[Clinical researchers and the pharmaceutic industry. The research contract is not an addendum].
The relation between a pharmaceutical company and a clinical investigator combines a certain form of entrepreneurship with scientific endeavour. Both parties are concerned with the content of the clinical study as well as with its business aspects. A good contract is essential for the project to succeed. In three cases based on actual experience the contract failed. In the first case, dosage miscalculation in the hospital pharmacy led to side effects in patients as a consequence of which the study was stopped. The pharmaceutical company sued the investigator. In the second case the investigator published data in a congress abstract, which prevented a patent by the company. In the third case scientific information was published by the company with the principal investigator featuring in the acknowledgement section of the article only. Investigators should have their own standard contract ready, and they should invest time and energy in understanding the contracts of the research they are carrying out.
Afd. Klinische Farmacologie, Universiteit Leiden. ac@chdr.nl
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AF
Cohen
D003284:Contract Services / Q000331:legislation & jurisprudence*; D004345:Drug Industry / Q000331:legislation & jurisprudence*; D006801:Humans; D018973:Intellectual Property; D016365:Liability, Legal; D009426:Netherlands; D012106:Research / Q000331:legislation & jurisprudence*; D000078329:Workforce
Klinisch onderzoekers en farmaceutische industrie. Het onderzoekscontract is geen bijzaak.