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A look at – Outsourcing in Clinical Trials West Coast Conference

by Kristin Gross

The 10th Annual Outsourcing in Clinical Trials West Coast Conference covered a wide range of subjects. New this year were three tracks on clinical innovation, early phase development, and data-driven approaches, and attendees heard the latest on artificial intelligence and blockchain technology. Whiteboard sessions, panel discussions, and workshops fostered active brainstorming. A couple of sessions arrived at strategies and study design that may enable faster progression to Phase 2b, while keeping patient safety intact. Q&A and roundtable discussions focused on the challenges around patient engagement as well as clinical ancillary supplies. The study hurdles discussed included getting clinical supplies through customs to sites on time with temperature stability, plus global patient recruitment.

The presentation I enjoyed most was a case study investigating the drivers and challenges of mobile-enabled clinical trials. The session began by focusing on the microbiome, part of the science behind the company’s lead program. The engaging speaker shared some great visuals and data. He then described how the company’s Phase 2b acne trial used a “site-less” clinical trial model. Lesion counts were assessed from “selfies” and screening occurred through iPhones with an interactive component prompting patients to respond. The software had the ability to gauge whether a patient was actually reading the content. This study marks the first time a Phase 2b interventional randomized placebo-controlled trial of this kind was completed entirely virtually! The study also achieved success in terms of accelerated enrollment and diversity of participants. I walked away from this session with more than I had expected.

I remember when OCT West Coast started a decade ago. It’s great to see how much the conference has grown over the years to the benefit of all who attend. It now offers a large Bay area representation with plenty of opportunities to network.

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