04 Nov 2020 by AXXELIS
COVID has had a huge impact on the processes of effective clinical trials. This has led to a huge pivot in the approach to carrying out clinical trials. In this article from Deloitte, they delve into the new ideas and practicalities when planning and running clinical trials.
“Clinical trials are vital to find out whether a new medicine (or medical device) is safe, effective and better than existing treatments. Essentially, clinical trials serve to accumulate sufficient, robust evidence to assure regulators of the patient benefits from a new medical intervention. The COVID-19 pandemic has overwhelmed medical infrastructures and had a significant disruptive effect on the current clinical trial landscape. A number of our previous blogs have examined the response of biopharma companies in pivoting their research activities to try and develop COVID-19 treatments and vaccines.1,2 This week we take a look at the challenges COVID-19 is presenting to the operation of other clinical trials, including site and participant selection recruitment and retention, and the strategies that biopharma is adopting to mitigate these challenges.
Impact of COVID-19 on ongoing and planned clinical trials
Clinical trials are expensive, lengthy (taking on average 10-12 years) and, in the latter phases, require the participation of a large number of participants to assess the efficacy and effectiveness of a new treatment (Figure 1).3″
Figure 1. Traditional approach to clinical development