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Financial disclosure and clinical research: what is important to participants?

Anastasia Hutchinson and Abe R Rubinfeld
Med J Aust 2008; 189 (4): 207-209. || doi: 10.5694/j.1326-5377.2008.tb01984.x
Published online: 18 August 2008

Abstract

Objective: To assess what participants in company-sponsored clinical trials wish to know about financial aspects of the study.

Design, setting and participants: 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).

Main outcome measures: 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 ≤ 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).

Conclusion: 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.

Methods

A questionnaire was developed to explore the information that participants wished to receive on financial aspects of clinical trials. To ensure correct focus and clarity, questions were developed by iterations after review by hospital staff, patients not involved in clinical trials, and clinical trial volunteers. Three areas were covered: (a) funds the department received for conducting a study; (b) whether investigators had a financial conflict of interest (eg, share ownership or receipt of compensation); and (c) how profits were to be spent. Participants were also asked about their motivation for participating in the clinical trial and whether they would participate in future without disclosure of financial arrangements.

Results

Two hundred and fifty-nine participants (80%) completed the survey; 134 (52%) were male, the median age was 70 years (range, 21–93 years), and 71 (27%) were aged ≤ 60 years. Participant demographics are shown in Box 1.

Discussion

Our findings suggest that about a third of subjects wished to have information on financial aspects of clinical trials. This proportion was relatively independent of the condition being studied, and we did not observe significant differences between the two time periods analysed. Our results indicate that younger participants had a greater preference for financial information than older participants. Importantly, participants wished to see accrued funds used for medical research in general or into their condition, or for staff education, but not for personal use by either patients or investigators.

A number of factors may limit the generalisability of our findings: our clinical trial participants were all English-speaking (to fulfil informed consent criteria) and tended to be around retirement age. In addition, clinical trials for malignancies or specific severe conditions with otherwise inadequate therapy were excluded.

Nevertheless, our findings are in broad agreement with those of an American study, which found that 64%–87% of potential trial participants with a wide variety of medical conditions would prefer to have disclosure of financial conflict of interest.7 In contrast, another study in the United States found that only 20% of subjects wished to receive this information;8 however, these subjects all suffered from malignancies and both their motivation to participate in clinical trials and their focus on financial disclosure may have been different from participants with other illnesses.

Participation motivated by lack of availability of medication or other treatment options, or for financial reasons, was not a significant factor in this survey. We excluded clinical trials for life-threatening or severely disabling conditions with limited therapeutic choices, where participants’ immediate health concerns might take priority over interest in the conduct of the clinical trial. Most internationally available medications for the conditions studied were readily available to patients under the Australian health care system. While financial rewards may improve patient adherence with therapy,9 they were not a basis for participation in these studies because, under the hospital’s guidelines, participants were either not paid at all or received only nominal payments for transport or parking expenses. The third of respondents who volunteered so they could receive close monitoring of their condition suggests that self-interest is a significant factor in clinical trial participation,10 possibly reflected in the preference for accrued funds to be spent on research into their own condition.

Younger adults with higher levels of education tended to be more interested in issues related to financial management of trials and potential conflicts of interest. This may reflect their level of education, their focus on financial issues in general, or their greater awareness of issues relating to conflict of interest or research integrity. On the other hand, older, predominantly retired adults may have been more able to donate their time to medical research and more willing to delegate responsibility for research integrity to bodies such as institutional ethics committees. We did not observe a substantial change in attitudes between the two periods when the surveys were conducted, but younger adults were not represented in the 2007 data. A larger study with more equal age distribution is needed to explore differences in attitudes between different generations.

While 88% of our respondents indicated that they would take part in clinical research again regardless of whether they had information on financial aspects of the trial, our findings suggest that providing information on the sponsor, the investigators’ financial interest in the company or the product, whether accrual of funds (after expenses) is expected, and how these funds will be spent should satisfy the interests of Australian participants in company-sponsored clinical trials.

Received 13 November 2007, accepted 7 May 2008

  • Anastasia Hutchinson1
  • Abe R Rubinfeld2

  • Department of Respiratory and Sleep Disorders Medicine, Royal Melbourne Hospital, Melbourne, VIC.


Correspondence: abe.rubinfeld@mh.org.au

Acknowledgements: 

We thank Annette Cross and Susanne Schultz, Clinical Research Coordinators, for their assistance with participant recruitment and distribution of surveys.

Competing interests:

Abe Rubinfeld has received honoraria for professional lectures from GlaxoSmithKline (GSK), AstraZeneca, Pfizer and Boehringer Ingelheim, and has participated in clinical trials conducted on behalf of GSK, AstraZeneca, Roche, ALTANA Pharma, Merck Sharp & Dohme and Bristol-Myers Squibb. No outside interests were involved in the conduct of this project or writing of this paper. This study was funded by the Respiratory Medicine Special Purposes Fund, Royal Melbourne Hospital, which has been accrued from participation in various company-sponsored clinical trials.

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