Adult patient perspectives on clinical trial result reporting: A survey of cancer patients

Elzinga, Kate; Khan, Omar; Tang, Andrew; Fernandez, Conrad V.; Elzinga, Christine L; Heng, Daniel Y.C.; Vickers, Michael M.; Truong, Tony H.; Tang, Patricia A.

doi:10.1177/1740774516665597

Cited by 22 publications

(34 citation statements)

References 40 publications

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“…Moreover, participants say that they want aggregated results that explain the overall findings of the trial more than they want individual results [ 4 ]. They are open to receiving results through relatively low-cost channels like email or websites [ 3 , 4 ]. They are willing to wait until results have been reviewed by other researchers for accuracy and until after the study has been published [ 4 ].…”

Section: Finding a Solution: Address The Knowledge Gaps Firstmentioning

confidence: 99%

“…Different channels of communication may provide different benefits and drawbacks [ 2 – 4 ]. Participants appear open to modes of communication that may have relatively low cost to researchers (e.g., email or websites) [ 3 , 4 ], but more interactive approaches (e.g., teleconferences) may assuage researchers’ ethical concerns or improve participants’ willingness to take part in future studies. There is evidence that participants’ communication preferences vary with study topics, the emotional valence of results, and the characteristics of participant populations [ 3 , 5 ].…”

Section: Finding a Solution: Address The Knowledge Gaps Firstmentioning

confidence: 99%

“…This situation raises ethical concerns, and it may negatively influence participants’ attitudes toward researchers and future research participation. Across many different types of research, participants speak of having a right to the results of the studies in which they have participated [ 1 , 3 , 5 ], and they emphasize the importance of receiving results for themselves, their quality of life, and their families and communities [ 3 , 4 ].…”

Section: Introductionmentioning

confidence: 99%

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Health research participants are not receiving research results: a collaborative solution is needed

Long

Stewart

McElfish

2017

Trials

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Health research participants want the results of the studies in which they participate but do not typically receive them. Researchers generally express support for sharing results with participants but, in practice, may be unprepared or unwilling to do so. Many funders call for increased dissemination of research results beyond academic and clinical audiences, but few funders sponsor research to improve result sharing with participants. Although the solution appears straightforward (e.g., funders could incentivize researchers to share results with participants), there are critical gaps in knowledge that suggest the need for a more deliberate approach. For example, what ethical or practical concerns discourage researchers from returning results to participants? What exactly do participants plan to do with the results that they would like to receive? What are the best channels of communication for sharing results with particular participant populations? To address these knowledge gaps, we argue for a collaborative process to develop a research agenda related to result sharing with participants. With support and encouragement by funders, such research should evaluate the effects of different types of results (and results from different types of studies) on participants’ behaviors, attitudes, and emotions; it should also examine the researchers’ ethical, financial, logistical, methodological, and skill-related concerns and constraints related to sharing results with participants. Over time, collaborative research between researchers and participants can yield an evolving set of evidence-based guidelines for ethical, effective result sharing with participants.

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Section: Finding a Solution: Address The Knowledge Gaps Firstmentioning

confidence: 99%

Section: Finding a Solution: Address The Knowledge Gaps Firstmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Health research participants are not receiving research results: a collaborative solution is needed

Long

Stewart

McElfish

2017

Trials

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“…The scientific community interest level can be low and journals may believe that negative reports adversely affect their impact scores. However, most clinical trial participants believe that they have a right to study result disclosure regardless of trial outcome [ 21 ]. Depositing the results on clinicaltrials.gov in a timely manner can make minimum data sets available to the research and patient communities.…”

Section: Discussionmentioning

confidence: 99%

Time to publication of oncology trials and why some trials are never published

et al. 2017

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BackgroundVery little is known about the proportion of oncology trials that get published, the time it takes to publish them, or the reasons why oncology trials do not get published.MethodsWe analyzed all clinical trials that closed to accrual at our cancer center between 2009–2013. Trials were categorized by study purpose (therapeutic vs. diagnostic), phase (pilot, phase I, II, or III), and sponsor (industrial, cooperative group, institutional, or peer-reviewed). Final publications were identified in MEDLINE and EMBASE by NCT numbers, or by querying the principal investigator. For trials not published, we surveyed the principal investigators to identify the reason for non-publication.Findings469 of 809 protocols (58%) had been published by November 2016. The calculated probability of publication 7 years after completing accrual was 70.4%; the calculated median time to publication was 47 months. Only 18.8% of protocols overall were estimated to be published within 2 years from completing accrual. The calculated probability of publication was higher for therapeutic trials than non-therapeutic trials, but there was no difference based on phase or sponsor. Among protocols not published, 45.3% had completed accrual, and among these, a majority had a manuscript in preparation or review, or the trial was still collecting data. Failure to publish due to a pharmaceutical sponsor was rare. 30.6% of unpublished trials had closed for various reasons before completing accrual, usually due to poor accrual or pharmaceutical sponsor issues.InterpretationAlmost 30% of trials were calculated to be unpublished by 7 years after closing to accrual at our institution. Failure to reach accrual goals was an important factor in non-publication. We have devised new institutional policies that identify trials likely not to meet accrual goals and require early closure. We should be able to shorten the time from accrual completion to publication, especially for pilot and phase I trials for which long follow up is not needed.

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“…Although ongoing monitoring and personalized feedback are perceived as important in CCM, it is generally not common to provide feedback from individual research data to research participants. However, some participants express a wish to receive such information [21][22][23]. Research on discussions regarding the dissemination of results at aggregated levels [24] and procedural guidelines for reporting individual research results are scarce [25].…”

Section: Introductionmentioning

confidence: 99%

“Becoming myself”: how participants in a longitudinal substance use disorder recovery study experienced receiving continuous feedback on their results

Svendsen

Bjørnestad

Slyngstad

et al. 2020

Subst Abuse Treat Prev Policy

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Background: Being a participant in longitudinal follow-up studies is not commonly a factor considered when investigating useful self-change aspects for individuals attempting recovery from substance use disorder (SUD). This study reports on how ongoing monitoring, and feedback on data results in a longitudinal follow-up study of SUD recovery were perceived by individuals who had achieved long-term abstinence and social recovery. Methods: Interviewers with first-hand experience with the topic conducted interviews with 30 participants and analysed the data using a thematic analytic approach within an interpretative-phenomenological framework. Results: Analyses resulted in the following themes. 1) Ongoing short text messaging (SMS) monitoring: helped participants by offering recovery milestones and reminders of the past. 2) Feedback on data results helped participants track physical and cognitive recovery: "I am more like myself". 3) Using feedback in treatment: understanding the importance of a functional brain to participants may help with long-term retention in treatment. Conclusions: Self-changes that were challenging to detect on a day-today basis were available for reflection through longitudinal study participation, including ongoing monitoring and feedback on the results, allowing personal consolidation of change processes. Clinical services could benefit from continuing development and implementation of such technology for ongoing monitoring and feedback on assessments to motivate self-change in SUD recovery. The development of guidelines for providing the results of research assessments to individuals could help reduce attrition in research projects and support recovery and healthy choices for study participants.

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Adult patient perspectives on clinical trial result reporting: A survey of cancer patients

Cited by 22 publications

References 40 publications

Health research participants are not receiving research results: a collaborative solution is needed

Health research participants are not receiving research results: a collaborative solution is needed

Time to publication of oncology trials and why some trials are never published

“Becoming myself”: how participants in a longitudinal substance use disorder recovery study experienced receiving continuous feedback on their results

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