harmaceutical, biotechnology and medical device companies need to ensure they have appropriate and transparent fair-market-value (FMV) procedures in place as regulatory, political and public scrutiny of industry relationships with physicians and thought leaders trickles down to clinical investigators, a US report warns.
“Currently, the focus appears to have settled on the effect of physicians consulting for pharmaceutical companies,” says the new report by Cutting Edge Information, Managing Clinical Investigator Compensation. “But the next logical step is the clinical side.”
Now is the time for companies to take proactive steps to counteract any perception of undue influence in their relationships with clinical investigators, the report urges, commenting: “Even if overcompensation is not tied to unethical actions, given the current public mood, it will reflect poorly”.
While Good Clinical Practice (GCP) standards would appear to preclude the kind of unethical situations often discussed in FMV deliberations, “the angle of scrutiny is different”, the report points out. “Much of the current concern deals more with influence than direct unethical behaviour by an investigator, whether due to company pressure or not.”
The authors call on companies to institute well-defined FMV processes based on meticulous data detailing costs and compensation ranges. The precision of these processes and the language used in making FMV determinations do matter, they stress. “It is not enough for a company to say that it is not in their best interest to overpay for investigator services.”
In contrast to their commercial activities, companies already have access to protocols and guidelines on the clinical side to support or help guide their operations towards FMV compliance, the report notes. Nonetheless, companies vary in their approaches to calculating investigator compensation.
Many, for example, “just negotiate per patient costs they deem reasonable”. This method, however, “does not drill down far enough for FMV considerations”, the report states. Compensation must also align with payments to other investigators working in the same therapeutic area or speciality, and with the same level of expertise, experience and influence.
There is an overarching need to formalise the process for determining compensation and cost structures “so that they show repeatable, precise, straightforward and transparent calculations that arrive at a certain compensation range, which is then included with other clinical cost stipulations”, the authors suggest.
The report also assembles and analyses investigator compensation data from 58 companies to identify trends and potential savings across the different phases of clinical development. In Phase 3b trials, for example, the companies surveyed budgeted on average for US$32,513 per primary investigator compensation, whereas investigators actually received US$13,436 for running a Phase 3b study.
This 59% discrepancy, together with the 34% average overspend on investigator compensation across all phases of clinical development, “validate the notion that pharmaceutical companies have more negotiating room with contract research organisations and other sites than they previously believed”, Cutting Edge Information comments.