The Yale University Open Data Access (YODA) Project has facilitated access to clinical trial data since 2013. The purpose of this article is to provide an overview of the Project, describe key decisions that were made when establishing data sharing policies, and suggest how our experience and the experiences of our first two data generator partners, Medtronic, Inc. and Johnson & Johnson, can be used to enhance other ongoing or future initiatives.

We conducted a systematic review to examine the substance use and recidivism outcomes of prison-based substance use interventions. We searched public health, criminology, and psychology databases, and conducted forward and backward snowballing methods to identify additional studies. Studies were included if they were published between January 1, 2000 and June 30, 2017; were published in English; and reported substance use and/or recidivism outcomes of prison-based substance use interventions. Studies were reviewed for methodological rigor using the Effective Public Health Practice Project's Quality Assessment Tool for Quantitative Studies. Our search returned 49 studies: 6 were methodologically strong, 20 were moderate, and 23 were weak. Results suggest therapeutic communities are effective in reducing recidivism and, to a lesser extent substance use after release. There is also evidence to suggest that opioid maintenance treatment is effective in reducing the risk of drug use after release from prison for opioid users. Furthermore, care after release from prison appears to enhance treatment effects for both types of interventions. Results provide evidence that policymakers can use to make informed decisions on best-practice approaches when addressing prisoner substance dependence and improving long-term outcomes. This comprehensive review highlights the difficulties of conducting quality research in the prison setting and suggests innovative study design for future research.

No abstract

ObjectiveTo characterise experiences using clinical research data shared through the National Institutes of Health (NIH)'s Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) clinical research data repository, along with data recipients’ perceptions of the value, importance and challenges with using BioLINCC data.Design and settingCross-sectional web-based survey.ParticipantsAll investigators who requested and received access to clinical research data from BioLINCC between 2007 and 2014.Main outcome measuresReasons for BioLINCC data request, research project plans, interactions with original study investigators, BioLINCC experience and other project details.ResultsThere were 536 investigators who requested and received access to clinical research data from BioLINCC between 2007 and 2014. Of 441 potential respondents, 195 completed the survey (response rate=44%); 89% (n=174) requested data for an independent study, 17% (n=33) for pilot/preliminary analysis. Commonly cited reasons for requesting data through BioLINCC were feasibility of collecting data of similar size and scope (n=122) and insufficient financial resources for primary data collection (n=76). For 95% of respondents (n=186), a primary research objective was to complete new research, as opposed to replicate prior analyses. Prior to requesting data from BioLINCC, 18% (n=36) of respondents had contacted the original study investigators to obtain data, whereas 24% (n=47) had done so to request collaboration. Nearly all (n=176; 90%) respondents found the data to be suitable for their proposed project; among those who found the data unsuitable (n=19; 10%), cited reasons were data too complicated to use (n=5) and data poorly organised (n=5). Half (n=98) of respondents had completed their proposed projects, of which 67% (n=66) have been published.ConclusionsInvestigators were primarily using clinical research data from BioLINCC for independent research, making use of data that would otherwise have not been feasible to collect.

ObjectivesThis study examined patterns of sexual violence against adults and children in Kenya during the COVID-19 pandemic to inform sexual violence prevention, protection, and response efforts.DesignA prospective cross-sectional research design was used with data collected from March to August 2020.SettingKenya.Participants317 adults, 224 children.Main measuresPerpetrator and survivor demographic data, characteristics of the assault.ResultsBivariate analyses found that children were more likely than adults to be attacked during daytime (59% vs 44%, p<0.001) by a single perpetrator rather than multiple perpetrators (31% vs 13%, p<0.001) in a private as opposed to a public location (66% vs 45%, p<0.001) and by someone known to the child (76% vs 58%, p<0.001). Children were violated most often by neighbours (29%) and family members (20%), whereas adults were equally likely to be attacked by strangers (41%) and persons known to them (59%). These variables were entered as predictors into a logistic regression model that significantly predicted the age group of the survivor, χ2(5, n=541)=53.3, p<0.001.ConclusionsPatterns of sexual violence against adult and child survivors during the COVID-19 pandemic are different, suggesting age-related measures are needed in national emergency plans to adequately address sexual violence during the pandemic and for future humanitarian crises.

No abstract

BackgroundIndustry‐sponsored clinical trials produce high‐quality data sets that can be used by researchers to generate new knowledge. We assessed the availability of individual participant‐level data (IPD) from large cardiovascular trials conducted by major pharmaceutical companies and compiled a list of available trials.Methods and ResultsWe identified all randomized cardiovascular interventional trials registered on ClinicalTrials.gov with >5000 enrollment, sponsored by 1 of the top 20 pharmaceutical companies by 2014 global sales. Availability of IPD for each trial was ascertained by searching each company's website/data‐sharing portal. If availability could not be determined, each company was contacted electronically. Of 60 included trials, IPD are available for 15 trials (25%) consisting of 204 452 patients. IPD are unavailable for 15 trials (25%). Reasons for unavailability were: cosponsor did not agree to make IPD available (4 trials) and trials were not conducted within a specific time (5 trials); for the remaining 6 trials, no specific reason was provided. For 30 trials (50%), availability of IPD could not be definitively determined either because of no response or requirements for a full proposal (23 trials).ConclusionsIPD from 1 in 4 large cardiovascular trials conducted by major pharmaceutical companies are confirmed available to researchers for secondary research, a valuable opportunity to enhance science. However, IPD from 1 in 4 trials are not available, and data availability could not be definitively determined for half of our sample. For several of these trials, companies require a full proposal to determine availability, making use of the IPD by researchers less certain.

No abstract