BMS Approach to Restarting Clinical Trial Operations
July 31, 2020
I appreciate your partnership and support of Bristol Myers Squibb (BMS) research at such a difficult time. The past several months have been very challenging for patients and for investigative sites due to the added burden COVID-19 has placed on researchers like you. The purpose of this letter is to provide Investigators a general update on BMS’ global clinical research recovery.
As you know, the prevalence of COVID-19 and the implications for our studies vary by region. Our recovery requires a flexible approach that accommodates local conditions while maintaining patient safety and the integrity of our clinical research data. Our intent with this letter is to share a general guide on recovery next steps. As always, please contact your site monitor or BMS contact for clarifications or additional details.
You may have previously received letters from Samit Hirawat, M.D., Chief Medical Officer, Global Drug Development at BMS, dated March 19, 2020 and April 9, 2020, which provided BMS’ position on initiation of new studies or new study sites as well as enrollment and treatment guidelines for active studies and study sites in light of the COVID-19 pandemic. These letters communicated that site initiations and activations for new studies were being suspended. After careful consideration, BMS has decided to resume start-up activities for new BMS clinical trials, subject to conditions summarized below. Please note that you may have received a similar letter in recent weeks, but our goal is to ensure all sites have similar information pertaining to our recovery.
If your site was previously activated and never asked by BMS to hold enrollment, no additional steps are required at this time. Please continue to partner with your site monitors, especially on procedural or patient-related questions.
Sites Pending Activation or Re-Activation:
If your site is waiting for activation for a new or ongoing study, or for re-activation after enrollment hold, the following guidance applies.
When and how we begin clinical trial work at sites requires a very thoughtful and inclusive approach. We also appreciate that your site is experiencing its own challenges as a result of COVID-19, and we know that is a key factor to be considered. Our goal is to listen and understand your specific situation and work with you to accelerate research at your site.
The decision to activate new sites will entail global, national, and local level considerations. Our site monitor teams will consider several criteria to assess your site’s ability to meet the study objectives and will decide whether to start or restart site operations. Some of these considerations include:
- Your country and site allows for monitoring to occur on-site or by others means of remote / virtual monitoring approved by BMS.
- Your site can comply with the requirements of the conduct of the study. In particular, this would include performing all study-mandated procedures, including physical exams, disease assessments, adverse event assessments, processing of biomarker and pharmacokinetic materials, as well as laboratory assessments and administration of trial product.
- You have determined that participation in the clinical trial does not pose an excessive or unacceptable risk on the trial participant in the unusual circumstances of the ongoing COVID-19 pandemic.
- You have a guidance/policy in place that describes preventative measures and required screening or clearances for safe participant visits to your site.
- You have a guidance/policy in place that describes the care for participants exposed to or infected with Severe Acute Respiratory Syndrome Corona Virus 2 (SARS-CoV-2), the virus that causes COVID-19, after enrollment.
If you believe that these conditions have been met, please reach out to your BMS Study Team. They will review your assessment and verify our ability to comply with GCP and safely monitor the conduct of the trial at your site. Following our assessment, we will inform you whether we are able to activate your site.
Thank you for your continued efforts to provide care to patients during these challenging times and for your partnership in determining when it is reasonable for BMS to initiate clinical research at your site. We look forward to better times.
Senior Vice President, Global Development Operations
Bristol Myers Squibb