation in clinical trials, Harvey said trust in the medical community is a big one.

Many of her older family members and friends do not interact with the health care system outside of emergencies or urgent problems because of the history of medical abuse. But she thinks that’s changing, as Black community members, especially young people like her, have access to more information than ever before.

“We are more connected than ever,” she said. “The Internet absolutely changed everything. It offered us a more level playing field in terms of access to information.”

This includes access to support groups, patient advocates as well as information about clinical trials and specific doctors.

Harvey said she has taken a proactive approach to her health, empowering herself with information to make sure she got the care she needed. She participated in two clinical trials on drugs and procedures for sickle cell disease. Plenty of internet research and conversations with her husband and trusted sickle cell physicians helped her come to the decision to enroll. She understood that even if the trials did not help her personally, the results of the studies could help others down the road.

“Because sometimes it takes several years, decades for people working on something to get it to where it really needs to be. None of that work is in vain,” she said.

Why Representation Matters

Clinical trials are typically initiated by a research question from community organizations or scientists at academic centers or industry labs.

Then, funding flows in from federal agencies, the private sector or charitable foundations. The clinical trial team then recruits participants through social networks or primary care settings. This is where more than half of the trials fail.

According to a report from the National Academies of Sciences, Engineering and Medicine, 55% of clinical trials stop because they were not able to recruit the participants needed to complete the study. This happens even after money and resources have been flowing into the trial for months or even years.

The financial fallout from lack of representation in clinical trials extends to individuals and their communities.

Disparities for some health and quality-of-life outcomes, including life expectancy and years in the labor force due to physical ability, could be mitigated if clinical trials were more inclusive.

“Of course, better representation in clinical research will not completely alleviate these disparities—after all, they have many interconnected and interdependent causes. However, to the extent that representation in clinical research may improve generalizability of scientific findings across a range of clinical studies for these important health states … representative clinical research may play a role in alleviating these inequities,” according to the NASEM report.

If better representation in clinical trials would alleviate just 1% of health disparities, it would result in economic gains of as much as $40 billion for diabetes and $60 billion for heart disease alone, the report explains.

Treatment and Prevention Depends on Studies

Experts refer to a drug called warfarin as a cautionary tale of how lack of representation can be detrimental to patients’ outcomes. Warfarin is used to prevent clots in blood vessels and is crucial to prevent deadly conditions like strokes and pulmonary embolisms. It is also a leading cause of adverse drug events in the U.S. because the wrong dose of warfarin can result in complications like excessive bleeding and even death.

Patients require different doses of warfarin, and that’s largely because of genetic factors. For example, patients of African ancestry require a higher average daily dose of the drug than patients of Asian ancestry. But most of the trials studying warfarin involved white people of European ancestry. Warfarin was approved for human use in 1951, but it took 62 years for scientists to learn that genotype-guided dosing is important for patient outcomes.

But it is not just the development and utilization of drugs that is affected by lack of representation in clinical trials. Preventative measures such as screening for certain diseases is also at stake.
One example that the NASEM report gives is screening for colorectal cancer in Black adults. The U.S. Preventive Services Task Force, which informs screening recommendations for different diseases, was not able to “make a separate, specific recommendation on colorectal cancer screening in Black adults” because of the lack of representative studies on Black adults. But data show that Black adults in the U.S. have the highest rates of being diagnosed with and dying from colorectal cancer. Other national guidelines suggest that they can benefit from earlier screenings.

This story comes from a reporting collaboration that includes the Indianapolis Recorder and Side Effects Public Media, a public health news initiative based at WFYI. Contact Farah at fyousry@wfyi.org. Follow on Twitter: @Farah_Yousrym.

To read the original article and learn more, visit here: https://indianapolisrecorder.com/inclusive-clinical-trials-could-improve-health-outcomes/ 

To search for medical conditions in a specific location, visit our Search Clinical Trials page.

To stay informed about clinical trials, visit our Resources page.

Volunteer opportunities with CISCRP, visit our Volunteer page.

Improving LGBTQ+ Inclusivity in Ovarian Cancer Care

In 2021, when the World Ovarian Cancer Coalition surveyed our advocacy partner organizations about what topics they would like to see on the agenda for our inaugural Partner Meeting, LGBTQ+ inclusiveness was a frontrunner topic.

