The compensation of patients injured in clinical trials.
The problem of 'no fault' compensation for patients who suffer adverse effects as a result of their participation in clinical trials is discussed in the light of the guidelines issued by the Association of the British Pharmaceutical Industry (ABPI) and our recent experiences in reviewing protocols submitted to the local ethics of surgical research sub-committee. We have found a variety of qualifications being applied by pharmaceutical firms which are not in the spirit of the guidelines, let alone the interests of the patient, and we suggest a means whereby the patients can be assured of fair treatment in the event of 'no fault' injury.
Barton
J M
JM
Borders Health Board, Edinburgh University.
Macmillan
M S
MS
Sawyer
L
L
D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D035881:Compensation and Redress; D004345:Drug Industry; D064420:Drug-Related Side Effects and Adverse Reactions; D026724:Ethical Review; D017041:Ethics Committees; D028744:Ethics Committees, Research; D006801:Humans; D016365:Liability, Legal / Q000191:economics; D033281:Nontherapeutic Human Experimentation; D010344:Patient Advocacy / Q000331:legislation & jurisprudence*; D035842:Research Subjects; D036302:Therapeutic Human Experimentation; D006113:United Kingdom