Transparency In Clinical Research Research Articles

Navigating the new era of clinical trial transparency

This issue of Medical Writing comes at a time when the summer holidays are behind us. Here’s hoping it has been a relaxing and rejuvenating time for all. As we get back to our day-to-day work, our fellow EMWA colleagues bring us an expert insight into the latest requirements in clinical trial transparency and disclosure. As medical writers, this has been on our agenda for many years now, but as we look to the future, transparency in clinical research is emerging as more than just a regulatory requirement – it is a cornerstone of public trust and ethical responsibility.

ANALYSIS OF REPORTING GUIDELINE AND TRIAL REGISTRATION POLICIES AMONG GERIATRIC JOURNALS: A CROSS-SECTIONAL STUDY

Abstract The use of reporting guidelines and clinical trial registration policies by academic journals reduces bias and improves transparency in clinical research. It is unknown whether geriatric and gerontology journals mention, recommend, or require their use for the studies they may potentially publish. The purpose of this study is to assess the submission guidelines of the top geriatric and gerontology journals for their editorial recommendation or requirement of predetermined reporting guidelines and clinical trial registration. We identified the top 100 journals in the “Geriatrics and Gerontology” subcategory using the 2021 Scopus CiteScore tool. We probed each journal’s “Instructions to Authors” for statements regarding reporting guidelines for popular study designs and extracted them as “Not Mentioned”, “Recommended”, “Does Not Require”, or “Required”. Further, we classified each journal’s reference to clinical trial registration in a similar manner. Of the 100 examined journals included in our analysis, the QUOROM statement was not mentioned by any journals, whereas the CONSORT statement (44/100, 44%) was mentioned and recommended/required the most often. PRISMA guidelines were not mentioned by 57 journals (57/100,57%). Furthermore, 45 journals (45/100,45%) did not mention study registration. Therefore, the recommendation or requirement of reporting guidelines and clinical trial registration in the top 100 geriatric and gerontology journals is inconsistent. Journal editors should strongly recommend that author’s follow validated reporting guidelines to reduce potential bias and improve transparency in the articles they publish.

A cross-sectional study of the endorsement proportion of reporting guidelines in 1039 Chinese medical journals

BackgroundReporting quality is a critical issue in health sciences. Adopting the reporting guidelines has been approved to be an effective way of enhancing the reporting quality and transparency of clinical research. In 2012, we found that only 7 (7/1221, 0.6%) journals adopted the Consolidated Standards of Reporting Trials (CONSORT) statement in China. The aim of the study was to know the implementation status of CONSORT and other reporting guidelines about clinical studies in China.MethodsA cross-sectional bibliometric study was conducted. Eight medical databases were systematically searched, and 1039 medical journals published in mainland China, Hong Kong, Macau, and Taiwan were included. The basic characteristics, including subject, language, publication place, journal-indexed databases, and journal impact factors were extracted. The endorsement of reporting guidelines was assessed by a modified 5-level evaluation tool, namely i) positive active, ii) positive weak, iii) passive moderate, iv) passive weak and v) none.ResultsAmong included journals, 24.1% endorsed CONSORT, and 0.8% endorsed CONSORT extensions. For STROBE (STrengthening the Reporting of Observational Studies in Epidemiology), PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses), STARD (An Updated List of Essential Items for Reporting Diagnostic Accuracy Studies), CARE (CAse REport guidelines), the endorsement proportion were 17.2, 16.6, 16.4, and 14.8% respectively. The endorsement proportion for SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials), TRIPOD (Transparent Reporting of a Multivariable Prediction Model for Individual Prognosis or Diagnosis), AGREE (Appraisal of Guidelines, Research, and Evaluation), and RIGHT (Reporting Items for Practice Guidelines in Healthcare) were below 0.7%.ConclusionsOur results showed that the implementation of reporting guidelines was low. We suggest the following initiatives including i) enhancing the level of journal endorsement for reporting guidelines; ii) strengthening the collaboration among authors, reviewers, editors, and other stakeholders; iii) providing training courses for stakeholders; iv) establishing bases for reporting guidelines network in China; v) adopting the endorsement of reporting guidelines in the policies of the China Periodicals Association (CPA); vi) promoting Chinese medical journals into the international evaluation system and publish in English.

More transparency in clinical research: How are the new transparency regulations assessed from the perspective of the pharmaceutical industry?