Many of the organizations that we work with do outstanding work in this area. However, and encouragingly so, there is increased recognition across the Coalition and within the global cancer community of the need to address the lack of diversity of data within cancer science. As well, there is a growing awareness of the need for relevant information, services and support to improve the experience of cancer care for those from the LGBTQ+ community.

From an ovarian cancer awareness perspective, there are specific messages for the LGBTQ+ community that need to be communicated. This includes busting myths, like the misconception that having your ovaries removed eliminates the risk of developing ovarian cancer. In addition, within the lesbian and bisexual communities, for example, fewer people take oral contraceptives, give birth, and breastfeed compared to heterosexual women – which are all factors that reduce the risk of developing ovarian cancer.

We also know that issues related to gender dysphoria, discrimination and adverse experiences with healthcare can impact a person’s willingness to trust or access health services.

Combating Barriers Facing LGBTQ+ Individuals

Our own work in this area started with a decision to run a LGBTQ+ focused awareness campaign during June under the banner of No Person Left Behind.

Our first step was to draw on the expertise within our partner organizations and stakeholders from the wider LGBTQ+ community. Noteworthy input came from Stewart O’Callaghan, founder of Live Through This and one of the Coalition’s partner organizations, Ovacome, and Tristan Bilash, a clinical oncology social worker, transgender man, and ovarian cancer suvivor.

I also participated in the LGBTQ+ focus group that Teckro sponsored, hosted by the non-profit organization CISCRP. Here, I listened to members of the LGBTQ+ community share their experiences with healthcare and clinical trials, and the steps that could be taken to improve these interactions.

The combination of all of these discussions has flagged-up some significant challenges that will take time to address, including:

  • Societal biases against the LGBTQ+ community
  • Mistrust by LGBTQ+ people towards healthcare providers and systems
  • Lack of awareness of ovarian cancer and the specific risks for those who are part of the LGBTQ+ community
  • The shocking lack of diversity that exists within cancer research, including clinical trials
    We need to work much, much harder to combat these barriers.

But I was also struck by some of the very simple and foundational ways we can make health services more welcoming and accessible to the LGBTQ+ community. We need to start with basic healthcare and then expand awareness and accessibility of clinical trials for this community.

Images and Words Matter

When it comes to something as personal as healthcare, people want to see themselves reflected back when they approach awareness information or a healthcare provider who will be privy to the most personal aspects of their lives.

Language is also key. Almost everyone we’ve listened to has shared a personal experience of completing medical forms that only offer male or female as gender options. They are not asked about preferred pronouns, or healthcare providers – either intentionally or unintentionally – use the patient’s “dead name.” (Deadnaming is the act of referring to a transgender or non-binary person by a name they used prior to transitioning, such as their birth name.)

Using the correct names and pronouns are meaningful ways to show respect, as they are wholly entwined with the concept of personal identity. Breaking the ice on this front can be as simple as health professionals sharing their own pronouns.

On a systemic level, it is also important to expand understanding that every person is a unique individual and should be approached as such. One of the most powerful stories we’ve heard is from from Tristan, a transgender man who is also an advanced ovarian cancer survivor. Tristan’s follow-up CA125 test was cancelled because the laboratory software restricted CA125 tests to female patients only. Tristan’s health card, and subsequent lab requisitions, reflect he is legally male so his test was automatically filtered out.

Everyone Deserves Best Quality of Life and
Chance of Survival

Many starting the journey into LGBTQ+ inclusivity worry about getting terms wrong or unintentionally offending people. One message that has come through quite clearly in our discussions is that mistakes will happen, and no one will get it right 100% of the time.

What is more important is that the conversations take place – and that they happen in good faith. Sincerity of purpose, genuine and honest dialogue, and being transparent about your limitations in knowledge and experience are the most important steps any person, organization, or company can take as they move towards building trust and a more inclusive future.

We can never truly know what it is like to be in someone else’s shoes, whether they be of a different economic status, live in another country, or identify a different way. As a Coalition, we acknowledge this and celebrate the diversity of our global community. And we are committed to our belief that every person with ovarian cancer deserves the best quality of life and best chance of survival – no matter where they live, who they love, or how they identify.

