Upcoming consequences of COVID-19 on clinical research will primarily include financial, regulatory and policy implications requiring the implementation of new strategies never tried before.
About the financial impact of the crisis, small biotechs might face severe cash shortfalls and financing issues as a result of trial delays. Companies with a single asset could also be especially vulnerable. These stoppings and delays in clinical research might lead smaller companies to ask for additional funding and to make difficult financial cuts ; companies with high-value products may also be at a higher risk of acquisition. Delays will also lead to the postponement of product launches on the market, thus leading to shorter periods of patent exclusivity and lower benefits from launched products. Finally, these delays could also shift the competitive landscape in many therapeutic areas by allowing competitors to quickly adapt in response.
From a regulatory point of view, many research stakeholders have anticipated the requests from agencies for additional documentation on new protocols and procedures. However, this unexpected requirement has also been a challenge for many staffs responsible for trials and their sponsors, as inquiries from agencies necessitate quick replies. Travel restrictions and physical distancing measures have also generated deviations from initial protocols; and even if the FDA and EMA have announced that deviations that do not significantly impact the validity of the studies do not have to be reported, sponsors have to make sure their deviations meet this requirement.
Finally, the impact of the pandemic on clinical studies will also be felt on a policy level, especially during drug pricing negotiations. Additional delays for pricing negotiations could be observed, even for non-COVID-19 therapies.
All these factors have to be considered by trial sponsors in order to ensure study integrity and safety during this pandemic, while also thinking about the strategy to employ to minimize burdens of the crisis on their financial revenues. Besides reassessing their clinical research programs, companies have to reconsider their pricing policies and financing of their R&D pipeline; and the challenges raised by COVID-19 will surely have serious impacts on smaller biotechs that only have little room to maneuver. In any case, there is no doubt that companies that will quickly anticipate and adapt their strategies to these changes are likely the ones to have the strongest chances to succeed.