Disruptions in Clinical Trials During Pandemic

Clinical Trials requires the patients to make visits to the clinical sites at various stages. If patients do not make site visits, the study may not proceed further at all. During the COVID-19 outbreak when people are asked to stay home, patients are reluctant to visit physicians except for emergency cases. In such a scenario, it is difficult for Pharma sponsors or CROs to continue existing studies or initiate a new study. Clinical trial is a complex process that requires a lot of planning and coordination. Any short-term disruptions in the clinical trial supply chain can have a long-term impact which could possibly force the sponsor to discontinue the study.

Clinical Trials requires the patients to make visits to the clinical sites at various stages. If patients do not make site visits, the study may not proceed further at all. During the COVID-19 outbreak when people are asked to stay home, patients are reluctant to visit physicians except for emergency cases. In such a scenario, it is difficult for Pharma sponsors or CROs to continue existing studies or initiate a new study. Clinical trial is a complex process that requires a lot of planning and coordination. Any short-term disruptions in the clinical trial supply chain can have a long-term impact which could possibly force the sponsor to discontinue the study.

The sponsors would be forced to temporarily suspend the ongoing studies. It would be very difficult for them to continue the study from a point it was discontinued after a long gap of 3-6 months. It is quite possible that sponsors may have to restart a study from the very starting point which could be challenging especially for large studies with hundreds or thousands of patients enrolled globally. The patients may have to be screened again to confirm their eligibility adhering to the protocol. In the case of screen failures, sponsors may have to recruit more patients to find enough participants at a clinical site. The money already spent on such clinical trials would be a sunk cost for the most part, which would ultimately add up to the cost of new drugs if it reaches the market.

With the economy slowing down, such discontinuity of business can have a disastrous impact on the balance sheet of sponsors and CROs. As per an article by Josh, IQVIA expected a $25 million impact on its revenue in first quarter. It is possible that many small and medium-sized sponsors may not be able to sustain the losses and go out of business, which may not be healthy for the economy as well as the patient community. Necessity is the mother of inventions. Sponsors are finding ways to fill the gaps and to set the ball rolling.

Patients make a visit to the clinical site for various reasons like screening, consultation with physicians, lab work or tests, collecting or taking the medicine, and reporting any adverse events. Sponsors are looking for ways to reduce or eliminate the need to visit the study site physically. Sponsors will be forced to leverage technologies and methods used in Telemedicine and virtual trials.