A review of data sharing statements in observational studies published in the BMJ: A cross-sectional study.
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ABSTRACT:
SUBMITTER: McDonald L
PROVIDER: S-EPMC5676190 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:To explore the effectiveness of data sharing by randomized controlled trials (RCTs) in journals with a full data sharing policy and to describe potential difficulties encountered in the process of performing reanalyses of the primary outcomes.Survey of published RCTs.PubMed/Medline.RCTs that had been submitted and published by The BMJ and PLOS Medicine subsequent to the adoption of data sharing policies by these journals.The primary outcome was data availability, defined as the eventual receipt of complete data with clear labelling. Primary outcomes were reanalyzed to assess to what extent studies were reproduced. Difficulties encountered were described.37 RCTs (21 from The BMJ and 16 from PLOS Medicine) published between 2013 and 2016 met the eligibility criteria. 17/37 (46%, 95% confidence interval 30% to 62%) satisfied the definition of data availability and 14 of the 17 (82%, 59% to 94%) were fully reproduced on all their primary outcomes. Of the remaining RCTs, errors were identified in two but reached similar conclusions and one paper did not provide enough information in the Methods section to reproduce the analyses. Difficulties identified included problems in contacting corresponding authors and lack of resources on their behalf in preparing the datasets. In addition, there was a range of different data sharing practices across study groups.Data availability was not optimal in two journals with a strong policy for data sharing. When investigators shared data, most reanalyses largely reproduced the original results. Data sharing practices need to become more widespread and streamlined to allow meaningful reanalyses and reuse of data.Open Science Framework osf.io/c4zke.
| S-EPMC5809812 | biostudies-other
Project description:A number of publishers and funders, including PLOS, have recently adopted policies requiring researchers to share the data underlying their results and publications. Such policies help increase the reproducibility of the published literature, as well as make a larger body of data available for reuse and re-analysis. In this study, we evaluate the extent to which authors have complied with this policy by analyzing Data Availability Statements from 47,593 papers published in PLOS ONE between March 2014 (when the policy went into effect) and May 2016. Our analysis shows that compliance with the policy has increased, with a significant decline over time in papers that did not include a Data Availability Statement. However, only about 20% of statements indicate that data are deposited in a repository, which the PLOS policy states is the preferred method. More commonly, authors state that their data are in the paper itself or in the supplemental information, though it is unclear whether these data meet the level of sharing required in the PLOS policy. These findings suggest that additional review of Data Availability Statements or more stringent policies may be needed to increase data sharing.
| S-EPMC5931451 | biostudies-literature
Project description:In June 2017, the International Committee of Medical Journal Editors (ICMJE) announced a requirement that authors reporting the results of clinical trials to journals that follow ICMJE recommendations must include an individual participant data (IPD) sharing statement with manuscripts submitted after 01 July 2018. Additionally, all new clinical trials for which enrollment began on or after 01 January 2019 must include a data sharing statement in the trial's publicly posted registration. This study sought to understand whether IPD sharing statements of clinical trials first registered on ClinicalTrials.gov before 01 January 2019 reflected comprehension of the expectations and a willingness to share. To establish baseline characteristics for the prevalence and quality of IPD sharing statements, we examined IPD sharing statements among 2,040 clinical trials first posted on ClinicalTrials.gov between 01 January 2018 and 06 June 2018. Two independent coders further analyzed the quality of the IPD sharing statements of trials whose registration records indicated the intent to share IPD. The vast majority of trials included in this study did not indicate an intent to share IPD (n = 1,928; 94.5%). Among the trials that did commit to sharing IPD (n = 112, 5.5%), significant variability existed in the content and structure of IPD sharing statements. The results of this study suggest that successful compliance with the IPD sharing statement requirements of the ICMJE will require further clarification, enhanced education, and outreach to investigators.
| S-EPMC7028256 | biostudies-literature
Project description:Sharing data and code are important components of reproducible research. Data sharing in research is widely discussed in the literature; however, there are no well-established evidence-based incentives that reward data sharing, nor randomized studies that demonstrate the effectiveness of data sharing policies at increasing data sharing. A simple incentive, such as an Open Data Badge, might provide the change needed to increase data sharing in health and medical research. This study was a parallel group randomized controlled trial (protocol registration: doi:10.17605/OSF.IO/PXWZQ) with two groups, control and intervention, with 80 research articles published in BMJ Open per group, with a total of 160 research articles. The intervention group received an email offer for an Open Data Badge if they shared their data along with their final publication and the control group received an email with no offer of a badge if they shared their data with their final publication. The primary outcome was the data sharing rate. Badges did not noticeably motivate researchers who published in BMJ Open to share their data; the odds of awarding badges were nearly equal in the intervention and control groups (odds ratio = 0.9, 95% CI [0.1, 9.0]). Data sharing rates were low in both groups, with just two datasets shared in each of the intervention and control groups. The global movement towards open science has made significant gains with the development of numerous data sharing policies and tools. What remains to be established is an effective incentive that motivates researchers to take up such tools to share their data.
