Letter on "Sharing trial results directly with trial participants and other stakeholders after the SARS-CoV-2 pandemic hit the UK - experience from the ActWELL trial".
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ABSTRACT:
SUBMITTER: Bruhn H
PROVIDER: S-EPMC8179700 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Product sharing among participants can impact on adherence and compromise the outcome in clinical trials. We describe incidents of product sharing at the Durban clinical research sites conducting the VOICE trial. The Durban sites enrolled 2750 women with 1103 and 1647 participants randomized to the vaginal gel and oral tablet arms respectively. Monthly pill and applicator counts including product assessments were conducted by pharmacists. Discrepancies with product counts prompted discussions with participants. Thirty-two cases of product sharing were identified. Vaginal gels were more commonly shared than oral tablets. Product sharing between study participants and their female friends or relatives living in the same household was identified as the most common source of product sharing in this analysis. Study product counts and pharmacist-driven discussions with participants may help to identify reasons for product sharing and inform the development of strategies for PrEP implementation outside of the research setting. ClinicalTrials.gov number: NCT00705679.
| S-EPMC5071120 | biostudies-literature
Project description:Background Sharing of participant-level clinical trial data has potential benefits, but concerns about potential harms to research participants have led some pharmaceutical sponsors and investigators to urge caution. Little is known about clinical trial participants' perceptions of the risks of data sharing. Methods We conducted a structured survey of 771 current and recent participants from a diverse sample of clinical trials at three academic medical centers in the United States. Surveys were distributed by mail (350 completed surveys) and in clinic waiting rooms (421 completed surveys) (overall response rate, 79%). Results Less than 8% of respondents felt that the potential negative consequences of data sharing outweighed the benefits. A total of 93% were very or somewhat likely to allow their own data to be shared with university scientists, and 82% were very or somewhat likely to share with scientists in for-profit companies. Willingness to share data did not vary appreciably with the purpose for which the data would be used, with the exception that fewer participants were willing to share their data for use in litigation. The respondents' greatest concerns were that data sharing might make others less willing to enroll in clinical trials (37% very or somewhat concerned), that data would be used for marketing purposes (34%), or that data could be stolen (30%). Less concern was expressed about discrimination (22%) and exploitation of data for profit (20%). Conclusions In our study, few clinical trial participants had strong concerns about the risks of data sharing. Provided that adequate security safeguards were in place, most participants were willing to share their data for a wide range of uses. (Funded by the Greenwall Foundation.).
| S-EPMC6057615 | biostudies-literature
Project description:AimTo understand stakeholders' views on data sharing in multicenter comparative effectiveness research studies and the value of privacy-protecting methods.Materials & methodsSemistructured interviews with five US stakeholder groups.ResultsWe completed 11 interviews, involving patients (n = 15), researchers (n = 10), Institutional Review Board and regulatory staff (n = 3), multicenter research governance experts (n = 2) and healthcare system leaders (n = 4). Perceptions of the benefits and value of research were the strongest influences toward data sharing; cost and security risks were primary influences against sharing. Privacy-protecting methods that share summary-level data were acknowledged as being appealing, but there were concerns about increased cost and potential loss of research validity.ConclusionStakeholders were open to data sharing in multicenter studies that offer value and minimize security risks.
| S-EPMC6022827 | biostudies-literature
Project description:This SuperSeries is composed of the SubSeries listed below.
