Are Well-Informed Potential Trial Participants More Likely to Participate?

Abstract Objectives To determine to which degree industry partners in randomised clinical trials own the data and can constrain publication rights of academic investigators. Methods Cohort study of trial protocols, publication agreements and other documents obtained through Freedom of Information requests, for a sample of 42 trials with industry involvement approved by ethics committees in Denmark. The main outcome measures used were: proportion of trials where data was owned by the industry partner, where the investigators right to publish were constrained and if this was mentioned in informed consent documents, and where the industry partner could review data while the trial was ongoing and stop the trial early. Results The industry partner owned all data in 20 trials (48%) and in 16 trials (38%) it was unclear. Publication constraints were described for 30 trials (71%) and this was not communicated to trial participants in informed consent documents in any of the trials. In eight trials (19%) the industry partner could review data during the trial, for 20 trials (48%) it was unclear. The industry partner could stop the trial early without any specific reason in 23 trials (55%). Conclusions Publication constraints are common, and data is often owned by industry partners. This is rarely communicated to trial participants. Such constraints might contribute to problems with selective outcome reporting. Patients should be fully informed about these aspects of trial conduct.

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A systematic review of risk communication in clinical trials: How does it influence decisions to participate and what are the best methods to improve understanding in a trial context?

PLoS ONE ◽

10.1371/journal.pone.0242239 ◽

2020 ◽

Vol 15 (11) ◽

pp. e0242239

Author(s):

Maeve Coyle ◽

Katie Gillies

Keyword(s):

Systematic Review ◽

Clinical Trial ◽

Clinical Trials ◽

Risk Communication ◽

Search Strategy ◽

Trial Participation ◽

Probabilistic Information ◽

Information Leaflets ◽

Trial Participants ◽

Potential Trial

Background Effective risk communication is challenging. Ensuring potential trial participants’ understand ‘risk’ information presented to them is a key aspect of the informed consent process within clinical trials, yet minimal research has looked specifically at how to communicate probabilities to support decisions about trial participation. This study reports a systematic review of the literature focusing on presentation of probabilistic information or understanding of risk by potential trial participants. Methods A search strategy for risk communication in clinical trials was designed and informed by systematic reviews of risk communication in treatment and screening contexts and supplemented with trial participation terms. Extracted data included study characteristics and the main interventions/findings of each study. Explanatory studies that investigated the methods for presenting probabilistic information within participant information leaflets for a clinical trial were included, as were interventions that focused on optimising understanding of probabilistic information within the context of a clinical trial. Results The search strategy identified a total of 4931 studies. Nineteen papers were selected for full text screening, and seven studies included. All reported results from risk communication studies that aimed to support potential trial participants’ decision making set within hypothetical trials. Five of these were randomised comparisons of risk communication interventions, and two were prospectively designed, non-randomised studies. Study interventions focused on probability presentation, risk framing and risk interpretation with a wide variety of interventions being evaluated and considerable heterogeneity in terms of outcomes assessed. Studies show conflicting findings when it comes to how best to present information, although numerical, particularly frequency formats and some visual aids appear to have promise. Conclusions The evidence base surrounding risk communication in clinical trials indicates that there is as yet no clear optimal method for improving participant understanding, or clear consensus on how it affects their willingness to participate. Further research into risk communication within trials is needed to help illuminate the mechanisms underlying risk perception and understanding and provide appropriate ways to present and communicate risk in a trial context so as to further promote informed choices about participation. A key focus for future research should be to investigate the potential for learning in the evidence on risk communication from treatment and screening decisions when applied to decisions about trial participation.

