Publishing Identifiable Patient Photographs in Scientific Journals: Scoping Review of Policies and Practices.

BACKGROUND: Publishing identifiable patient data in scientific journals may jeopardize patient privacy and confidentiality if best ethical practices are not followed. Current journal practices show considerable diversity in the publication of identifiable patient photographs, and different stakeholders may have different opinions of and practices in publishing patient photographs. OBJECTIVE: This scoping review aimed to identify existing evidence and map knowledge gaps in medical research on the policies and practices of publishing identifiable photographs in scientific articles. METHODS: We performed a comprehensive search of the Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, CINAHL with Full Text, Database of Abstracts of Reviews of Effects, Ovid MEDLINE, and Scopus. The Open Science Framework, PROSPERO, BASE, Google Scholar, OpenGrey, ClinicalTrials.gov, the Campbell Collaboration Library, and Science.gov were also searched. RESULTS: After screening the initial 15,949 titles and abstracts, 98 (0.61%) publications were assessed for eligibility at the full-text level, and 30 (0.19%) publications were included in this review. The studies were published between 1994 and 2020; most had a cross-sectional design and were published in journals covering different medical disciplines. We identified 3 main topics. The first included ethical aspects of the use of facial photographs in publications. In different clinical settings, the consent process was not conducted properly, and health professionals did not recognize the importance of obtaining written patient consent for taking and using patient medical photographs. They often considered verbal consent sufficient or even used the photographs without consent. The second topic included studies that investigated the practices and use of medical photography in publishing. Both patients and doctors asked for confidential storage and maintenance of medical photographs. Patients preferred to be photographed by their physicians using an institutional camera and preferred nonidentifiable medical photographs not only for publication but also in general. Conventional methods of deidentification of facial photographs concealing the eye area were recognized as unsuccessful in protecting patient privacy. The third topic emerged from studies investigating medical photography in journal articles. These studies showed great diversity in publishing practices regarding consent for publication of medical photographs. Journal policies regarding the consent process and consent forms were insufficient, and existing ethical professional guidelines were not fully implemented in actual practices. Patients' photographs from open-access medical journals were found on public web-based platforms. CONCLUSIONS: This scoping review showed a diversity of practices in publishing identifiable patient photographs and an unsatisfactory level of knowledge of this issue among different stakeholders despite existing standards. Emerging issues include the availability of patients' photographs from open-access journals or preprints in the digital environment. There is a need to improve standards and processes to obtain proper consent to fully protect the privacy of patients in published articles.

Celecoxib for osteoarthritis.