2019-02-15 | GSE103740 | GEO
Project description:BackgroundSharing trial results with participants is an ethical imperative but often does not happen. We tested an Enhanced Webpage versus a Basic Webpage, Mailed Printed Summary versus no Mailed Printed Summary, and Email List Invitation versus no Email List Invitation to see which approach resulted in the highest patient satisfaction with how the results were communicated.Methods and findingsWe carried out a cluster randomised, 2 by 2 by 2 factorial, nonblinded study within a trial, with semistructured qualitative interviews with some patients (ISRCTN96189403). Each cluster was a UK hospital participating in the ICON8 ovarian cancer trial. Interventions were shared with 384 ICON8 participants who were alive and considered well enough to be contacted, at 43 hospitals. Hospitals were allocated to share results with participants through one of the 8 intervention combinations based on random permutation within blocks of 8, stratified by number of participants. All interventions contained a written plain English summary of the results. The Enhanced Webpage also contained a short video. Both the Enhanced Webpage and Email contained links to further information and support. The Mailed Printed Summary was opt-out. Follow-up questionnaires were sent 1 month after patients had been offered the interventions. Patients' reported satisfaction was measured using a 5-point scale, analysed by ordinal logistic regression estimating main effects for all 3 interventions, with random effects for site, restricted to those who reported receiving the results and assuming no interaction. Data collection took place in 2018 to 2019. Questionnaires were sent to 275/384 randomly selected participants and returned by 180: 90/142 allocated Basic Webpage, 90/133 Enhanced Webpage; 91/141 no Mailed Printed Summary, 89/134 Mailed Printed Summary; 82/129 no Email List Invitation, 98/146 Email List Invitation. Only 3 patients opted out of receiving the Mailed Printed Summary; no patients signed up to the email list. Patients' satisfaction was greater at sites allocated the Mailed Printed Summary, where 65/81 (80%) were quite or very satisfied compared to sites with no Mailed Printed Summary 39/64 (61%), ordinal odds ratio (OR) = 3.15 (1.66 to 5.98, p < 0.001). We found no effect on patient satisfaction from the Enhanced Webpage, OR = 1.47 (0.78 to 2.76, p = 0.235) or Email List Invitation, OR = 1.38 (0.72 to 2.63, p = 0.327). Interviewees described the results as interesting, important, and disappointing (the ICON8 trial found no benefit). Finding out the results made some feel their trial participation had been more worthwhile. Regardless of allocated group, patients who received results generally reported that the information was easy to understand and find, were glad and did not regret finding out the results. The main limitation of our study is the 65% response rate.ConclusionsNearly all respondents wanted to know the results and were glad to receive them. Adding an opt-out Mailed Printed Summary alongside a webpage yielded the highest reported satisfaction. This study provides evidence on how to share results with other similar trial populations. Further research is needed to look at different results scenarios and patient populations.Trial registrationISRCTN: ISRCTN96189403.
| S-EPMC8523080 | biostudies-literature
Project description:BackgroundThe social/behavioral HIV Decision-Making Study (DMS) assesses informed consent and trial experiences of individuals in HIV remission trials in Thailand. We convened a 1-d multi-stakeholder participatory workshop in Bangkok. We provide a meeting summary and reactions from DMS investigators.MethodsWorkshop members viewed de-identified interview excerpts from DMS participants. They deliberated on the findings and made recommendations regarding informed choice for remission trials. Notes and recordings were used to create a summary report, which was reviewed by members and refined.ResultsWorkshop members' recommendations included HIV education and psychosocial support to establish the basis for informed choice, key trial information to be provided in everyday language, supportive decision-making processes and psychosocial care during and after the trial. Concerns included participant willingness to restart antiretrovirals after trial-mandated treatment interruption, unintended influence of the research team on decision-making and seemingly altruistic motivations for trial participation that may signal attempts to atone for stigmatized behavior.ConclusionsThe workshop highlighted community perspectives and resulted in recommendations for supporting informed choice and psychosocial and physical health. These are the first such recommendations arising from a deliberative process. Although some elements are rooted in the Thai context, most are applicable across remission trials.
