FDA Issues Guidelines for conducting Covid 19 Trials
The FDA protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.
The FDA protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. FDA is issuing this guidance to provide general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity during the COVID-19 pandemic.
The virus has been named “SARSCoV-2” and the disease it causes has been named “Coronavirus Disease 2019” (COVID-19). Food and Drug Administration (FDA or Agency) identifies that the COVID-19 pandemic may impact the conduct of clinical trials of medical products. Challenges may arise, for example, from quarantines, site closures, travel limitations, interruptions to the supply chain for the investigational product, or other considerations if site personnel or trial subjects become infected with COVID-19.
These challenges may lead to difficulties in meeting protocol-specified procedures, including administering or using the investigational product or adhering to protocol-mandated visits and laboratory/diagnostic testing. FDA recognizes that protocol modifications may be required, and that there may be unavoidable protocol deviations due to COVID-19 illness and/or COVID-19 control measures. Although the necessity for, and impact of, COVID-19 control measures on trials will vary depending on many factors, including the nature of disease under study, the trial design, and in what region(s) the study is being conducted, FDA outlines the following general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity. The appendix further explains those general considerations by providing answers to questions about conducting clinical trials that the Agency has received during the COVID-19 pandemic.
Some Guidelines for conducting Covid 19 clinical Trials
- In clinical trials the primary objective ‘safety’ plays a crucial role. So, sponsors should consider that and conduct the trials including continuing trial recruitment, investigational product for patients already involved in the trial, need to change the patient monitoring, throughout the trial.
- In trial sponsors should consider safety while Continuing use of the investigational product for patient already involved in the trial with consultation with Institutional Review boards (IRBS)/Independent Ethics Committees (IECs), to make a decision that depends on the specific circumstances.
- Clinical trial mainly focusses on participants safety and also it requires additional safety monitoring. In some cases, trial participants may be unable to come to investigational sites due to protocol-specified visits.
- Throughout the clinical trials, existing regulatory constraints for maintaining investigational product accountability remain and should be addressed and documented. While conducting clinical trials if any changes in study visit schedules, missing visits, or patient discontinuations gives missing data reports.