The year 2014 was aturning point for transparency in clinical research. Two regulatory innovations comprehensively changed the rules in the EU. For one thing, Regulation (EU) No.536/2014 on clinical trials of medicinal products for human use (Clinical Trials Regulation - CTR) came into force, and for another thing, Policy 0070 of the European Medicines Agency (EMA) on the publication of and access to clinical data was published. While the policy has been occupying the pharmaceutical industry in practice since 2015, the requirements of the CTR came into effect at the end of January 2022.The main innovation of the CTR is public access to the majority of documents and records that are created during the application process as well as during the course and after completion of aclinical trial. The special feature of Policy 0070 is the possibility for EU citizens to inspect the essential parts of amarketing authorisation application, such as the Clinical Study Report.This contribution to the discussion describes the completely new challenges in the area of transparency that the pharmaceutical industry is facing as aresult of the new requirements. In principle, transparency is to be welcomed in order to achieve the goals of the EU in the development and availability of medicines and vaccines. However, the protection of trade and business secrets of the pharmaceutical industry would be jeopardised. In the worst case, this could lead to adecline in investment in research and development within the scope of this regulation and to an international shift of clinical trials, including developing or emerging countries. Germany could lose more and more its leading role in conducting clinical trials in the EU.

Science for all: Is it all about the publication of data, or beyond?

This article presents an overview of open access initiatives by researchers, journals, government bodies, and regulatory authorities. Open access initiatives are valuable to the scientific community and have increased the amount of clinical research information available to the general public. Sharing this information in a manner that is understood by those without scientific training is important. This article discusses plain language summaries, their requirements and benefits, and what additional steps should be taken to improve transparency in clinical research.

Nonregistration, discontinuation, and nonpublication of randomized trials: A repeated metaresearch analysis.

We previously found that 25% of 1,017 randomized clinical trials (RCTs) approved between 2000 and 2003 were discontinued prematurely, and 44% remained unpublished at a median of 12 years follow-up. We aimed to assess a decade later (1) whether rates of completion and publication have increased; (2) the extent to which nonpublished RCTs can be identified in trial registries; and (3) the association between reporting quality of protocols and premature discontinuation or nonpublication of RCTs. We included 326 RCT protocols approved in 2012 by research ethics committees in Switzerland, the United Kingdom, Germany, and Canada in this metaresearch study. Pilot, feasibility, and phase 1 studies were excluded. We extracted trial characteristics from each study protocol and systematically searched for corresponding trial registration (if not reported in the protocol) and full text publications until February 2022. For trial registrations, we searched the (i) World Health Organization: International Clinical Trial Registry Platform (ICTRP); (ii) US National Library of Medicine (ClinicalTrials.gov); (iii) European Union Drug Regulating Authorities Clinical Trials Database (EUCTR); (iv) ISRCTN registry; and (v) Google. For full text publications, we searched PubMed, Google Scholar, and Scopus. We recorded whether RCTs were registered, discontinued (including reason for discontinuation), and published. The reporting quality of RCT protocols was assessed with the 33-item SPIRIT checklist. We used multivariable logistic regression to examine the association between the independent variables protocol reporting quality, planned sample size, type of control (placebo versus other), reporting of any recruitment projection, single-center versus multicenter trials, and industry versus investigator sponsoring, with the 2 dependent variables: (1) publication of RCT results; and (2) trial discontinuation due to poor recruitment. Of the 326 included trials, 19 (6%) were unregistered. Ninety-eight trials (30%) were discontinued prematurely, most often due to poor recruitment (37%; 36/98). One in 5 trials (21%; 70/326) remained unpublished at 10 years follow-up, and 21% of unpublished trials (15/70) were unregistered. Twenty-three of 147 investigator-sponsored trials (16%) reported their results in a trial registry in contrast to 150 of 179 industry-sponsored trials (84%). The median proportion of reported SPIRIT items in included RCT protocols was 69% (interquartile range 61% to 77%). We found no variables associated with trial discontinuation; however, lower reporting quality of trial protocols was associated with nonpublication (odds ratio, 0.71 for each 10% increment in the proportion of SPIRIT items met; 95% confidence interval, 0.55 to 0.92; p = 0.009). Study limitations include that the moderate sample size may have limited the ability of our regression models to identify significant associations. We have observed that rates of premature trial discontinuation have not changed in the past decade. Nonpublication of RCTs has declined but remains common; 21% of unpublished trials could not be identified in registries. Only 16% of investigator-sponsored trials reported results in a trial registry. Higher reporting quality of RCT protocols was associated with publication of results. Further efforts from all stakeholders are needed to improve efficiency and transparency of clinical research.

