Since the initial outbreak, Covid-19 has rapidly evolved into a global pandemic. The pandemic has had some direct and indirect detrimental effects on humans. Direct impacts such as infections and deaths and indirect effects such as increased burden on health services, social distancing measures, travel restrictions, have ultimately led to difficulties in performing clinical studies and treatment decisions.
Challenges faced by Bioequivalence studies (BE studies)
FDA recognizes that bioequivalence service providers are facing a steep challenge in performing bioavailability and bioequivalence studies (BABE studies). BABE studies are imminent if sponsors want approval for an ANDA submission. Trial site closures, travel restrictions, and laboratory closures have further impacted the conduct of BE studies. The impact has led to BE study suspension at different stages ranging from study development, recruitment period, during a trial, or in between trial periods.
The unprecedented pandemic has forced the clinical and pharma industry to look out for short-term sustainable alternatives for BE studies. However, such feasible measures should also incorporate the key focus areas of subject rights protection and data integrity along with necessary long-term considerations for the Covid-19 pandemic.
How to successfully navigate Covid-19 challenges?
In general, conducting BE studies requires a careful approach towards study participants. Moreover, the FDA has guided sponsors on how to perform BE studies during the ongoing pandemic. Let us explore the ways of moving forward with BE studies in clinical research during the Covid-19 pandemic.
The safety of study participants is of utmost importance during the ongoing pandemic. As BE studies generally involve the participation of healthy patients, sponsors should take additional measures for the safety of both healthy and patient populations enrolled in bioequivalence testing. The inclusion criteria should involve the enrollment of local volunteers whereas populations with relevant comorbidities should be excluded from BE studies.
Before commencing or restarting BE studies, bioequivalence service providers should execute screening, admission, and risk reduction approaches. If needed, sponsors can confine the participants and staff members in the trial facility. If this is not possible, the sponsors should screen participants before a BE study and limit the contact between participants and staff members.
There are some approaches sponsors can employ to reduce Covid-19 infections. The alternative PK approach involves utilizing earlier PK data from reference listed drug data and leveraging them with PK modeling to reduce the number of site visits. Spaced dosing involves scheduling participant visits in such a way that they do not overlap each other. Moreover, whenever possible PK sampling should be done through home visits. Most importantly, bioequivalence service providers should be equipped with detailed standard-operating-procedures to reduce the risks involved with conducting BE studies during the current global crises.
The pandemic has had a significant impact on bioequivalence testing with posing novel challenges in the interpretation and utility of clinical trial data. A collaborative strategy is obliged if sponsors want to comprehend and mitigate Covid-19 ramifications. However, it is also true that Covid-19 has provided a common ground for various stakeholders to assess and modulate the impact in a transparent and structured fashion.