BACKGROUND: Osteoarthritis (OA) is the most common form of arthritis and is caused by degeneration of the joint cartilage and growth of new bone, cartilage and connective tissue. It is often associated with major disability and impaired quality of life. There is currently no consensus on the best treatment to improve OA symptoms. Celecoxib is a selective non-steroidal anti-inflammatory drug (NSAID). OBJECTIVES: To assess the clinical benefits (pain, function, quality of life) and safety (withdrawals due to adverse effects, serious adverse effects, overall discontinuation rates) of celecoxib in osteoarthritis (OA). SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase and clinical trials registers up to April 11, 2017, as well as reference and citation lists of included studies. Pharmaceutical companies and authors of published articles were contacted. SELECTION CRITERIA: We included published studies (full reports in a peer reviewed journal) of prospective randomized controlled trials (RCTs) that compared oral celecoxib versus no intervention, placebo or another traditional NSAID (tNSAID) in participants with clinically- or radiologically-confirmed primary OA of the knee or hip, or both knee and hip. DATA COLLECTION AND ANALYSIS: Two authors independently performed data extraction, quality assessment, and compared results. Main analyses for patient-reported outcomes of pain and physical function were conducted on studies with low risk of bias for sequence generation, allocation concealment and blinding of participants and personnel. MAIN RESULTS: We included 36 trials that provided data for 17,206 adults: 9402 participants received celecoxib 200 mg/day, and 7804 were assigned to receive either tNSAIDs (N = 1869) or placebo (N = 5935). Celecoxib was compared with placebo (32 trials), naproxen (6 trials) and diclofenac (3 trials). Studies were published between 1999 and 2014. Studies included participants with knee, hip or both knee and hip OA; mean OA duration was 7.9 years. Most studies included predominantly white participants whose mean age was 62 (± 10) years; most participants were women. There were no concerns about risk of bias for performance and detection bias, but selection bias was poorly reported in most trials. Most trials had high attrition bias, and there was evidence of selective reporting in a third of the studies. Celecoxib versus placeboCompared with placebo celecoxib slightly reduced pain on a 500-point Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain scale, accounting for 3% absolute improvement (95% CI 2% to 5% improvement) or 12% relative improvement (95% CI 7% to 18% improvement) (4 studies, 1622 participants). This improvement may not be clinically significant (high quality evidence).Compared with placebo celecoxib slightly improved physical function on a 1700-point WOMAC scale, accounting for 4% absolute improvement (95% CI 2% to 6% improvement), 12% relative improvement (95% CI 5% to 19% improvement) (4 studies, 1622 participants). This improvement may not be clinically significant (high quality evidence).There was no evidence of an important difference for withdrawals due to adverse events (Peto OR 0.99, 95% CI 0.85 to 1.15) (moderate quality evidence due to study limitations).Results were inconclusive for numbers of participants experiencing any serious AEs (SAEs) (Peto OR 0.95, 95% CI 0.66 to 1.36), gastro-intestinal events (Peto OR 1.91, 95% CI 0.24 to 14.90) and cardiovascular events (Peto OR 3.40, 95% CI 0.73 to 15.88) (very low quality evidence due to serious imprecision and study limitations). However, regulatory agencies have warned of increased cardiovascular events for celecoxib. Celecoxib versus tNSAIDsThere were inconclusive results regarding the effect on pain between celecoxib and tNSAIDs on a 100-point visual analogue scale (VAS), showing 5% absolute improvement (95% CI 11% improvement to 2% worse), 11% relative improvement (95% CI 26% improvement to 4% worse) (2 studies, 1180 participants, moderate quality evidence due to publication bias).Compared to a tNSAID celecoxib slightly improved physical function on a 100-point WOMAC scale, showing 6% absolute improvement (95% CI 6% to 11% improvement) and 16% relative improvement (95% CI 2% to 30% improvement). This improvement may not be clinically significant (low quality evidence due to missing data and few participants) (1 study, 264 participants).Based on low or very low quality evidence (downgraded due to missing data, high risk of bias, few events and wide confidence intervals) results were inconclusive for withdrawals due to AEs (Peto OR 0.97, 95% CI 0.74 to 1.27), number of participants experiencing SAEs (Peto OR 0.92, 95% CI 0.66 to 1.28), gastro-intestinal events (Peto OR 0.61, 0.15 to 2.43) and cardiovascular events (Peto OR 0.47, 95% CI 0.17 to 1.25).In comparisons of celecoxib and placebo there were no differences in pooled analyses between our main analysis with low risk of bias and all eligible studies. In comparisons of celecoxib and tNSAIDs, only one outcome showed a difference between studies at low risk of bias and all eligible studies: physical function (6% absolute improvement in low risk of bias, no difference in all eligible studies).No studies included in the main comparisons measured quality of life. Of 36 studies, 34 reported funding by drug manufacturers and in 34 studies one or more study authors were employees of the sponsor. AUTHORS' CONCLUSIONS: We are highly reserved about results due to pharmaceutical industry involvement and limited data. We were unable to obtain data from three studies, which included 15,539 participants, and classified as awaiting assessment. Current evidence indicates that celecoxib is slightly better than placebo and some tNSAIDs in reducing pain and improving physical function. We are uncertain if harms differ among celecoxib and placebo or tNSAIDs due to risk of bias, low quality evidence for many outcomes, and that some study authors and Pfizer declined to provide data from completed studies with large numbers of participants. To fill the evidence gap, we need to access existing data and new, independent clinical trials to investigate benefits and harms of celecoxib versus tNSAIDs for people with osteoarthritis, with longer follow-up and more direct head-to-head comparisons with other tNSAIDs.

Interventions to prevent misconduct and promote integrity in research and publication.

