From the Editor

Written by Brandis Pickard 

Dear Readers, 

We’re pleased to share with you our summer (yes, summer!) edition of the CISCRP newsletter. It’s hard to believe that just a few months ago, most of us were living in some form of quarantine, and COVID-19 vaccinations had just become available for groups deemed most at risk. As CISCRP brings you our second newsletter of 2021, there’s anticipation in the air that as more of us become fully vaccinated, we can celebrate a “normal” summer. While we embrace the chance to resume the activities we love, we know the pandemic will leave a lasting impact and that we have an opportunity to inform our approach to clinical research based on what we have learned over the past months. 

One of the things we have come to appreciate most is the importance of human connection. Whether it’s the sting of not visiting our loved ones or the challenge to have our voices heard when we aren’t in the same room as our colleagueswe have all encountered and conquered new obstacles over the past year. This has been especially true when it comes to healthcare. For those with limited access to technology or information, the burden has been particularly heavy. As we noted in our winter newsletter, and what we all need to remember as we move forward: the pandemic has underscored existing racial and economic disparities that we must acknowledge to remedy.  

In this issue, we highlight how two supporters of our Patient Diversity Campaign plan to identify and address diversity challenges in clinical trial participation. Not surprisingly, communication is a key factor in their approaches. Honest communication—making that human connection—is critical to improving health literacy and education. It’s something that Melvin Mann, this issue’s Medical Hero, touches on when reflecting about clinical trial participationPlease follow the link to read Melvin’s inspiring story about fighting chronic myelogenous leukemia. 

When thinking about transparency in health communication, a good place to start is with the development of the COVID-19 vaccines. In this newsletter, you’ll find an article that highlights how CISCRP is answering important questions about the COVID-19 vaccines—not only how they were created, but which populations were included in the clinical trials and what is being done to monitor safety. 

We’ve also included some thoughtful insights from patients about the difficulties of clinical trial participation during the pandemic, and the solutions identified—some of which will likely change the way future trials are conducted.  

Finally, were happy to share our own successes in maintaining our human connections and engaging the community in important conversations about clinical research. Read on to learn about our first regional AWARE for All  webinar, our Medical Heroes  Appreci-a-thon, and our Third Annual Plain Language Summary of Trial Results User Group Meeting. 

As always, thank you for your ongoing support in initiatives like these, and in all that we do. We wish you a happy and healthy summer. 


Brandis Pickard 
Senior Manager, Editorial 


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Medical Hero Spotlight: Melvin Mann & Chronic Myelogenous Leukemia (CML)

Melvin Mann with his wife, Cecelia, and their daughter, Dr. Patrice Mann

Written by Melissa Daley

“CML (chronic myelogenous leukemia) is supposed to be a disease that strikes people in their sixties, and I was in my thirties,” recalls Melvin Mann. A family man and Army major, Melvin was stunned to learn he had CML at the age of 37.

His symptoms had started out as back pain and fatigue, which he had been treating with medication and physical therapy, to no avail. In a visit with his physician at a local military clinic, an MRI was ordered requiring Melvin to drive several hours to another military base that had the MRI equipment. It would be a month before Melvin learned the results of the full-body scan.

It was January of 1995. Melvin received the diagnosis of CML, which was confirmed by a second opinion he sought. Melvin was advised by his doctor that without a successful bone marrow transplant, his life expectancy was about three years. The best bone marrow matches are with a patient’s relatives, but if they are not a match, a donor must be of the same ethnicity. No relatives matched, nor did any registered donors. At that time, there were a limited number of African Americans on the bone marrow donor registry. Melvin began the treatment prescribed by his physician, which were daily injections of interferon.

Melvin thought about his wife, Cecelia, and his daughter, Patrice, who was just five years old and decided to take action in the search for a donor. Working with marrow donor organizations, and the Department of Defense (DOD) Marrow Foundation, marrow drives were launched within the military. Melvin participated in these outreach efforts, which scaled to include college campuses, malls and churches, radio and television interviews, as well as military bases. His experience as an Army recruiter and public relations officer and degree in public relations propelled him to forge ahead, even when he didn’t find a match. Melvin medically retired from the Army in 1995 and continued his outreach efforts with bone marrow drives, as his health would allow.

At a marrow drive organized by his aunt in April of 1996, Melvin had a life-changing meeting with a local businessman who had seen Melvin’s TV promotions for the event. This individual had been gravely ill with hairy cell leukemia and had been treated at MD Anderson Cancer Center in Houston, Texas, with excellent results. He urged Melvin to contact them.

