A Message to?Clinical Trial Investigators on Bristol Myers Squibb’s Response to COVID-19
April 09, 2020
As previously communicated on March 20, 2020, Bristol Myers Squibb (BMS) is rapidly responding to the arising challenges in relation to coronavirus (COVID-19) and the effect this is having on the conduct of clinical trials.
We continue to closely monitor the evolving situation across the globe, and we are taking proactive steps to protect the safety of study participants, our employees and staff at our clinical trial sites while also ensuring regulatory compliance and the scientific integrity of trial data. We are also taking into consideration that your time and your clinic’s resources may need to be re-directed in support of the broader community during this time.
To this end, we would like to provide a few updates to the overarching principles and guidance for the conduct of BMS clinical research in light of COVID-19 that we recently shared. These decisions pertain to trials executed by BMS directly or through a Contract Research Organization (CRO) and include the following:
- For ongoing studies - those that have passed global First Patient First Visit (FPFV) – new site activations will be suspended until further notice. Activations will continue in cases where the study site moves a patient to a long-term extension/roll over study to ensure continuation of care.
- For new studies – those yet to achieve global FPFV – we will not initiate or activate any sites globally until further notice. We will also not perform further retraining or refresher visits during this time for sites that are not actively treating participants in a trial.
- Enrollment – the conditions allowing enrollment of new patients defined previously and how they apply to your site continue to be applicable.
- For healthy volunteers (HV) studies – these studies should not initiate and new sites should not be activated until further notice. If the HV study has not begun enrolling (i.e. in screening, but not yet reached FPFV) it should be paused until further notice.?If the HV study is at a natural break point (e.g. in between cohorts, between study parts, etc.), it should be paused until further notice. All recommendations for BMS studies, ethics committees, local health authorities and central health authorities should be followed.
We recognize this is a rapidly evolving situation with different geographical considerations. We will continue to provide timely updated guidance related to BMS clinical research. This includes, in some cases, additional guidance and actions for your specific trial(s) and/or geographical location. In these cases, your local study team will be in contact with you. ?
We also wanted to remind you of the following advice regarding patients suspected of or who have tested positive for COVID-19:
- New Patient Enrollment (for sites allowed to continue enrollment) - For patients who are exhibiting symptoms consistent with COVID?19 or have tested positive using a test consistent with the institutional standard of care, we advise you to consider not enrolling or initiating protocol treatment until resolution of symptoms and evaluation by you.
- Ongoing Patient Treatment - For patients who are exhibiting symptoms consistent with COVID-19, we advise you to consider holding dosing of investigational product and consult the Medical Monitor. In the event a patient tests positive for COVID-19, or if no testing is available, we advise you to consider holding dosing until such time as symptoms resolve. If a positive COVID-19 test result is reported, please consult with the Medical Monitor on whether resolution of symptoms alone without retesting is sufficient to resume dosing of the investigational product.
To assist with understanding the impact of our investigational treatments on patients in the setting of COVID-19, we also request that if a patient tests positive for COVID-19 that the test result be reported to BMS within 24 hours by entering the adverse event into EDC, regardless of seriousness, per the adverse event reporting guidelines in the protocol (CRF or SAE form, as appropriate).
Further, across all studies, you should weigh the public health considerations and individual benefit-risk in enrollment and treatment decisions for trial participants during the COVID-19 pandemic. You should carefully consider the impact of any travel restrictions implemented by local/regional health authorities and local institutions on the benefit-risk in enrollment and treatment decisions.
As always, please reach out to your BMS Study Team with any questions and as you become aware of new information that would impact your ability to safely treat patients in any of our studies. Please also ensure this communication is filed in your study file and notify your IRB/Ethics Committee, as applicable, based on your institution’s policy. We will inform Health Authorities of our decisions in accordance with local regulations.
As a reminder, you may also contact the BMS Medical Information line in your region for customer service, patient assistance information, product information and adverse event reporting. You can find the local contact information at www.globalbmsmedinfo.com
Thank you for your continued partnership as we work together to effectively manage through this challenging and rapidly evolving situation.
Samit Hirawat, M.D.
Chief Medical Officer, Global Drug Development
Bristol Myers Squibb
This letter originally posted on March 20, 2020 and was most recently updated on April 9, 2020