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Relative importance of informational items in participant information leaflets for trials: a Q-methodology approach

BMJ Open ◽

10.1136/bmjopen-2018-023303 ◽

2018 ◽

Vol 8 (9) ◽

pp. e023303 ◽

Cited By ~ 2

Author(s):

Karen Innes ◽

Seonaidh Cotton ◽

Marion K Campbell ◽

Jim Elliott ◽

Katie Gillies

Keyword(s):

Q Methodology ◽

Trial Participation ◽

Sufficient Information ◽

Think Aloud ◽

Stakeholder Groups ◽

Information Leaflets ◽

Research Nurses ◽

Trial Participants ◽

Potential Trial ◽

Participant Information

ObjectivesTo identify which information items potential participants and research nurses rank as the most important, and the reasons for this, when considering participation in a randomised controlled trial.DesignQ-methodology approach alongside a think-aloud process. Using a vignette outlining a hypothetical trial, participants were asked to rank statements about informational items usually included in a participant information leaflet (PIL) on a Q-grid, while undertaking a real-time think-aloud process to elicit the underpinning decision processes. Analysis of quantitative data was conducted using descriptive statistics and qualitative data was coded using content analysis.Participants20 participants (10 potential trial participants and 10 research nurses).SettingUK-based participants.ResultsTen research nurses and 10 potential trial participants provided data for the study. Both stakeholder groups ranked similar statements in their top three most important statements, with ‘What are the possible disadvantages and risks of taking part?’ featuring in both. However, considerable variability existed between the groups with regard to their ranking of statements of least importance. Participants identified that sufficient information to make a decision was secured using around 14 items. Participants also identified other items of importance not routinely included in PILs.ConclusionsThis study has provided a unique insight into how and why different trial stakeholder groups rank informational items currently contained within PILs. These results have implications for those developing future PILs and those who develop guidance on their content; PILs should focus most on the information items that potential trial participants want and need to make an informed choice about trial participation.

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Surgery for women with endometrioma prior to in vitro fertilisation: proposal for a feasible multicentre randomised clinical trial in the UK

Human Reproduction Open ◽

10.1093/hropen/hoaa012 ◽

2020 ◽

Vol 2020 (3) ◽

Author(s):

Abha Maheshwari ◽

Jemma Healey ◽

Siladitya Bhattacharya ◽

Kevin Cooper ◽

Lucky Saraswat ◽

...

Keyword(s):

Live Birth ◽

Study Design ◽

Controlled Trial ◽

Public Funding ◽

Individual Interviews ◽

Live Birth Rates ◽

Randomised Controlled ◽

The Uk ◽

Trial Participants ◽

Potential Trial

Abstract STUDY QUESTION Is it feasible to undertake a randomised controlled trial to establish whether surgical removal of endometrioma or not, improves live birth rates from IVF? SUMMARY ANSWER A randomised controlled trial (RCT) comparing surgery versus no surgery to endometrioma prior to IVF is only feasible in UK if an adaptive rather than traditional study design is used; this would minimise resource wastage and complete the trial in an acceptable time frame. WHAT IS KNOWN ALREADY There is wide variation in the management of endometriomas prior to IVF, with decisions about treatment being influenced by personal preferences. STUDY DESIGN, SIZE, AND DURATION This was a mixed-methods study consisting of an online survey of clinicians, a focus group and individual interviews with potential trial participants. PARTICIPANTS/MATERIALS, SETTING, METHODS Endometriosis and fertility experts across the UK were invited to participate in an online anonymised questionnaire. Potential future trial participants were recruited from a tertiary care fertility centre and invited to participate in either individual interviews or focus groups. MAIN RESULTS AND THE ROLE OF CHANCE Clinicians and potential trial participants confirmed the need for an RCT to inform the management of an endometrioma prior to IVF. There were 126 clinicians who completed the survey, and the majority (70%) were willing to recruit to a trial. Half of those who responded indicated that they see at least 10 eligible women each year. The main barriers to recruitment were waiting lists for surgery and access to public funding for IVF. One focus group (n = 7) and five interviews were conducted with potential trial participants (n = 3) and their partners (n = 2). The findings from these discussions highlighted that recruitment and retention in a potential RCT could be improved by coordination between IVF and surgical services such that an operation does not delay IVF or affect access to public funding. Live birth was considered the most important outcome with an improvement of at least 10% considered the minimum acceptable by both patients and clinicians. LIMITATIONS, REASONS FOR CAUTION This feasibility study captured views of clinicians across the UK, but as patients were from a single Scottish centre, their views may not be representative of other areas with limited public funding for IVF. WIDER IMPLICATIONS OF THE FINDINGS There is a need for an appropriately powered RCT to establish whether or not surgical treatment of endometrioma prior to IVF improves live birth rates. There are logistical issues to be considered due to limited number of participants, funding of IVF and waiting times. These could be overcome in a RCT by using an adaptive design which would include a prospectively planned opportunity for modification of specified aspects of the study design based on interim analysis of the data, coordination of IVF treatments and endometriosis surgeries and international collaboration. Similar principles could be used for other questions in fertility where a traditional approach for randomised trials is not feasible. STUDY FUNDING/COMPETING INTEREST(S) Funding was received from the NHS Grampian R&D pump priming fund (RG14437-12). S.B. is Editor-in-Chief of HROPEN, and A.W.H. is Deputy Editor of HROPEN. Neither was involved in the review of this manuscript. L.S. reports grants from CSO and NIHR to do endometriosis research, outside the submitted work. K.C. reports grants from NIHR/HTA and CSO during the conduct of the study. J.H.e., A.W.H., J.D., S.B.r., K.B., G.B., J.H.u. and K.G. report no conflict of interest.

