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Money-oriented risk-takers or deliberate decision-makers: a cross-sectional survey study of participants in controlled human infection trials.

ABSTRACT: OBJECTIVE:To quantitatively investigate the motivations, decision-making and experience of participants in controlled human infection (CHI) studies. DESIGN:Cross-sectional descriptive survey study. SETTING:Previous participants of CHI studies at the Leiden Controlled Human Infection Center, control group of students from Leiden University. PARTICIPANTS:61 previous participants and 156 controls. MEASUREMENTS:Ranking of motivational and decisional factors, risk propensity score and multiple-choice questions on experience of trial participation and ethical aspects of CHI studies. RESULTS:Motivating factors for participants were contributing to science (81%), contributing to research that may benefit developing countries (72%) and the financial compensation (63%). For 51% of participants, a reason other than financial compensation was the most important motivational factor. Participants considered trust in the study team (70%), time investment (63%), severity of symptoms (54%), chance of developing symptoms (54%) and whether it is an easy way to make money (54%) in their decision to participate. Most CHI participants (84%) were proud of their participation, would advise others to participate (89%) and would participate in a similar trial again (85%). CHI participants had a higher risk propensity score than students (estimated difference 0.9, p<0.001). CONCLUSION:Although financial compensation is important, the motivations for participants in a CHI study are diverse and participants make a balanced appraisal of risks and burden before participating.

SUBMITTER: Hoogerwerf MA

PROVIDER: S-EPMC7383945 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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Money-oriented risk-takers or deliberate decision-makers: a cross-sectional survey study of participants in controlled human infection trials.

Hoogerwerf Marie-Astrid MA de Vries Martine M Roestenberg Meta M

BMJ open 20200726 7

<h4>Objective</h4>To quantitatively investigate the motivations, decision-making and experience of participants in controlled human infection (CHI) studies.<h4>Design</h4>Cross-sectional descriptive survey study.<h4>Setting</h4>Previous participants of CHI studies at the Leiden Controlled Human Infection Center, control group of students from Leiden University.<h4>Participants</h4>61 previous participants and 156 controls.<h4>Measurements</h4>Ranking of motivational and decisional factors, risk ...[more]

PMID: 32713843

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Project description:BACKGROUND:Knowledge of what the pharmaceutical industry emphasizes when assessing trial sites during site selection is sparse. A better understanding of this issue can improve the collaboration on clinical trials and increase knowledge of how to attract and retain industry-sponsored trials. Accordingly, we investigated which site-related qualities multinational biopharmaceutical companies and clinical research organizations (CROs) find most important during site selection. METHODS:An online survey among decision-makers for trial site selection in the Nordic countries employed at multinational biopharmaceutical companies and CROs was conducted. The respondents' experiences with and perceptions of site selection were addressed to evaluate the relative importance of site-related qualities. We included up to four respondents per company, representing different geographic regions. Descriptive statistics were used to summarize findings. RESULTS:Of 49 eligible companies, 20 biopharmaceutical companies and 23 CROs participated. In total, 83 responses were analyzed (estimated response rate 78%). A relative importance of site-related qualities was identified: For example, 88% (binomial 95% confidence interval [CI] ±7%) preferred reaching enrollment goals at trial sites in their region 10% quicker rather than cutting the costs at all sites by 20%. Likewise, 42% (CI ±11%) of the respondents preferred that trial sites were best at having the first patients ready for inclusion right after site initiation visit compared to having good data entry, documentation, and reporting practice (25% [CI ±9%]), easily reachable site personnel and backup (23% [CI ±9%]), fast contractual procedure times (6% [CI ±5%]), a key opinion leader associated with the site (3% [CI ±4%]), and updated equipment and facilities (1% [CI ±2%]). In total, 75% [CI ±9%] agreed that their company would be interested in cooperating with an inexperienced trial site if the site had access to a large patient population and 52% [CI ±11%] had experienced that their company selected an inexperienced trial site in favor of an experienced site due to a higher level of interest and commitment. CONCLUSIONS:This study indicates that recruitment-related factors are pivotal to the pharmaceutical industry when assessing trial sites during site selection. Data quality-related factors seem highly valued especially in early phase trials whereas costs and investigator's publication track record are less important. Experience in conducting clinical trials is not imperative. However, this applies primarily to late phase trials.

