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Attitudes Toward Research Participation and Investigator Conflicts of Interest Among Advanced Cancer Patients Participating in Early Phase Clinical Trials

Stacy W. Gray, Fay J. Hlubocky, Mark J. Ratain, Christopher K. Daugherty

From the Section of Hematology/Oncology, Cancer Research Center, Committee on Clinical Pharmacology and Pharmacogenomics, and MacLean Center for Clinical Medical Ethics, University of Chicago, Chicago, IL

Address reprint requests to Christopher Daugherty, MD, The University of Chicago, MC 2115, 5841 S Maryland Ave, Chicago, IL 60637; email: cdaugher{at}medicine.bsd.uchicago.edu

	ABSTRACT

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Purpose Although both financial and intrinsic conflicts of interest can exist throughout the drug development process, little is known about how advanced cancer patients enrolled onto early phase clinical trials perceive investigator conflicts of interests.

Patients and Methods We interviewed 102 advanced cancer patients enrolled onto phase I clinical trials using a standardized survey that addressed multiple issues related to conflicts of interest and research participation.

Results Fifty-five percent of patients would not be concerned if physicians involved in running a clinical trial had financial conflicts of interest, whereas 65% of patients would be concerned if physicians involved in running a trial had intrinsic conflicts of interest. Most patients reported that potential conflicts of interest should be disclosed to patients on research trials (52% for financial conflicts of interest and 61% for more intrinsic conflicts of interest). Most patients would be willing to participate in trials after learning conflict of interest information (63%). Younger patients expressed more concern regarding financial conflict of interest than older patients (odds ratio, 6.22; 95% CI, 1.41 to 27.24).

Conclusion Patients with advanced cancer are equally, if not more, concerned about traditional intrinsic conflicts of interest as compared with financial conflicts of interest. Patients generally believed that conflict of interest information should be disclosed to research participants. The fact that younger patients expressed more concern about financial conflicts of interest may have the potential to influence clinical trial participation rates. The actual impact of conflict of interest disclosure to research subjects needs to be evaluated more carefully.

	INTRODUCTION

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Recent studies report that 70% of funding for clinical drug trials comes from industry and approximately one third of investigators at academic institutions have personal financial ties with industry sponsors.^1-4 Although collaboration between industry and academic investigators has led to important scientific advances,^5,6 there is concern about how such collaborations create physician-investigator or institutional conflicts of interest (COIs).^7-9

For biomedical investigators, significant COIs can be delineated into two broad categories: financial and intrinsic.¹⁰ Common examples of financial COIs include ownership of stock or stock options in a company involved in investigating the technology or drug under development, paid honoraria for speaking or consulting for the sponsor of a trial, ownership of patents on a technology or drug being studied, and acting as a direct employee of the industry sponsor.^7,7a Intrinsic COIs are ubiquitous in research and include an investigator's perceived need to engage in and publish research to achieve career advancement, to receive accolades from peers and professional societies, and to be competitive for grant funding.^10-12 Intrinsic COIs are well described in the basic sciences, where the pressure to "publish or perish" can lead to data falsification and poor quality research methods.^13-15

Both financial and intrinsic COIs can bias research at multiple levels: during the design of the study, during the enrollment process, during collection of data, at the time of data analysis, and at the time of publication. Financial COIs and industry funding have been shown to be correlated with pharmaceutical treatment recommendation guidelines, likelihood of research publication, and trial outcome.^16-20 There are also real concerns that COIs can cloud investigators' judgments, leading to research activities that inappropriately increase risks to prospective participants.^21,22

Government agencies, professional organizations, and scholars have examined how COIs ought to be managed.^7-9,23-27 Although recommendations have ranged from effectively prohibiting financial COIs to advocating policies that consider financial COIs on a case-by-case basis, these recommendations have not included any uniform penalties.^27-31 A notable exception is the action initiated in 2000 by the Department of Health and Human Services to pursue legislation enabling the US Food and Drug Administration to levy civil monetary penalties with fines of up to $250,000 per investigator and up to $1 million per institution for violations of "important research practices," including those related to financial COIs.³²

Within academic medicine, investigators (and institutions) have been allowed to monitor and regulate COIs in research only when (and if) they are perceived to arise. Overall, there is a great deal of diversity in policies from institution to institution,^33,34 with many academic investigators poorly informed about their own institutional policies.³⁵