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Clinical Comparison Between Trial Participants and Potentially Eligible Patients Using Electronic Health Record Data: A Generalizability Assessment Method

Journal of Biomedical Informatics ◽

10.1016/j.jbi.2021.103822 ◽

2021 ◽

pp. 103822

Author(s):

James R. Rogers ◽

George Hripcsak ◽

Ying Kuen Cheung ◽

Chunhua Weng

Keyword(s):

Electronic Health Record ◽

Assessment Method ◽

Health Record ◽

Electronic Health Record Data ◽

Clinical Comparison ◽

Record Data ◽

Electronic Health ◽

Trial Participants

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Cyber-Situational Awarenss in Clinical Trials Using Wearable Device Technology

Proceedings of the International Symposium on Human Factors and Ergonomics in Health Care ◽

10.1177/2327857921101011 ◽

2021 ◽

Vol 10 (1) ◽

pp. 33-36

Author(s):

Elizabeth A. Johnson ◽

Jane M. Carrington

Keyword(s):

Clinical Trials ◽

Informed Consent ◽

Best Practices ◽

Situational Awareness ◽

Implantable Devices ◽

Wearable Device ◽

Sleep Habits ◽

Privacy Issues ◽

Trial Participants ◽

Device Technology

It is estimated 1 in 3 clinical trials utilize a wearable device to gather real-time participant data, including sleep habits, telemetry, and physical activity. While wearable technologies (including smart watches, USBs, and implantable devices) have been revolutionary in their ability to provide a higher precision and accuracy to data acquisition external to the research milieu, there is hesitancy among providers and participants alike given security concerns, perception of cyber-related threats, and meaning attributed to privacy issues. The purpose of this research is to define cyber-situational awareness (CSA) as it pertains to clinical trials, evaluate its current measurement, and describe best practices for research investigators and trial participants to enhance protections in the digital age. This paper reviews integrated elements of CSA within the process of informed consent when wearable devices are implemented for trial procedures. Evaluation of CSA as part of informed consent allows the research site to support the participant in knowledge gaps surrounding the technology while also providing feedback to the trial sponsor as to technology improvements to enhance usability and wearability of the device.

