The pharmaceutical industry has a shortage of experienced principal investigators (PIs). A survey of 201 PIs who completed a FDA Statement of Investigator 1574 form showed that more than half were classed as ‘one and done’ (although other surveys have put this closer to 20%).
The statistics are stark: just 10 percent of PIs who have filed 1574 forms conduct more than five studies per year. Another concern is that the experienced PI pool seems to be aging, and there are not enough new PIs to replace those planning to retire.
Arguably the most important stakeholders in a clinical trial when it comes to success and efficiency, it’s no surprise that sponsors and regulators are considering how best to recruit and retain a community of experienced clinical researchers. Without them, site selection, qualification, and startup will continue to be a bottleneck – all resulting in cost increases for sponsors. But why are so many PIs abandoning their clinical research?
Barriers to Pursuing a Clinical Research Career
Being a PI on clinical trials is a challenging job. You’re there to ensure that patients receive appropriate care in line with the study protocol, you’re responsible for making sure all study-related activities comply with Good Clinical Practice (GCP), and that the results of your clinical trial are accurate and credible.
This has always been the case. But today’s trials are increasingly complex – larger, international, and using novel study designs and endpoints – as is the global regulatory and ethical landscape. Patient recruitment is tougher than ever, with narrow eligibility criteria and a greater number of trials resulting in a smaller pool of patients to recruit from. Additionally, the number of procedures per patient is increasing, while trial budgets are not. Study sites are being asked to do much more with much less.
In an analysis of factors that affect PI's decisions to conduct another trial, three categories of burdens were identified: workload balance, time to initiate and implement the trial, and data and safety reporting. A further 46% of PIs were dissatisfied with not being paid in a timely way.
The impact of this is clear, as one of the PIs interviewed said: “Conducting research costs me money, the time and effort is not paid and takes me away from the financially rewarding parts of my job. There is constant paperwork, site visits, protocol amendments and need to re-consent. All time sucking.”
According to Ken Getz, Associate Professor and Director of Sponsored Research at Tufts CSDD, efforts to hire and train more investigators are helpful, but “don’t touch on root causes like regulatory burden and performance inefficiencies, and it is that protocol or blueprint that needs to be improved.”
A number of solutions have been proposed to this end, ranging from providing a support structure for new investigators, to fostering more of a partnership between sponsor and PI, to integrated technologies that can support site staff running the trial.
Clearly, getting PIs paid on time is an essential. However, the Clinical Trial Transformation Initiative has taken this a step further, with a set of recommendations for strengthening the investigator site community. Across these recommendations sit a number of themes that are close to our heart at Longboat:
- supporting continuous training
- maintaining clear communications, and
- fostering a climate of mutual respect
We create technological solutions that – put simply – make life easier, not harder for PIs. From planning the logistics of patient visits, to ensuring they know what to do to stay compliant and flagging any missed procedures.
The learning curve to become an investigator is steep. Yet, if PIs are supported with the right tools we can make it easier for them, and shift them from being ‘one and done’ to ‘two, three and beyond’.