After a clinical trial is completed, most trial participants are interested in knowing if anything useful resulted from their participation, and whether their contributions were worthwhile.1,2 Trial participants express that receiving final overall trial results make them feel valued, fostered their trust in research, and could help in making decisions about their health.1 A review of studies focused on communicating trial results to participants revealed that 90% expressed a desire to receive trial results.2 In another survey conducted in the United States with 400 patients, 91% wanted to receive trial results after participation, and 68% of patients expressed that they would not participate in clinical trials in the future unless trial results were returned to them.3 Within pediatrics, this sentiment also holds true, because trial participants and their families feel strongly that they have a right to receive trial results after participation.2,4–6
Investigators have an ethical obligation to share trial results back to participants.1,5,7 Studies show that they are aware of this and express intentions to do so1,7 ; however, investigators most often do not share trial results.7 This is attributed, at least in part, to various barriers that prevent investigators from sharing study results with participants, including a need to amend institutional review board (IRB) applications, and limited resources or support in preparing trial results in plain language at the end of the study.1 Some investigators have expressed ethical concerns in communicating “negative trial” results, which they presume may cause potential psychological distress to participants.1,2 Certainly, there is a lack of practical guidance for investigators on when and how to share trial results.1,7
In pediatrics, there have been efforts to improve the return of results to trial participants. In 2008, the US Children’s Oncology Group formed a Return of Results Task Force to develop recommendations and guidance to serve as a framework on returning trial results to participants and their guardians.5 In 2021, the Clinical Trials Expert Group of the European Commission adopted the Good Lay Summary Practice guidelines, which include considerations and guiding points when preparing pediatric plain language summaries (PLS) of trial results.8 In 2022, the updated European Union Clinical Trials Regulation made it mandatory for investigators to publish such a PLS 6 months after study completion for any pediatric clinical trial.9 Most recently, in 2023, the United Kingdom mandated all trialists to share findings with trial participants.10 Beyond these guidance and regulations, efforts to understand the preferences of pediatric trial participants and parents in receiving trial results have been explored through surveys with youth and families over the years.4,6,8,11
Although recent developments regarding PLS of trial results for pediatric trials are a step forward, they mostly originate and occur in Europe. Widespread adoption of these regulations and guidelines, with a focus on targeted patient and family information needs, is needed beyond Europe. In a 2020 online survey conducted by the Center for Information and Study on Clinical Research Participation based in the United States, only 38% of parents whose child participated in a clinical research study had received a summary of the trial results after participation.11 Few efforts to meaningfully partner with youth and families in the development of guidelines and resources on how to return trial results to ensure that their information needs and preferences are integrated exist. One recent example is the CommuniKIDS initiative, which we were fortunate to lead.12 CommuniKIDS worked with youth advisors aged 13 to 18 years and parent advisors to codevelop a PLS results template to be used by pediatric clinical trialists to communicate trial results. Advisors brought lived experiences, perspectives, and preferences related to their involvement in pediatric clinical trials to inform CommuniKIDS’ template’s sections, design, and formatting. Tips for investigators using the template were codeveloped with an example of a completed PLS using the template.12
Call to Action: As Part of Any Pediatric Trial or Other Research Study Design, Establish Plans and Support for Sharing the Final Study Results With Participants, Youth, and Families
We argue that, with little effort, the practice of sharing study results from pediatric clinical trials and other research studies involving youth can be vastly improved. Although some funders of pediatric trials, such as the National Institutes of Health, support sharing of trial results back to participants,1 it is not yet a mandate for investigators who have received National Institutes of Health funding.13 Funders can support the sharing of trial results to participants by providing, in extension to their requirement of sharing trial results through updating trial registries and publishing in peer-reviewed journals, dedicated resources to prepare for such sharing. Procedures could be put in place to verify that study results are shared according to plan. Since 2020, the US Patient-Centered Outcomes Research Institute (PCORI) has asked applicants applying for funding through PCORI to budget up to $2500 specifically for activities related to sharing study results back to participants.13 PCORI supports investigators in preparing lay language summaries of PCORI-funded study results, which investigators are free to disseminate to participants; summaries are publicly shared on the PCORI Web site.1,14 Awardee institutions are asked to make “reasonable efforts” in sharing such summaries back to participants and any patient partners, and that any database and trial registration for the corresponding study are updated with a link to the summary.14 In addition to funders, peer-reviewed journals could require the inclusion of PLS in publications, as some already do, making study results accessible to the general public.
Beyond funders and journals, sharing of study results with participants is not yet consistently endorsed at research institutions and IRBs.15,16 For example, 49% of reviewed documents, such as checklists, guidelines, and consent form templates, from Canadian universities and research institutions’ IRBs, did not have any language that endorsed study results to be shared with participants.15 To standardize practice, consistency in statements related to sharing study results back to participants is needed.15 IRBs can require investigators to include details on how results will be shared, and what resources are available for these activities. Procedures for IRBs to check that investigators have shared results with participants as planned could be implemented.
Sharing study results requires intentionality, mitigating challenges through early planning.1 We believe that appropriate planning of partnership activities to prepare and share plain language materials for both clinical trials and other types of research with children, youth, and families is an integral part of transparent, responsible research practice. The minimum of sharing results should be with those who have participated in the study. We recommend current and prospective investigators to formulate a “study results sharing plan” with their pediatric research partners. Partners with lived experience can help determine how the results would be best communicated (eg, by e-mail, postal mail), the timing of delivery, and critically, ensure that any materials, such as PLS, use understandable and inclusive language. They can help proactively address potential concerns about any psychological or emotional impact of sharing disappointing study results with participants. Despite this possibility, most participants still want the option to receive the results.2 We suggest including an option for individual participants to indicate if they do or do not want to receive results. This can be done through the consent form and updated throughout the course of the study if needed.
In summary, partnering with pediatric participants and their families, exploring their information needs and wishes, and sharing study results demonstrates respect and advances the practice of partnership. We believe that having clear plans on when and how to share study results publicly with participants should be a requirement of investigators enforced by funders, IRBs, and research institutes. Well-planned and timely sharing of results that integrate input from pediatric participants and their families is a novel addition to responsible research practice, increases transparency, and may improve the general public’s trust in research. Use of the freely available CommuniKIDS template (https://www.ctontario.ca/patients-public/resources-for-engaging-patients/toolkit-to-improve-clinical-trial-participants-experiences/plain-language-result-summary-for-pediatric-clinical-trials/), and the examplar plain language results summary, may help improve the practice of sharing results in pediatric research, and may be a useful resource to support investigators in communicating pediatric study results back to their participants and their families.
Ms Baba was responsible for conceptualization, writing of the original draft and review, and editing; Drs Offringa and Butcher were responsible for conceptualization, supervision, writing of the review, and editing; and all authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work.
FUNDING: No external funding.
CONFLICT OF INTEREST DISCLOSURES: Ms Baba and Dr Offringa declare being part of the CommuniKIDS project team. Dr Butcher declares being the principal investigator of the CommuniKIDS initiative.
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