Patient Resources: COVID-19 and Participation in Clinical Trials
The work to fight disease has always been about the patient. It always will be.
Patient Insights and Resources
Health Disparities in Minority Communities
COVID-19 Doesn’t Play Fair: What We Need to Understand About Racial Disparities
Hong Liu, PhD, Making Chicago a Healthier City for Asian Americans
Dorelia Rivera talks about health disparities, a career in advocacy and saving her daughter’s life
Roslyn Daniels, Black Health Matters Founder and President, on Health Disparities and Exciting Communities About Health
Patient Perspective: COVID-19, Community, and Plea for Equitable Participation in Clinical Trials
We Should Not Be Surprised: COVID-19 Disparities Lay Bare What’s Been There All Along
Patient Perspective: The Forgotten and the Pandemic of 2020
Getting the Word Out About Prostate Cancer with Entrepreneur, Engineer, Advocate and Survivor Thomas Farrington
Communicating the Value of Clinical Trials to Underserved Minority Communities
Concerns of Patient Advocates in a Time of COVID-19
Through the Patient Lens: The Patient’s New Normal in Society’s New Abnormal
Patient Perspective: My Clinical Trial Was Cancelled Due To COVID-19
The Patient Perspective: Facing COVID-19 with Research, Action, and Hope
Raise Your Voices: Social Network Provides Safe Place for Patients to Share Stories and Influence Research
WCG: Advocating for Patients in a time of COVID-19
Patient Perspective: How COVID-19 is Helping Everyone Experience Life as a Patient
What Clinical Trials Sites Are Doing to Increase Inclusion and Reduce Disparities
Bringing Clinical Trials Closer to Home: Smaller, Local Sites Build Trust & Provide Access to Local Communities
There is Value to Patients When Independent Sites Offer Clinical Trials
Turning Passion Into a Career: Insights from a Physician and Industry Medical Director of AbbVie Pharmaceuticals, Charlotte Owens, MD, FACOG
It’s all about the trust: Authentic community engagement key to diverse trial enrollment
Health Disparities and COVID-19 in Minority Communities
Find the Trial that’s Right for You
Quickly sift through hundreds of thousands of clinical trials to find the right match.
CenterWatch is a powerful search engine that matches your personal data to ongoing clinical trials: COVID-19 trials and hundreds of thousands of ongoing trials finding treatments for other serious disorders.
Here’s how CenterWatch works:
- You answer a few simple questions.
- The algorithm processes your answers and shows only the trials relevant to you.
- Check back any time 24/7 or sign up for automatic alerts.
Note: WCG CenterWatch strongly urges you to conduct this search—and others like it—in counsel with your caregivers.
Patient Concerns and Questions in the time of COVID-19
How can I learn the facts about COVID-19?
Answer:
There is a lot of potentially confusing and conflicting information about COVID-19. Reliable and informative resources include:
What are the most common changes to clinical trial sites due to COVID-19?
Answer:
- Elimination and reduction in frequency of study visits;
- A shift from on-site to telemedicine and home healthcare;
- Offsite collection of lab tests;
- Decisions pertaining to continuing or pausing enrollment; and
- Off-site monitoring.
What questions are typical for clinical trial participants and volunteers?
Answer:
Your study coordinator should be able to speak to these and other common questions:
- Elimination/reduction in frequency of study visits: Will this affect my care negatively? Will it affect my outcome negatively?
- Shift from on-site to telemedicine or home healthcare: Will I still receive an adequate level of care?
- Collection of lab tests offsite: How will this work? Will someone come to my home? Will I need to leave home to visit a local laboratory? Somewhere more distant or hard to get to?
- Changes to drug delivery: Will my meds arrive on time? Will they arrive at all? What if they aren’t administered by mouth? What processes will ensure that I receive treatment without a break in schedule?
- Lab tests off premises: If I am required to go to an off-premise site for lab tests, can my caregiver enter the off-premise facility too? My trial visits typically take five hours, too long for my caregiver to wait outside; will a taxi or car service be provided? What are other alternatives?