Challenges and Hopes: Clinical Research Towards An International Framework of Transparency

Lack of transparency in clinical research is a global problem that has drawn recent attention due the SARS-Cov-2 pandemics. Clinical trials results may be biased by selective publication, publication of partial or fraudulent results, suppression of negative results, publication delay, and even lack of publication of an entire study. Such practices endanger the right to health, undermine evidence-based medicine, and breach the ethical duties of researchers and sponsors. Transparency requires the enactment of uniform laws and joint efforts of all social and political actors involved in health research, in order to comply with the ethical and legal issues surrounding the need for open and clearly designed clinical trials.

Transparency in clinical trials: Adding value to paediatric dental research.

Even though considered as studies with high methodological power, many RCTs in paediatric dentistry do not have essential quality items in their design, development, and report, making results' reliability questionable, replication challenging to conduct, wasting time, money, and efforts, and even exposing the participants to research for no benefit. We addressed the main topics related to transparency in clinical research, with an emphasis in paediatric dentistry. We searched for all controlled clinical trials published from January 2019 up to July 2020 in the three paediatric dentistry journals with high journal Impact Factor, indexed on Medline. These papers were assessed for transparency according to Open Science practices and regarding reporting accuracy using some items required by CONSORT. 53.6% of the studies declared registration, 75% had sample size calculation, 98.2% reported randomisation, and from those, 65.4% explained the randomisation method. Besides that, no study shared their data, and 6.8% were published in open access format. Unfortunately, a large proportion of RCTs in paediatric dental research show a lack of transparency and reproducibility.

Deepen the transparency concept of clinical research and strengthen whole-process supervision and administration of research

Objective To acquire specific suggestions for improving the transparency of clinical research. Methods Summarize main challenges for transparency in clinical research, propose possible solutions. Results Currently the common practice of clinical research transparency is to promote study registration in the beginning phase, and reporting guildlines, data sharing in the end phase of the study. The main challenges identified in clinical research transparency are (1) lacking awareness of transparency among investigators, (2) poor data integrity and traceability of research data resulted by the ignorance of transparency during study implementation process. To face the challenges, investigator should be more proactive and related research administration should be streamlined. Conclusions To improve the transparency of clinical research, better understandings of the concept of clinical research transparency for investigators and whole-process supervision from the administrative aspect should be strengthened. Furthermore, advanced information technology should be adopted to construct a hospital-based source data platform for complete clinical research process management, it helps in promoting research data quality and could become a suitable tool for clinical research administration in hospitals. Ultimately, full research transparency would be achieved. Key words: Clinical research; Transparency; Source data; Process supervision; Traceability

Transparency in ovarian cancer clinical trial results: ClinicalTrials.gov versus PubMed, Embase and Google scholar

BackgroundIn recent years the question of the lack of transparency in clinical research has been debated by clinicians, researchers, citizens and their representatives, authors and publishers. This is particularly important for infrequent cancers such as ovarian cancer, where treatment still gives disappointing results in the majority of cases. Our aim was to assess the availability to the public of results in ClinicalTrials.gov, and the frequency of non-publication of results in ClinicalTrials.gov and in PubMed, Embase and Google Scholar. We collected all trials on ovarian cancer identified as “completed status” in the ClinicalTrials.gov registry on 17 January 2017. We checked the availability of the results in ClinicalTrials.gov and systematically identified published manuscripts on results.ResultsOut of 2725 trials on ovarian cancer identified, 752 were classified as “completed status”. In those closed between 2008 and 2015, excluding phase I, the frequency of results in ClinicalTrials.gov was 35%. Of the 752 completed studies the frequency of published results in PubMed, Embase or Google Scholar ranged from 57.9% to 69.7% in the last years.ConclusionsThese findings show a lack of transparency and credibility of research. Citizens or patients’ representatives, with the medical community, should continuously support initiatives to improve the publication and dissemination of clinical study results.

A metadata schema for data objects in clinical research.