Thus began Melvin’s experience with clinical trial participation. It had been 16 months since his diagnosis of CML, and none of the medical professionals involved in his care had broached the topic of clinical trials. The bone marrow drives he was involved with were finding donors for many patients, but not for him. Melvin decided that participating in a clinical trial was his next step towards fighting the illness.

Over the next two years, Melvin traveled between his home in Atlanta and Houston, trying different combinations of vetted and clinical trial medications through MD Anderson. At the outset of the Imatinib clinical trial, he had to stay in Houston for three months. Over time, the interferon and other clinical trial medications stopped working. A lifelong competitive runner, his body weakened and he suffered intense fatigue. He was, however, eight months past his original prognosis of surviving three years, when he had the opportunity to participate in an Imatinib clinical trial. The Phase I trial tested for the drug’s safety in humans, dosage level and evidence of efficacy.

The Imatinib clinical trial had three locations: MD Anderson, Oregon Healthy & Science University in Portland and UCLA Medical Center in California. Melvin’s medical care continued to be seated in Houston.

“It was for quality of life – not a cure. I was hoping for a better outcome,” Melvin explained. He also thought about how his participation would help other cancer patients.

The process was rigorous. In the first week, Melvin had blood drawn up to 10 times per day. He was required to keep a detailed record of side effects, the time he took the medication, his energy level, diet and other daily details. He experienced severe nausea and was prescribed medication to alleviate it. Melvin’s effort, perseverance and grit paid off. The drug was a game-changer for him. In June of 1999, nine months after starting the clinical trial, Melvin participated in fundraising events for the Leukemia & Lymphoma Society by running a marathon in Alaska and a few months after that, cycling 111 miles in Tucson, Arizona.

Melvin has been taking Imatinib ever since. The medication was approved for use in CML in May 2001 by the United States FDA (Food and Drug Administration). Melvin participated in another clinical trial to see if he could come off the medication, but he could not. Over the past 26 years, Melvin has participated in three clinical trials for different combinations of medications.

“Trials have changed over the years,” said Melvin. “The last (Imatinib) trial I was in was in 2017. I had to travel every three months to the trial site, although some testing was done at home. The COVID-19 pandemic has increased that whatever you can do at home or with a local doctor, in terms of aspirations and blood draws.”

For some patients, particularly members of the Black and African American communities, the specter of the unethical Tuskegee Syphilis Study still influences opinions about the safety of clinical research, despite vast advances in oversight and regulation made in subsequent years by the United States government to ensure the safe and ethical treatment of all patients. It is important that patients are asked if they would like to participate in a clinical trial.

Melvin advises patients and the public that “It’s vital to know that clinical trials are an option. There can be benefits from a clinical trial. You are getting more attention because the studies often require you to be watched more and seen by staff more frequently. In oncology clinical trials, you’re not getting a placebo, you’re at least getting the standard of care treatment. It’s important to weigh your options. Can you get the support you need from family or a caregiver? Ask questions of the study staff. There are risks involved, so ask about them. You have the choice to stop being in a clinical trial, whenever you decide.”

Melvin is now the world’s longest living Imatinib and tyrosine kinase inhibitor CML survivor. Melvin had a MBA, but in 2000 he decided to change his career focus. He returned to higher education and earned an BA in English Literature, M. Ed. In Secondary English and a teaching license, all within the span of three and a half years. He and Cecelia continue to volunteer for various cancer and bone marrow donation organizations. Melvin continues to participate in marathon and half-marathon events, and sometimes 10Ks with his wife and daughter, Dr. Patrice Mann, a psychiatry specialist, graduate of Harvard College and Emory Medical School.

“I recommend clinical trials, at least to ask about them. It’s also important for doctors to ask patients if they want to participate in clinical research,” said Melvin.

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.

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The Role of Clinical Trials in COVID-19 Vaccine Development

Written by Behtash Bahador, MS 

As COVID-19 vaccinations are rolled out, some people still have questions and concerns about the safety of the vaccines. How were they made so fast? How do we know they work and are safe? Were they studied in a diverse group of people? 

To help address these questions, CISCRP developed an infographic: “The Facts About COVID-19 Vaccine Clinical Trials.” The overall goal of this piece is to provide engaging educational content to people who may still be deciding if they or their family will get vaccinated.  

To complete the project, we brought together a team with years of experience sharing clear, unbiased, nonpromotional messaging about clinical trials. To create the infographic, we reviewed news and information from trustworthy sources.  These included national and global health organizations, universities, and peer-reviewed publications. This helped us learn what people still want to understand about the COVID-19 vaccine trials, and what else they may need to know.  

