Clinical Trial Transparency Research Articles

Obtaining self-archiving permissions at scale to realize the potential of green Open Access

Background. While there is evidence that open access (OA) has been growing (Hobert et al., 2021; Piwowar et al., 2018), many publications remain behind a paywall. In many cases, journal or publisher self-archiving policies allow researchers to make a version of their publication openly accessible in a repository, sometimes after an embargo period (green OA). The UNESCO Recommendation on Open Science (UNESCO, 2021) adopted in November 2021 recommends several priority areas of action, including fostering a culture of open science by ensuring diversity in scholarly communications and supporting non-commercial publishing models. In this study, we evaluated the potential of journal articles from clinical trials conducted at German university medical centres to become green OA. Methods. We assessed a sample of clinical trials registered with ClinicalTrials.gov or DRKS completed between 2009 and 2017 (Riedel et al., 2021). The analysis was limited to their results published between 2010 and 2020 in 1907 unique journal articles with a DOI resolved in Unpaywall. We queried Unpaywall (OurResearch) via its API to identify paywalled publications in our sample. A publication was considered paywalled if it was not accessible via any OA route (gold, green, hybrid, or bronze). We then queried Shareyourpaper (OA.Works) via its API to obtain self-archiving permissions of publications in our sample. Shareyourpaper combines publication metadata and policy information to derive selfarchiving permissions at the level of individual publications. Publications were considered to have the potential for green OA if a “best permission” was found for archiving the accepted or published version in an institutional repository, and if the embargo (if applicable) had elapsed by the query date. The Unpaywall API was queried on 13 May 2022 and the Shareyourpaper API on 14 May 2022. Results. We identified 870 (46%) articles that were not openly accessible via any route (gold, green, hybrid, or bronze). Of these, 753 (87%) had a “best permission” in Shareyourpaper for archiving the accepted or published version in an institutional repository. At the time of the query, 136 (15%) of otherwise paywalled publications with a permission for self-archiving in an institutional repository had been made openly accessible via this route. Conclusions. For clinical trials to generate useful and generalizable medical knowledge, their results should be openly accessible, in line with established guidelines (World Health Organization, 2017). We found, however, that many results from clinical trials conducted at German university medical centres remained behind a paywall, even though they could be self-archived in an institutional repository. Our findings suggest that the potential of green OA to broaden the dissemination of scientific knowledge and ensure equitable access remains relatively unfulfilled and encourage an ongoing intervention at the Charité to increase clinical trial transparency. This case study clearly illustrates how openly available tools can be used to obtain actionable information related to self-archiving at scale, and thereby empower authors and institutions to increase science discoverability. Funding. This project was funded by the BMBF (01PW18012).

Clinical trial transparency regulations: Implications to various scholarly publishing stakeholders

Abstract As thousands of 2019 Corona virus disease (Covid-19) clinical trials are continuously getting added to various registries these days, good practices on data sharing and transparency have become one of the prime topics of discussion than ever before. Although trial registration is considered a crucial step, there is a lack of integration between registration and published literature. Trial outcomes are a matter of public interest, but sponsor compliances are not adequate with the recommended guidelines. Although the global recognition of data transparency increases day by day, there is still a long journey to travel. It is high time that scholarly publishing stakeholders should put in a collaborative effort to check author compliance. In this article, we aimed to comprehend and discuss the imperative roles of various scholarly publishing stakeholders in improving clinical trial transparency during this pandemic situation and highlight the changing paradigm towards the pressing need for reporting clinical trial data more effectively.

Adoption of World Health Organization Best Practices in Clinical Trial Transparency Among European Medical Research Funder Policies

