Over the past four months, COVID has led to widespread changes across the clinical research industry, many of which will be carried forwards.
1. Changes in Clinical Trial Protocol & Design
According to data collected by the Tufts Center for the Study of Drug Development (CSDD), as of May 20, 2020, more than half of the top 50 pharmaceutical sponsors had to make changes to their clinical trial protocols since the pandemic began. The remaining 45% have continued to follow their original protocols.
The CSDD also found that 30% of sponsors have switched from the standard clinical trial model to those with remote or virtual components. While interest in decentralized trial designs had been growing slowly, the pandemic quickly accelerated the implementation of hybrid models. By including technological solutions, researchers are able to collect accurate and more frequent data from patients outside of the clinic. Furthermore, it allows for the collection of more diverse data.
As Mark Wildgust, vice president of global medical affairs, oncology at Janssen, says, “We are creating a new normal and we can and should live in the new normal. We have found ways to succeed in this new virtual world and we have to retain the learnings and apply those going forward.”
2. Improvements in Clinical Trial Participant Involvement & Enrollment
To continue conducting study visits while complying with social distancing or stay-at-home mandates and to collect the necessary endpoints, research sites and sponsors rapidly adopted new technology. As such, patients have been presented with flexibility and more options that were previously unseen by the industry. Moving away from site centered approaches and towards patient centric approaches, site staff have been able to engage more closely with their patients and reduce the amount of burden on participants.
According to an analysis by Ken Getz, deputy director and research professor at the CSDD, Black patients and Hispanic patients have been underrepresented in every area of research and there has been no improvement over the past 10 years. By creating more options for participation through electronic solutions, research becomes accessible and convenient to a more diverse population. Consequently, the industry will be able to start tackling another key concern in research: representative clinical trial enrollment. Editor’s note: For more information on how the industry can achieve representative enrollment, read advice from Dr. Mitchell.
3. An Increase in Collaboration In the Clinical Trial Industry
With the common goal of developing a vaccine or treatment for the novel coronavirus, there has been significantly more collaboration among researchers, sponsors and regulators. In the analysis by the CSDD, data revealed that the number of co-development arrangements publicly announced over the past four months is greater than the total that have been made in the three years before the pandemic. The CSDD examined 50 sponsors and found that as of March 30, 2020, 34% were involved in the independent development of treatments and vaccines and 42% were engaged in collaborative development. Fast forwarding to May 8, 2020, these numbers increased to 46% and 56% respectively.
While collaboration has always been a part of clinical research, the past few months have resulted in a massive increase in partnerships as pharmaceutical research companies are no longer viewing each other as competitors. “We all see each other as members of the same team with one enemy, and that is COVID-19,” said Wildgust. Getz adds that collaboration is also happening in more innovative and intense ways.