Project description:BackgroundPatient-Oriented Research (POR) is a Canadian initiative for health research that refers to research processes informed by full and active patient involvement in all aspects of the research. Ideally, POR results in a wide dissemination of the research findings and the uptake of such findings in both clinical practice and health policy. The Canadian Institute for Health Research (CIHR) identifies four stakeholder groups that are involved in POR who are envisioned to take on a collaborative role in enacting this approach to research. Those stakeholder groups are patients, researchers, health care providers and healthcare decision-makers. To achieve collaboration among stakeholders in POR, tools, resources, education/training and capacity building are required for each stakeholder group engaged in this work. Therefore, this review focuses on understanding and articulating competencies needed by participants to engage in POR. The aim is to summarize existing knowledge on discrete POR competencies for the four stakeholder groups; to support collaboration among them for uptake and strengthening of POR; and to inform policy, education and future research. Accordingly, our research question is 'What are the POR core competencies needed by patients, researchers, healthcare providers, and decision-makers?' The main objectives are to (1) systematically explore the academic and grey literature on competencies needed for these stakeholder groups to engage in POR; (2) map the eligible publications and research gaps in this area; (3) gain knowledge to support collaboration among stakeholders; and (4) provide recommendations for further research to use competencies that emerge in developing stakeholder groups' readiness to conduct POR.Methods/designWe will use a methodologically rigorous scoping review approach including formulation of the research question and development of the protocol; screening and identification of the literature; selection of relevant studies; data extraction; and collation, summary and report of the results. Our eligibility criteria include elements of population (patients, researchers, healthcare providers and decision-makers); concept (competencies: knowledge, skills, attitudes; and POR); context (level of involvement in research, settings, funding sources); study design (sample, stakeholder group, methodology, grey literature, theoretical framework); outcomes (primary: relevant to decision-making/policy and practice; and secondary: relevant to education and research); language (English, French); and timing (1990-2017). Registration with PROSPERO is not eligible for scoping reviews; so, it has not been registered.DiscussionResearch on core competencies required to enact POR is in its infancy. In this review, we can articulate what is known and thought about competencies (knowledge, skills and attitudes) needed by individuals on POR research teams and ultimately provide knowledge that could impact research, practice, education and policy. Identification of competencies can contribute to design of healthcare professionals' basic and ongoing educational programmes, patient training in research, and professional development activities for health care providers and decision-makers. In addition, knowledge of core competencies can permit individuals to evaluate their own readiness to enter POR research teams.

Project description:BackgroundMigraine is the world's second most common disabling disorder, affecting 15% of UK adults and costing the UK over £1.5 billion per year. Several costly new drugs have been approved by National Institute for Health and Care Excellence.AimTo assess the cost-effectiveness of drugs used to treat adults with chronic migraine.MethodsWe did a systematic review of placebo-controlled trials of preventive drugs for chronic migraine. We then assessed the cost-effectiveness of the currently prescribable drugs included in the review: Onabotulinum toxin A (BTA), Eptinezumab (100mg or 300mg), Fremanezumab (monthly or quarterly dose), Galcanezumab or Topiramate, each compared to placebo, and we evaluated them jointly. We developed a Markov (state-transition) model with a three-month cycle length to estimate the costs and quality-adjusted life years (QALYs) for the different medications from a UK NHS and Personal Social Services perspective. We used a two-year time horizon with a starting age of 30 years for the patient cohort. We estimated transition probabilities based on monthly headache days using a network meta-analysis (NMA) developed by us, and from published literature. We obtained costs from published sources and applied discount rates of 3.5% to both costs and outcomes.ResultsDeterministic results suggest Topiramate was the least costly option and generated slightly more QALYs than the placebo, whereas Eptinezumab 300mg was the more costly option and generated the most QALYs. After excluding dominated options, the incremental cost-effectiveness ratio (ICER) between BTA and Topiramate was £68,000 per QALY gained and the ICER between Eptinezumab 300mg and BTA was not within plausible cost-effectiveness thresholds. The cost-effectiveness acceptability frontier showed that Topiramate is the most cost-effective medication for any amount the decision maker is willing-to-pay per QALY.ConclusionsAmong the various prophylactic medications for managing chronic migraine, only Topiramate was within typical cost-effectiveness threshold ranges. Further research is needed, ideally an economic evaluation alongside a randomised trial, to compare these newer, expensive CGRP MAbs with the cheaper oral medications.

Dataset Information

Money-oriented risk-takers or deliberate decision-makers: a cross-sectional survey study of participants in controlled human infection trials.

Publications

Money-oriented risk-takers or deliberate decision-makers: a cross-sectional survey study of participants in controlled human infection trials.

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