F1000Research F1000Research 2046-1402 F1000 Research Limited London, UK 10.12688/f1000research.166358.2 Policy Brief Articles Enhancing global clinical trial transparency for better health outcomes for all 

[version 2; peer review: 2 approved with reservations]

 Zhang Wei Conceptualization Methodology Project Administration Writing – Original Draft Preparation Writing – Review & Editing https://orcid.org/0000-0002-6022-6832 a 1 DeVito Nicholas J. Conceptualization Data Curation Formal Analysis Methodology Writing – Original Draft Preparation Writing – Review & Editing https://orcid.org/0000-0001-8286-1995 2 Chan An-Wen Conceptualization Data Curation Formal Analysis Methodology Writing – Original Draft Preparation Writing – Review & Editing 3 4 Cunningham Christine Data Curation Formal Analysis 2 Pymento Justin Data Curation Formal Analysis 3 Karam Ghassan Conceptualization Data Curation Methodology Writing – Original Draft Preparation Writing – Review & Editing 1 OWUOR John Writing – Review & Editing 1 Moorthy Vasee Conceptualization Funding Acquisition Methodology Project Administration Resources Supervision Validation Writing – Review & Editing 1 Research for Health Department, World health organization, Geneva, Switzerland Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxfordshire, UK Women’s College Research Institute, Women’s College Hospital, Toronto, Canada Department of Medicine, University of Toronto, Toronto, Canada wzhang@who.int

No competing interests were disclosed.

 15 6 2026 2025 14 626 9 6 2026 Copyright: © 2026 Zhang W et al. 2026 This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Background

In 2022, WHO’s World Health Assembly adopted resolution WHA75.8, emphasizing the critical role of clinical trials in generating high-quality evidence and promoting equitable access to health interventions globally. In response, rapid landscape reviews were conducted to assess global clinical trial regulations, capacities, and funding distribution.

 Methods

The analysis synthesized regulatory frameworks from 94 countries, institutional capacity data from the WHO International Clinical Trial Registry Platform (ICTRP), and funding data from World RePORT for trials registered between 2018-2022. Gaps in data availability and quality were assessed.

 Results

Most countries reference international ethical guidelines, with universal requirements for ethics approval and informed consent. However, only 66% mandate public trial registration, and 40% require results reporting, with stark disparities between high- and low-income countries. High-income countries host over half of global trials; low-income countries contribute less than 1% despite high disease burden. Clinical trials sponsored by non-commercial entities are particularly scarce in low- and middle-income countries. Funding remains concentrated in the Americas and European regions, primarily driven by major funders such as the National Institutes of Health in the United States of America and European Commission. Significant data accessibility challenges persist due to incomplete registry records, inconsistent standards, lack of harmonized identifiers, and limited bulk data access.

 Recommendations

Urgent actions include reinforcing international standards for trial registries, harmonizing data fields, improving registry interoperability, leveraging unique identifiers, enhancing multilingual accessibility, auditing data quality, pooling analytical resources, promoting open data policies, and investing in registry infrastructure and trained personnel.

 Conclusion

Addressing data gaps and inequities in clinical trial ecosystems requires concerted action by global stakeholders. Improved data transparency and interoperability are essential to guide equitable research investments, foster coordination, and strengthen clinical trial capacity worldwide.

 Clinical trials registries research transparency research data accessibility world health assembly resolution. Department of Health and Social Care, UK WHO_ClinicalTrials European and Developing Countries Clinical Trials Partnership CSA2023WHO-3454-WHORCT Gates Foundation INV-064296 This work was funded as part of the EDCTP2 programme supported by the EU (grant number CSA2023WHO-3454-WHORCT) with funds from the UK National Institute for Health and Care Research with the use of UK aid from the UK Government to support global health research. Consultations contributed to this work was enabled by funding from the UK Department of Health and Social Care (project ID: DHSC WHO_ClinicalTrials), and Bill & Melinda Gates Foundation (grant number INV-064296). The views expressed here are those of the authors and do not necessarily represent the position or policy of WHO, UK Department of Health and Social Care, European and Developing Countries Clinical Trials Partnership (EDCTP), Bill and Melinda Gates Foundation, or other organisations with whom the authors are affiliated. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Amendments from Version 1

The revised manuscript added a new table (Table 2) to extend the information in Figure 3. Two footnotes were added to explain the terminologies. Other revisions were made in the introduction, recommendations and conclusion to clarify the points that reviewers requested.

