Patient motivations surrounding participation in phase I and phase II clinical trials of cancer chemotherapy

Abstract

Successful advances in the treatment of advanced malignant diseases rely on recruitment of patients into clinical trials of novel agents. However, there is a genuine concern for the welfare of individual patients. The aim of this study was to examine motives of patients entering early clinical trials of novel cancer therapies. Questionnaire survey with both open- and close-ended questions. The patients were surveyed after they had given informed consent and before or during the first cycle of treatment. In all, 38 phase I/II trial patients participated and completed the survey. Obtaining possible health benefit was listed by 89% as being a ‘very important' factor in their decision to participate, with only 17% giving reasons of helping future cancer patients and treatment. Other items cited as a ‘very important' motivating factor were ‘trust in the doctor' (66%), ‘being treated by the latest treatment available' (66%), ‘better standard of care and closer follow-up' (61%), and ‘closer monitoring of patients in trials' (58%). Only 47% patients indicated that someone had explained to them about any ‘reasonable' alternatives to the trial. In total, 71% strongly agreed that ‘surviving for as long time as possible was the most important thing (for them)'. Nearly all (97%) indicated that they knew the purpose of the trial and had enough time to consider participation in the trial (100%). In this survey, most patients entering phase I and II clinical trials felt they understood the purpose of the research and had given truly informed consent. Despite this, most patients participated in the hope of therapeutic benefit, although this is known to be a rare outcome in this patient subset. Trialists should be aware, and take account of the expectations that participants place in trial drugs.

Oncologists’ recommendations of clinical trial participation to patients

“…In fact, when patients in the current study were asked during a follow-up phone interview about factors that played a role in treatment decisions, 45% said that physician recommendations were a major factor, and another 35% said that physician recommendations were somewhat of a factor. This finding also supports previous studies demonstrating that physician behavior influences patient decisions regarding clinical trials [5,6,14,15,22]. Daugherty et al [15] found that many patients who participated in Phase I clinical trials were motivated by trust in their oncologist and in the institution.…”

“…Research indicates that oncologists' recommendations may indeed influence patients' decision to participate in a clinical trial [5,14,15,22]. However, existing empirical research to inform this debate is lacking.…”

“…At issue is a key controversy regarding informed consent-whether clinicians should make explicit recommendations to patients about whether to accept the offer to participate in a clinical trial. Some ethicists and scholars have suggested that clinician recommendations (e.g., "I think this study would be good for you,") may unduly influence patients, potentially inhibiting patients' right to make autonomous decisions [7,8], violating the principle of equipoise [9], and contributing to therapeutic misconception [10][11][12][13][14][15]. Others argue that true equipoise rarely exists [16] and therefore that physicians have a duty to provide their recommendations so that patients can consider this information as they make informed treatment decisions [17,18].…”

Når er et samtykke frivillig?

“…Kanskje de trenger mindre paternalistisk beskyttelse enn vi er vant med å tro. Noen empiriske undersøkelser viser at pasienter er motivert til å delta fordi det kan gi direkte fordeler hva angår deres egen helse, men også fordi det kan bidra til å hjelpe andre og til økt kunnskap (5,6). Betaling kan vaere en tilleggsmotivasjon for å delta, men langt fra avgjørende hvis betalingen er moderat og standardisert (7).…”

Stakeholder Views on Participant Selection for First-in-Human Trials in Cancer Nanomedicine

“…A significant body of literature has explored the motivations, hopes, and expectations of healthy volunteers and patients who participate in various clinical trials, including fih trials [19][20][21][22][23][24][25] . Patient-related factors influencing the decision about whether to participate in fih trials include unmet need for treatment options, lived illness experience, suffering and impact on quality of life, willingness to accept higher risks in the hope that the experimental treatment might provide at least symptom relief if not cure, and familiarity with and understanding of clinical trials and investigational molecules.…”