PAREXEL - Paul Evans Discusses the Trends in Feasibility and Recruitment for Clinical Trials
Feasibility and recruitment are both interesting points. The trends we see revolve around data and the availability of data and, in the latter case, around patient involvement. We start we feasibility. The old fashioned way of doing feasibility was to ask multiple investigators what they thought the recruitment rate was going to be and come up with some sort of average as the result of those. Or we would ask about the opinion leaders what they thought about the protocol. These days, what our clients expect us to do is be able to provide data to support the conclusions we make about the right strategy for delivering a trial. There are a number of tools that we’ve had to develop in order to deliver that type of data customers are after. For example, we have the country allocation tool. That’s an analysis of all of the possible countries we can go to and quantifies the attractiveness of each of those countries so that we have a clear rationale for why we’ve chosen the countries that we’ve chosen to work with. Patient insights, or EHR insights, allows us to get patient data from their EHR record. That will tell us very accurately whether the patient population that the protocol defines actually exists. Then we have a number of tools around patient recruitment that allows us to get our message out to the patients so that we can estimate whether there is patient interest in taking part in the trial. There are many data sources that we have to combine into our single strategy. When it comes to patients, the internet, and particularly social media, has probably made patients more interested than ever in their healthcare. Consequently, the key trend that we’re seeing is of greater patient involvement in clinical trials. We are increasingly involved in surveying patients or in digital listening in order to get patient views before we start the trial. We’re no longer developing clinical trials in a patient vacuum and we also see that with patient advisory groups. Increasingly, they’re becoming more and more activist and wanting to be more involved in the development of drugs for their disease and in how clinical trials are designed. All of those things are coming together to make our design better informed and more data driven.