 Introduction

In May 2022, recognizing the indispensable role of clinical trials in advancing knowledge about health interventions, and the importance of promoting equity in clinical trial capabilities globally, the 75th World Health Assembly adopted resolution WHA75.8: Strengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordination. 1 The resolution highlights key gaps that limit the generation of robust and equitable clinical evidence, including wide variation in national clinical trial capabilities, insufficient regulatory and ethical oversight in some settings, limited inclusion of under-served and under-represented populations, fragmented coordination of clinical trial priorities, and inconsistent timely reporting of trial results. The resolution underscores the importance of prioritizing resources to address health needs and ensuring the rigorous scientific and ethical conduct of clinical trials. It also emphasizes the necessity for trials to be conducted across diverse settings, particularly among historically under-represented and under-served populations, in order to advance equitable access to health interventions with a favourable risk-benefit profile. The resolution advocates for enhanced collaboration and coordination among public and private entities to align clinical trial efforts with public health priorities, especially in addressing the health needs of lower income countries. It also calls for the development of robust national clinical trial capabilities, adherence to international standards, and promotion of transparency through the prospective registration and timely reporting of trial results.

In response to this resolution, rapid landscape reviews were conducted in 2023 to better understand the current global clinical trial regulatory frameworks, who is funding trials and where, and current capacities. Building on these reviews, this policy brief explores international priorities in the space and provides actionable recommendations for future progress in strengthening clinical trial ecosystems.

 Policy outcomes and implications Regulatory and legislative gaps

Our analysis ( Table 1) of clinical trial regulations identified from 94 countries observed that, despite regional variation, 75 of 94 countries’ national regulatory frameworks cover 9 or more of 11 key components of clinical trial conduct and governance. International guidelines, such as Declaration of Helsinki and The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), are commonly referenced, and research ethics committee approval and informed consent from trial participants are universally required by national guidelines.

Coverage of key clinical trial components in national guidance (data of 94 countries).
Component Number of countries Percentage
Requirements for regulatory approval 94 100%
Oversight by a research ethics committee 94 100%
Informed consent 93 99%
Timeline for reporting adverse events 88 94%
Content of protocols 87 93%
Privacy 86 91%
Study monitoring 82 87%
Auditing 82 87%
Data management 79 84%
Registration in a clinical trial registry 62 66%
Reporting results in a clinical trial registry 38 40%
All 37 39%

However, the review revealed a lack of governmental requirements for public registration of clinical trials and reporting of trial results in many countries. Two-thirds (66%) of the 94 countries require prospectively registering all clinical trials in a public registry prior to enrolling participants, while 40% have mandates for public reporting of trial findings—two critical mechanisms to promote transparency and increase the value of trials. Furthermore, disparities in governmental guidance are seen between high-income countries (N = 44) and low-income countries (N = 12), in particular on explicit privacy protections (100% vs. 58%), trial registration (80% vs. 25%), and reporting of trial results in registries (66% vs. 0%).

 Institutional capacity disparity

Between 2018 and 2022, about half of the 340,397 trials in WHO International Clinical Trial Registry Platform (ICTRP), were recruiting participants in high-income countries (HICs), with the highest number of recruitments in the United States ( Figure 1). China and India saw fast-growing clinical trial activity, being 2nd and 3rd among the top 10 countries by the total number of trials registered, the others being HICs in North America, Europe, and Japan ( Figure 2). Low-income countries accounted for less than 1% of total clinical trials worldwide, which is disproportionate to their high disease burden. The numbers of clinical trials, sponsored by entities other than commercial companies or individuals [1], are disproportionately lower in WHO’s African region and South-eastern Asian region, compared to other regions ( Table 2, Figure 3). This indicates that clinical trials for non-commercial purposes face particular challenges in low- and middle-income regions (LMIC).

Distribution of clinical trials registered in high-income (HI), upper-middle-income (UMI), lower-middle-income (LMI) and low-income (LI) countries between 2018 and 2022 (data extracted from ICTRP). Top 10 countries of recruitment between 2018 and 2022 in ICTRP. Number of clinical trials sponsored by non-commercial entities (i.e., not companies or individuals) in each WHO region (2018-2022).
Region Education Health care Nonprofit Facility Government Other Sum
Africa 590 134 118 69 60 40 1011
Americas 23140 11608 1623 1607 1383 258 39619
Eastern Mediterranean 9229 1045 121 115 58 67 10635
Europe 17912 17996 1487 1258 874 628 40155
South-East Asia 2910 1145 173 107 377 38 4750
Western Pacific 5091 9821 177 277 219 50 15635
Percentage of clinical trials sponsored by non-commercial entities (i.e., not companies or individuals) in each WHO region (2018-2022) <xref ref-type="fn" rid="fn3">[3]</xref>. Research funding inequity