Research funders can reduce research waste and publication bias by requiring their grantees to register and report clinical trials. To determine the extent to which 21 major European research funders' efforts to reduce research waste and publication bias in clinical trials meet World Health Organization (WHO) best practice benchmarks and to investigate areas for improvement. This cross-sectional study was based on 2 to 3 independent assessments of each funder's publicly available documentation and validation of results with funders during 2021. Included funders were the 21 largest nonmultilateral public and philanthropic medical research funders in Europe, with a combined budget of more than US $22 billion. Scoring of funders using an 11-item assessment tool based on WHO best practice benchmarks, grouped into 4 broad categories: trial registries, academic publication, monitoring, and sanctions. Funder references to reporting standards were captured. The primary outcome was funder adoption or nonadoption of 11 policy and monitoring measures to reduce research waste and publication bias as set out by WHO best practices. The secondary outcomes were whether and how funder policies referred to reporting standards. Outcomes were preregistered after a pilot phase that used the same outcome measures. Among 21 of the largest nonmultilateral public and philanthropic funders in Europe, some best practices were more widely adopted than others, with 14 funders (66.7%) mandating prospective trial registration and 6 funders (28.6%) requiring that trial results be made public on trial registries within 12 months of trial completion. Less than half of funders actively monitored whether trials were registered (9 funders [42.9%]) or whether results were made public (8 funders [38.1%]). Funders implemented a mean of 4 of 11 best practices in clinical trial transparency (36.4%) set out by WHO. The extent to which funders adopted WHO best practice items varied widely, ranging from 0 practices for the French Centre National de la Recherche Scientifique and the ministries of health of Germany and Italy to 10 practices (90.9%) for the UK National Institute of Health Research. Overall, 9 funders referred to reporting standards in their policies. This study found that many European medical research funder policy and monitoring measures fell short of WHO best practices. These findings suggest that funders worldwide may need to identify and address gaps in policies and processes.

Clinical trial transparency in gastrointestinal endoscopy research.

Under-reporting of clinical trial results can lead to negative consequences that include inhibiting propagation of knowledge, limiting the understanding of how devices work, affecting conclusions of meta-analyses, and failing to acknowledge patient participation. Therefore clinical trial transparency, through publication of trial results on ClinicalTrials.gov or in manuscript form, is important. We aimed to examine clinical trial transparency in endoscopic clinical trials. The ClinicalTrials.gov database was searched for endoscopy trials up to October 2019. Adherence to the reporting of results to the database or in publication form was recorded for each trial. The final analysis included 923 trials, of which 801 were completed and 122 were either terminated or suspended. Results were available either on ClinicalTrials.gov or in publication for 751/923 trials (81.4 %). Other fields have reported a publication rate of 40 %-63 %. Results were available on ClinicalTrials.gov for 168 trials (18.2 %) and in the form of a publication for 720 trails (78.0 %). Compared with other fields in medicine, endoscopy clinical trials have a high rate of clinical trial transparency. However, there is room for improvements as close to one-fifth of trials fail to report results and 81.8 % do not report results to ClinicalTrials.gov.

Embracing the European Regulation in The Netherlands: VGO implementation status, its threats and opportunities

BackgroundIn 2014, the European Clinical Trials Regulation was drawn up by the European Commission to replace the Clinical Trials Directive. The new Regulation aims to solve the shortcomings revealed by the Directive, such as extensive timelines and high bureaucratic costs, while increasing standards for safety and transparency of clinical trials. Importantly, the Regulation also points at harmonizing procedures among European Member States. From January 31st, 2022, it will be possible to submit clinical studies through a new portal, namely the Clinical Trials Information System. Since not complying to the Regulation implies not participating in clinical trials, many European countries underwent changes in national documents and related procedures. In The Netherlands, the Site Suitability Declaration, a document necessary to ascertain the adequacy of a site to perform a trial, was reviewed. MethodsIn our research, we investigated the status of the VGO implementation during a transition period among different stakeholders involved in the start-up process through a validated questionnaire and subsequent semi-structured interviews. ResultsThis project showed a slow-paced implementation, linked to communication and organizational challenges but also to a negative approach towards the change. Nevertheless, some stakeholders expressed constructive feedback as well, indicating the VGO as an upgrade. The latter was mainly achieved through establishing a trustful relationship with other stakeholders, undergoing additional adjustments, and having a positive mindset. ConclusionsThis research pointed at a still too scarce collaboration between stakeholders, who should rather actively contribute to achieve the implementation goal.

Despite The FDA's Five-Year Plan, Black Patients Remain Inadequately Represented In Clinical Trials For Drugs.

For decades Black patients have been underrepresented in clinical trials of new treatments. In response, in 2015 the Food and Drug Administration (FDA) launched a five-year action plan aimed at improving diversity in and transparency of pivotal clinical trials for newly approved drugs. The plan contained many action steps that were aimed at improving the racial representativeness of clinical trials and enhancing the reporting of new drug side effects and benefits across diverse populations. Yet, relying on the FDA's Drug Trials Snapshots website, we failed to find evidence that the action plan improved representation of Black trial participants. Black patients remained inadequately represented in clinical trials for drugs, with a median of one-third the enrollment that would be required, whether the trials were started before, during, or after the action plan. Fewer than 20percent of drugs had data regarding treatment benefits or side effects reported for Black patients; neither measure improved during the action plan period.

