A Message to Clinical Trial Investigators on Resuming Site Activation of Ongoing Studies
I appreciate your continued interest and willingness to participate in Bristol Myers Squibb (BMS) research at such a difficult time. The past several weeks have been very challenging for patients and for investigative sites due to the added burden COVID-19 has placed on researchers like you.
I would like to describe conditions for site initiation for ongoing BMS clinical trials including healthy volunteer studies. BMS is not beginning new studies at this time. 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 new site activations in ongoing studies (those that passed First Patient First Visit) were being suspended and established requirements to continue recruitment of new patients into ongoing studies.
For those sites that remained active for recruitment, nothing changes and you should continue on with those activities. When and how we begin clinical trial work at sites where initiation or recruitment was on hold will require a very thoughtful and inclusive approach with input from multiple functions at the global, country, and local level. 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 recovery at your site.
In order to initiate your site or resume enrollment if a hold was in place, we will require all of the following conditions to be met:
- Your country/state has lifted any restrictions on travel or commerce that would restrict the ability of BMS to safely monitor the conduct of trial activities at your site (for continuation of enrollment, required only if remote access to Electronic Medical Records is not feasible)
- The local/national BMS or Contract Research Organization (CRO) operational team has determined that they can safely monitor the conduct of trial activities at your site.
- Your site has lifted any restrictions on in-person site monitoring or remote access to the Electronic Medical Record has already been enabled to allow for remote monitoring.
- Your site has no restrictions in place that would limit your ability to fully comply with the requirements of the conduct of the study. In particular, this would include your ability for subjects enrolled to have all study-mandated procedures performed on site including physical exams, disease assessments, adverse event assessments, processing of biomarker and pharmacokinetic materials, as well as laboratory assessment and administration of trial product.
- You have determined that your site has sufficient resources to allow you to safely care for subjects enrolled in the trial.
- You have determined that the benefits to the subject of enrolling in the clinical trial exceed the risks of trial participation in the unusual circumstances of the 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.
When you believe that these conditions have all 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 schedule an in-person site initiation visit at your site or if you can continue with recruitment of new patients.
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