The shorter a new pharmaceutical product, a drug or a medical device, takes from beginning development to its commercialization the higher the profit for the developing company. This simple fact has stimulated the pharmaceutical companies to use any monetary and non-monetary inducements in their reach to obtain approval for marketing and commercialization in the shortest possible time. ). As pharmaceutical companies are facing bigger competition they develop more aggressive enrolment techniques for their clinical studies (Larkin 1999). It is a common practice for pharmaceutical companies to encourage recruitment with monetary incentives to medical practices (McKinstry 2007.
As has been extensively commented monetary incentives to site investigators are an effective strategy to positively influence enrollment in a clinical trial (Foy 1998). Compensation in the form of cash increases the response of physicians to mail surveys (Deehan 1997).
One of the biggest risks to the ethical conduction of clinical trials is that investigators/physicians may 1) exert some pressure to their patients to enter a clinical trial, and b) the inclusion / exclusion criteria may not be strictly followed when selecting possible research subjects. In order to counteract them, some investigators have suggested that investigator/physician monetary remuneration must be included as an important part of the ICF (Ferguson 1998).
It is important to also consider that providing a very low monetary incentive to physicians/investigators will result in lack of interest and devoted time to the trial itself, which not only results in less subjects recruited but in overall less attention to detailed reported of adverse events and a higher rate of patients dropping out of the study because of less information provided to them. Hence adequate compensation for time spent conducting a clinical trial is important (Raftery 2008) as the ICH GCP allows reasonable payments to physicians/investigators. The major difficulty is to define what a reasonable or adequate compensation is. A common belief would be that the physicians/investigators need to be compensated for the devoted time and effort as what they would be compensated during similar work is provided in clinical care. This approach raises the question how to compensate multiple physicians/investigators participating in a multicenter international clinical trial, do physician/investigators located in developing nations, where the healthcare salaries are significantly lower, should be paid differently from their counterparts in developed nations when doing the same exact work?. What seems to be an adequately fair compensation in the US or Europe might be a coercible high compensation in South East Asia.
As commented by Jeff Parke in Applied Clinical Trials: “Documentation will also ensure that all payments are fair, reasonable and generally commensurate with Fair Market Value (FMV) and will not create conflicts of interest that could jeopardize the health or welfare of human subjects participating in a