Then, the hard work began: we had to decide which topics and messages would be covered in the limited space of an infographic, and how. In the end, the main take-aways we aimed to provide are:  

  1. Teamwork and years of knowledge and experience allowed the vaccines to be made quickly. 
  2. Trials have shown the available vaccines are safe and effective. 
  3. The vaccines will continue to be studied and monitored for safety.  
  4. The COVID-19 vaccine trials included more diverse participants than many other trials. 
  5. There was diversity among the many professionals involved in vaccine development.  

As with all of our health communications, we received feedback from an editorial panel of patients, advocates, health professionals and members of the public. This was an essential step to make sure the infographic is clear, is not missing important information, and is not misleading in any way. We hope that the end result is an informative, easy-to-understand snapshot of some key elements of the vaccine development and rollout. 

The full infographic can be viewed on this page in CISCRP’s Education Center. The page also includes the sources used to create the infographic and additional links to useful educational content.  

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AWARE for All Northeast

Written by Hope Ventricelli | Manager of Events and Community Engagement

For the first time, CISCRP brought its AWARE for All program to regional areas across the United States while remaining virtual. The AWARE for All program was created to raise awareness about the clinical research process and to provide education among diverse communities. The webinar for the first edition of this series, AWARE for All — Northeast, went live through the virtual platform ON24 on April 15th. For those who wish to watch on-demand or continue their learning, a recording of this webinar is available through the Informational Exhibit Center (IEC) found on the CISCRP website. The IEC features educational content from organizations across the Northeast, spanning multiple states and therapeutic areas. The IEC is designed to be easily accessible and to address the lack of knowledge about the clinical research and health resources in the audience’s “own backyard.”  

The CISCRP Events Team brought in more than 40 exhibiting organizations for the series’ opening event, from clinical research sites to community clinics and local health centers. Each shared free educational resources with the audience in the IEC. While several groups offer information about the trials they offer, most exhibitors simply aim to provide general education or medical information about specific health conditions. This helps to include those not as familiar with research and to make them feel comfortable learning more. Attendees cited their desire to learn more about research as their main reason for registering. Many also shared that they have a friend or loved one with a health problem.  

The IEC had an impressive number of viewers. More than 1,800 new and returning community members visited the virtual educational booths and the new Health and Wellness Pavilion, which features health tips and exercises.  

Through post-event surveys, audience members shared that their biggest takeaway was that they better understood the clinical research process and were grateful to have their questions answered in real time. As to their favorite part of the program, most attendees referenced the panel discussion. 

Through the panel discussion, AWARE for All — Northeast focused on key health issues such as oncology, Parkinson’s Disease, asthma, and the importance of diversity among trial participants. Outreach to minority health groups helped to bring a diverse audience from the local population to hear more from the speakers themselves. The lively discussion, which was moderated by CISCRP’s own Behtash Bahador, included several study participants as well as local researchers and industry stakeholders. These experts shared their individual experiences and answered questions the audience most wanted to know. 

Each virtual AWARE for All program aims to bring the research community, patients, and the public together to support a discussion in understanding clinical research and, most importantly, the role of study participants. 

Including the Northeast edition, CISCRP’s AWARE for All program will virtually host in 5 different regions through 2021. Future programs include Northwest on May 20th, Midwest on July 22nd, Southwest on October 21st, and Southeast on November 18th.  

To learn more about exhibiting at AWARE for All, contact 

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Supporter Spotlight: Patient Diversity Initiatives

CISCRP is developing a series of articles about initiatives from pharmaceutical companies to address racial inequities and health care disparities with a focus on clinical trial diversity.   

For our first Supporter Spotlight piece of the series, we feature two companies—Merck and Pfizer—our 2021 “Patient Diversity Campaign” editorial content providers.  

The COVID-19 pandemic has heightened awareness about the importance of clinical research. The pandemic has also placed a spotlight on racial inequalities within our U.S. health care system. Over this past year, we’ve seen many companies increase transparency by publishing clinical trial results summaries, hosting advisory boards, supporting mass media awareness-building campaigns, and collaborating with local communities.  

We met with colleagues from Merck and Pfizer to learn how they’re understanding critical barriers to participation and increasing health literacy among patients and the public.  

Here are three key insights from these two industry leaders that showcase their commitment to improving diversity and inclusion: 

Develop solutions that resonate among different stakeholders.  

“There are multiple barriers to diversity in clinical trials and multiple stakeholders who have the responsibility to address them,” shared Luther Clark, Deputy Chief Patient Officer at Merck. “We are strongly committed to conducting research that is safe and effective in all patients.” To demonstrate this commitment, Merck executes their clinical trials with a focus on meaningful patient and community engagement, addressing the social determinants of health, logistical and financial barriers, and minority investigator shortages.