What type of communication should trial sites provide to ongoing trial subjects, volunteers, and those waiting in the queue?
Answer:
The following is essential information at a patient level:
- Study delays, suspended procedures, site closures, study hold for new participants;
- Transitions to remote, home-based or digital study visits;
- Conducting training to trial participants and/or caregivers for digital or remote visits, or home care.
My state/city/county has placed restrictions on ‘nonessential’ travel. Do my study visits fall into this category?
Answer:
It is important to maintain your clinical trial study visit schedule. Please contact your study coordinator and/or study site with any questions regarding how on-time visits will take place, whether in person or on line.
What happens if I miss a study visit during the COVID-19 crisis?
Answer:
It is important for you to notify your study coordinator if you are unable to make an appointment. The coordinator can assist you with scheduling another appointment and/or help with travel arrangements if needed. However, we strongly encourage you to try to attend all of your regularly scheduled study visits.
I was supposed to screen for a clinical trial. What is going to happen to me now?
Answer:
Whether screening for a particular trial is continued or placed on hold will likely depend on the research organization, the local effect of the pandemic, any applicable mandates/policies, and the availability of people and resources to carry out the procedures necessary for that visit. While many clinical trials are being placed on hold, some are moving forward if they are considered essential (e.g. COVID-19 trials, potential life-saving studies, or those with direct benefit that outweigh the risks of visiting the site in person).
Best advice: call your Investigative Site and speak to your research coordinator.
How does one find a patient advocacy group?
Answer:
Highly regarded organizations including the National Health Council, NIH, and FasterCures list hundreds of advocacy groups. Googling a specific disease may turn up an advocacy group. Bear in mind that each group has its own mission. It is important to find a group that meets one’s specific needs.
I am in remission from cancer and enrolled in a clinical trial. If I come down with COVID-19, I want to enroll in a COVID-19 trial too. How do I locate a COVID-19 trial in my area?
Answer:
Use WCG CenterWatch iConnect, a search engine that matches patients to the right clinical trial for their needs. CenterWatch iConnect pairs an easy-to-use proprietary search engine with a database of all ongoing COVID-19 clinical trials, plus hundreds of thousands of other trials under way worldwide. View COVID-19 Trials
Patient Advocacy Groups: Here’s How They Can Help During COVID-19
Patient advocacy groups are a trusted source for persons seeking clinical trials as well as those already enrolled. During the COVID-19 crisis, pharmaceutical sponsors and study sites also are encouraged to join advocacy-sponsored discussions. First, it’s a way to hear important questions and concerns they might miss otherwise. Second, it can help study teams develop communications throughout this crisis that are patient-friendly and meaningful to patients and their families alike.
Many advocacy groups are convening daily and weekly informational webinars, discussions, and question and answer sessions. These communications with others living with your disease can be quite comforting during uncertain times. You can learn more about such offerings on the advocacy groups’ websites.
If you already had a serious condition and now are concerned about COVID-19 too, chances are your advocacy group has information on their website of help to people like you. Plus, they often have staff who can answer questions person-to-person, provide direct help, guide you to help you can get on your own, and steer you to sources of trustworthy advice.
Resources for finding patient advocacy groups:
Non-governmental organizations:
- National Health Council
- National Organization for Rare Disorders
- FasterCures
- INSPIRE (online communities for many sites)
Government websites:
You can also search using your web browser for other advocacy groups, using the name of the disorder you are interested in as the main search term.
A note to Sites and Sponsors:
Find out what resources are available to your patient participants. It is important to trial participants to hear which support systems you recommend. It can be important to the success of your study too.
Inside View: COVID-19 and Clinical Trials
Listen in to WCG’s webinar series for front-line clinical trial professionals combating COVID-19. Top experts (doctors, scientists, medical ethicists, patient advocates and more) hash out the promise and the problems of cutting-edge drugs, therapies and modalities while you watch.