One common theme that arises repeatedly in these recommendations is the perceived need to mandate disclosure of COIs to academic institutions, peer-reviewed journals, professional society meetings, government agencies, research staff, and—perhaps most significantly—to research participants themselves. Such disclosure presumably allows increased transparency in medical research and has wide appeal because it aims to simultaneously curb abuses and avoid additional government regulation.³⁶ Proponents of disclosure argue that it can increase patient autonomy, benefit research participants, garner greater public trust, and decrease legal liability.^24,37,38 However, on the basis of the most recently published data, only 40% of academic institutions mention COI disclosure to research participants in their policies, and only 1% actually have required disclosure to research participants.^33,38

Little published research exists examining how patients as participants in clinical research view any such COI information. A study by Kim et al³⁹ showed that 64% to 87% of patients afflicted by chronic illness believe that financial COIs should be disclosed to study participants, and approximately 30% of these patients would not enroll onto a clinical trial after learning about such conflicts. A recent study by Hampson et al⁴⁰ found that only 35% of interviewed patients participating in cancer clinical trials believed that financial ties should be disclosed to participants, and approximately 80% reported that financial COI information would not affect their trial participation.

To examine these issues in greater detail, we conducted a prospective study evaluating how advanced cancer patients enrolled onto early-phase clinical trials of experimental agents perceive investigator COIs. The early phase of cancer drug development is a particularly important setting in which to examine issues of COIs because the principal investigators who conduct early-phase clinical trials often are intimately involved with the drugs that are being tested and/or the research-sponsoring companies. It is not uncommon for these physician-scientists to have worked on the molecules in the discovery phase or the preclinical phase, and/or to have proprietary interest in the drugs being studied. These investigators potentially may be more susceptible to COIs than are investigators of later phase clinical trials (which often are conducted by a collaborative group) who often do not have the same level of intellectual and/or financial investment in the drug. The second reason that it is important to study the influence of COIs in advanced cancer patients is that these patients often have few therapeutic choices and may be more willing to take risks than cancer patients who have more well-defined therapeutic options. Lack of alternate options may lead some advanced cancer patients to be more vulnerable to persuasion and more inclined to participate in trails of experimental agents. It is arguably more imperative that these patients be aware of all of the risks involved in trial participation, including those that may be a result of possible COIs, so that they can make more informed decisions.

	PATIENTS AND METHODS

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Participants
Participants were selected by convenience sampling from the University of Chicago Advanced Solid Tumor Clinic at the time of enrollment onto a phase I trial or at trial participation follow-up. Participants were eligible if they were enrolled onto a phase I research trial, could communicate effectively in English, and were medically and mentally capable of participating in the study. We chose to interview patients enrolled onto early-phase clinical trials rather than all eligible patients because we were specifically interested in learning about attitudes toward COIs from actual trial participants. Efforts were made to approach every patient enrolling onto a phase I trial until a target goal of 100 interviews was completed. Interviews were conducted between May 2005 and February 2006. Participants were approached in clinic or in the chemotherapy suite by a research coordinator, who provided participants with a scripted description of the study and obtained oral informed consent before conducting the interviews.

Interviewer
The interviewer held a masters degree in bioethics with additional training in the behavioral sciences. In addition, the interviewer had prior experience in obtaining medical histories and conducting surveys of advanced cancer patients.

Interview and Survey Instrument
Information was obtained from the participants via structured, face-to-face interviews using both quantitative and semiquantitative methods, including open-ended questions seeking short but unstructured responses. Questions were read from a standardized survey form and interviews lasted 30 to 45 minutes. Participants' responses were handwritten on the survey form by the research coordinator.

All survey questions were developed by the investigators or adapted from prior studies.^39,41 The survey initially was given to a pilot sample of 29 participants. The results of the pilot guided the investigators to refine, clarify, and improve some of the questions. Information obtained also included patients' sociodemographic and cancer-specific clinical information, and history of prior research trial participation.

Participants were asked if they believed that other people might benefit when patients participate in a research trial in a dichotomous question (yes/no). This was followed up with an open-ended question asking the participant to state who would benefit. Additional information was then obtained through a series of dichotomous questions that asked about the possibility of benefit to specific populations (eg, society, future patients). Participants were asked a dichotomous question regarding whether they believed research participants should be concerned about potential investigator financial COIs (eg, stock ownership, acting as a paid consultant) and potential intrinsic COIs (eg, needing to enroll patients onto trials and publish results to advance the investigator's career). Participants were also asked to identify why research participants should/should not be concerned about the potential COIs, if they believed research participants should be informed of potential investigator financial COIs, and if they believed patients would still be willing to participate in research trials if they learned that investigators had potential COIs.