BackgroundA large number of stakeholders have accepted the need for greater transparency in clinical research and, in the context of various initiatives and systems, have developed a diverse and expanding number of repositories for storing the data and documents created by clinical studies (collectively known as data objects). To make the best use of such resources, we assert that it is also necessary for stakeholders to agree and deploy a simple, consistent metadata scheme.MethodsThe relevant data objects and their likely storage are described, and the requirements for metadata to support data sharing in clinical research are identified. Issues concerning persistent identifiers, for both studies and data objects, are explored.ResultsA scheme is proposed that is based on the DataCite standard, with extensions to cover the needs of clinical researchers, specifically to provide (a) study identification data, including links to clinical trial registries; (b) data object characteristics and identifiers; and (c) data covering location, ownership and access to the data object. The components of the metadata scheme are described.ConclusionsThe metadata schema is proposed as a natural extension of a widely agreed standard to fill a gap not tackled by other standards related to clinical research (e.g., Clinical Data Interchange Standards Consortium, Biomedical Research Integrated Domain Group). The proposal could be integrated with, but is not dependent on, other moves to better structure data in clinical research.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1686-5) contains supplementary material, which is available to authorized users.

Shoulder Arthroplasty Trials Are Infrequently Registered: A Systematic Review of Trials.

IntroductionWith the intent of improving transparency in clinical research, the International Committee of Medical Journal Editors (ICMJE) established guidelines in 2005 regarding prospective clinical trial registration. This action worked to address bias related to selective outcome reporting in the medical literature. The objective of this study was to assess and characterize the quality of registration of clinical trials appearing in shoulder arthroplasty-related medical journals.MethodsAll randomized trials involving human subjects, pertaining to shoulder arthroplasty, published between July 1, 2005 and December 31, 2015, and indexed in either PubMed or SportDISCUS were analyzed. We assessed the prevalence of registration, the timing of registration relative to patient enrollment periods, and the variable rates of orthopedic journal compliance with ICMJE and Food and Drug Administration clinical registration standards for our study.ResultsOf the 382 articles identified, 345 (90.3%) were excluded due to failure to meet inclusion criteria. From the remaining 37, only 12 (32.4%) studies were found to be registered in a trial registry. Ten (10/12, 83.3%) of these provided their registration information within the body of the article. None of the included studies from ICMJE-recognized journals were registered. From 34 included studies from non-ICMJE recognized journals, 12 (35.3%) were registered.ConclusionThe level of compliance with clinical trial registration guidelines in the decade since their release among shoulder arthroplasty trials in orthopedic journals is poor. Given the importance of the issue, the prevalence of the problem, and the fact that many other medical specialties have already made efforts to improve ICMJE compliance, further work on the part of orthopedic surgery journal authors and editors is needed to ensure the publication of unbiased results.Trial RegistrationUMIN000022487

Opinions about the future of Clinical Trial in Turkey

Even though all the rights and obligations of all parties of clinical trial – the researching physician, the volunteering patient, the industry, research institutions- have been assured with ethico-legal regulations, there still exist many problems in the world of clinical research, and suggestions of solutions to the said problems. As a medical ethicist who has been a permanent member of the Hacettepe University Ethical Committee since 2000, I have decided to write a short report that is a general look at the world of clinical research in Turkey. I wanted this report to be one that talks about some of the issues I believe are important about this subject, which include expectations and predictions on it. All of the headlines in this report are without doubt, issues that can be researched and written about widely and with much more details. Especially the process of adjustment to the new regulation of the EU (No 536/2014 of The European Parliament), the condition of non-medicational/non interventional clinical research, transparency in clinical research and budget issues are to me controversial subjects that should be especially and primarily discussed.

Transparency in Clinical Research and Status in Turkey & Middle East

Though there have been on-going discussions about transparency in clinical research for the last three decades, the first piece of regulation toward this end only came into being in 2005. Today many regulations and registry systems are in use globally and in Middle East countries naturally. Attempts to attain transparency in clinical research are currently paving the way for universal disclosure of all clinical trials. Keywords: Clinical, disclosure, registry, research, transparency, trial.

More is needed by all for transparency in clinical research

• Few institutional registries exist, but these can make information more accessible by calling for the collection of data for trials that may not normally be considered suitable by researchers for registration in the international registries.

