The Covid-19 pandemic has the potential to disrupt new and ongoing clinical trials of various medical products. To help combat these complications, on March 18, the FDA issued guidance for the execution of clinical trials during this viral pandemic.
One of the challenges facing the proper conducting of clinical trials is quarantines. Both trial participants and trial personnel may be quarantined and become unavailable for in-person visits. On a related note, trial participants and personnel may also become infected with the virus. An infection in the participants may affect the outcomes of the study and in some cases, some participants may need to be removed from the trial. Additionally, medical centres utilised by the trials may no longer be easily accessible or safe to use. Finally, there may be difficulties with the supply chain, as well as the availability and access to the products being investigated.
The FDA’s new guidance for industry, investigators, and institutional review boards is aimed at ensuring the safety of trial participants as well as the integrity of clinical trials during the Covid-19 pandemic. The FDA states that it recognises the need for amendment of clinical trial protocols due to this evolving health crisis. Changes will depend on the particulars of each trial including participant population, location, and medical products used. One of the recommendations was the assessment of alternatives to in-person visits for communication and patient evaluation. Alternate methods may include phone or virtual visits. Additionally, locations other than hospitals and medical centres, such as labs, may be used.
Depending on the severity and duration of this pandemic, increasing difficulties may arise for conducting clinical trials. This is especially true for trials that are not directly related to Covid-19 prevention or treatment and trials that require in-person access to participants in hospitals and medical facilities.