Written by Clara MacKay, CEO, World Ovarian Cancer Coalition

To read the original article and learn more, visit Teckro’s website here:  https://teckro.com/resources/blog/lgbtq-inclusivity-ovarian-cancer-care

To search for medical conditions in a specific location, visit our Search Clinical Trials page.

To stay informed about clinical trials, visit our Resources page.

Volunteer opportunities with CISCRP, visit our Volunteer page.

 

Put Your Customers in Focus With Patient Experience Mapping

Public health emergencies, staffing shortages, and disruptions to the global supply chain are just a few of the barriers the healthcare industry has encountered over the past several years. This environment has proven to be a challenge when delivering the high level of services that patients and customers have come to expect.

So what can healthcare organizations do to maintain resilience while ensuring their products make it to those who need them most? They must focus on their customer — the patient — and dedicate themselves to a patient-centric model. Experience mapping (sometimes referred to as journey mapping) allows organizations to build a competitive advantage by tapping into and thoroughly understanding their customers’ needs.

The techniques used in patient journey mapping can help companies identify opportunities to build trust and improve customer support while also enabling them to adapt to changing social, competitive, and geopolitical conditions. As the healthcare industry continues to evolve, it’s critical that organizations recognize patient experience mapping as more than just a tool to drive meaningful change — but a continuous practice required to remain competitive.

What is Patient Experience Mapping & Why Is It Important?

Research found that between 2010 and 2019, an average of 38 new drugs were approved each year — a 60 percent increase compared to the previous decade. With that number continuing to rise amidst increasingly volatile market conditions, organizations must understand where they fit into a patient’s journey if they want to improve productivity without sacrificing the value offered to patients. When deployed correctly, a patient journey map can organize and communicate information about how the company’s actions and customer interactions contribute to the success (or failure) of a patient’s treatment plan.     

What Patient Experience Mapping Does

Experience mapping explores what a person is thinking, feeling, and questioning during a defined period of time (for example, during a course of treatment). The results found during experience mapping make it easier to define a customer’s pain points, uncover growth opportunities, and re-align processes with desired business outcomes to benefit both the company and the patient.

Patient experience maps analyze the different stages of care and sort patient events into distinct categories. Below are a few examples of these categories:

  • Emotional — A patient who experiences needle anxiety may fail to adhere to the treatment schedule.
  • Medical — A patient’s pre-existing condition interacts with the treatment unexpectedly.
  • Practical — A patient who has difficulty getting to and from treatment centers due to a lack of transportation may opt to forgo treatment.

A clear picture of the patient’s experience makes it easier to design support services and resolve problems before they become significant issues or impact adherence. Furthermore, we can optimize patient programs more effectively by considering the patient’s well-being, loved ones, and journey during treatment. Patient experience mapping adds much-needed empathy to process optimization and can reaffirm a company as a leader in the mode of treatment and the service it offers.

Why Patient Experience Mapping Matters

Patient experience mapping is a crucial, proactive measure that can reveal ways to address process gaps or opportunities before beginning a new project or program. Whether the product is a surgical device that’s long been on the market or a prescription drug in its trial stage, patient support systems and change initiatives will benefit from a better understanding of the end-to-end patient experience.

Customer Service with Heightened EQ

Organizations looking to strengthen their patient-centric focus will explore implementing new care delivery models but may not recognize one of the most vital factors in customer care: emotional intelligence (EQ). Improving organizational EQ can help bridge the gap between distressed customers and a customer service team — and patient experience mapping can fast-track the emotional understanding teams need to de-escalate tensions with compassion.

Imagine a pharma company is rolling out a new drug and is preparing its customer service team to provide support for the product. By mapping out a patient experience prior to launch, a company can prepare its team to manage rightfully concerned customers with the sensitivity the situation necessitates.

Maintaining Adherence and Improving Outcomes

In the healthcare industry, ensuring patients can maintain their quality of life should be the first priority.

By concentrating on improving adherence rates and treatment outcomes, not only do patients benefit, but companies do as well. Patients following through with prescribed treatments drive refill rates and improved clinical outcomes, leading to stronger revenue and overall improvement in patient health. A patient experience map can serve as a great first step in identifying any barriers to adherence.

Patient journey maps may even help a company identify ways to support patients post-treatment, leading to product and service innovations that can bolster testimonials and garner trust from patients who may be considering other treatment methods.

To read the full article and learn more about SEI, click here.