The True Problem of COVID-19 Misinformation: How the Spread of Inaccurate Information Harms our Progress toward New Therapies
[8/19]The problem of the spread of scientific misinformation is very real. We’ve probably all seen stories on social media about COVID-19, or anonymous testimonies from alleged healthcare providers, some of which seem obviously untrue. But we can’t dismiss the impact that misinformation is having on our ability to combat COVID-19, in terms of mistrust of the scientific community, resistance to following COVID-19 precautions, hesitancy to participate in clinical trials and predicted concerns about wide-spread agreement to COVID-19 vaccine use. In this webinar, the speakers will:
- Discuss a recent study looking at how willing people are to share COVID-19 news on social media, and the intervention that reduced the spread of false information
- Consider how misinformation about clinical trials, treatments and vaccines disproportionally impacts minority communities, including willingness to participate in research and seek treatment
- Provide suggestions for how our clinical research community can help to stop the spread of misinformation
COVID-19 Ethics: Looking at Scientific Data Dissemination, Vaccine Development and Access to New Therapies Through an Ethical Lens
[8/5] The COVID-19 pandemic has brought accessibility to scientific and clinical trial data and information to the general public. But with this eagerness for scientists to share and for media to amplify new information, sometimes even before it has been vetted by other scientists, we also have ethical challenges. In this webinar, our expert bioethicist guests will discuss:
- The complex ethical questions of the quickly evolving COVID-19 vaccine development landscape
- How the rush to quickly share scientific information can potentially disrupt progress in clinical trials, and create a minefield for front-line healthcare providers
- That this unprecedented access to information creates a tsunami of demand for access to unapproved and sometimes barely tested potential therapies and the regulatory system designed to manage that process
Clinical Trials Transformation & Easing the Patient Burden – How COVID-19 is Moving Us Into A Future Where Trials Are More Accessible and Convenient
[7/22] There is so much discussion going on across all of clinical research – operations, regulatory, compliance and patient advocacy as it relates to how we’re all handling the COVID-19 environment. We’ve seen adaptations to telemedicine, shipping study drugs to participants, remote endpoint assessments and laboratory testing collected locally or at home. But how many of those changes will stick when the “new normal” comes? The changes that allowed studies to continue through COVID are many of the ones that patients have been asking for to decrease participant burden and expense, and to make trial participation available to a broader and more diverse population. In this webinar, we’ll discuss:
- Was this the shock that will finally lead to change?
- Why are these changes to study conduct so important to participants?
- How can biopharma sponsors use what was learned to make important and lasting changes?
Conducting Research at Institutions Post-COVID-19 – Exploring New Norms in the Conduct of Sponsored Clinical Research
[7/8] The resumption of Clinical Research is underway, with new precautions and procedures in place for the protection of research participants and research staff. As institutions resume clinical research and initiate new clinical trials, there is growing stress on the internal resources necessary to support key study-related activities for both COVID-19 and non-COVID-19 trials – including data entry, monitoring, and patient enrollment and engagement. There is growing concern that sites, CRAs and other critical resources will be unable to absorb the volume of work required in the short-term to make up for lost time.
