Trial oversight in SMB Pharma – Reflections on 6th CQOF

Having attended, presented at and round-table hosted at, we wanted to share some observations on the excellent 6th Clinical quality Oversight Forum in Philadelphia last week.

Firstly, I wanted to say what a great event the CQOF was – well attended, well organised, great presentations and great dialogue. Well done Kristen and her team.

There were a few more attendees than last year which is always positive, but a very different demographic and feel to the event. The focus on the relationship between trial oversight and risk-based monitoring (RBM) was much stronger than last year and interest levels in how to use trial data during the course of the trial to inform operational decision making was much stronger.

The demographic was interesting – a few large pharma companies, one CRO and the rest was all small to mid-sized Pharma. I think this is a reflection on how RBM  once was more the domain of large Pharma and CROs, but is now being focused on across the whole spectrum of companies involved in clinical trials.

My fourth observation and possibly the most important one of all is that despite the desire to move forward with better trail oversight and RBM, that most companies are struggling with knowing where to start. This feeling was cemented when I chaired a round table discussion on KRI design with 15 companies. I started the meeting by asking each of the attendees what they would like to get out of the session. A few very clear themes emerged:

  • What key risk indicators should I use?
  • How do I prioritize / weight those indicators?
  • How do I look proactively at risk, not retrospectively?
  • How do I keep things simple and affordable?

My immediate response was that those are really not difficult needs to meet. We only had 30 minutes, so we weren’t going to address all that immediately, so I offered the group that if anyone wanted to give me their business card, I’d reply the following week with a list of the top 10 KRIs which we see industry using, a description of how to derive the KRIs and how they should be used operationally. I got 15 business cards immediately!

So this week we’ve delivered on that promise and sent that information to those people who responded, and we look forward to their feedback.

On the last day in the wrap up meeting with all attendees we talked about why the smaller companies were struggling to get up and running. the feedback was really interesting:

  • We don’t have much time or resource, and so just need quick and simple guidance
  • We don’t have the resource to develop our own solutions and can’t afford the big software companies’ offerings
  • Ultimately, we need a little guidance, but not an organization wide change management program, and we need simple and cost effective technology, not expensive enterprise solutions.

At TRI we strive to work across all levels of industry and as such will be working to put together a simple and very inexpensive offering for the companies that really care about trial quality but are being overlooked by so many solution providers.

Watch this space!