Dataset Information

Predictors of clinical trial data sharing: exploratory analysis of a cross-sectional survey.

ABSTRACT: 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.

SUBMITTER: Rathi VK

PROVIDER: S-EPMC4192345 | biostudies-literature | 2014 Oct

REPOSITORIES: biostudies-literature

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Predictors of clinical trial data sharing: exploratory analysis of a cross-sectional survey.

Rathi Vinay K VK Strait Kelly M KM Gross Cary P CP Hrynaszkiewicz Iain I Joffe Steven S Krumholz Harlan M HM Dzara Kristina K Ross Joseph S JS

Trials 20141002

<h4>Background</h4>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.<h4>Methods</h4>We conducted an exploratory analysis of re ...[more]

PMID: 25277128

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Project description:ObjectivesTo gather knowledge on the current debate, opinions and attitudes of Italian patient and citizen groups on individual participant data (IPD) sharing from clinical studies.DesignCross-sectional online survey.Setting and participantsA 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 measureData on Italian patient and citizen groups' self-reported knowledge, attitudes and opinions on IPD sharing, mechanisms for IPD access, advantages and risks.ResultsHalf 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.ConclusionsHalf 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.

Project description:BackgroundEligibility criteria are a fundamental element of clinical trial design, defining who can and who should not participate in a trial. Problems with the design or application of criteria are known to occur and pose risks to participants' safety and trial integrity, sometimes also negatively impacting on trial recruitment and generalisability. We conducted a short, exploratory survey to gather evidence on UK recruiters' experiences interpreting and applying eligibility criteria and their views on how criteria are communicated and developed.MethodsOur survey included topics informed by a wider programme of work at the Clinical Trials Research Unit, University of Leeds, on assuring eligibility criteria quality. Respondents were asked to answer based on all their trial experience, not only on experiences with our trials. The survey was disseminated to recruiters collaborating on trials run at our trials unit, and via other mailing lists and social media. The quantitative responses were descriptively analysed, with inductive analysis of free-text responses to identify themes.ResultsA total of 823 eligible respondents participated. In total, 79% of respondents reported finding problems with eligibility criteria in some trials, and 9% in most trials. The main themes in the types of problems experienced were criteria clarity (67% of comments), feasibility (34%), and suitability (14%). In total, 27% of those reporting some level of problem said these problems had led to patients being incorrectly included in trials; 40% said they had led to incorrect exclusions. Most respondents (56%) reported accessing eligibility criteria mainly in the trial protocol. Most respondents (74%) supported the idea of recruiter review of eligibility criteria earlier in the protocol development process.ConclusionsOur survey corroborates other evidence about the existence of suboptimal trial eligibility criteria. Problems with clarity were the most often reported, but the number of comments on feasibility and suitability suggest some recruiters feel eligibility criteria and associated assessments can hinder recruitment to trials. Our proposal for more recruiter involvement in protocol development has strong support and some potential benefits, but questions remain about how best to implement this. We invite other trialists to consider our other suggestions for how to assure quality in trial eligibility criteria.

Project description:Background. The high prevalence of HPV infection among Kazakhstani women and the absence of an HPV vaccination program are directly reflected in increasing rates of cervical cancer incidence and mortality. Kazakhstan made its first attempt at introducing the HPV vaccine in 2013, but was unsuccessful due to complications and low public acceptance. The attitudes of Kazakhstani women towards the vaccine were never measured. Therefore, this study aims to investigate the attitudes of women towards the HPV vaccine and determine factors associated with positive, negative, or neutral attitudes. Methods. A 29-item survey consisting of 21 demographic and contextual questions and 8 Likert-scale questions was distributed among women attending gynecological offices in four major cities of Kazakhstan from December 2021 until February 2022. Attitudes of women were measured based on their answers to the eight Likert-scale questions. Ordinal logistic regression was built to find associations between demographic characteristics and attitudes of women. Results. Two hundred thirty-three women were included in the final analysis. A total of 54% of women had positive attitudes towards the vaccine. The majority of women did not trust or had a neutral attitude towards the government, pharmaceutical industry, and traditional and alternative media. However, the trust of women was high in medical workers and scientific researchers. Women's age, education, number of children, effect of the 2013 HPV program, and trust in alternative medicine were included in the ordinal logistic model. Women with a low level of education, a high number of children, who believe in alternative medicine, and who were affected by the failed 2013 vaccination program were less likely to have a positive attitude towards the vaccine. Conclusions. Contrary attitudes towards HPV vaccination exist among Kazakhstani women, with approximately half having positive and almost half having negative or neutral attitudes towards the vaccine. An informational campaign that takes into consideration women's levels of trust in different agencies, as well as targets those who are the most uninformed, might help in a successful relaunch of the HPV vaccination program. However, more studies that cover a higher number of women are required.

Project description:ObjectivesTo examine company characteristics associated with better transparency and to apply a tool used to measure and improve clinical trial transparency among large companies and drugs, to smaller companies and biologics.DesignCross-sectional descriptive analysis.Setting and participantsNovel drugs and biologics Food and Drug Administration (FDA) approved in 2016 and 2017 and their company sponsors.Main outcome measuresUsing established Good Pharma Scorecard (GPS) measures, companies and products were evaluated on their clinical trial registration, results dissemination and FDA Amendments Act (FDAAA) implementation; companies were ranked using these measures and a multicomponent data sharing measure. Associations between company transparency scores with company size (large vs non-large), location (US vs non-US) and sponsored product type (drug vs biologic) were also examined.Results26% of products (16/62) had publicly available results for all clinical trials supporting their FDA approval and 67% (39/58) had public results for trials in patients by 6 months after their FDA approval; 58% (32/55) were FDAAA compliant. Large companies were significantly more transparent than non-large companies (overall median transparency score of 95% (IQR 91-100) vs 59% (IQR 41-70), p<0.001), attributable to higher FDAAA compliance (median of 100% (IQR 88-100) vs 57% (0-100), p=0.01) and better data sharing (median of 100% (IQR 80-100) vs 20% (IQR 20-40), p<0.01). No significant differences were observed by company location or product type.ConclusionsIt was feasible to apply the GPS transparency measures and ranking tool to non-large companies and biologics. Large companies are significantly more transparent than non-large companies, driven by better data sharing procedures and implementation of FDAAA trial reporting requirements. Greater research transparency is needed, particularly among non-large companies, to maximise the benefits of research for patient care and scientific innovation.

Dataset Information

Predictors of clinical trial data sharing: exploratory analysis of a cross-sectional survey.

Publications

Predictors of clinical trial data sharing: exploratory analysis of a cross-sectional survey.

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