In this webinar, we will:
- Provide insights around what the clinical research world is doing to expeditiously resume studies that were paused, and start initiation of delayed studies
- Understand how external resources can be leveraged by clinical sites to get back to research-readiness, given resource constraints
- Learn how sites are preparing to manage the bolus of monitoring and study activities that will hit as research resumes
COVID-19 Changed Everything – Now Contracts and Budgets Need to Catch Up
[6/24] As clinical trials shift quickly and necessarily from in-person to hybrid trials, remote visits, and virtual experiences and support, new opportunities and challenges emerge. While the industry figures out how to best navigate these new challenges, and much remains unresolved, we do know this: Sites and sponsors will be recalibrating everything, especially contract terms and budgets for either new components of trials or changes to clinical research. Site budgets for ongoing studies will need to be recalculated, amended and renegotiated, and contracts and budgets for new studies will have new considerations. In this webinar, we’ll explore:
- How sponsors and sites are managing revisions of agreements for existing studies where visits, tasks and activities have changed
- What sponsors and sites are thinking about with regard to new COVID-19-related expenses and contracting requirements (e.g., coverage of site-mandated COVID-19 screening or required PPE)
- How to build flexibility into contracts and budgets so that significant shifts in study conduct can be managed without requiring major revisions to budget or legal terms
PART 12: Public awareness of clinical research and the path to diversity in clinical trials
[6/3] COVID-19 and the effort to develop treatments and vaccines for COVID-19 have brought awareness of clinical trials into the public view like never before. What impact is that discussion having on the public’s understanding of clinical trials as part of the drug development process? In addition, there’s been extensive conversation about ensuring COVID-19 treatment studies include an appropriately representative population. How can we advance this important discussion to achieve diversity in research study enrollment?
In this webinar we:
- Review a recent CISCRP survey examining how COVID-19 has affected awareness, perceptions and understanding of clinical research for the general public
- Discuss how future understanding of and participation in clinical research may be affected by the pandemic
- Review the disproportionate impact that COVID-19 is having on minority communities in the U.S. and discuss the need to ensure appropriate representation in COVID-19 clinical trials
PART 11: The Impact of COVID-19 on Oncology Research – Immediate and Long-term Effects
[5/27] More clinical trials are conducted for cancer than for other therapeutic areas, and these trials often include participants who have exhausted the available treatment options. So when COVID-19 forced a re-assessment of ongoing and upcoming studies, patients and care providers were placed in a difficult situation. We’ll talk to a leading cancer researcher and a patient who was in screening for a new clinical trial, about the present and future of oncology clinical trials.
Our expert speakers discuss:
- How did cancer research centers react to COVID-19 and make decisions about continuing or pausing clinical trials, and what are they planning for the near future?
- What kind of long-term effects might we see in the design and conduct of oncology clinical trials as a result of COVID-19?
- The patient perspective: How it feels to get the call that your cancer clinical trial has been put on indefinite hold
Part 10: Unique Challenges and Opportunities for Emerging Biopharma Companies with Focused Pipelines
[5/20] In this webinar, we turn our focus to the challenges unique to our innovative colleagues in the emerging biopharma space. With smaller and focused-pipeline organizations making up over 50% of clinical trials activity pre-COVID-19, these sponsors represent the potential for enormous advances in development, but also shoulder the challenges of keeping projects moving in highly concentrated pipelines during this time. Our expert speakers discuss:
- How the agile nature of emerging biopharma has uniquely enabled them to pivot quickly and map to new methodologies to sustain and manage ongoing trials during the pandemic
- How organizations with focused pipelines or single assets are facing development and commercial realities going forward
We’ll speak with leaders from emerging biopharma organizations with assets in different therapeutic areas and in various phases of development and commercialization; and about the evolving resources that address biopharma needs during this time.
Part 9: The Challenges of Developing Vaccines and Treatments for COVID-19
[5/13] In this webinar, our expert speakers turn their attention to challenges of doing research on the COVID-19 pandemic. They discuss:
- The remdesivir development pathway and the experience of designing and conducting clinical trials in a brand-new disease without the benefit of medical guidance or regulatory precedent
- The status and future of prophylactic vaccine development for COVID-19
- The ethical issues of human challenge studies, which can speed vaccine development timelines but require careful consideration because they would intentionally expose study volunteers to COVID-19
Part 8: The Realities of Restart
[5/6] In this webinar, we turned our focus to the realities of restarting clinical trials by examining WCG data spanning the clinical trials ecosystem. We talked to leaders at research sites to understand their key issues and we’re helping sponsors understand what they should be aware of as they prepare to re-engage. We speak with our expert panel about the following:
- WCG is evaluating data and trends based on a panoramic view of the clinical trials ecosystem and supported by our proprietary WCG Knowledge Base™ decision engine. We will highlight critical data points and share what today’s trends are telling us about what to expect next.