BACKGROUND: Improper practices and unprofessional conduct in clinical research have been shown to waste a significant portion of healthcare funds and harm public health. OBJECTIVES: Our objective was to evaluate the effectiveness of educational or policy interventions in research integrity or responsible conduct of research on the behaviour and attitudes of researchers in health and other research areas. SEARCH METHODS: We searched the CENTRAL, MEDLINE, LILACS and CINAHL health research bibliographical databases, as well as the Academic Search Complete, AGRICOLA, GeoRef, PsycINFO, ERIC, SCOPUS and Web of Science databases. We performed the last search on 15 April 2015 and the search was limited to articles published between 1990 and 2014, inclusive. We also searched conference proceedings and abstracts from research integrity conferences and specialized websites. We handsearched 14 journals that regularly publish research integrity research. SELECTION CRITERIA: We included studies that measured the effects of one or more interventions, i.e. any direct or indirect procedure that may have an impact on research integrity and responsible conduct of research in its broadest sense, where participants were any stakeholders in research and publication processes, from students to policy makers. We included randomized and non-randomized controlled trials, such as controlled before-and-after studies, with comparisons of outcomes in the intervention versus non-intervention group or before versus after the intervention. Studies without a control group were not included in the review. DATA COLLECTION AND ANALYSIS: We used the standard methodological procedures expected by Cochrane. To assess the risk of bias in non-randomized studies, we used a modified Cochrane tool, in which we used four out of six original domains (blinding, incomplete outcome data, selective outcome reporting, other sources of bias) and two additional domains (comparability of groups and confounding factors). We categorized our primary outcome into the following levels: 1) organizational change attributable to intervention, 2) behavioural change, 3) acquisition of knowledge/skills and 4) modification of attitudes/perceptions. The secondary outcome was participants' reaction to the intervention. MAIN RESULTS: Thirty-one studies involving 9571 participants, described in 33 articles, met the inclusion criteria. All were published in English. Fifteen studies were randomized controlled trials, nine were controlled before-and-after studies, four were non-equivalent controlled studies with a historical control, one was a non-equivalent controlled study with a post-test only and two were non-equivalent controlled studies with pre- and post-test findings for the intervention group and post-test for the control group. Twenty-one studies assessed the effects of interventions related to plagiarism and 10 studies assessed interventions in research integrity/ethics. Participants included undergraduates, postgraduates and academics from a range of research disciplines and countries, and the studies assessed different types of outcomes.We judged most of the included randomized controlled trials to have a high risk of bias in at least one of the assessed domains, and in the case of non-randomized trials there were no attempts to alleviate the potential biases inherent in the non-randomized designs.We identified a range of interventions aimed at reducing research misconduct. Most interventions involved some kind of training, but methods and content varied greatly and included face-to-face and online lectures, interactive online modules, discussion groups, homework and practical exercises. Most studies did not use standardized or validated outcome measures and it was impossible to synthesize findings from studies with such diverse interventions, outcomes and participants. Overall, there is very low quality evidence that various methods of training in research integrity had some effects on participants' attitudes to ethical issues but minimal (or short-lived) effects on their knowledge. Training about plagiarism and paraphrasing had varying effects on participants' attitudes towards plagiarism and their confidence in avoiding it, but training that included practical exercises appeared to be more effective. Training on plagiarism had inconsistent effects on participants' knowledge about and ability to recognize plagiarism. Active training, particularly if it involved practical exercises or use of text-matching software, generally decreased the occurrence of plagiarism although results were not consistent. The design of a journal's author contribution form affected the truthfulness of information supplied about individuals' contributions and the proportion of listed contributors who met authorship criteria. We identified no studies testing interventions for outcomes at the organizational level. The numbers of events and the magnitude of intervention effects were generally small, so the evidence is likely to be imprecise. No adverse effects were reported. AUTHORS' CONCLUSIONS: The evidence base relating to interventions to improve research integrity is incomplete and the studies that have been done are heterogeneous, inappropriate for meta-analyses and their applicability to other settings and population is uncertain. Many studies had a high risk of bias because of the choice of study design and interventions were often inadequately reported. Even when randomized designs were used, findings were difficult to generalize. Due to the very low quality of evidence, the effects of training in responsible conduct of research on reducing research misconduct are uncertain. Low quality evidence indicates that training about plagiarism, especially if it involves practical exercises and use of text-matching software, may reduce the occurrence of plagiarism.

Bridging knowledge translation gap in health in developing countries: visibility, impact and publishing standards in journals from the Eastern Mediterranean.