Written by Kellie Duci and Alex VanderEls

Learn more about CISCRP’s Research Services here.

To search for medical conditions in a specific location, visit our Search Clinical Trials page.

To stay informed about clinical trials, visit our Resources page.

Volunteer opportunities with CISCRP, visit our Volunteer page.

 

 

Patient Data Collection 101: Curebase FLASH Webinar Overview

There are a variety of ways in which patient data can be collected in clinical research. As such, it’s critical to keep patients informed on these methods as they progress through trials. In Episode One of Voices from Within: Humanizing Clinical Research Data, Curebase experts share a comprehensive overview of how patient data is collected and the safeguards in place. This 15-minute Flash Webinar was led by Vice President of Clinical Trial Innovation, Jane Myles, and Director of Data Management, Kim Andreasen.

 

“There are many existing myths and stories regarding data collection in clinical trials,” Jane notes. On a foundational level, there are two types of clinical trials: brick-and-mortar and decentralized clinical trials (DCTs). The traditional brick-and-mortar trial refers to in-person visits that take place in centralized hospitals and doctors’ offices with care teams. With technological advances, DCTs have become available to patients, making healthcare more accessible to a wider more diverse population. This format allows participants to participate in clinical trials from remote settings through technology-enabled services including telehealth appointments, at-home testing, mobile phlebotomists, and more. Some DCTs even utilize patients’ own local doctors to perform wellness checkups, biopsies, and other care procedures that require an in-person aspect. 

 

“Ultimately, the purpose of clinical trials continues to be the collection of clinical data to make decisions about the safety and efficacy of new treatments,” Jane explains. For research teams, data collection is the primary deliverable of clinical trials. A recent study by Tufts University concluded that the amount of data collected each year in clinical trials is increasing exponentially, likely caused by new technology, new research fields, and other variables.

Understanding the importance of data collection in clinical trials is critical. Understanding as a patient how your data is being collected, used, and protected is even more important. Kim, an expert in data management, breaks down the process of data collection. To begin, participants share information with their clinical trial care team or provide this data themselves through survey responses about their experiences, symptoms, and medical history. Further data is collected through medical testing, dependent on the type of treatment the participant is in a trial for.


Once this data is collected, it’s then digitized. Clinical data management systems assign numbers to patients, controlling who can see their personal information. “This process is called deidentification, where the actual data sent to government entities for drug approval cannot be linked back to individuals,” Kim explains. “This is set by global and national regulations in each country.” It’s important to note that although patient data collected cannot be traced back to individual people, physicians and study staff still have access in the case of medical intervention should a patient have a health risk or concern. This adds an additional layer of safety for patients.

As a participant, do I have the right to review my own data?

“As a patient in any medical situation we have the right to see our information. As a clinical trial participant, not all information will be available immediately unless there is an emergency regarding the health of the patient,” Kim notes. There are circumstances in clinical trials where studies require blinded data to ensure accurate results. If this is the case, that information will not be available to participants immediately. For example, if you were testing a diabetes drug and a lab value could give away which treatment group you were in, you would likely not be able to view that data until your participation had concluded.


“Clinical trials are all about collecting data in a rigorous way,” Jane summarizes. “That data is managed in a way that protects privacy and allows physicians appropriate medical oversight of the patient. Ultimately, the data is used to make decisions on the safety and effectiveness of new treatment options – we take immense care of the data to ensure its complete and accurate!”

 

Learn more about patient data collection by accessing the webinar recording here. View CISCRP’s library of webinars and podcasts here.

To search for medical conditions in a specific location, visit our Search Clinical Trials page.

To stay informed about clinical trials, visit our Resources page.

Volunteer opportunities with CISCRP, visit our Volunteer page.

Broadening the Lens of Diversity for More Inclusion in Clinical Research

Although there is still a “guinea pig” stigma associated with clinical research participation, for many, clinical trials offer free or low-cost access to testing, care, and cutting-edge treatments that are simply not accessible or available. Years ago, my own mother’s participation in an Alzheimer’s Disease study uncovered a life-threatening condition that she wouldn’t have known about, had she not been a participant. Thankfully, after a required surgery, she is still alive and well. Many other friends, family, and colleagues have shared stories with me about their chronically and terminally ill loved ones who extended their lives and improved their quality of life thanks to clinical trial participation. However inspiring, the commonality across these success stories is that the patients belong to an essentially homogenous population of white, insured patients living in or near urban areas.

