Having just attended the SCOPE Summit last month, I wanted to provide some general insights uncovered from

the event. These gatherings are still going strong and are a great place to network and get first-hand knowledge into what your peers are experiencing or initiating in their companies. There wasn’t a session that I didn’t walk away from with a new idea. But SCOPE has a lot of sessions daily to choose from, so it can be a challenge trying to decide which to go to. Here’s some highlights.

RBM is the gift that keeps on giving. While some may lament that RBM has never really taken off, or morphed into new-world risked-based quality management, a great goal in and of itself, don’t be fooled. RBM is going places, if based on the number of attendees at these sessions at SCOPE. The level of sharing of implementations, lessons learned, challenges acknowledged, and overall idea exchange and engagement was very high, and the excitement around others’ work was real. Hopefully, we will be able to track down some speakers for our May issue on change management in RBM to discuss their efforts.

Decentralized clinical trials, or because you need another acronym in our industry, DCTs, are on everyone’s minds. From the lessons learned from remote trials just a few years ago, DCTs are mainstream and gaining ground because of their efficiency and patient-friendly ways. eCOA, ePRO, sensors, wearables, telemedicine, mobile nurses, eConsent-you name it. If it has a need for a distant relationship for trial participation, it will be baked into a DCT. DCTs will certainly be a part of our conversation in June when we tackle patient-centric trial design.

The percentage of FDA approvals obtained by big pharma in 2018 was 26%, compared to 60% that went to firms that had never before re-ceived an approval. What this means is that the smaller or emerging biopharma needs help with its clinical trials pipeline, and, largely, they are not happy with CROs.

This is a trend that I’ve written on before and continued to hear at SCOPE outsourcing and resourcing sessions. Stories from the smaller sponsor about dissatisfaction with the attention they receive from their CRO; a lack of accountability or initiative requiring a higher level of oversight by an already stretched thin clinops department of one or two people; high costs that accompany lackluster performance. Why is the relationship management between the smaller sponsor and the CRO so bad? Apparently, we can only speculate. Is it a large CRO problem? Is it the expectation level of the smaller sponsor? Is it a lack of communication or culture problem?

I hope that this is an area that can start to get it together. Small biopharma operates on very small margins, and putting their whole hopes and dreams into a CRO that doesn’t work for them is a sad thing for medicine and discovery. We will be focusing on that issue more closely in September.

There’s always a lot to talk about in clinical trials, so keep reading us in print or online and we will keep you up to date.

 

Lisa Henderson is Editor-in-Chief of Applied Clinical Trials. She can be reached at lhenderson@mmhgroup.com. Follow Lisa on Twitter: @trialsonline