BACKGROUND: Local and regional scientific journals are important factors in bridging gaps in health knowledge translation in low-and middle-income countries. We assessed indexing, citations and publishing standards of journals from the Eastern Mediterranean region. METHODS: For journals from 22 countries in the collection of the Index Medicus for the Eastern Mediterranean Region (IMEMR), we analyzed indexing in bibliographical databases and citations during 2006-2009 to published items in 2006 in Web of Science (WoS) and SCOPUS. Adherence to editorial and publishing standards was assessed using a special checklist. RESULTS: Out of 419 journals in IMEMR, 19 were indexed in MEDLINE, 23 in WoS and 46 in SCOPUS. Their impact factors ranged from 0.016 to 1.417. For a subset of 175 journals with available tables of contents from 2006, articles published in 2006 from 93 journals received 2068 citations in SCOPUS (23.5% self-citations) and articles in 86 journals received 1579 citations in WoS (24.3% self-citations) during 2006-2009. Citations to articles came mostly from outside of the Eastern Mediterranean region (76.8% in WoS and 75.4% in SCOPUS). Articles receiving highest number of citations presented topics specific for the region. Many journals did not follow editorial and publishing standards, such addressing requirements about the patient's privacy rights (68.0% out of 244 analyzed), policy on managing conflicts of interest (66.4%), and ethical conduct in clinical and animal research (66.4%). CONCLUSION: Journals from the Eastern Mediterranean are visible in and have impact on global scientific community. Coordinated effort of all stakeholders in journal publishing, including researchers, journal editors and owners, policy makers and citation databases, is needed to further promote local journals as windows to the research in the developing world and the doors for valuable regional research to the global scientific community.

Motivations for performing scholarly prepublication peer review: A scoping review.

Prepublication peer review is a cornerstone of science. Overburdened reviewers invest millions of hours in this voluntary activity. In this scoping review, we aimed at identifying motivations for performing prepublication peer review of scholarly manuscripts. Original research studies investigating actual peer reviewers' motivations were included. We excluded modeling studies, studies related to other types of peer review, guidelines, peer review processes in particular journals. Medline, WoS, and Scopus were searched in February 2016, with no language or time limitations, and the search was updated in July 2019. The search yielded 5,250 records, and 382 were chosen for full text analysis, out of which 10 were appropriate for synthesis. Reference snowballing identified one eligible study. Eleven studies were appropriate for synthesis: four qualitative, four mixed qualitative/quantitative, and three qualitative studies, published from 1998 to 2018, involving 6,667 respondents. Major internal incentive was "communal obligations and reciprocity." Major external incentives were "career advancement," "being recognized as an expert," and "building relationships with journals and editors." Major disincentive was the "lack of time." Editors could incentivize peer review process by choosing highest quality articles, improving communication with peer reviewers, in order to make the process of peer review as short and efficient as possible. The gaps in research concern disincentives to review.

Croatian Medical Journal citation score in Web of Science, Scopus, and Google Scholar.

AIM: To analyze the 2007 citation count of articles published by the Croatian Medical Journal in 2005-2006 based on data from the Web of Science, Scopus, and Google Scholar. METHODS: Web of Science and Scopus were searched for the articles published in 2005-2006. As all articles returned by Scopus were included in Web of Science, the latter list was the sample for further analysis. Total citation counts for each article on the list were retrieved from Web of Science, Scopus, and Google Scholar. The overlap and unique citations were compared and analyzed. Proportions were compared using chi(2)-test. RESULTS: Google Scholar returned the greatest proportion of articles with citations (45%), followed by Scopus (42%), and Web of Science (38%). Almost a half (49%) of articles had no citations and 11% had an equal number of identical citations in all 3 databases. The greatest overlap was found between Web of Science and Scopus (54%), followed by Scopus and Google Scholar (51%), and Web of Science and Google Scholar (44%). The greatest number of unique citations was found by Google Scholar (n=86). The majority of these citations (64%) came from journals, followed by books and PhD theses. Approximately 55% of all citing documents were full-text resources in open access. The language of citing documents was mostly English, but as many as 25 citing documents (29%) were in Chinese. CONCLUSION: Google Scholar shares a total of 42% citations returned by two others, more influential, bibliographic resources. The list of unique citations in Google Scholar is predominantly journal based, but these journals are mainly of local character. Citations received by internationally recognized medical journals are crucial for increasing the visibility of small medical journals but Google Scholar may serve as an alternative bibliometric tool for an orientational citation insight.

Correcting duplicate publications: follow up study of MEDLINE tagged duplications.

