Pros & Cons of DCTs & Virtual Clinical Trials

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

They are known by different names: DCTs (decentralized clinical trials), remote, direct-to-patient, virtual, digital, site-less or simply patient centric clinical trials. All of these approaches share the common goal of making it easier to participate in research by reducing—or eliminating altogether—the number of study visits patients must make to conventional investigative sites or labs and allowing for more flexibility in carrying out study-related activities. Many of these approaches use smartphones, mobile devices, and wearable sensors to collect and evaluate patient data during the study.

Study volunteers often need to travel long distances to medical facilities, many need to stay overnight in a hotel, and take time off work to participate in a conventional clinical trial. Research from CISCRP shows that about one-fifth of study volunteers find clinical trial participation stressful and report the investigative site location and time-consuming study visits are among the least-liked aspects of the experience. Half of volunteers also feel that participation causes disruption to their daily routine. New, more convenient approaches are especially valuable for patients who may be too sick to travel or for those who rely on caregivers for support. Study volunteers who find it difficult to fit additional medical appointments into an already busy schedule or those who live far from the investigative site and wouldn’t otherwise be able to participate in the trial also benefit.

Not every clinical trial currently offers study volunteers an in-home or remote option, and it will take quite some time for a large number of trials to be done this way, but use of these approaches is expected to increase as pharmaceutical and biotechnology companies invest more widely in efforts to improve the clinical trial experience for patients. Research sponsors and regulators are working on initiatives that better take patient needs into account and could eventually allow patients to participate in clinical research wherever and whenever they want, whether it be their own primary-care doctor’s office, home, workplace, school, or anywhere else.

You shouldn’t feel forced to participate in a remote or at home study if you live near an investigative site and would prefer to have a face-to-face relationship with the study staff.

Pros:

  • You won’t need to travel and make frequent visits to an investigative site.
  • You’ll spend less time in a medical office.
  • You can participate in telemedicine visits at a time convenient for you, perhaps in the evening or on weekends.
  • You can contact someone on the research team 24 hours a day.
  • You may feel empowered by being able to participate whenever it is convenient to do so.

Cons:

  • You won’t have the same number of face-to-face interactions with study staff.
  • If you have a technical problem, you have to reach someone on your own to resolve the issue.
  • You’ll need to make sure you’re home to sign for clinical trial-related deliveries.
  • You may be asked to take your own vital signs or perform tests several times a day.
  • You may need to travel to a lab or medical facility for lab work or exams.
  • You may be asked to collect samples and arrange for them to be picked up.
  • You’ll likely need to send back all of the loaned devices and monitors at the end of the trial.
  • Not all wearable technologies have been validated, so you may need to repeat tests or travel to the research center for a special assessment.

When deciding whether a home-based or remote clinical trial is right for you, after you’ve learned as much as you can about the study visits and what activities you’ll need to perform on your own, discuss the pros and cons with your family, friends and primary care physician. It’s best to ask for input from people you know and trust and to involve your support network in your decision-making process.

For more information on decentralized 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.

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2021 Q2 Clinical Trials Supplement, USA Today

The Clinical Trials Supplement features a variety of informative and timely articles about clinical research. This supplement covers the importance of clinical trial participation, how clinical studies are building a brighter future for people with deafness, and stories from three different clinical trial participants sharing their own “why” about participating in clinical trials.

The “Medical Hero” spotlight cover story features Melvin Mann, a cancer survivor who shares how a clinical trial gave him a new lease on life.

A Very Special “Thank You” to the supporting organizations:

Pfizer                         Oxford PharmaGenesis             
Biogen                      Boehringer Ingelheim
Segal Trials              HyperCore International
SubjectWell             Allergy & Asthma Network
Lilly                            Praxis 

CISCRP would like to recognize and extend a “Thank You” to Praxis for donating their pro bono graphic design expertise to create the advertisement.

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 hventricelli@ciscrp.org. 

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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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The Facts About COVID-19 Vaccine Clinical Trials

Are you still deciding whether to get the COVID-19 Vaccine? To help you make the decision that you believe is best for you, your family, and your community, we made an infographic about the role of clinical trials in the development of the vaccines. 

Relevant resources:

  • A list of resources used to develop the COVID-19 vaccines infographic
  • Recognizing Research Professionals Who Participated in COVID-19 Trials Video
  • CISCRP’s Education Center

If you are interested in licensing this infographic or other CISCRP content for use within your organization or in your public-facing website, please contact Ellyn Getz at egetz@ciscrp.org.

Rare Disease Clinical Trials: How to Prepare for When the Clinical Trial Ends

Part 2 of a 3-part series. Learn about clinical trials, what it means to participate, and what happens when the clinical trial is completed. Moderated by Marsha Lanes of NORD (National Organization for Rare Disorders).

Access the webinar here.

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Moderator
Marsha Lanes,
Genetic Counselor/
Medical Editor,
NORD

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Panelist
Dr. Tracy Dixon-Salazar,
Executive Director,
Lennox-Gastaut
Syndrome Foundation

Panelist
Richie Kahn, MPH
Senior Director,
Patient Engagement,
Medable Inc.

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Panelist
Dana Holinka,
Operating Board Member,
TSC Alliance

PLSP: Plain Language Summaries of Publication

This webinar provides a greater understanding on how Plain Language Summaries of Publication (PLSP) can help meet the demand and expectations for the disclosure of clinical trial results. Additionally, gaining insights on how to plan and turn a scientific manuscript into a PLSP.

Access the webinar here.