While the SARS CoV-2 emerged back in the year 2019, no approved therapeutics or vaccines were made available to stop its spread. Thus, an urgent requirement for establishing successful counter-measures throughout the crisis has been challenging the existing paradigm of the several stages of the traditional drug discovery and development. it was soon realised that the world is in immediate need of appropriate approaches for accelerating this process of drug discovery and development. 

The rising urgency for making life-saving treatment options available for the Covid-19 pandemic as resulted in the preclusion of the traditional paths and measures involved in the process of drug discovery and development. Traditionally, this used to be an iterative and multi-step process for identifying the potent compounds backed with properties for supporting their potent clinical benefits. Here are few strategies that kept the pace of pharmacokinetics vs pharmacodynamics studies steady even during the stretch of the ongoing pandemic – 

Re-initiating the clinical trials – 

As the immediate future looks no good amidst Covid-19 pandemic, strict government-imposed mitigation efforts have become the need of the hour. In such cases where lockdown has been made mandatory, regulatory professionals and the drug discovery scientists can continue their engagement of the abreast hub of current regulatory guidelines.

These guidelines may prove out to be crucial in assessing their impacts on the study designing decisions. Recently, FDA has also issued a new guideline named ‘Conducting Clinical Trials During the Covid-19 Pandemic’. This is labelled to be a living document which the food and drug regulatory agency considers important to be kept updated with all the latest research information and industrial regulations.

The prime motive of this guidelines is to make the drug researchers and discoverers potent enough of consulting the regulatory agencies about the planning and implementation of the drug research, discovery, and development processes. 

For increasing your efficiency, you may easily reconsider activities such as generating ICFs, clinical reports, eCRFs, and other relevant clinical documents to pace off your clinical trials. 

Initiate New Clinical Studies – 

In case we go into the phase of second worldwide lockdown, nothing should disturb your future planning. Even if it is unlikely for you to conduct clinical trials for the next year, you can plan on for the future trials as well. To stay proactive, you may consider writing fresh or amendments to all your existing protocols thereby engaging with study sites for understanding if there is any such special requirement. 

While you decide on a study site location, make sure to critically analyse the regional impact of the ongoing pandemic. A backup clinical site at your fingertips can prove to be useful for you to accelerate the pace of your future clinical trials. 

Use your spare time for conducting gap analysis – 

Invest your time wisely into prioritizing the goals of your future clinical plans. Regardless of which position you are currently standing in, make the best out of this opportunity for assessing the quality of your program. You may consider performing a gap analysis to take down the advantage of your spare time while all other of your clinical routine is at halt.