INTRODUCTION: As MEDLINE indexers tag similar articles as duplicates even when journals have not addressed the duplication(s), we sought to determine the reasons behind the tagged duplications, and if the journals had undertaken or had planned to undertake any actions to address them. MATERIALS AND METHODS: On 16 January 2013, we extracted all tagged duplicate publications (DPs), analysed published notices, and then contacted MEDLINE and editors regarding cases unaddressed by notices. For non-respondents, we compared full text of the articles. We followed up the study for the next 5 years to see if any changes occurred. RESULTS: We found 1011 indexed DPs, which represented 555 possible DP cases (in MEDLINE, both the original and the duplicate are assigned a DP tag). Six cases were excluded as we could not obtain their full text. Additional 190 (35%) cases were incorrectly tagged as DPs. Of 359 actual cases of DPs, 200 (54%) were due to publishers' actions (e.g. identical publications in the same journal), and 159 (46%) due to authors' actions (e.g. article submission to more than one journal). Of the 359 cases, 185 (52%) were addressed by notices, but only 25 (7%) retracted. Following our notifications, MEDLINE corrected 138 (73%) incorrectly tagged cases, and editors retracted 8 articles. CONCLUSIONS: Despite clear policies on how to handle DPs, just half (54%) of the DPs in MEDLINE were addressed by journals and only 9% retracted. Publishers, editors, and indexers need to develop and implement standards for better correction of duplicate published records.

Antimicrobial efficacy of commercially available endodontic bioceramic root canal sealers: A systematic review.

BACKGROUND: Recently, a new generation of bioceramic root canal sealers has been introduced onto the market. Many in vitro studies have investigated the antimicrobial properties of these sealers, but their comparative efficacy in antimicrobial activity is still unknown. METHODOLOGY: Three electronic databases were searched: MEDLINE and Embase via the OvidSP platform, and Web of Science, up to June 25, 2019. Studies were included irrespective of study design, type of publication and language. Reporting quality was assessed by two authors independently. Meta-analysis was not performed due to studies being highly heterogeneous. RESULTS: We included 37 studies that analysed the antimicrobial effects of bioceramic sealers. Most of them used a planktonic cell model, with the exception of nine studies which used biofilms. It was not possible to make direct comparison of results from studies and to give a clear conclusion about the comparative antimicrobial activity of these materials because the studies used heterogeneous sources and ages of microorganisms, setting and contact times of sealers, and antimicrobial tests. Furthermore, some materials showed completely different results when tested with different methods. CONCLUSIONS: In conclusion, multiple in vitro studies have shown that bioceramic sealers may have various degrees of antimicrobial activity. However, it is still impossible to make conclusions about their comparative efficacy and to recommend the use of one over another in clinical practice because the studies available were conducted in different ways, which makes meta-analysis futile. A uniform methodological approach, consistent definitions and studies on humans are urgently needed in this field of research so that recommendations for practice can be made.

Essential medicines availability is still suboptimal in many countries: a scoping review.

OBJECTIVES: To identify uses of WHO Model list of essential medicines (EMs) and summarize studies examining EM and national EM lists (NEMLs). STUDY DESIGN AND SETTING: In this scoping review, we searched PubMed, Scopus, WHO website and WHO Regional Databases for studies on NEMLs, reimbursement medicines lists, and WHO EML, with no date or language restrictions. RESULTS: Three thousand one hundred forty-four retrieved documents were independently screened by two reviewers; 100 full-text documents were analyzed; 37 contained data suitable for quantitative and qualitative analysis on EMs availability (11 documents), medicines for specific diseases (13 documents), and comparison of WHO EML and NEMLs (13 documents). From the latter, two documents analyzed the relevance of evidence from Cochrane systematic reviews for medicines that were on NEMLs but not on the WHO EML. EMs availability is still suboptimal in low-income countries. Availability of children formulations and EMs for specific diseases such as chronic, cancer, pain, and reproductive health is suboptimal even in middle-income countries. CONCLUSION: WHO EML can be used as a basic set of medicines for different settings. More evidence is needed into how NEMLs can contribute to better availability of children formulations, pain, and cancer medicines in developing countries.

The STROBE extensions: protocol for a qualitative assessment of content and a survey of endorsement.