Based on data of 4829 trials (approximately 1%) registered between January 2018 and December 2022, whose funding information could be traced in World RePORT, 3 the WHO Americas region accounts for 77% of clinical trial funding, reflecting a stark imbalance in the global distribution of clinical research funding relative to the population size and gross domestic product (GDP). The National Institutes of Health in the United States of America, European Commission, European and Developing Countries Clinical Trials Partnership, Wellcome Trust and Bill and Melinda Gates Foundation were the largest funders of clinical trials. 3 Furthermore, the lack of transparency in funding sources - reflected by the very low percentage of registered trials that could be linked to a grant number in the World RePORT, reveals a gap in clinical trial oversight and public reporting, that could hinder funding coordination and exacerbate inequities in clinical trial capability and infrastructure.

 Barriers to mapping the global clinical trial landscape

The rapid reviews highlight significant gaps in the availability and accessibility of information about the global clinical trial landscape. Better completeness and quality of data would facilitate a better understanding of regional disparities and areas for improvement.

A substantial proportion of government documents, particularly in low- and middle-income countries, were either unavailable online or accessible only in local languages—not only limiting their utility in informing global mapping initiatives, but also hindering cross-border knowledge-sharing and opportunities for increased international collaboration and investment.

Clinical trial registry records also often lacked consistency and completeness in data quality as well as a lack of harmonization in the way data are collected both between and within registries. This makes aggregation challenging. Additionally, some registries do not support requests for bulk data access or do not support automated data extraction, further constraining the potential for summary analyses. These limitations are compounded by inconsistencies in regulatory requirements regarding the public registration of trials before they begin and the reporting of results after trial completion.

Furthermore, it is difficult to analyse fragmented datasets that include free-text data fields, different names for the same sponsor [2], and incomplete reporting on data components such as recruitment sites and funding sources. Limited curation and oversight of data entry processes further compromise data quality. For instance, deduplication of trials registered across multiple platforms is hindered by inconsistencies in trial identifiers, sponsor names and other data inconsistencies. Similarly, noncompliance with WHO’s international standards for trial registration and results reporting reduces the completeness and accuracy of data available for global analyses of the trial landscape. 4– 6

Such barriers undermine efforts to establish equitable representation of trial activity, particularly in underrepresented regions and resource-constrained settings. These issues not only obscure insights into the true scale and distribution of clinical trials, but also hinder efforts to improve transparency, accountability, and ethical standards in clinical research worldwide.

 Actionable recommendations

To improve transparency and accountability for a strengthened and equitable global clinical trial ecosystem, urgent actions to enhance accessibility and quality of information about clinical trial are of paramount importance and need to emphasize on governance, resources, and capacity. We recommend the following actions:

Reinforce and promote adherence to the WHO International Standards for Clinical Trial Registries, which covers registrations and results reporting standards, to ensure uniformity and interoperability across registries. 7 Implement standardized fields across all clinical trial registries, covering essential data such as sponsor names, recruitment locations, and funding sources. Wherever feasible, use structured formats rather than free-text entries to increase reliability and facilitate quality control and analyses.

Enhance functions of existing global platforms, such as the WHO ICTRP, for harmonizing trial data, including mechanisms to address cross-registry duplication. This could leverage unique identifiers such as the Universal Trial Number (UTN) and Research Organization Registry (ROR) IDs, to ensure consistent identification of sponsors, funders, and recruitment sites across registries and facilitate accurate linkages to facilitate and expedite analyses.

Leverage advanced technology, cross-country partnerships, and funding resources for curation of critical datasets informing evidence generation and research prioritization and provide multilingual interfaces and resources to increase accessibility.

Regularly audit registry data for accuracy and completeness against established standards, coupling with training and support to sponsors and investigators to enhance compliance with registration and reporting standards. 8

Pool resources and capacity to enhance ongoing data analysis and visualization, such as the WHO Global Observatory of Health R&D, to make clinical trial data accessible and digestible to stakeholders, such as policymakers and researchers.

Establish multi-stakeholder initiatives involving governments, international organizations, and sponsors to streamline data input and facilitate data transfer between trial registries, particularly for multinational trials.

Advocate for open data policies and infrastructure investment that encourage the inclusion of bulk download and access in all clinical trial registries, enabling automated data collection and integration. Establish performance metrics to monitor progress with data accessibility, quality, and completeness.

