Our “5 Minutes 5 Questions” interviews have been fascinating. All the industry leaders we’ve talked to have a great story to tell. There are some common themes, like the hope that the pandemic will force the industry to adapt and adopt technology, and grasp the opportunity to properly embrace remote and central monitoring. In her interview, Suzanne Kincaid from Aperio said that a poll taken at the recent Society for Clinical Data Management (SCDM) conference showed 72% of respondents still haven’t fully adopted RBQM in spite of it being a requirement. In our most recent interview with Kristen Stallcup from Covance, she made a comment about Technology Debt in clinical trials and it struck me as a really important and interesting concept.
Most people are familiar with the term Technology Debt in relation to software development. The idea that you can create software quickly to get something done, but by doing that you’re storing up problems (‘debt’) that will have to be fixed (‘repaid’) at some point when you need to re-do the work in a more structured form it in order to scale. This is often more expensive than doing it right at the start, but people do it because of time and other pressures. You may also be familiar with the term Management Debt. Making short-term, expedient decisions (often in relation to hiring or promoting) that store up bigger problems that will need to be addressed in the future.
When it comes to RBQM, companies are often storing up ‘debt’ because they don’t implement RBQM tools and approaches right from the start of a trial. Where they do they obviously get the benefits of good risk assessment, management and controls, putting the trial in the best possible shape for success. But what about trials that haven’t had RBQM implemented from the start? While lots of people think it doesn’t matter, it does. We know that the FDA have issued notices for companies to retrospectively conduct protocol risk assessments for example. They are taking it seriously, and are ramping up the pressure on the industry to comply.
The reality is that it’s relatively easy to apply RBQM to an existing trial, and it can have an instant and significant impact. Applying Risk Assessment and Central Monitoring tools to an existing study immediately identifies trends, patterns and outliers that trial teams didn’t know were there. When you do know, you can do something about it and focus your precious and limited resources on the most important areas. That could be the difference between success and failure, not just for an individual site, but for the whole trial.
So, if you haven’t applied RBQM to all of your trials and you’re storing up debt for the future, think about paying down that RBQM debt today. You know it makes sense.