INTRODUCTION: The STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) Statement was developed in response to inadequate reporting of observational studies. In recent years, several extensions to STROBE have been created to provide more nuanced field-specific guidance for authors. The content and the prevalence of extension endorsement have not yet been assessed. Accordingly, there are two aims: (1) to classify changes made in the extensions to identify strengths and weaknesses of the original STROBE checklist and (2) to determine the prevalence and typology of endorsement by journals in fields related to extensions. METHODS AND ANALYSIS: Two independent researchers will assess additions in each extension. Additions will be coded as 'field specific' (FS) or 'not field specific' (NFS). FS is defined as particularly relevant information for a single field and guidance provided generally cannot be extrapolated beyond that field. NFS is defined as information that reflects epidemiological or methodological tenets and can be generalised to most, if not all, types of observational research studies. Intraclass correlation will be calculated to measure reviewers' concordance. On disagreement, consensus will be sought. Individual additions will be grouped by STROBE checklist items to identify the frequency and distribution of changes.Journals in fields related to extensions will be identified through National Library of Medicine PubMed Broad Subject Terms, screened for eligibility and further distilled via Ovid MEDLINE® search strategies for observational studies. Text describing endorsement will be extracted from each journal's website. A classification scheme will be created for endorsement types and the prevalence of endorsement will be estimated. Analyses will use NVivo V.11 and SAS University Edition. ETHICS AND DISSEMINATION: This study does not require ethical approval as it does not involve human participants. This study has been preregistered on Open Science Framework.

Effectiveness and efficacy of nutritional therapy: A systematic review following Cochrane methodology.

BACKGROUND & AIMS: Disease-related malnutrition has deleterious consequences on patients' outcome and healthcare costs. The demonstration of improved outcome by appropriate nutritional management is on occasion difficult. The European Society of Clinical Nutrition and Metabolism (ESPEN) appointed the Nutrition Education Study Group (ESPEN-NESG) to increase recognition of nutritional knowledge and support in health services. METHODS: To obtain the best available evidence on the potential effects of malnutrition on morbidity, mortality and hospital stay; cost of malnutrition; effect of nutritional treatment on outcome parameters and pharmaco-economics of nutritional therapy, a systematic review of the literature was performed following Cochrane methodology, to answer the following key questions: Q1) Is malnutrition an independent predictive factor for readmission within 30 days from hospital discharge? Q2) Does nutritional therapy reduce the risk of readmission within 30 days from hospital discharge? Q3) Is nutritional therapy cost-effective/does it reduce costs in hospitalized patients? and Q4) Is nutritional therapy cost effective/does it reduce costs in outpatients? RESULTS: For Q1 six of 15 identified observational studies indicated that malnutrition was predictive of re-admissions, whereas the remainder did not. For Q2 nine randomized controlled trials and two meta-analyses gave non-conclusive results whether re-admissions could be reduced by nutritional therapy. Economic benefit and cost-effectiveness of nutritional therapy was consistently reported in 16 identified studies for hospitalized patients (Q3), whereas the heterogeneous and limited corresponding data on out-patients (Q4) indicated cost-benefits in some selected sub-groups. CONCLUSIONS: This result of this review supports the use of nutritional therapy to reduce healthcare costs, most evident from large, homogeneous studies. In general, reports are too heterogeneous and overall of limited quality for conclusions on impact of malnutrition and its treatment on readmissions.

IMPACT Observatory: tracking the evolution of clinical trial data sharing and research integrity.

INTRODUCTION: The opening of research data is emerging thanks to the increasing possibilities of digital technology. The opening of clinical trial (CT) data is a part of this process, expected to have positive scientific, ethical, health, and economic impacts thus contributing to research integrity. The January 2016 proposal by the International Council of Medical Journal Editors triggered ample discussion about CT data sharing and reconfirmed the need for an ongoing assessment of its dynamics. The IMProving Access to Clinical Trials data (IMPACT) Observatory aims to play such a role, and assess the data sharing culture, policies, and practices of key players, the impact of their interventions on CTs, and contribute to a transformation of research. The objective of this paper is to present the IMPACT Observatory as well as share some of its preliminary findings. MATERIALS AND METHODS: Methods include a scoping study of research, surveys, interviews, and an environmental scan of research data repositories. RESULTS: Our preliminary findings indicate that although opening of CT data has not yet been achieved, its evolution is encouraging. Initiatives by key players contribute to increasing of CT data sharing, and many barriers are shrinking or disappearing. CONCLUSIONS: The major barrier is the lack of data sharing standards, from preparing data for public sharing to its curatorship, findability and access. However, experiences accumulated by sharing CT data according to "upon request" or "open" mechanisms could inform the development of such standards. The Vivli, CORBEL-ECRIN and Open Trials projects are currently working in this direction.