Promoting transparency in clinical research: Systematic review of disclosure and data-sharing policies in surgical journals

Promoting transparency in clinical research: Systematic review of disclosure and data-sharing policies in surgical journals

An overview of minor surgery practice and performance in primary care

s / International Journal of Surgery 12 (2014) S13eS117 S52 coordination. 2. no case notes in clinic reducing the cost of retrieval. 3. Health staff can access information anywhere real-time. 4. The clinical entries are clear and legible improving safety. Disadvantages 1.Lack of integration across all systems 2.Constant training required to engage workforce. 3. Potential difficulties if computer systems crash. Conclusions: A paperless service can be set up with full CRS utilisation to create a seamless path from outpatients or casualty to discharge. 1305: AN OVERVIEW OF MINOR SURGERY PRACTICE AND PERFORMANCE IN PRIMARY CARE Julia Ruston, Adebayo Alade , Ben Miranda , Henry Attard , Saul Kaufman . North Central Thames Foundation Deanery, London, UK; Pan-Thames Higher Surgical Training, London, UK. Introduction: General Practitioners (GP) perform thousands of surgical procedures annually. The literature on this topic is, however, sparse and with no national standards interpreting individual performance is difficult. Our aimwas to review primary care minor surgery and provide a snapshot of the GP surgeon workload. Methods: Retrospective analysis of 384 procedures performed over a 3 year period in 3 different primary care centres. Notes were reviewed and demographics, procedure, diagnosis (clinical and histological) and complications noted. Results: 406 skin lesions were removed. Other procedures included abscess and seroma drainage (7), and removal of foreign body (3). Procedures were on: head/neck 39.4%, trunk 26.6%, Arm 17.8%, leg 11.5%, groin 4.7%. 98.5% of excised skin lesions were sent for histopathological analysis; most common werebenignnaevi (139),fibroepithelialpolyps (100)and sebaceous cysts (75). 4were confirmedmalignant; adenocystic carcinoma (1),melanoma (1), basal cell carcinoma (1) and squamous cell carcinoma (1). There were 5 atypical/ dysplastic naevi, 1 possible early SCC and 1 giant cell tumour. Complications included infection (2.3%), wound breakdown (2.1%) and recurrence (1.8%). Conclusions: The study provides a comprehensive review of GP minor surgery. Complication rates were acceptable and low malignancy rates suggest appropriate referral to secondary services. 1306: PROMOTING TRANSPARENCY IN CLINICAL RESEARCH: SYSTEMATIC REVIEW OF DISCLOSURE AND DATA-SHARING POLICIES IN SURGICAL JOURNALS S.J. Chapman, B. Shelton , H. Mahmood , J.E.F. Fitzgerald , E. Harrison , A. Bhangu . University of Leeds, School of Medicine, Leeds, UK; University of Birmingham, School of Medicine, Birmingham, UK; St. George's University Medical School, London, UK; Barnet Hospital, London, UK; West Midlands Deanery, West Midlands, UK; Edinburgh Royal Infirmary, Edinburgh, UK. Introduction: The primary aim of this study was to determine author compliance with surgical randomised controlled trial (RCT) registration. The secondary aimwas to explore data sharing policies of surgical journals. Methods: A systematic assessment of RCT publishing and registration practices in 10 high-impact surgical journals during 2009 and 2012. Data relating to trial registration, statements of disclosure and data sharing were extracted. Trials were systematically cross-matched to registration databases. Data expressed descriptively (%) with longitudinal comparisons (2009 vs. 2012) using Chi-squared analyses. Predictors of non-registration are explored using logistic regression. Results: 246 RCTswere identified (2009: n1⁄4109 vs. 2012: n1⁄4137), of which 76.4% (67.0% vs. 83.9% respectively; p1⁄40.062) were registered on a clinical trials database. Author disclosure and funding statements were present in 71.5% (49.5% vs. 89.1%; p<0.01) and 60.01% (55.1% vs. 65.0%; p1⁄40.074) respectively. Data sharing statements were only included in two studies. Year of publication (p1⁄40.005) and year-specific journal impact factor (p<0.001) were strong predictors of registration status. Only one journal held a policy of mandatory data sharing in their author instructions. Conclusions: Registration of surgical RCTs is increasing over time but remains sub-optimal. The principle of open access data sharing is poorly endorsed in surgical research. 1317: THE IMPACT OF PREOPERATIVE TEXT MESSAGES ON PATIENT KNOWLEDGE AND ADHERENCE TO FASTING GUIDELINES Aneesha Verma, Asela Dharmadasa , Jeremy Prout , George Hamilton . Royal Free Hospital, London, UK; Imperial College Healthcare Trust, London,

Surgical trials and trial registers: a cross-sectional study of randomized controlled trials published in journals requiring trial registration in the author instructions