Improving clinical trial transparency at UK universities: Evaluating 3 years of policies and reporting performance on the European Clinical Trial Register.

Background:January 2019, the House of Commons’ Science and Technology Committee sent letters to UK universities admonishing them to achieve compliance with results reporting requirements for Clinical Trials of Investigative Medicinal Products by summer 2019. This study documents changes in the clinical trial policies and Clinical Trials of Investigative Medicinal Product reporting performance of 20 major UK universities following that intervention.Methods:Freedom of Information requests were filed in June 2018 and June 2020 to obtain clinical trial registration and reporting policies covering both Clinical Trials of Investigative Medicinal Products and all other clinical trials. Two independent reviewers assessed policies against transparency benchmarks based on World Health Organization best practices. To evaluate universities’ trial reporting performance, we used a public online tracking tool, the European Union Trials Tracker, which assesses universities’ compliance with regulatory Clinical Trials of Investigative Medicinal Product disclosure requirements on the European Clinical Trial Register. Specifically, we evaluated whether universities were adhering to the European Union requirement to post summary results on the trial registry within 12 months of completion.Results:Mean policy strength increased from 2.8 to 4.9 points (out of a maximum of 7 points) between June 2018 and June 2020. In October 2018 the average percentage of due Clinical Trials of Investigative Medicinal Products that had results available on the European trial registry across university sponsors included in the cohort was 29%. By June 2021, this had increased to 91%, with 5 universities achieving a reporting performance of 100%. All 20 universities reported more than 70% of their due trial results on the European trial registry.Interpretation:Political pressure appears to have a significant positive impact on UK universities’ clinical trial reporting policies and performance. Similar approaches could be used to improve reporting performance for other types of sponsors, other types of trials, and in other countries.

Registration and primary outcome reporting in behavioral health trials

BackgroundRegistration of research studies is designed to lock investigators into a data collection and analysis plan before a study starts and thereby limit their ability to engage in flexible data analysis and selective outcome reporting. Studies of registered clinical trials show that one- to two-thirds are registered after the study has started and that non-adherence to important design and analytic features, such as reporting data pertaining to all primary outcomes, remains high. Less is known about the effects of registration on research transparency and integrity outside of clinical trials. To address this gap in knowledge, the current study examined the effects of registration on the reporting of research findings in a sample of behavioral health trials published in BMC Public Health.MethodsRegistered trials published in the BMC Public Health section “Health Behavior, Health Promotion and Society” between 2011 and 2015 were included in the study. For each trial, we reviewed associated online submissions from 13 different registration sites. For those determined to have been prospectively registered, we used the trial registry, MEDLINE (Pubmed), PsychINFO, Web of Science and e-mails to investigators to identify subsequent publications from the study that reported results pertaining to primary outcomes. The two investigators then independently reviewed the outcome publication(s) and compared the primary outcomes reported in these to the registered primary outcomes.ResultsThe final analytic sample comprised 136 locatable, registered trials with an identifiable start date. Sixty-eight of the 136 were prospectively registered. Among these prospectively registered trials, only 16 published manuscripts reported outcomes and methods that were concordant with their registrations.ConclusionsRetrospective submission of protocols for publication and retrospective registration remain common in public health research, and adherence to prespecified outcomes is rare. In its current form, registration of behavioral and health promotion trials is likely to have minimal effect on preventing selective outcome reporting in publications, and the pervasiveness of vague and incomplete registry entries means that registries will have limited utility in terms of facilitating replication studies.

Investigators' sense of failure thwarted transparency in clinical trials discontinued for poor recruitment

Background and ObjectiveWhen a randomized clinical trial (RCT) prematurely discontinues, it is essential that stakeholders do the right thing to ensure that lessons can be learnt and trust in clinical research is maintained. There is, however, a lack of evidence exploring this issue. This study aimed to examine clinical trial stakeholders’ practices following trial discontinuation due to poor participant recruitment and their views on implications of such discontinuation. MethodsIndividual semi-structured qualitative interviews were conducted with 49 clinical trial stakeholders from Switzerland (n = 39), Germany (n = 9) and Canada (n = 1) between August 2015 and November 2016. ResultsAfter interviews with 49 clinical trial stakeholders (75% male presenting), it was found that stakeholders were aware of the risks of premature trial discontinuation wasting limited resources, adversely impacting scientific evidence, and having negative personal and professional implications. However, barriers continue to undermine transparency regarding trial discontinuation in practice, with it being reported that most investigators of discontinued trials are failing to notify stakeholders or publishing their results. Investigators sense of failure and associated negative emotions were identified as a key reason why investigators are not more transparent following discontinuation. ConclusionThe decision to notify stakeholders and publish results of a discontinued clinical trial should not rest solely on individual investigators but come from a systemic approach. However, until health research proactively requires the dissemination of results of all clinical trials, much will rest on individual investigators being motivated to do the right thing. Support programs might be helpful for investigators involved in discontinued trials and promote transparency and learning lessons.

