Whether deemed appropriate or not, incentive payments and non-monetary inducements have become a part of Sponsors’ strategy worldwide to boost recruitment, to reduce study duration, and to receive marketing approval within the shortest possible time period. The reasons why such incentives are popular among Sponsors and investigators are well-known (HHS, 2000, p.1):
- Too many drugs (often, competitive) are in development simultaneously,
- Increased costs of drug development due to more complex nature of RCTs ,
- Desire to decrease development time and to extend marketing time under a patent,
- Recruitment has become slower and complicated due to excessive number of studies and inclusion/exclusion criteria that are often unfeasible in the developed world (e.g., limited number of untreated patients, the number of patients who would agree to take placebo, insurance issues, etc.).
Though some assert that financial incentives are necessary to compensate investigators for their professional efforts and time (and I tend to agree that it is logical and necessary, as one can hardly imagine that busy physicians would participate in a third party’s clinical research at their own expense), there are several major concerns with regard to such stimuli that should be addressed (HHS, 2000, pp.2-3):
- Violations of subjects’ rights: often highly abusive recruitment strategies are used to enroll sufficient number of subjects (such as coercive character of participation, threat to be deprived of certain rights / treatment options, insistent contacts of study personnel, etc.),
- Confidentiality and privacy issues: unwanted calls/e-mails from investigators, use of personal medical charts or other personal information to retrieve data of potential subjects, use of personal data and subsequent contacts by third parties that are not authorized by patients to use their data/contact them,
- Principles of informed consent are compromised or neglected: subjects have right to receive comprehensive information about the research, to ask questions and to receive explanations, as well as to voluntarily agree or refuse to participate without any penalties. However, highly competitive environment often cause investigators to wrongly interpret the nature or aspects of a study in order to induce subjects into the trial,
- Violation of inclusion/exclusion criteria: if enrollment is too slow, investigators may neglect or alter some criteria to include patients that are ‘almost’ suitable (Macklin, R., n.d., cited in Larkin, M., 1999). This is alarming because of possible AEs/SAEs and also because of problems with further interpretation and applicability of trial results,
- Representativeness of cases/patients’ populations: financial incentives in certain practices/clinics can lead to difficulties in generalizability due to inclusion of limited populations with specific conditions different from average (Foy R., Parry, J., McAvoy, B., 1998, p. 1169),
- Disproportion of grants within industry: according to Rao, J.N. (1999), difference between grant amounts offered by different sponsors to different investigators leads to possibility that certain trials will be preferred because of grant and not because of its scientific importance. Another problem is that patients outside trial protocols can receive worse treatment and care that involved subjects.
Generally, it is necessary to find balance between sponsors’ and investigators’ interests and subjects’ wellbeing. I believe that incentive payments are necessary, but both patients and investigators must always have choice to make fully informed decisions.
- Foy R., Parry, J., McAvoy, B. (1998) ‘Clinical trials in primary care: Targeted payments for trials might help improve recruitment and quality’, BMJ, 317, October, p. 1169 [Online]. Available from: http://www.bmj.com.ezproxy.liv.ac.uk/cgi/reprint/317/7167/1168 (Accessed: 23 October 2010).
- HHS (2000) Recruiting Human Subjects: Pressures in Industry-Sponsored Clinical Research [Online]. Available from: http://www.oig.hhs.gov/oei/reports/oei-01-97-00195.pdf (Accessed: 22 October 2010).
- Larkin, M. (1999) ‘Clinical trials: what price progress?’, The Lancet, 354 (9189), October, p. 1534 [Online]. Available from: http://dx.doi.org.ezproxy.liv.ac.uk/10.1016/S0140-6736(05)76572-7 (Accessed: 23 October 2010).
- Rao, J.N. (1999) ‘Paying doctors for clinical trials is unethical’, BMJ, 318, May, p. 1485 [Online]. Available from: http://www.bmj.com.ezproxy.liv.ac.uk/content/318/7196/Letters.full.pdf (Accessed: 24 October 2010).