As I have been attending industry events and watching the topic of diversity trend in our sector of the world, I see the emerging initiatives to impact racial and ethnic diversity in clinical research and ask myself whether the pharmaceutical and biotechnology sector can and should do more to leapfrog historic approaches to diversity. That is, instead of simply forcing statistical study populations to reflect traditional demographic categories, can we make trials truly inclusive and inviting to all people so that the resulting participant population is reflective of all facets of culture? If we do this one group at a time – race, ethnicity, religion, biological sex, socio-economic class, etc. – we risk leaving people without access to a valuable health care resource and our industry without access to important information.

Beyond the Binary

An important group for our industry to consider are those who identify as being part of the LGBTQ+ community. How one identifies is an integral part of traditional inclusion/exclusion from clinical research trials and limits access for people who do not self-identify in traditional categories.

A recent survey conducted on Ipsos’ Global Advisor online platform among more than 19,000 individuals aged 16 (or 18, depending on the country), illustrated that on average, 80% of people identify as heterosexual, 3% as gay, lesbian or homosexual, 4% as bisexual, 1% as pansexual or omnisexual, 1% as asexual, 1% as “other,” and 11% don’t know or won’t say. On average, 1% of adults identify as transgender, nonbinary/nonconforming/gender in another way – rather than as male or female.

As the population of earth approaches 8 billion people, we must consider how to engage this important community in healthcare generally and clinical research specifically. Diversity is inherent, inclusion is a choice. This data underscores the need to put aside binary categories and move to criteria that include all eligible patients regardless of how they identify against the traditional paradigm of gender and sexuality.

Recently, our team partnered with the non-profit organization CISCRP to convene a group of patients who identified as being part of the LGBTQ+ community and explore their experience with the healthcare system generally and clinical research specifically. I had the privilege of participating in the conversation and was stunned by the feedback from the group.

Key Takeaways

Over the course of two, two-hour virtual sessions, there was a lot of really interesting discussion. For me, some of the key takeaways were:

  • The LGBTQ+ community is a broad category of communities so there is no one-size-fits-all approach
  • Trust is a key barrier to care for the LGBTQ+ community
  • Patients actively seek LGBTQ+ providers and those trained on LGBTQ+ issues
  • Representing the LGBTQ+ community in research as a driver for participation but diversity quotas are not enough to drive engagement

There are also considerations of what inclusivity of the full range of LGBTQ+ identities in all aspects of care mean, including:

  • Removing unnecessarily gendered language, imagery, and décor from forms, patient materials, and clinical areas
  • Creating inclusive options on multiple-choice forms to account for all LGBTQ+ identities
  • Refining approaches to clinical lines of questioning to ensure sensitivity to LGBTQ+ identities and focus on questions required for care and research
  • Including trusted LGBTQ+ advocacy organizations and local, community centers in health and research initiatives

Diversity is Inherent, Inclusion is a Choice

Including the LGBTQ+ community in diversity, equity, and inclusion initiatives is not only good for patients, but also valuable, important, and essential for the pharmaceutical and biotechnology industry. When discussing the value of clinical trial participation to the industry, the ratio we all talk about is 1 in 200 – meaning that one in 200 people, regardless of health status, need to participate in clinical research to enroll all the studies in clinical trials.gov at any given time. Allowing barriers to access for any population is not just unethical and bad for science, it’s also bad for business. Ensuring diversity, equity and inclusion means more study participants, thorough science, and predictable outcomes for all potential patients.

The path to inclusivity for the LGBTQ+ community is no different from those proposed for the inclusion of other populations underrepresented in clinical research. As Van Johnson suggested in a recent episode of the Totally Clinical podcast and echoed by our LGBTQ+ patient panel, the key to diversity, equity and inclusion is a holistic approach. The way to create a clinical trial environment that is inclusive is to ensure that community members have a seat at the table – LGBTQ+ patients, physicians, advocates, and others. In addition to promoting the diversity in today’s research community, this work will likely involve an expansion to include new investigators, sites and site networks that serve the LGBTQ+ community and enablement of those sites with tools, training, and technologies that can bring them onboard quickly and guide them with consistent, responsive and proactive content and communication.