The radiotherapy quality assurance gap among phase III cancer clinical trials

PurposeQuality assurance (QA) practices improve the quality level of oncology trials by ensuring that the protocol is followed and the results are valid and reproducible. This study investigated the utilization of QA among randomized controlled trials that involve radiotherapy (RT). Methods and MaterialsWe searched ClinicalTrials.gov in February 2020 for all phase III oncology randomized clinical trials (RCTs). These trials were screened for RT-specific RCTs that had published primary trial results. Information regarding QA in each trial was collected from the study publications and trial protocol if available. Two individuals independently performed trial screening and data collection. Pearson’s Chi-square tests analyses were used to assess factors that were associated with QA inclusion in RT trials. ResultsForty-two RCTs with RT as the primary intervention or as a mandatory component of the protocol were analyzed; the earliest was started in 1994 and one trial was still active though not recruiting. Twenty-nine (69%) trials mandated RT quality assurance (RTQA) practices as part of the trial protocol, with 19 (45%) trials requiring institutional credentialing. Twenty-one (50%) trials published protocol deviation outcomes. Clinical trials involving advanced radiation techniques (IMRT, VMAT, SRS, SBRT) did not include more RTQA than trials without these advanced techniques (73% vs. 65%, p = 0.55). Trials that reported protocol deviation outcomes were associated with mandating RTQA in their protocols as compared to trials that did not report these outcomes (100% vs. 38%, p < 0.001). ConclusionsThere is a lack of RTQA utilization and transparency in RT clinical trials. It is imperative for RT trials to include increased QA for safe, consistent, and high-quality RT planning and delivery.

Strengthening the FDA’s Enforcement of ClinicalTrials.gov Reporting Requirements

This Viewpoint discusses ways in which the FDA could harness its enforcement tools to bring important missing clinical trial results information to light and demonstrate its commitment to protecting patients through clinical trial transparency.

Pharmaceutical Industry's Engagement in the Global Equitable Distribution of COVID-19 Vaccines: Corporate Social Responsibility of EUL Vaccine Developers.

(1) Objectives: Inequality in the global distribution of COVID-19 vaccines has brought about great challenges in terms of resolving the pandemic. Although vaccine manufacturers are undoubtedly some of the most influential players, studies on their role in global vaccine distribution have been scarce. This study examined whether the pharmaceutical industry is acting according to the principles of corporate social responsibility (CSR) during the pandemic. (2) Methods: Three categories were used to analyze the CSR of vaccine developers. The first was research and development: effectiveness, funding, and profits were measured. The second was transparency and accountability: the transparency of clinical trials and vaccine contracts was analyzed. The final was vaccine delivery: the status of the provision of vaccines to COVAX and lower-income countries, intellectual property management, manufacturing agreements, and equitable pricing were measured. (3) Results: Vaccine developers have acquired large profits. The vaccine delivery category faces the most challenges. Participation of pharmaceutical companies through COVAX was significantly low, and most vaccine supply agreements were secretive, bilateral deals. It was not clear if companies were maintaining equitable pricing. The evaluation indicated that the companies’ CSR practices have differed during the pandemic. (4) Conclusions: Our study contributes to the methodology of assessing the CSR of vaccine developers. This would help understand the current COVID-19 vaccine distribution inequality and propose that pharmaceutical companies re-examine their roles and social responsibilities.

Gastroenterology Clinical Trials Transparency: An Analysis of Publication Rates From the ClinicalTrials.gov Database.

