Decentralized is the keyword

I stumbled across a McKinsey article back in June, which gave me some food for thought but also confirmed some of my assumptions on the future of clinical trials. I have summarized some of its findings for you. The link to the full article is also listed at the bottom of this post.

The main point of the article is that the Covid-19 pandemic has catalyzed the adoption of decentralized clinical trials. The increase in trial activities conducted remotely and in participants’ home has been tremendous. The conclusion is obvious: the future trial paradigm is meeting patients where they are.

This development has been enabled by a constellation of evolving technologies and services (electronic consent, telehealthcare, remote patient monitoring, etc..

This could theoretically lead to fully virtual trials, but in the short term, most sponsors and investigators rather expect to use one of more decentralization elements based on their suitability for their end points, patient population and treatments.

Biopharma companies tell us that the time is ripe for a step-up in clinical trial decentralization because of:

• growing comfort with health technology, including from the physicians end
• enhanced importance of patient convenience
• maturing tools for data gathering (novel sensors, voice, camera, video) which are increasingly validated
• regulatory acceptance: prompted by the pandemic, regulators have issued guidance permitting the use of alternative clinical trial approaches
• partner ecosystem: technology innovators are investing and integrating to provide sponsors with more seamless and complete offerings.

The article also lists challenges to this important development. I encourage you to read the full version.

My next post will expand on the numerous statistics included in this article and my personal thoughts on the whole issue!

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