Finally, participants were asked a series of questions about their attitudes toward medical research, whether physicians might be pressured by their institution to enroll patients onto trials, and if patients should feel differently about trials funded in different ways (eg, government-funded trials, industry-sponsored trials). Responses were measured on a five-point Likert scale (strongly agree to strongly disagree) with an open ended follow-up response option. To clearly dissociate the interview topics from the patients' participation in a clinical trial and to avoid a negative impact on patients' relationships with their physicians (and at the request of our institutional review board), all questions regarding investigator COIs were framed as entirely hypothetical in nature and not related to specific trials or investigators in the Advanced Solid Tumor Clinic at the University of Chicago (Chicago, IL).

Statistical Methods
The primary statistical analyses were descriptive in nature. ² tests examined the associations between attitudes toward investigator COIs, respondent demographics, and attitudes toward research. Multivariate logistic regression analysis examined the association of demographic variables and attitudes toward investigator COIs. All analyses were completed using STATA 8 statistical software (STATA Corp, College Station, TX). Missing data were excluded from the analysis.

	RESULTS

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A total of 119 patients were approached for participation and 102 patients completed the interview (86% response rate). Sixteen patients (14%) refused or failed to complete the interview, as a result of patients' current medical status and/or interruption by clinical staff. The characteristics of the participants are listed in Table 1 (survey questions 1 to 5 and 9 to 11).

Multivariate analyses were performed to test for associations among patient characteristics and concern about investigator financial COIs (Table 6). After controlling for sex, race, marital status, and education, concern was found to be associated with age, with participants younger than age 50 years more concerned than those older than 70 years (odds ratio [OR] = 6.22; P = .02). The association between age and concern about financial COIs held when age was dichotomized (younger than v older than age 50 years; OR, 1.35; P = .011) and trended toward significance when age was analyzed as a continuous variable (OR, –0.04; P = .055; age from youngest to oldest).

	DISCUSSION

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A majority of participants believed that patients enrolled onto research trials should be concerned about investigator intrinsic COIs, whereas less than half of participants believed that patients should be concerned about investigator financial COIs. One possible explanation for these findings is that participants may be more comfortable and familiar with financial payments for work performed than they are with the rewards associated with an academic career. In fact, in several open-ended responses to our questions, participants explained that financial incentives for investigators were expected, integral to the research process, and deserved, especially if the research was successful. For example, one participant said "why should they [research participants] worry about financial ties, it is all part of the process" and another explained that it is like "other jobs where you get a bonus." Another possibility is that financial incentives are seen as appropriate because free market principles are prominent in American culture. A number of participants mentioned that they were comfortable with financial payments because it is a "capitalist society" and physicians could make choices in a "free enterprise system." In contrast, participants seemed to view intrinsic COIs with more skepticism and had a greater amount of concern that the physician/investigator was conducting the research for selfish means rather than to benefit patients enrolled onto a trial. Some participants expressed concerns about how intrinsic COI could introduce bias into research, as well as concerns that patients would be used as "guinea pigs," and the fact that physician-investigators should have a moral or ethical obligation to put the patient's interests before their own interests.

It is interesting to note that 44% of participants in our study reported concern about financial COIs, whereas Hampson et al⁴⁰ found that less than 10% of participants were worried about financial COIs. A possible explanation to account for this apparent discrepancy may be that in the study by Hampson et al, participants were asked about how worried they are about their doctor having financial COIs, whereas we asked participants if patients should be concerned if a physician has financial COIs. Participants may think that their own physician would be unlikely to be influenced by COIs but they might feel that other physicians (with whom they have no personal relationship) would be more likely to be negatively influenced by financial ties.