There is limited information on the transparency of gastroenterology clinical trials. The ClinicalTrials.gov database was searched for trials focused on most common gastrointestinal diseases up to August 2018. Adherence to reporting of results to the database or in publication form was recorded for each trial along with trial characteristics. Of the 2,429 trials included in the final analysis, 1824 (75%, 95% confidence interval: 73.4%-76.8%) had results on ClinicalTrials.gov or in the form of a publication. However, only 534 (29%) had results posted on ClinicalTrials.gov. Improvement of clinical trial transparency is needed in gastroenterology.

Clinical trials history &amp; trends in Qatar

Background: Clinical trial registries ensure the transparency and accountability of clinical trials (CTs) internationally. It is important to safeguard the public's safety through the delivery of quality clinical research. Since the start of the COVID-19 pandemic there has been a tremendous increase in the number of CTs globally. The MENA region has an opportunity to increase its overall contribution to CTs, which is less than 1%, in particular, through Qatar given its substantial economical growth and healthcare advancements. This review aims to explore the characteristics of clinical trials performed in Qatar, registered on ClinicalTrials.gov. Methods: The ClinicalTrials.gov registry was searched for trials conducted in Qatar using the appropriate keywords and advanced search options. Data retrieved was downloaded and sorted within Microsoft Excel then reviewed by two independent co-investigators. Results: The preliminary search yielded 143 entries with 32.1% (46) registered as multisite trials. The first trial in Qatar was registered in 2005. There has been a noticeable increase in CTs with its peak in 2020 , with currently 39.1% (9) of registered CTs on COVID-19; 83% of the completed studies were published, with the highest number of publications (8) in 2020 . Several specialties contributed to the CTs, with the highest participation and contribution rate of 31 CTs being in the field of pediatrics. Furthermore, some variations were found in recruitment status as reflected in with ∼65% (93) of studies being interventional and ∼35% being observational. Conclusion: The CTs conducted in Qatar are still relatively low despite the rapidly evolving healthcare system. Immediate updates and follow-ups could be considered by research investigators in Qatar with regards to CTs registration and updating. Further analysis is needed to elucidate the discrepancy of CTs reporting and to increase the contribution of CTs from Qatar to improve the health of its people.

Diversity and transparency in gynecologic oncology clinical trials

<h3>Objectives:</h3> Racial disparities in clinical trial enrollment are ethically dubious and, in some cases, threaten the applicability of results beyond the studied population. The objective of this study is to assess racial diversity, and reporting thereof, in gynecologic oncology clinical trials. <h3>Methods:</h3> Clinical trials in gynecologic oncology were identified by searching ClinicalTrials.gov for the following cancer types: ovarian, uterine, endometrial, cervical, vaginal, and vulvar. Data collection was performed in February 2020. Data on these trials were downloaded from the website and supplemented with manual codification. We excluded trials that were currently active, duplicative, and/or not enrolling patients with gynecologic malignancies. Race and ethnicity data were extracted from participant demographics included on ClinicalTrials.gov; trials that did not include this data were considered non-reporters. <h3>Results:</h3> A total of 1882 trials met inclusion criteria, of which 179 (10%) reported the race of trial participants. Racial reporting in domestic trials was slightly higher compared to international trials, at 12% domestically vs 7% internationally. Of the trials that reported race, the majority of participants were White for both international and domestic U.S. trials, though international trials enrolled a higher proportion of White and Asian patients than domestic trials and a far lower percentage of Black/African American patients (Figure 1). Globally, 14% of the trials that reported race enrolled zero non-White participants, and 34% enrolled fewer than 10% non-White participants. Fourteen percent of industry funded trials reported race, higher than the global average of 10%. Industry funded trials enrolled a higher percentage of White participants (68%) as compared to non-industry funded trials (58%) globally. Reporting of race has increased from 4% for trials started 2000-2004, to 12% for trials started between 2014-2018. Between 2000-2004, 79% of participants were White, as compared to 63% between 2014-2018. <h3>Conclusions:</h3> There is a paucity of data about ethnic and racial composition of participants in gynecologic oncology clinical trials. The majority of trials do not provide demographic data on publicly accessible platforms. Where the data are reported, clinical trials for patients with gynecologic malignancies enroll White patients at rates that exceed the epidemiologic burden of disease. International and industry funded trials enroll a higher percentage of White participants than domestic and non-industry funded trials, respectively. Reporting rates and diversity of enrollees appear to be improving modestly with time.

Clinical trial transparency and data sharing among biopharmaceutical companies and the role of company size, location and product type: a cross-sectional descriptive analysis

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...