One way Merck works to remove barriers and ensure equitable access to clinical trials is through heat map technology. This allows them to identify patients with the greatest disease disparity and need for medication. Adrelia Allen, Director of Clinical Trial Patient Diversity at Merck, shared the importance of this technology and of working closely with sites and community leaders. “[Prioritizing diversity and inclusion] is a part of the fabric of our corporate culture. It’s embedded into our clinical trial operations,” said Allen. 

At Pfizer, effective communication with community members is a priority. “Clinical trial accessibility starts with clinical trial awareness,” shared David Leventhal, Senior Director of Clinical Trial Experience at Pfizer. “There’s a difference between reading about clinical trials on the internet and really understanding a clinical trial as a care option.”  

Both Pfizer and Merck support CISCRP’s Perceptions & Insights bi-annual study to understand public and patient perceptions around trial participation and barriers. Both companies are writing full-page editorials about their commitment to achieving health equity in CISCRP’s Patient Diversity 2021 campaign.  

Learn about what matters most to patients and their families.  

Pfizer incorporates patient insights into their protocol designs and engages with patients and local advocacy groups. “We’ve learned that being a part of an alumni network is important to our participants, so we’ve expanded that around providing individual results, data return, and an opportunity to share stories,” said Leventhal. They also partner with local communities and work with advisory boards to ensure clear, consistent messaging.  

At Merck, organizing advisory panels, partnering with advocacy groups, and hosting forums helps gather direct input from patients. In addition, Merck is committed to improving health literacy around the world to advance health equity, impact population health outcomes, and drive efficiencies in health care systems. 

To develop best practices to increase diversity, Merck and Pfizer also work with major consortia, such as CISCRP’s AWARE Industry Consortium, PhRMA, the Diversity & Inclusion in Clinical Trials (DICT) Collaborative, and the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard. 

Maintain relationships with local communities.  

“With educational awareness programs, we’re showing that we’re there to support communities,” said Allen. Merck has supported external grass-roots programs, such as CISCRP’s AWARE for All events and the Lazarex Cancer Center’s equitable access initiative. 

Clark added, “The first step is recognizing and overcoming mistrust, fear, and lack of comfort with the clinical trial process. Ultimately, it’s the patient who will make the decision about participation, but they’re influenced by people close to them—their families, friends, and the greater community.” 

Pfizer supports CISCRP’s AWARE for All programs and developed an FAQ on to increase transparency and address concerns among underserved communities. They develop their educational materials in partnership with academic centers and advocacy groups to build trust, cultivate strong collaborations, and ensure best practices in health literacy. Pfizer also partners with large health systems to avoid multiple data collection mechanisms and support interoperability.  

Taking the time to understand participation barriers and meet the needs of participants is an investment in the future. 

“It’s not a sprint; it’s a marathon,” said Allen. “We’re willing to put forth the effort and resources to improve patient outcomes and achieve health equity for all.” To learn more about Merck’s commitment to diversity in clinical trials, click here. 

Tune in to the next article of the series where we’ll be profiling other companies!  

Author: Ellyn Getz, MPH, Associate Director, Business Development 

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Endpoint Selection in Plain Language Summaries: Insights from CISCRP’s Third Annual User Group Meeting

Written by Kim Edwards

On February 19, 2021, CISCRP hosted our Third Annual Plain Language Summary of Trial Results Virtual User Group Meeting. This meeting provides an opportunity for sponsors to participate in facilitated discussions about evolving or challenging aspects of developing plain language trial results summaries (referred to here as “PLS”). This year, topics included adverse events/reactions reporting, translations, dissemination, posting deadlines, and endpoint selection.  

In particular, the discussion about endpoint selection was spirited.  The group addressed the ongoing debate about whether it is appropriate to include secondary endpoints in PLS, and how this decision should be guided and documented. The biggest challenge with including secondary endpoints is striking a balance between providing the reader with relevant results of interest while also avoiding “cherry-picking” that leads to perception of bias. To avoid this perception, some sponsors advocate for clear guidelines across all plain language summaries within their organization. For example, some companies have created a policy to include only the results of the primary endpoint, regardless of the nature of the trial. Other sponsors suggest that this is not necessarily a patient-focused approach, as there may be secondary endpoints that are of particular interest to the trial participants.  

To get a snapshot of the current practices among our User Group participants, CISCRP asked the following poll question: Does your organization have a documented endpoint selection process and/or policy for plain language summaries? Interestingly, the responses, presented in the graph below, were quite evenly distributed.  