| S-EPMC7137948 | biostudies-literature
Project description:Data sharing is central to the rapid translation of research into advances in clinical medicine and public health practice. In the context of COVID-19, there has been a rush to share data marked by an explosion of population-specific and discipline-specific resources for collecting, curating, and disseminating participant-level data. We conducted a scoping review and cross-sectional survey to identify and describe COVID-19-related platforms and registries that harmonise and share participant-level clinical, omics (eg, genomic and metabolomic data), imaging data, and metadata. We assess how these initiatives map to the best practices for the ethical and equitable management of data and the findable, accessible, interoperable, and reusable (FAIR) principles for data resources. We review gaps and redundancies in COVID-19 data-sharing efforts and provide recommendations to build on existing synergies that align with frameworks for effective and equitable data reuse. We identified 44 COVID-19-related registries and 20 platforms from the scoping review. Data-sharing resources were concentrated in high-income countries and siloed by comorbidity, body system, and data type. Resources for harmonising and sharing clinical data were less likely to implement FAIR principles than those sharing omics or imaging data. Our findings are that more data sharing does not equate to better data sharing, and the semantic and technical interoperability of platforms and registries harmonising and sharing COVID-19-related participant-level data needs to improve to facilitate the global collaboration required to address the COVID-19 crisis.
| S-EPMC10552001 | biostudies-literature
Project description:ObjectiveTo investigate clinical trialists' opinions and experiences of sharing of clinical trial data with investigators who are not directly collaborating with the research team.Design and settingCross sectional, web based survey.ParticipantsClinical trialists who were corresponding authors of clinical trials published in 2010 or 2011 in one of six general medical journals with the highest impact factor in 2011.Main outcome measuresSupport for and prevalence of data sharing through data repositories and in response to individual requests, concerns with data sharing through repositories, and reasons for granting or denying requests.ResultsOf 683 potential respondents, 317 completed the survey (response rate 46%). In principle, 236 (74%) thought that sharing de-identified data through data repositories should be required, and 229 (72%) thought that investigators should be required to share de-identified data in response to individual requests. In practice, only 56 (18%) indicated that they were required by the trial funder to deposit the trial data in a repository; of these 32 (57%) had done so. In all, 149 respondents (47%) had received an individual request to share their clinical trial data; of these, 115 (77%) had granted and 56 (38%) had denied at least one request. Respondents' most common concerns about data sharing were related to appropriate data use, investigator or funder interests, and protection of research subjects.ConclusionsWe found strong support for sharing clinical trial data among corresponding authors of recently published trials in high impact general medical journals who responded to our survey, including a willingness to share data, although several practical concerns were identified.
| S-EPMC3502744 | biostudies-literature
Project description:OBJECTIVES:To gather knowledge on the current debate, opinions and attitudes of Italian patient and citizen groups on individual participant data (IPD) sharing from clinical studies. DESIGN:Cross-sectional online survey. SETTING AND PARTICIPANTS:A 22-item online questionnaire was sent by email to 2003 contacts of patient and citizen groups in Italy. We received 311 responses, checked for duplicate respondents (16); 295 single groups responded, 280 providing questionnaires eligible for analysis (response rate 15%). Ninety (32.1%) dealt with oncology and palliative care, 175 (46.2%) operated locally or regionally and 136 (48.6%) were involved in clinical research. OUTCOME MEASURE:Data on Italian patient and citizen groups' self-reported knowledge, attitudes and opinions on IPD sharing, mechanisms for IPD access, advantages and risks. RESULTS:Half the respondents (144 out of 280, 51%) had some knowledge about the IPD sharing debate, and 60 (42%) stated they had an official position (35 in favour, 19 in favour with restrictions, 2 against, 1 neither for nor against, 3 missing). Nineteen discussed the topic encouraged by this survey; 39% approved broad access by researchers and other professions and identified information to participants, data de-identification, secure archives, access agreements and sanctions for misuse as important aspects of IPD sharing models. Respondents highlighted re-identification, privacy and re-use of data for purposes that participants do not agree on, as main risks, advancement of innovation and reducing waste in research as main advantages. Around half believed IPD sharing would not discourage study participation. CONCLUSIONS:Half the respondents were aware of the debate. Those who had an official position were mainly in favour of IPD sharing. Many supported broad access, asking for conditions important for building trust in entities that handle IPD sharing.Although limited by the low response rate, these findings reinforce the demand for reliable and transparent processes where accountabilities are clear.