BackgroundTrial registration and the reporting of trial results are essential to increase transparency in clinical research. Although both have been strongly promoted in recent years, it remains unclear whether they have been successfully implemented in surgery and surgery-related disciplines. In this cross-sectional study, we assessed whether randomized controlled trials (RCTs) published in surgery journals requiring trial registration in their author instructions were indeed registered, and whether the study results of registered RCTs had been submitted to the trial register and were thus publicly available.MethodsThe ten highest ranked surgery journals requiring trial registration by impact factor (Journal Citation Reports, JCR, 2011) were chosen. We then searched MEDLINE (in PubMed) for RCTs published in the selected journals between 1 June 2012 and 31 December 2012. Any trials recruiting participants before 2004 were excluded because the International Committee of Medical Journal Editors (ICMJE) first proposed trial registration in 2004. We then searched the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) to assess whether the identified RCTs were indeed registered and whether the results of the registered RCTs were available in the register.ResultsThe search retrieved 588 citations. Four hundred and sixty references were excluded in the first screening. A further 25 were excluded after full-text screening. A total of 103 RCTs were finally included. Eighty-five of these RCTs (83%) could be found via the ICTRP. For 7 of 59 (12%) RCTs, which were registered on ClinicalTrials.gov, summary study data had been posted in the results database.ConclusionsAlthough still not fully implemented, trial registration in surgery has gained momentum. In general, however, the submission of summary study data to ClinicalTrials.gov remains poor.

Globalization of Clinical Trials – Where are We Heading?

The last decade has witnessed a greater transparency in clinical research with the advent of clinical trial registries. The aim of the study was to describe the trends in the globalization of clinical trials in the last five years. We performed an internet search using the WHO International clinical trials registry platform (WHO ICTRP) to identify the clinical trials conducted from January 2007 to December 31, 2011 among 25 countries. Among the 25 countries, the United States, Japan and Germany occupy the top positions in the total number of clinical trials conducted. Clinical trials in the US (36312) constituted 31.5% of the total number of trials performed during this period. However over a period of five years both US and Western Europe appear to show a decline, while the emerging countries show a rise in clinical trials registered. Among the emerging countries China, India and Republic of Korea are most active regions involved in clinical trials. Cancer, diabetes and respiratory diseases were most widely researched areas overall. Although the study confirms the transition in the clinical trials research towards emerging countries, the developed regions of the world still contribute to more than 70% of the trials registered worldwide.

Access to regulatory data from the European Medicines Agency: the times they are a-changing

Systematic reviewers are increasingly trying to obtain regulatory clinical study reports (CSRs) to correct for publication bias. For instance, our organization, the Institute for Quality and Efficiency in Health Care, routinely asks drug manufacturers to provide full CSRs of studies considered in health technology assessments. However, since cooperation is voluntary, CSRs are available only for a subset of studies analysed. In the case of the inhaled insulin Exubera, the manufacturer refused to cooperate and in 2007 we asked the European Medicines Agency (EMA) to provide the relevant CSRs, but EMA denied access. Other researchers have reported similar experiences.In 2010 EMA introduced a new policy on access to regulatory documents, including CSRs, and has also undertaken further steps. The new policy has already borne fruit: in 2011, by providing additional sections of relevant CSRs, EMA made an important contribution to a review of oseltamivir (Tamiflu).Unfortunately, speedy implementation of the new policy may be endangered. We define a CSR following the International Conference on Harmonisation (ICH) E3 guideline. Although this guideline requires individual patient data listings, it does not necessarily require that these listings be made available in a computer-readable format, as proposed by some regulators from EMA and other agencies. However, access to raw data in a computer-readable format poses additional problems; merging this issue with that of access to CSRs could hamper the relatively simple implementation of the EMA policy. Moreover, EMA plans to release CSRs only on request; we suggest making these documents routinely available on the EMA website.Public access to regulatory data also carries potential risks. In our view, the issue of patient confidentiality has been largely resolved by current European legislation. The risk of other problems, such as conflicts of interest (CoIs) of independent researchers or quality issues can be reduced by transparency measures, such as the implementation of processes to evaluate CoIs and the publication of methods and protocols.In conclusion, regulatory data are an indispensable source for systematic reviews. Because of EMA’s policy change, a milestone for data transparency in clinical research is within reach; let’s hope it is not unnecessarily delayed.