- From there, we’ll transition to on-the-ground perspective from sites about the challenges, concerns and opportunities posed by this moment.
- Finally, we’ll consider how those challenges translate into readiness considerations for sponsors and CROs.
Part 7: Imagining the Future State of Clinical Research
[4/29] In this webinar, our expert, Ken Getz of Tufts CSDD, explores 3 facets of this transitional period:
- What the clinical research world was really like in 2019, by drawing from the rich data of the Tufts Center for the Study of Drug Development (CSDD).
- What the clinical research world may look like in 2021 and beyond, and the potential changes to the ways we design protocols, select clinical sites, and operationalize studies.
- Whether the public discussion of the development of COVID-19 therapies could potentially be a turning point in the public’s understanding, awareness and engagement with clinical trials.
Part 6: Going Remote During COVID-19: Considerations When Moving Studies Out of the Clinic Setting
[4/22] In this webinar, our panel of experts discuss what you need to know about the impact of COVID-19 on your clinical trials:
- Informed consent: what’s allowed and what’s practical in obtaining consent remotely, where does electronic consent come in, and whether participant compensation needs to be modified
- How do IRBs consider the review of “virtual” clinical trials?
- What do sponsors consider when deciding whether study visits can be conducted remotely, both when planning ahead, and when reacting to urgent issues?
Part 5: Maintaining Data Collection and Data Validity Amidst Major Study Changes
[4/15] In this webinar, our panel of experts discuss what you need to know about the impact of COVID-19 on your clinical trials:
- How do you continue to collect data and preserve your study?
- Considerations for your endpoints; are your outcome measures still valid if you go remote?
- What is the impact on interpretation of outcomes; can you combine pre-event and post-event data and baselines?
Part 4: Planning for Recovery: How Research Sponsors and Research Sites are Thinking Ahead to Restart Research
[4/8] Our panel of experts discuss what you need to know about the impact of COVID-19 on your clinical trials:
- What are sponsors doing now to plan ahead and to position studies to return to full activity as precautions release?
- How can sites prepare for the wave of study restarts? What can be done now- even remotely- to maintain contact with participants, sponsors and vendors?
- What will be different about our research studies, procedures and practices as we move into a post-COVID world?
Part 3: Clinical Trials in the Era of COVID-19: Changes You Need to Make Now
[4/1] Our panelists discuss best practices for:
- Evaluating whether there is enough reliable data to draw meaningful clinical study conclusions
- Assessing the status of each clinical study – what challenges and opportunities are presented based on study characteristics and timeline?
- Determining how studies can be designed now to build in future flexibility in schedules, procedures and analysis plans
- Leveraging DMCs/DSMBs to play a role in the assessment and modification of studies
- Revisiting safety data collection and reporting during the COVID-19 crisis
Part 2: Clinical Trials in the Era of COVID-19: Changes You Need to Make Now
[3/25] Our panelists cover how clinical sites and institutions are making decisions about what research should continue during COVID-19, what resources site teams are utilizing to shift study visits to virtual and remote assessments, and what changes are being made to protocols based on site policies and precautions. Also presented is the participant perspective: how we can manage fear, change, and messages about “non-essential” research priorities.
Part 1: Clinical Trials in the Era of COVID-19: Changes You Need to Make Now
[3/18] From protocol amendments to participant recruitment and retention, the impact of COVID-19 could be enormous. What can you do to minimize the disruption to your ongoing, or upcoming, clinical trial? Our panel of experts from NYU Langone Medical Center and WCG discuss ways to reduce the impact of this pandemic on your studies to keep them on track.
COVID-19 Preparedness for Health Care Institutions
[3/13] In this webinar, experts from the FDA and Massachusetts General Hospital discuss what we know, and don’t know, about the nature and epidemiology of COVID-19, what’s happening as we work to develop vaccines and therapeutic agents, and how health care institutions are preparing for COVID-19 across different divisions.