As the global head of strategy at Teckro and daughter of a clinical trial participant, it is my intention to play an active role in supporting diversity, equity, and inclusion efforts so that clinical research is a care option available to all patients. If you are a sponsor, investigator, patient, or other stakeholder in clinical research and are advancing a DEI or CRAACO initiative, I invite you to join the conversation on our Totally Clinical industry podcast.

Written by Malia Lewin, Global Head of Strategy at Teckro | www.teckro.com

To read the original article and learn more, visit Teckro’s website here: https://teckro.com/resources/blog/lgbtq-inclusion-clinical-trials  

To search for medical conditions in a specific location, visit our Search Clinical Trials page.

To stay informed about clinical trials, visit our Resources page.

Volunteer opportunities with CISCRP, visit our Volunteer page.

New Data Reveals Decentralized Clinical Trials Yield Better Clinical Trial ROI

In a recent article published by Applied Clinical Trials, CISCRP Founder and Board Chair, Ken Getz, discusses decentralized clinical trials (DCTs) and how their value can be measured. During the pandemic, there became a need for DCTs, and a rapid adoption took place by many CROs. 

“DCT adoption has occurred without the normal phased adoption process that has time to unfold. Because it’s been so rapid, the industry has a lot of questions on how to manage the best DCT moving forward, how to allocate resources, and where to invest,” Ken shares. 

At the recent DIA Annual Meeting in June, Ken presented alongside Pam Tenaerts, MD, Chief Scientific Officer at Medable, providing an overview of their recent work aiming to understand whether DCTs live up to the expectations of better research. Tuft’s CSDD study with Medable on DCTs is the first study quantifying the return on investment of DCTs, an important metric to measure as it can inform decision-making on future projects. 

For this study, Tufts used data from a mixed sample of trials; 150 that used traditional in-person clinical trial methods, and 33 using DCT methodology. This model developed by Tufts and Medable focuses on the value drivers of clinical trials, calculating the overall ROI of a decentralized clinical trial based on value drivers such as cost, trial duration, and execution efficiency. 

The study shows evidence that DCT’s drive speed and efficiency in clinical studies as well as patient recruitment and retention. “Dropout rates appear to be lower in our comparative assessment,” Ken notes. “Second, the screen failure rates improved, and that may be because there is greater decentralized access to a trial. More people who may be eligible are willing to inquire about participating in a study, essentially self-selecting because it appears to be more accessible to join, either because it’s conducted locally or there are more opportunities to participate from home.” 

To read the full article visit Applied Clinical Trials website here: https://www.appliedclinicaltrialsonline.com/view/new-data-reveals-dcts-yield-better-clinical-trial-roi  

To search for medical conditions in a specific location, visit our Search Clinical Trials page.

To stay informed about clinical trials, visit our Resources page.

Medical Hero Spotlight: Marc Yale, Mucous Membrane Pemphigoid Advocate

marc yale
Pemphigoid Diagnosis

In 2007, Marc Yale visited his optometrist for a case of what he thought was conjunctivitis (pink eye). After running some tests, his doctor could not determine the cause of his symptoms. Within days, Marc broke out in blisters across his skin, mouth, nasal cavity, and throat. The blisters, especially those in his mouth and throat began causing other problems, including jaw clenching and difficulty swallowing. “In the beginning, I didn’t realize my eye symptoms and the blisters had any relation,” Marc recalls. “I visited the dentist who thought the jaw clenching was from impacted wisdom teeth. I went ahead and had those teeth removed, but then the hole wouldn’t heal and began to blister.”

After several months of pain and discomfort and multiple visits with specialists, Marc saw his General Physician, desperate for answers. “At this point, the blisters were so painful I couldn’t shower, I had lost 40 pounds from struggling to eat, and was losing vision in one of my eyes as it began to swell and close,” Marc shares.

Marc’s doctor referred him to a dermatologist who referenced a medical textbook, believing Marc may have an autoimmune condition he had never seen in real life. One biopsy later, the dermatologist’s suspicion was confirmed, and Marc was finally diagnosed with a chronic condition, Mucous Membrane Pemphigoid.

“Finally receiving a diagnosis was such a relief,” Marc remembers. “I’ve learned since then, that this process of delayed diagnosis is common with rare diseases. Most individuals with Pemphigoid see 5-10 doctors before learning what condition they have and their treatment options.”