These results highlight the lack of a standard approach to endpoint selection. Later this month, we expect the release of a paper from industry stakeholders that offers suggestions on endpoint selection. In the meantime, we offer these three considerations: 

  1. Audience – Do your trials include secondary endpoints that participant readers will care about and want to learn about? 
  2. Cherry-picking – Can your organization implement secondary endpoint selection criteria across all trials and/or require protocol authors to indicate participant-relevant secondary endpoints prior to data collection? 
  3. Feasibility – Will a standard approach be practical for those in your organization who must operationalize it?  

We are grateful to the participating sponsors for their insights, collaboration, and dedication to providing participants with meaningful plain language trial results.  

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CISCRP’s Third Annual Medical Heroes Appreci-a-thon

Written by Justine Holleran

Throughout the month of March, CISCRP hosted its 3rd annual Medical Heroes Appreci-a-thon to bring together a community of almost 350 “racers” to express their appreciation for all “Medical Heroes”—medical and healthcare professionals, researchers, and clinical trial participants. 

This month-long virtual fitness challenge encouraged racers to go the distance to recognize Medical Heroes by tracking any form of exercise—cycling, running, yoga, yard work, pet-walking, and more. Any physical activity was translated into “miles,” and racers and their teams could virtually track their progress through a trail of U.S. national parks. 

Racers were able to stay active, strike up friendly competitions, and participate in fun weekly challenges all while learning about clinical research and reading stories about the Medical Heroes that brought them all together for this event. 

Appreci-a-thon attracted 346 racers and 90 teams. Our athletes collectively covered 29,647 miles of the course. Racers participated from almost all 50 U.S. states, Russia, England, Japan, Belgium, Germany, and more! With the support of our sponsors and racers, we were able to exceed our fundraising goal for this program. All funds support important CISCRP initiatives such as our educational events, appreciation programs, and more.  

The Value of Patient Advisory Boards in Understanding Receptivity to New Technologies in Healthcare and Clinical Research

Written by Rebecca Nordland

The COVID-19 pandemic has forever changed nearly all aspects of the way we live and work. Healthcare, and by association, clinical research, has been among the sectors most affected by significant changes to their standard practices and procedures.  

Given the need for reduced in-person interaction between healthcare providers and patients and the resulting shift to virtual engagement, the use of patient technology and telemedicine has significantly increased during the pandemic.  

But how do patients feel about this change to a more remote healthcare model—particularly when it is part of a clinical trial? Is the added technology beneficial to patients, or is it creating more burdens for them? Are patients satisfied with the remote care they are receiving, and do they consider it to be “as good” as their previous in-person care? 

Patient Advisory Boards (PABs) provide the perfect opportunity to gain rich insights on these very topics. The valuable feedback from PABs can be used to inform protocol designs and patient engagement strategies, ultimately improving the overall experiences of trial participants.  

CISCRP has conducted several PABs over the past year. We have found that a number of common themes have arisen regarding perceptions of remote patient technology and telemedicine in clinical trials:  

  • Instructions and Training on Technology Use: Providing patients with clear instructions and training on the use of any technology or device is critical to ensuring a positive experience. Instructions should be provided in multiple formats (e.g., text instructions, video instructions) and be made readily available to patients (e.g., on a computer or mobile device, as a hard copy, etc.). People also prefer to have some indicator from the technology or device that they are using it correctly. This helps them feel confident that they are taking the appropriate steps in self-management of their care. 
  • Convenience and Quality: Many people appreciate the convenience of telemedicine and remote assessments that can be done from the comfort of their home.  However, many still prefer to have a choice between virtual or in-person appointments, as some perceive virtual appointments to be less thorough and not an accurate way to get a diagnosis. This is particularly true for conditions that present with more visual or tactile symptoms (e.g., dermatological conditions). 
  • Accessibility Factors: It is important to be aware that geographical and socioeconomic factors may affect ability to use telemedicine or patient technology. Many patient-facing technologies require a stable internet connection, creating access issues for those who live in rural locations or are unable to afford internet service. Shipping of devices could also be challenging for those living in rural areas. 
  • Privacy Concerns: When it comes to using technology as part of medical care, people have major concerns about data security and privacy. Additionally, some may not have a private location in their home for attending telemedicine appointments. It is important for researchers to be transparent and to clearly communicate the data protection measures that are in place. Patients should be aware of how and with whom their health information is being shared. 

Given the changes to the clinical trial landscape and the pace of technological advancements that we have seen over the past year, soliciting patient feedback has never been more important. Patient Advisory Boards offer a practical way for industry to keep a pulse on patient needs and preferences. 

Click here to learn how a CISCRP Patient Advisory Board can help your organization gather important patient insights.  

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