| S-EPMC7650909 | biostudies-literature
Project description:This is a test on a couple of samples from a bigger metagenomics study
| PRJEB50543 | ENA
Project description:Backgroundand purpose Participant recruitment is central to all clinical trials. Any delay in recruitment affects the completion and ultimate success of the trial. We report our experience with patient screening and randomization in CombiRx, which may inform the design of other trials. CombiRx was a multicenter, phase III, double-blind, randomized clinical trial comparing the combined use of interferon beta-1a and glatiramer acetate to either agent alone in patients with relapsing-remitting multiple sclerosis (RRMS). This trial was launched in January 2005 in 69 centers in the United States and Canada under a co-operative agreement with the National Institute of Neurological Disorders and Stroke (NINDS). The goal was to recruit 1000 patients over 1.5 years after a 6-month start-up period. Instead, the investigators required 4.25 years to enroll 1008 patients.MethodsDuring this trial, we assessed the effectiveness of various recruitment strategies, utility of rescreening prior screen failures, and potential factors and strategies used in study conduct, research, and infrastructure, all of which affected recruitment of participants and ultimately time to completion of CombiRx. We particularly were interested in the variability in time to site initiation between academic centers and private practice sites.ResultsPhysicians who were directly involved in the medical care of patients with RRMS were the primary source of patients recruited to CombiRx. A flexible study design that allowed for rescreening of the initial screen failures after a period of time was useful due to the relapsing/remitting course of the disease. Academic centers took longer to implement the trial than the private practice centers, but once sites were approved for enrollment, there was no important difference in the number of participants enrolled.LimitationsThe CombiRx trial was conducted during a period when multiple new medications were being tested, thus affecting the pace of recruitment and limiting ability to generalize our experiences. However, the lessons we learned about process are relevant.ConclusionParticipants can be enrolled successfully in a clinical trial for RRMS, but factors affecting the time to achieve the requirements needed to start screening can be unpredictable and problematic. Prospective planning by the sponsors and investigators, use of central institutional review boards (IRBs), master trial agreements and secure remote desktop access to the trial database may expedite trial implementation and participant recruitment. A good scientific research question with flexible study design and active involvement of the clinicians are important factors driving recruitment. Clinical trials can be implemented successfully both in private practices and at academic centers, a consideration when selecting sites.
| S-EPMC3972629 | biostudies-literature
Project description:BackgroundRoutinely-collected mental health data could deliver novel insights for mental health research. However, patients' willingness to share their mental health data remains largely unknown. We investigated factors influencing likelihood of sharing these data for research purposes amongst people with and without experience of mental illness.MethodsWe collected responses from a diverse sample of UK National Health Service (NHS) users (n = 2187) of which about half (n = 1087) had lifetime experience of mental illness. Ordinal logistic regression was used to examine the influence of demographic factors, clinical service experience, and primary mental illness on willingness to share mental health data, contrasted against physical health data.ResultsThere was a high level of willingness to share mental (89.7%) and physical (92.8%) health data for research purposes. Higher levels of satisfaction with the NHS were associated with greater willingness to share mental health data. Furthermore, people with personal experience of mental illness were more willing than those without to share mental health data, once the variable of NHS satisfaction had been controlled for. Of the mental illnesses recorded, people with depression, obsessive-compulsive disorder (OCD), personality disorder or bipolar disorder were significantly more likely to share their mental health data than people without mental illness.ConclusionsThese findings suggest that positive experiences of health services and personal experience of mental illness are associated with greater willingness to share mental health data. NHS satisfaction is a potentially modifiable factor that could foster public support for increased use of NHS mental health data in research.
| S-EPMC8858475 | biostudies-literature
Project description:Introduction: Health research is gradually embracing a more collectivist approach, fueled by a new movement of open science, data sharing and collaborative partnerships. However, the existence of systemic contradictions hinders the sharing of health data and such collectivist endeavor. Therefore, this qualitative study explores these systemic barriers to a fair sharing of health data from the perspectives of Swiss stakeholders. Methods: Purposive and snowball sampling were used to recruit 48 experts active in the Swiss healthcare domain, from the research/policy-making field and those having a high position in a health data enterprise (e.g., health register, hospital IT data infrastructure or a national health data initiative). Semi-structured interviews were then conducted, audio-recorded, verbatim transcribed with identifying information removed to guarantee the anonymity of participants. A theoretical thematic analysis was then carried out to identify themes and subthemes related to the topic of systemic fairness for sharing health data. Results: Two themes related to the topic of systemic fairness for sharing health data were identified, namely (i) the hypercompetitive environment and (ii) the legal uncertainty blocking data sharing. The theme, hypercompetitive environment was further divided into two subthemes, (i) systemic contradictions to fair data sharing and the (ii) need of fair systemic attribution mechanisms. Discussion: From the perspectives of Swiss stakeholders, hypercompetition in the Swiss academic system is hindering the sharing of health data for secondary research purposes, with the downside effect of influencing researchers to embrace individualism for career opportunities, thereby opposing the data sharing movement. In addition, there was a perceived sense of legal uncertainty from legislations governing the sharing of health data, which adds unreasonable burdens on individual researchers, who are often unequipped to deal with such facets of their data sharing activities.
| S-EPMC8131670 | biostudies-literature