| S-EPMC6377545 | biostudies-other
Project description:There are numerous benefits to the research community from data sharing, and yet the open sharing of participant level data is not without potential pitfalls. In addition to the scientific community, the interests of study participants who volunteered their data must be considered, along with the interests of study investigators who expend a substantial amount of effort into the design, conduct, and analytical plans for the study. The National Heart, Lung, and Blood Institute (NHLBI) has developed a data-sharing protocol focused on balancing the interests of study participants, study investigators, and the research community with independent oversight by the NHLBI IRB. The data repository presently includes individual level data on more than 560,000 participants from 100 Institute-supported clinical trials and observational studies.
| S-EPMC3750470 | biostudies-literature
Project description:ObjectiveTo quantify data sharing trends and data sharing policy compliance at the British Medical Journal (BMJ) by analysing the rate of data sharing practices, and investigate attitudes and examine barriers towards data sharing.DesignObservational study.SettingThe BMJ research archive.Participants160 randomly sampled BMJ research articles from 2009 to 2015, excluding meta-analysis and systematic reviews.Main outcome measuresPercentages of research articles that indicated the availability of their raw data sets in their data sharing statements, and those that easily made their data sets available on request.Results3 articles contained the data in the article. 50 out of 157 (32%) remaining articles indicated the availability of their data sets. 12 used publicly available data and the remaining 38 were sent email requests to access their data sets. Only 1 publicly available data set could be accessed and only 6 out of 38 shared their data via email. So only 7/157 research articles shared their data sets, 4.5% (95% CI 1.8% to 9%). For 21 clinical trials bound by the BMJ data sharing policy, the per cent shared was 24% (8% to 47%).ConclusionsDespite the BMJ's strong data sharing policy, sharing rates are low. Possible explanations for low data sharing rates could be: the wording of the BMJ data sharing policy, which leaves room for individual interpretation and possible loopholes; that our email requests ended up in researchers spam folders; and that researchers are not rewarded for sharing their data. It might be time for a more effective data sharing policy and better incentives for health and medical researchers to share their data.
| S-EPMC5073489 | biostudies-literature
Project description:BACKGROUND:A number of research funders, biomedical journals, pharmaceutical companies, and regulatory agencies have adopted policies advocating or mandating that clinical trialists share data with external investigators. We therefore sought to determine whether certain characteristics of trialists or their trials are associated with more unfavorable perceptions of data sharing. To date, no prior research has addressed this issue. METHODS:We conducted an exploratory analysis of responses to a cross-sectional, web-based survey. The survey sample consisted of trialists who were corresponding authors of clinical trials published in 2010 or 2011 in one of six general medical journals with the highest impact factors in 2011. The following key characteristics were examined: trialists' academic productivity and geographic location, trial funding source and size, and the journal in which it was published. Main outcome measures included: support for data sharing in principle, concerns with data sharing through repositories, and reasons for granting or denying requests. Chi-squared tests and Fisher's exact tests were used to assess statistical significance. RESULTS:Of 683 potential respondents, 317 completed the survey (response rate 46%). Both support for data sharing and reporting of specific concerns with sharing data through repositories exceeded 75%, but neither differed by trialist or trial characteristics. However, there were some significant differences in explicit reasons to share or withhold data. Respondents located in Western Europe more frequently indicated they have or would share data in order to receive academic benefits or recognition when compared with respondents located in the United States or Canada (58 versus 31%). In addition, respondents who were the most academically productive less frequently indicated they have or would withhold data in order to protect research subjects when compared with less academically productive respondents (24 versus 40%), as did respondents who received industry funding when compared with those who had not (24 versus 43%). CONCLUSIONS:Respondents indicated strong support for data sharing overall. There were few notable differences in how trialists viewed the benefits and risks of data sharing when categorized by trialists' academic productivity and geographic location, trial funding source and size, and the journal in which it was published.
| S-EPMC4192345 | biostudies-literature