Observations on CTTI’s Vision for Clinical Trials in 2030

The Clinical Trials Transformation Initiative (CTTI) presented its vision for clinical trials in 2030 this week building on its six focus areas for clinical trial improvement. The COVID-19 pandemic has certainly disrupted clinical trials, pushing several focus areas to the forefront and driving the necessity for industry to reflect on needed changes for long-term success.

• Quality by design (QbD) to write better protocols is particularly important. Researchers must ask themselves questions like: “Could this protocol be less burdensome to the site and patient without negating data collection or compromising safety?” As industry tries to strike this balance, it is imperative that researchers think critically when developing protocols to ensure a sound trial foundation.
• Patient engagement certainly came to the forefront as researchers worked to troubleshoot how to both recruit and retain patients during a pandemic. 
• Lastly, the need to shift to virtual trials in response to COVID-19 has made industry consider the benefits of digitization more than ever before. The pandemic has changed hybrid and virtual trials from ‘a nice to have’ to a ‘must have,’ or at least ‘must think about.’ Industry has had to get smart and embrace initiatives that have been waiting in the wings for quite a while. 

The COVID-19 pandemic has globally demonstrated how important clinical research is and also how quickly our industry can adapt and collaborate. It’s clear that we need to revisit the makeup of clinical trials to ensure we are conducting the most efficient and accurate trials we can.

I hope CTTI’s vision for clinical trials in 2030 will help provide a roadmap of tangible actions and activate industry change. We cannot go back to the way things were. We all need to play our part in rethinking clinical trials for the betterment of humanity. We must never forget that we are trying to progress healthcare for friends, family, neighbors, and our global community.

Aman Khera is the global head of regulatory strategy at Worldwide Clinical Trials