Healthy Skepticism Library item: 2025
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: Journal Article
Miller FG, Shorr AF.
Ethical assessment of industry-sponsored clinical trials: a case analysis.
Chest 2002 Apr; 121:(4):1337-42
http://www.chestjournal.org/cgi/content/full/121/4/1337
Abstract:
The rapid growth of clinical trials sponsored by the pharmaceutical industry and conducted by community physicians raises concerns about the scientific quality of this research and the adequacy of protections for research participants. In this article, we present an in-depth ethical analysis of a recent industry-sponsored placebo-controlled study for treatment of asthma. The ethical analysis uses a proposed ethical framework for evaluating clinical research focusing on seven ethical requirements: (1) scientific value, (2) scientific validity, (3) fair subject selection, (4) favorable risk/benefit ratio, (5) independent review, (6) informed consent, and (7) respect for enrolled subjects.
Keywords:
Administration, Inhalation
Adolescent
Adult
Asthma/drug therapy*
Beclomethasone/adverse effects
Beclomethasone/therapeutic use*
Comparative Study
Conflict of Interest*
Controlled Clinical Trials/economics*
Controlled Clinical Trials/statistics & numerical data
Double-Blind Method
Drug Industry*
Ethics Committees, Research
Ethics, Medical*
Female
Forced Expiratory Volume/drug effects
Humans
Informed Consent
Male
Patient Selection*
Pregnadienediols/adverse effects
Pregnadienediols/therapeutic use*
Research Support*
Treatment Outcome
*analysis
United States
clinical trials
bioethics
relationship between medical profession and industry
private physicians
clinical trials
drug company sponsored research
conflict-of-interest
reimbursement to doctors
declaration of interests
randomized controlled trials, evaluation of
recruitment of participants
safety of participants
informed consent
placebo controls
asthma
ETHICAL ISSUES IN PROMOTION: ETHICS OF TRIALS
ETHICAL ISSUES IN PROMOTION: PAYMENTS IN STUDIES
INFLUENCE OF PROMOTION: OUTCOME OF CLINICAL TRIALS
PROMOTION DISGUISED: CLINICAL TRIALS
SPONSORSHIP: RESEARCH
