COVID-19 & IBD: Clinical Trials
As a clinical trial participant, whether currently or newly enrolled, you may have questions and concerns about how COVID-19 impacts your participation. The COVID-19 pandemic may add uncertainty, anxiety, and a sense of urgency about your treatment during a trial. We're here to help you throughout the process and provide you with helpful tips.
The impact of COVID-19 on clinical trials
COVID-19 has made a global impact on clinical trials—since the start of the outbreak, there have been disruptions and delays. Challenges may arise due to social/physical distancing guidelines, site closures, travel limitations, interruptions to the supply for the investigational product, or other considerations if study staff or trial participants become infected with COVID-19. In addition to disruptions, patients may be hesitant or nervous to enroll in trials or continue study visits for fear of exposure to COVID-19.
Participation in IBD clinical trials
Clinical trials are an important step in the drug development process and are used to determine the most effective and safest treatment for a disease by translating research into new medicines that can provide better outcomes for patients.
Your safety is paramount at this time. Clinical trials aim to avoid/limit exposure to the virus for participants and staff. Studies may continue activities virtually if feasible, or in person if and when it is safe to do so. Governing agencies like the U.S. Food and Drug Administration (FDA) have provided guidance to industry sponsors and investigators on how to continue studies and monitoring during this time. If you have any concerns about your safety with these trials, please discuss this with your research team. You can also see our Clinical Trials Discussion Guide for guidance on what to ask your doctor and research coordinator.
Recommendations for enrolled or newly-enrolled patients and their families:
- If you are currently enrolled in a trial:
- Contact your clinical research staff for updates regarding any changes to trials
- For example, there may be changes to the how study visits are conducted and how you will be monitored. Telemedicine visits may be an option
- If you are newly enrolled in a trial:
- Contact your clinical research staff ask about the status of the study
- For those newly enrolled, there may be a pause or new methods or procedures implemented to ensure continued participation and safety
Other considerations to discuss with the clinical research staff include:
- Are there changes in the country and region-specific approaches such as trials being paused or restarted at a later date?
- These changes are often due to recommendations by a federal or state government
- Have trials postponed on-site monitoring or implemented remote monitoring methods, such as virtual or phone visits, or digital tools for use at home?
- Have there been changes to way your medication is administered?
- Have screening measures for COVID-19 symptoms prior to and at visits (when they resume) been implemented?
For more information, and to read the guidance on conduct of clinical trials of medical products during COVID-19 pandemic, please visit: https://www.fda.gov/drugs/coronavirus-covid-19-drugs/clinical-trial-conduct-during-covid-19-pandemic.
Most importantly, if you have fears about your risk and are considering discontinuing your participation in the trial, talk to your research coordinator and healthcare team. They want to hear your concerns and are available to help you better understand the risks involved.
If you would like more information and resources on SARS-COV-2 (coronavirus) and COVID-19, we encourage you to visit our COVID-19 Resource Center. You’ll find the latest information about COVID-19 along with specifics related to IBD medications, surgery, and managing the emotional aspects of the pandemic.
Participation in research
IBD Partners is a partnership of the Foundation and the University of North Carolina at Chapel Hill that brings patients and researchers together to better understand IBD. Patients are involved in every part of the process—from deciding survey questions to choosing priority topics for research. We invite you to propose, vote, and discuss research ideas in our research portal. IBD researchers will review these ideas, and your idea may even lead to a study. This online registry is used to gain a better understanding of how things you do affect your disease activity. We hope that understanding these how behaviors affect your disease will lead to improved quality of life for all individuals with IBD. If you choose to enroll, you will be asked to complete a baseline survey to learn more about your health. You will be contacted a few times per year by email and you will be asked to update your health information. You can find more information about IBD Partners here: www.ibdpartners.org