Treatment for Pemphigoid: Pandora’s Box

Although Marc was excited to finally have answers for his painful symptoms, reviewing treatment options for this condition opened a “Pandora’s Box” of new challenges. The mainstay therapy for Pemphigoid is corticosteroids given in very high dosages, which can cause many side effects. Other popular treatments include immunosuppressant medications, which can help suppress the autoimmune condition, but come at the risk of making patients vulnerable to secondary infections. Marc’s doctors recommended he begin treatment using a “stairstep approach”; trying the drugs that work the fastest in hopes that they would be effective. In Marc’s case this meant beginning a combination of corticosteroids combined with the immunosuppressant medication.

Although these treatment options may be the fastest, they still take 6-8 weeks to work. “While I waited to see if this treatment plan would be effective, my condition began to progress,” Marc notes. “My blisters caused constant bleeding, making tasks like sleeping and getting dressed challenging. The blisters in my mouth and throat felt like I was swallowing razor blades all day long. Eventually, my drooping eye fused close and I lost my vision permanently. I couldn’t see, so I couldn’t work or drive.”

Finding a Clinical Trial

During this time, Marc began to research if there was anything new available for patients beyond his current treatment plan. While there were very few clinical trials being held for Pemphigoid 15 years ago, there was one drug trial Marc found in France. “I knew getting into a trial was my best chance of remission and figured I would be a great candidate. My wife and I were ready to move to France for this opportunity,” Marc shares.

Unfortunately, Marc was not eligible for the trial and had to continue with standard care until another option was found. Eventually, when his doctors had exhausted their resources, Marc was sent to see eye and dermatologist specialists in Boston, who suggested he go on therapy for a trial happening for an off-label drug, not yet approved by the FDA. Marc was able to find a doctor who would prescribe this drug to him at home and began the new therapy. In the meantime, he continued his research online to find a community of other people experiencing this disease.

Barriers to Accessing Clinical Trials

In Marc’s case, as with many other patients, one major barrier for treatment and clinical trial access is a delay in diagnosis. “Our healthcare system is set up in a way that makes it difficult for patients to access the specialists who can diagnosis them with these conditions. Additionally, this is not a common condition, so many doctors have never seen it and can’t readily diagnose it,” Marc notes.

Another barrier for the Pemphigus and Pemphigoid community is the lack of standardized guidelines regarding treatment for this disease in the US. Treatment is up to the individual doctor and can vary greatly. Marc advocates for consensus guidelines for all patients and doctors to follow. Patients also must consider the financial burden of treatment, as the price for these medications is astronomically high.

“Anyone with a rare or debilitating disease will feel a loss of control in their life. Treatment should be made simpler and more available for patients,” Marc explains.
Patient Advocacy with the International Pemphigus and Pemphigoid Foundation

After looking around online, Marc found the International Pemphigus and Pemphigoid Foundation (IPPF), a site dedicated to spreading awareness and sharing resources for patients. After reaching out, the organization asked Marc to join and offered volunteer and advocacy work. Marc took on an outreach project to find doctors who specialized in these conditions across the country, as the site currently only had 30 doctors listed. Marc also helped form a peer health coach program, where patients were available to help other patients with managing the disease. These peer health coaches could help navigate newly diagnosed individuals through challenges, such as finding the right doctors, choosing a treatment, possible symptoms, and how to get involved in clinical research.

“I was happy to volunteer at IPPF because I found it rewarding to help others so they wouldn’t have to go through the diagnosis and treatment process alone like I did. I found mentoring very cathartic and used it as a coping mechanism to manage my own disease. During this time, I became passionate about advocating for the Pemphigus and Pemphigoid community,” Marc shares.

Although Marc was working part time as a volunteer at IPPF to start, after two years his condition went into remission and he was able to dedicate his time fully as a coach, and later as the Executive Director of IPPF from 2016-2020. Marc spent his time as a director building educational resources for medical professionals, students, and policymakers in Washington, DC. After he experienced a flare up, Marc made the decision to step down from his role and work on a volunteer-basis again, this time focusing on advocacy for the foundation.

Marc remains a coach in the peer health coach program today, staying in contact with others he has coached or met through his advocacy work. “It’s the best and worst part of my job. I love having the opportunity to build those relationships and help others, but it’s hard because I know what these people are going through. This is a truly devastating disease,” Marc reflects.

