Our Chief Commercial Officer, Rob Nichols, and I just returned from the CBI RBM (risk based monitoring) conference in Philadelphia. Although we have attended a number of conferences around the world this year, this was my first RBM focused event in a while. The progress from vendors, pharma and CROs was truly impressive. A year ago there were few who could speak to their experience executing risk based trial oversight; much of the dialogue centered around the feared negative effects of what we at least all agreed could be tremendously disruptive. At this conference, case studies abounded, and there was much more time spent thinking about the possibilities that face us, not just the challenges. And kudos to CBI for putting together a good mix of themes and presentations, MC’ed with humor by Sina Djali of Janssen.

With all that, I thought I would share the most interesting themes of the presentations, Q&A and discussions over food and drinks, in no particular order:

  • There is a growing effort to embed statistical review. At Algorics it has always been a core goal of ours, one that we have begun to realize with the release of Decision Factory. The conference saw several other examples of methods for investing greater meaning in the data we review, many an implementation of site risk scoring.
  • At a more granular level, questions are being asked about validating algorithms for risk scores etc. We know these systems will be closely assessed by auditors and inspectors.
  • There are several companies (CRO and pharma) that have 10s of studies ongoing using an RBM approach of some sort. PPD noted 75 active trials, BMS noted 30 and that all future trials would now use the model. We were also presented with the results of several surveys – while 60% of responders in one said they expected to be running RBM trials in the next 2 years, only 48% think they will decrease their burden.
  • There was a deeper dialogue on the quality model that underpinned the original effort – Quality by Design. We still struggle to fully understand and apply the concepts in the GCP world but that knowledge is growing across the sector and will allow us to develop more sophisticated operational implementations in the future. There was an interesting discussion on how we measure risk, ‘not very well’ being the consensus. A common concern was how to focus high risk, high frequency issues.
  • Our presentation with Clinical Ink on combining Acuity with their eSource platform SureSource was well received (sorry, had to pat myself and Jonathan Andrus of Clinical Ink on the back there J). In subsequent conversations with attendees it was clear that the benefits of eSource in terms of data entry lag, cleanliness etc. are magnified in a continuous RBM model.
  • The site’s voice was well represented in a talk and a panel. The central theme for me here was communication. Some really interesting information shared was that more remote monitoring adds complexity in providing information when needed to the clinical team. The sites need warning of what will be needed so they can be ready when a call comes in from a monitor. Sites would also welcome transparency of their performance in relation to their peers, to help them drive improvements and would truly welcome guidance on what triggers site visit or audits, in order to focus resources on keeping those issues from arising. In summary the site is as much a partner in RBM as the other stakeholders.
  • Keep It Simple…several of the case studies illustrated that the TransCelerate framework is in use, and is proving valuable in implementation efforts. However, there was a repeated statement that starting with the simplest implementation of those concepts that meets need was the best way to roll out RBM. I expect that the sophistication of the models in use will increase as organizations become more familiar with them.
  • Risk based prioritization of activities has led to the expected side effect of reducing SDV and reducing site visits by anything from 50% to 100%. However, the goal is clearly not to stop visiting sites but to visit when it adds the most value. Now we are thinking about what do with that hard won free time! Cost control is a goal but there are opportunities to use resources on more high value activities.

    And last but not least…we still have debates to work through on what exactly RBM is, and even what to call it! On the latter for now I will give the nod to CBI themselves with the formal conference title ‘Risk based trial management’.