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

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          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.

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          Trends in the risks and benefits to patients with cancer participating in phase 1 clinical trials.

          In the past, cancer patients entering phase 1 studies confronted the prospects of high risk and unlikely benefit. Over the last decade, cancer drugs under development have become more targeted, and the clinical research environment has become more scrutinized. The impact of these changes on the risks and benefits to patients who participate in phase 1 cancer trials is unknown. To determine trends in the rates of treatment-related (toxic) death, objective response, and serious toxicity and to identify factors associated with these outcomes. We searched abstracts and journal articles reporting the results of phase 1 cancer treatment trials originally submitted to annual meetings of the American Society of Clinical Oncology (ASCO) from 1991 through 2002. We focused on published single-agent trials that enrolled patients with advanced solid tumors and excluded studies testing agents already approved by the US Food and Drug Administration at the time of the ASCO presentation. Multiple observers independently extracted information on trial design, location, sponsorship, types of tumors treated, drug class, route of administration, and clinical outcomes. The overall toxic death rate for 213 studies (involving 6474 cancer patients) published in peer-reviewed journals was 0.54%, while the overall objective response rate was 3.8%. Toxic death rates decreased over the study period, from 1.1% over the first 4 years of the study (1991-1994) to 0.06% over the most recent 4-year period (1999-2002) (P<.01). Response rates also decreased but by proportionally much less. After adjusting for characteristics of the experimental trials and the investigational agents, the odds of a patient dying from an experimental treatment while participating in a trial submitted during the most recent 4-year period were less than one tenth those of a patient participating in a trial submitted during the first 4-year period (odds ratio, 0.09; 95% confidence interval, 0.01-0.67; P = .009). In comparison, the adjusted odds of a patient experiencing an objective response over the same time periods decreased by approximately half (odds ratio, 0.46; 95% confidence interval, 0.32-0.66; P<.001). The level of risk experienced by cancer patients who participate in phase 1 treatment trials appears to have improved over the 12-year period from 1991 through 2002. Because toxic death rates have decreased more quickly than have objective response rates, the ratio of risk to benefit may have also improved. These changes relate in part to the targeted and less-toxic nature of newer cancer drugs and are coincident with the increased attention that has been paid to the safety of clinical research over the time period we analyzed.
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            Attitudes to chemotherapy: comparing views of patients with cancer with those of doctors, nurses, and general public.

            To compare responses of patients with cancer with those of a matched control group, cancer specialists, general practitioners, and cancer nurses in assessing personal cost-benefit of chemotherapy. Prospective study of consecutively recruited patients with cancer and other groups by questionnaire; half of the patients received the questionnaire again three months after starting treatment. A medical oncology ward of a London teaching hospital. 106 Patients with newly diagnosed solid tumours referred to the unit for consideration of treatment with cytotoxic chemotherapy, 100 of whom were able to complete the questionnaire. 100 Matched controls, 315 cancer doctors (238 radiotherapists and 77 medical oncologists), 1500 randomly chosen general practitioners, and 1000 randomly chosen cancer nurses. Percentage chance of cure, prolonging life, or palliation of symptoms required to make treatment worth while with two hypothetical chemotherapy treatments, with severe and mild side effects respectively. Respondents to the questionnaire comprised 100 patients, 100 controls, 60 (78%) medical oncologists, 88 (37%) radiotherapists, 790 (53%) general practitioners, and 303 (30%) cancer nurses. Most patients were willing to accept intensive chemotherapy for a very small chance of benefit. The median benefit required to make the hypothetical intensive treatments worth while for patients compared with controls were: for chance of a cure (range 1 to 100%) 1% v 50%, for prolonging life (range three months to five years) 12 months v 24-60 months, and for relief of symptoms (range 1 to 100%) 10% v 75% respectively. There were no significant differences in the responses of the 50 patients completing the questionnaire on a second occasion. Doctors and nurses were less likely to accept radical treatment for minimal benefit compared with the patients (median scores 10-50%, 12-24 months, and 50-75%, for chance of cure, prolonging life, and relief of symptoms respectively). Significantly more patients than controls accepted treatments giving the minimal benefit for each category (cure 53.1 v 19.0%, 67.0 v 35.0%; prolonging life 42.1 v 10.0%, 53.0 v 25.0%; relief of symptoms 42.6 v 10.0%, 58.7 v 19.0% for intensive and mild treatments respectively, p less than 0.001) as was the case for comparison of patients with other groups. Patients with cancer are much more likely to opt for radical treatment with minimal chance of benefit than people who do not have cancer, including medical and nursing professionals. This could be taken into account when discussing treatment options with patients and their relatives.
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              The Belmont report: ethical principles and guidelines for the protection of human subjects of research

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                Author and article information

                Journal
                Br J Cancer
                British Journal of Cancer
                Nature Publishing Group
                0007-0920
                1532-1827
                15 March 2005
                22 March 2005
                28 March 2005
                : 92
                : 6
                : 1001-1005
                Affiliations
                [1 ]Pharmacy Department, Aberdeen Royal Infirmary, Foresterhill Site, Aberdeen AB25 2ZN, UK
                [2 ]Department of General Surgery, Aberdeen Royal Infirmary, Foresterhill Site, Aberdeen AB25 2ZN, UK
                [3 ]Department of General Practice and Primary Care, Foresterhill Health Centre, Aberdeen University Medical School, University of Aberdeen, Westburn Road, Foresterhill, Aberdeen AB25 2AY, UK
                [4 ]ANCHOR Unit, Department of Clinical Oncology, Aberdeen Royal Infirmary, Foresterhill Site, Aberdeen AB25 2ZN, UK
                [5 ]Beatson Oncology Center, The Western Infirmary, Dunbarton Road, Glasgow G11 6NT, UK
                [6 ]ANCHOR Unit, Department of Medical Oncology, Aberdeen Royal Infirmary, Foresterhill Site, Aberdeen AB25 2ZN, UK
                Author notes
                [* ]Author for correspondence: n.campbell@ 123456abdn.ac.uk
                Article
                6602423
                10.1038/sj.bjc.6602423
                2361930
                15770219
                99e38877-006a-413e-9ca2-e0be921d6f49
                Copyright 2005, Cancer Research UK
                History
                : 03 June 2004
                : 21 December 2004
                : 04 January 2005
                Categories
                Clinical Studies

                Oncology & Radiotherapy
                phase i/ii cancer clinical trials,informed consent,patient motivations

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