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Assessing an Electronic Health Record research platform for identification of clinical trial participants

Contemporary Clinical Trials Communications ◽

10.1016/j.conctc.2020.100692 ◽

2021 ◽

Vol 21 ◽

pp. 100692

Author(s):

Niina Laaksonen ◽

Juha-Matti Varjonen ◽

Minna Blomster ◽

Antti Palomäki ◽

Tuija Vasankari ◽

...

Keyword(s):

Clinical Trial ◽

Electronic Health Record ◽

Health Record ◽

Research Platform ◽

Electronic Health ◽

Trial Participants

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Providing trial results to participants in phase III pragmatic effectiveness RCTs: a scoping review

Trials ◽

10.1186/s13063-021-05300-x ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Hanne Bruhn ◽

Elle-Jay Cowan ◽

Marion K. Campbell ◽

Lynda Constable ◽

Seonaidh Cotton ◽

...

Keyword(s):

Scoping Review ◽

Health Care Professionals ◽

Search Strategy ◽

Phase Iii ◽

Future Research ◽

To Receive ◽

Emotional Effects ◽

Trial Participants ◽

Narrative Description ◽

Do So

Abstract Background There is an ethical imperative to offer the results of trials to those who participated. Existing research highlights that less than a third of trials do so, despite the desire of participants to receive the results of the trials they participated in. This scoping review aimed to identify, collate, and describe the available evidence relating to any aspect of disseminating trial results to participants. Methods A scoping review was conducted employing a search of key databases (MEDLINE, EMBASE, PsycINFO, and the Cumulative Index to Nursing & Allied Health Literature (CINAHL) from January 2008 to August 2019) to identify studies that had explored any aspect of disseminating results to trial participants. The search strategy was based on that of a linked existing review. The evidence identified describes the characteristics of included studies using narrative description informed by analysis of relevant data using descriptive statistics. Results Thirty-three eligible studies, including 12,700 participants (which included patients, health care professionals, trial teams), were identified and included. Reporting of participant characteristics (age, gender, ethnicity) across the studies was poor. The majority of studies investigated dissemination of aggregate trial results. The most frequently reported mode of disseminating of results was postal. Overall, the results report that participants evaluated receipt of trial results positively, with reported benefits including improved communication, demonstration of appreciation, improved retention, and engagement in future research. However, there were also some concerns about how well the dissemination was resourced and done, worries about emotional effects on participants especially when reporting unfavourable results, and frustration about the delay between the end of the trial and receipt of results. Conclusions This scoping review has highlighted that few high-quality evaluative studies have been conducted that can provide evidence on the best ways to deliver results to trial participants. There have been relatively few qualitative studies that explore perspectives from diverse populations, and those that have been conducted are limited to a handful of clinical areas. The learning from these studies can be used as a platform for further research and to consider some core guiding principles of the opportunities and challenges when disseminating trial results to those who participated.

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Redundant trials can be prevented, if the EU clinical trial regulation is applied duly

BMC Medical Ethics ◽

10.1186/s12910-020-00536-9 ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Daria Kim ◽

Joerg Hasford

Keyword(s):

Clinical Trials ◽

Health Risks ◽

Ethics Committees ◽

Medical Community ◽

Significant Extent ◽

Regulatory Requirements ◽

Trial Participants ◽

Clinical Trials Regulation ◽

Clinical Trial Regulation ◽

The Eu

Abstract The problem of wasteful clinical trials has been debated relentlessly in the medical community. To a significant extent, it is attributed to redundant trials – studies that are carried out to address questions, which can be answered satisfactorily on the basis of existing knowledge and accessible evidence from prior research. This article presents the first evaluation of the potential of the EU Clinical Trials Regulation 536/2014, which entered into force in 2014 but is expected to become applicable at the end of 2021, to prevent such trials. Having reviewed provisions related to the trial authorisation, we propose how certain regulatory requirements for the assessment of trial applications can and should be interpreted and applied by national research ethics committees and other relevant authorities in order to avoid redundant trials and, most importantly, preclude the unnecessary recruitment of trial participants and their unjustified exposure to health risks.

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