While the coronavirus still runs rampant throughout the country, stay-at-home mandates continue to prevent employees from being fully functional, and this is particularly true with the clinical research industry.  In fact, more than 70 biotech companies and over 100 clinical trials have been affected, according to BioPharmaDive. The FDA states that “quarantines, site closures, travel limitations, interruptions to the supply chain for the investigational product” are all circumstances that will cause disruptions to drug development. Due to these barriers, clinical trials (that are not involved in COVID-19 testing) may take a backseat as attention is instead being diverted to drugs that would manage and treat the coronavirus.

In order for researchers to continue execution of clinical trials, they will need to adopt technologies that will allow them to switch to a more remote means of conducting the study, such as mailing the drug to the patient and using video technology to communicate. Wearable devices will also be a means of collecting evidence and monitoring patient data. There are possibilities of limited supplies and shipping delays and the deprioritization of clinical trials while hospitals shift all resources to the COVID-19 response. GlobalData Healthcare reports that Dr. Leonard Saltz, Medical Oncologist at Memorial Sloan Kettering Cancer Center, New York is anticipating a three-month delay at a minimum on trial operations but clarifies that it is uncertain what will continue to be impacted beyond that period.

For those researchers who are unsure if they should pause, restart or begin new clinical trials, they should refer to the FDA’s recently published guidance on the topic. This guidance offers options based on some determining factors including, will lapse of a drug or procedure put the participant at risk? If not, do the participants need to come to the facility for check-ups? Answering these questions is important in order to make patient safety a priority and to take steps to limit exposure to COVID-19. The FDA has also taken action within its own organization to reduce exposure. In the FDA’s recent announcement it states it will be shifting its focus on the safety of regulated products while scaling back domestic inspections to reduce the spread of COVID-19 and protect its staff.

A further concern manifested by COVID-19 is the accuracy of the data, given that participating patients may have unusual stress in the current state and are not adhering to their normal life routines. Many individuals are more susceptible to any illness during the current months because their increased stress levels are directly correlated with a weakened immune system. Additionally, patients in the study may already have the virus and not know they are infected which may alter the results of their response to the study. Investigators will be forced to take extra steps to confirm their data is accurate and build this into their timelines.

Although many things are uncertain during the COVID-19 pandemic, it is necessary all industries within healthcare adapt and improve their procedures to combat the drug development delays. By acting quickly to find solutions to the issues that have arisen, we can increase the number of positive patient outcomes now and in the future.

The PharmaOut team remains committed to doing our part to fight COVID-19 and help keep our families safe. Our team of expert recruiters and consultants have years of experience to assist our clients in successfully continuing their business with our staffing, consulting, HR and investigator meeting services. Please contact us if you would like to discuss how PharmaOut can be your strategic partner.

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