 

Marc’s advocacy has not only impacted the lives of others in his community but also his own. “Even with a support system, only someone who has your disease really knows what you’re going through which is why patient networks are so important.”

“I’m a serial advocate,” Marc jokes, “I can’t stop advocating because it’s part of who I am; it’s what I’m passionate about. The more people know about this disease, the more resources will become available.”

Today, with the help of Marc and many other volunteers, IPPF has increased their list of specialty doctors from 30 to 400, opened sister organizations internationally, and increased awareness and funding for the disease. Currently, there are 10 Pemphigus clinical trials running and 4 for Pemphigoid, a major jump from the single trial Marc found available decades ago.

Marc’s advice to patient advocates just starting out is to “Never take no for an answer. Be committed, persistent, and keep trying. Whether you’re a small organization, a newly diagnosed patient, or an advocate, you’re never alone. There are so many others out there wanting to make a change or difference just like you.”

To search for medical conditions in a specific location, visit our Search Clinical Trials page.

To stay informed about clinical trials, visit our Resources page.

Sources: https://www.pemphigus.org/

Written by Lindsey Elliott, Marketing & Communications Manager, CISCRP | lelliott@ciscrp.org

Voices From Within: Humanizing Clinical Research Data: Episode 1 – Patient Data Collection 101 Flash Webinar

3 Part Flash Webinar Series

There are a variety of ways in which patient data can be collected in clinical research. As such, it’s critical to keep patients informed on these methods as they progress through trials. Jane Myles, Curebase’s VP of Clinical Trial Innovation and Director of Data Management, Kim Andreasen, discuss how patient data is collected in clinical trials.

View the webinar below. View article brief here.

Watch Webinar Episodes 2 & 3

Voices from Within: Humanizing Clinical Research Data:
Episode 2 – Conversations on DCTs: Data Privacy
Watch Here

Voices from Within: Humanizing Clinical Research Data:
Episode 3 – Conversations on Clinical Trials
Watch Here

Panelists:

Jane Myles

VP, Clinical Trial Innovation at Curebase

Kim Andreasen

Director, Data Management at Curebase

Clinical Trial Care and Compensation

From "The Gift of Participation" by Ken Getz, Founder & Board Chair, CISCRP

Payment for participation is considered compensation for your time and commitment to comply with the protocol. Healthy volunteers in phase I studies of a new treatment or device are usually paid for their participation. Study volunteers in phase IV studies of drugs already on the market often receive compensation. And payments in clinical trials are often given to study volunteers when the health benefits of an experimental treatment or new device are not known or are remote.

The compensation amount varies widely and depends on many factors including the length of the clinical trial, the number of visits that you’ll need to make during the study and the number and types of procedures that will be performed. Compensation can range from a hundred dollars to several thousand dollars. Partial payments are made over the course of participation. The amount and schedule of payments is proposed by the sponsor of the clinical trial to the IRB overseeing the study. The IRB will review, and in some cases revise, the proposal to ensure that it does not coerce or influence someone to agree to participate. Patient recruitment advertisements usually list compensation amounts. The informed consent document lists compensation amounts and payment schedules. You can also ask whether a trial is offering compensation and the amount when calling a research center to inquire about participation.

Once participation begins, the research center typically writes each volunteer a check as the study progresses—usually on a per-visit basis. A small bonus may also be paid to volunteers who complete the entire study. In some cases, study doctors may dispense approved medication samples and provide additional care free of charge after the trial to show their appreciation to study volunteers.
Any financial compensation paid to study participants is considered taxable income by the Internal Revenue Service (IRS). However, research centers are obliged to report to the IRS only payments to individuals that total $600 or more for the year. These Form 1099s for “Miscellaneous Income” are generally sent out to participants in January, the same month employers are shipping out W-2 forms to their employees.

If a volunteer decides to withdraw from the study before completing the trial, the research center will usually provide partial compensation.

For more information on clinical trials and making informed decisions about volunteering for clinical research, read “The Gift of Participation” by Ken Getz, Founder and Board Chair, CISCRP.

You can find the book here.

To search for medical conditions in a specific location, visit our Search Clinical Trials page.

To stay informed about clinical trials, visit our Resources page.