Financial disclosure and clinical research: what is important to participants?
OBJECTIVE
To assess what participants in company-sponsored clinical trials wish to know about financial aspects of the study.


METHODS
Cross-sectional questionnaire administered to 324 participants in six clinical trials conducted at the Royal Melbourne Hospital in 1999-2000 and 2006 for non-acute conditions (asthma, chronic obstructive pulmonary disease, osteoporosis, rheumatoid arthritis, diabetes and influenza vaccine efficacy).


METHODS
Participants' desire for information on study funding, investigators' conflicts of interest, and use of accrued funds.


RESULTS
259 participants (80%) completed the survey. Participants wanted to be informed about the identity of the project sponsor (148 participants; 57%), whether the investigators owned shares in the company (105; 41%) or received travel grants (83; 32%), how much funding was accrued at study completion (88; 34%), how accrued funds were used (98; 38%), and who approved their use (91; 35%). After adjusting for year of survey and level of education, younger subjects (aged <or= 60 years) wished to be informed more often than older participants of who sponsored the project (odds ratio [OR], 2.35 [95% CI, 1.21-4.55]; P=0.012), whether the investigators owned shares in the company (OR, 2.41 [95% CI, 1.27-4.60]; P=0.007) and how much funding was available for other uses (OR, 1.79 [95% CI, 0.94-3.41]; P=0.078).


CONCLUSIONS
While most participants indicated that they would take part in clinical research again regardless of whether they received financial information, providing information on the sponsor, the investigators' financial interest in the company, whether accrual of funds is expected, and how these funds will be spent should satisfy the interests of participants in company-sponsored clinical trials.
Hutchinson
Anastasia
A
Department of Respiratory and Sleep Disorders Medicine, Royal Melbourne Hospital, Melbourne, VIC.
Rubinfeld
Abe R
AR
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D035843:Biomedical Research / Q000191:economics*; D002986:Clinical Trials as Topic / Q000191:economics; D003430:Cross-Sectional Studies; D030881:Disclosure; D005260:Female; D005378:Financial Support; D006784:Hospitals, Teaching / Q000191:economics; D006801:Humans; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D011795:Surveys and Questionnaires; D014739:Victoria