Assessment of COVID-19 Vaccine Acceptance among Health Care Workers and General Population - A Cross-Sectional Survey

Introduction: This cross-sectional survey was conducted to estimate the proportion of participants among health care workers and general population who are willing to get vaccinated against COVID-19 and those who are not, and to identify the reasons for vaccine hesitancy among the participants. Methods: Health care workers of a tertiary care hospital and the general population residing in the nearby areas of the tertiary care hospital were predominantly included in the study. A specific questionnaire was designed, validated, and administered to the participants after obtaining consent. Result: The responses were collected using Google Form and compiled in an excel sheet for analysis. The difference in opinion with regard to acceptance of the COVID-19 vaccine was statistically analysed using Chi-square test. The vaccine acceptance rate was high among the general population (70.2%) as compared to health care workers (56.7%) (p = 0.0006, highly significant). The remaining proportions of participants (43.3% of health care workers and 29.8% of general population) were hesitant to receive the COVID-19 vaccine. Conclusion: The reasons for vaccine hesitancy were fear of harmful effects, doubtful efficacy, lack of transparency in clinical trials, and fast track vaccine development.

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.

Plain Language Summaries of Clinical Trial Results: A Preliminary Study to Assess Availability of Easy-to-Understand Summaries and Approaches to Improving Public Engagement.

BackgroundEasy-to-understand, stand-alone factual summaries of clinical trial results have the potential to improve public understanding of and engagement with pharmaceutical research. The European Clinical Trial Regulation (EU) No. 536/2014 is a major regulatory initiative that will result in a large number of such plain language summaries (PLSs) posted in the public domain. Today, however, little is known about the extent to which PLSs are written and are available to the general public.ObjectivesThis preliminary study assessed (i) 20 top pharmaceutical companies’ positions on improving transparency and commitment to disclosing trial result summaries in an easy-to-understand format and (ii) the availability of such summaries in the public domain and the ease of locating them via general web searches.MethodsThe availability of PLSs in the public domain was estimated based on the number of EudraCT technical result summaries in four disease areas: chronic obstructive pulmonary disease, asthma, meningitis, and influenza. The likelihood of PLSs being easy to find through internet search engine queries by members of the public was assessed using Google.ResultsAll 20 sponsors had committed to improve clinical trial transparency, 17 committed to sharing PLSs with trial participants, and 14 had at least one PLS available in the public domain. A total of 99 clinical studies in these four disease areas had technical summaries posted on EudraCT between 1 January 2017 and 30 June 2020. Of these 99, 14 studies had PLSs in the public domain. A total of 12 of 14 PLSs were directly captured by search engine. However, the sponsor trial identifier or EudraCT number had to be included in the search term to locate them. Generic search terms resulted in large volumes of non-relevant results.ConclusionDespite the progressive movement towards clinical trial transparency, easily accessible PLSs on clinical trials are currently scarce. The provision of a European mandate and framework for non-technical result summaries by Regulation (EU) 536/2014 will be a major step to bring about positive change.

Ensuring protocol compliance and data transparency in clinical trials using Blockchain smart contracts

BackgroundClinical Trials (CTs) help in testing and validating the safety and efficacy of newly discovered drugs on specific patient population cohorts. However, these trials usually experience many challenges, such as extensive time frames, high financial cost, regulatory and administrative barriers, and insufficient workforce. In addition, CTs face several data management challenges pertaining to protocol compliance, patient enrollment, transparency, traceability, data integrity, and selective reporting. Blockchain can potentially address such challenges because of its intrinsic features and properties. Although existing literature broadly discusses the applicability of blockchain-based solutions for CTs, only a few studies present their working proof-of-concept.MethodsWe propose a blockchain-based framework for CT data management, using Ethereum smart contracts, which employs IPFS as the file storage system to automate processes and information exchange among CT stakeholders. CT documents stored in the IPFS are difficult to tamper with as they are given unique cryptographic hashes. We present algorithms that capture various stages of CT data management. We develop the Ethereum smart contract using Remix IDE that is validated under different scenarios.ResultsThe proposed framework results are advantageous to all stakeholders ensuring transparency, data integrity, and protocol compliance. Although the proposed solution is tested on the Ethereum blockchain platform, it can be deployed in private blockchain networks using their native smart contract technologies. We make our smart contract code publicly available on Github.ConclusionsWe conclude that the proposed framework can be highly effective in ensuring that the trial abides by the protocol and the functions are executed only by the stakeholders who are given permission. It also assures data integrity and promotes transparency and traceability of information among stakeholders.