A relative majority of participants believed that both intrinsic (61%) and financial (52%) investigator COIs should be disclosed to patients participating in research trials. Prior work has shown that calls for disclosure range from 35% to 87%.^39,40 Our data also confirm prior work demonstrating that a majority of individuals believe that patients would still be willing to participate on clinical trials after learning COI information.^39,40

The fact that concerns about financial COIs were strongly associated with younger age is worth noting. Low cancer clinical trial recruitment rates have been a longstanding problem, with trial participation estimated at 2% to 5% of the cancer patient population.^42-47 Younger age has been shown to be a predictor of trial participation, interest in clinical trial information, and positive attitudes toward clinical trials.^42,46-51 Thus, our results suggest that concerns about financial COIs may be highest among the population of cancer patients that is the most likely to enroll onto a clinical trial. Despite the fact that a majority of participants stated that they believed patients would be willing to participate in clinical trials after learning COI information, a sizable minority (37%) stated either participants would be unwilling to participate or that they were uncertain if patients would participate in trials after learning about investigator COIs. Importantly, willingness to participate did not vary by age in our study. These data suggest that the increased levels of concern about investigator financial COIs in younger participants will not translate into lower clinical trial participation. Our results highlight the need for a better understanding of whether and how disclosure of COI information to participants might influence clinical trial participation rates and the pace of biomedical research.

It is also interesting to note that participants expressed equal or greater concern about intrinsic COIs than they did about financial COIs. Yet there has been little emphasis on managing intrinsic COIs in the same way that institutions and investigators are increasingly managing financial COIs. Certainly, management of intrinsic COIs would require the restructuring of academic medical careers and departments, and the methods for resolving intrinsic COIs are arguably more problematic than are those for dealing with financial COIs.^10,11 The lack of a clear path for managing intrinsic COIs makes mandates for disclosure extremely complicated. Although we believe that disclosures of COIs, both intrinsic and financial, are necessary for fully informed consent, more research is needed with larger cohorts and in different cancer patient populations to better define how disclosure affects research participation.

There are several limitations to this study. First, our sample is a convenience sample from a large, urban, midwestern hospital, and the results of our study may not generalize to other populations. Second, all of our participants were exclusively those with advanced disease who were enrolled onto early-phase clinical trials of experimental agents. It is possible that the views of these selected patients may be different from patients who are eligible or enrolled onto later-phase clinical trials for which therapeutic alternatives exist and the disease may not necessarily be fatal. Our study participants may have been less likely to express concerns about COIs than patients with more treatable disease because our participants have fewer treatment options. In addition, our study is limited by the hypothetical nature of our survey questions. We believe hypothetical questions would be less threatening to participants. In addition, our participants did not have information about COI information for the trials in which they were participating. A final limitation may be in the wording of our question specifically regarding intrinsic COIs, which intentionally specified the relationship between the physician and the hypothetical research participant, whereas the financial COIs question did not. Participants may have perceived the phrasing of the intrinsic COIs question to more explicitly depict investigator personal gain.

Although investigator financial COIs have received a great deal of attention from the scientific community and the lay press in recent years, we believe the importance of intrinsic COI should not go unrecognized. Both intrinsic and financial COIs are of particular importance to the oncology community because so much of the research intimately involves both human participants with life-threatening illness and the industry. Given this intimacy, there is no doubt that COIs in oncology research need to be addressed and managed in a way that ensures the safety of human participants and maintains the trust and confidence of the cancer patient community at large. It is also imperative that we work to understand better our options for COI management and to understand how changes in COI policies might influence clinical trial participation.

	AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST

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The author(s) indicated no potential conflicts of interest.

	AUTHOR CONTRIBUTIONS

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Conception and design: Stacy W. Gray, Fay J. Hlubocky, Mark J. Ratain, Christopher K. Daugherty

Financial support: Christopher K. Daugherty

Administrative support: Mark J. Ratain, Christopher K. Daugherty

Provision of study materials or patients: Mark J. Ratain

Collection and assembly of data: Fay J. Hlubocky, Christopher K. Daugherty

Data analysis and interpretation: Stacy W. Gray, Fay J. Hlubocky, Christopher K. Daugherty

Manuscript writing: Stacy W. Gray, Fay J. Hlubocky, Mark J. Ratain, Christopher K. Daugherty

Final approval of manuscript: Stacy W. Gray, Fay J. Hlubocky, Mark J. Ratain, Christopher K. Daugherty

	ACKNOWLEDGMENTS

 
We thank Caren Campbell for assistance with data management.

	NOTES

 
Supported by the National Institutes of Health Grant No. RO1 CA 087605-01A1 (C.K.D.).

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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Submitted March 21, 2007; accepted May 24, 2007.

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