Conclusion

Implementation and periodic monitoring of progress on the recommended actions can help to address the global disparities and data gaps in trial regulation, capacity, and funding identified in our rapid landscape reviews. A critical next step is to invest in increasing accessibility and quality of data about clinical trials. National and global health stakeholders, including research funders, policymakers, oversight agencies, sponsors and researchers, must take concerted action to comply with international standards and ensure sufficient financial support for the data infrastructure of trial registries as well as their highly trained personnel. Better data about clinical trials will enable transparency, prioritization, and coordination. The effort will better guide investments to fill the research gaps in health needs and to develop equitable clinical trial capabilities and health outcomes globally.

 Data availability

Methodologies of the rapid landscape review and dataset are accessible via https://osf.io/j6nkq/?view_only=ff77ceefd169452ebf877b80ac770ebc. DOI: 10.17605/OSF.IO/J6NKQ. 9

Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0).

 Acknowledgements

Authors are grateful for the contributions from Dr Paula Fearon and Dr Heather Eshleman in the data analysis of clinical trial funding.

 References World Health Assembly: Strengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordination. 2022. Reference Source The Research Organization Registry: ROR Data Structure. 2025 [cited 2025 May 13]. Reference Source U.S. National Institutes of Health: World RePORT: International Biomedical Research Organization Support. 2022 [cited 2025 May 13]. Reference Source Dal-Ré R Mahillo-Fernández I : Posting of clinical trial results and other critical information from completed medicines trials on ClinicalTrials.gov. Eur. J. Clin. Pharmacol. 2023 Oct;79(10):1385–1390. 37581640 10.1007/s00228-023-03550-z DeVito NJ Goldacre B : Trends and variation in data quality and availability on the European Union Clinical Trials Register: A cross-sectional study. Clin. Trials Lond. Engl. 2022 Apr;19(2):172–183. 35144496 10.1177/17407745211073483 PMC9036151 Speich B Gryaznov D Busse JW : Nonregistration, discontinuation, and nonpublication of randomized trials: A repeated metaresearch analysis. PLoS Med. 2022 Apr;19(4):e1003980. 35476675 10.1371/journal.pmed.1003980 PMC9094518 WHO: International Standards for Clinical Trial Registries. 2018 [cited 2025 May 13]. Reference Source WHO: ICTRP audit. International Clinical Trials Registry Platform (ICTRP) Registry Criteria: Audit. 2025 [cited 2025 May 13]. Reference Source WHO: Rapid landscape review of clinical trials. Open Science Framework. 2025 [cited 2025 Jun 17]. Reference Source

The types of organizations are based on a controlled list of categories defined by The Research Organization Registry (ROR) – a global, community-led, curated registry of open persistent identifiers for research organizations. 2

Sponsor is an individual or an organization that is responsible for the initiation, management and financing of a clinical trial.

Education refers to academic and research organizations such as universities; healthcare refers to organizations providing healthcare services such as hospitals and clinics.

 10.5256/f1000research.183335.r428486 Reviewer response for version 1 Flather Marcus 1 Referee https://orcid.org/0000-0001-5644-3116 University of East Anglia Norwich Medical School, Norwich, England, UK

Competing interests: No competing interests were disclosed.

 25 11 2025 Copyright: © 2025 Flather M 2025 This is an open access peer review report distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. recommendation approve-with-reservations

This is a useful report on the international clinical trials landscape with a focus on regulatory oversight and number of trials conducted in relation to socio-economic status of countries. Unsurprisingly lower income countries appear to have less regulatory oversight and overall very few registered clinical trials and of these a lower proportion of academically led trials compared to North American and Europe.  The report also points out limitations of clinical trial registration data in particular the difficulties obtaining information on ongoing or completed trials in the lower income countries.  Some comments:

- authors should provide a bit more detail about WJHA 75.8 as the current description is a bit vague and generic.  What are the key gaps to be addressed?

- authors should acknowledge that establishing clinical trials as a useful method to test new treatments strategies has been academically led, and industry has adopted these methods as they are well accepted for evaluating evidence and for promoting their products.

- Clinical trials activity, both non-commercial and commercial, depends on the strength and depth of academic trials leadership and the extent of collaboration with national and international clinical networks. Many non-commercial and commercial trials rely on international networks of investigators in different income countries but as the report rightly suggests the presence of these trial in low income countries is relatively low.

- the aim of complete clinical trial registration and reporting is well established and if this is not happening in lower income areas then the issue is likely related to local governance, resources and academic capacity to address these issues.

- I think the Actionable Recommendations about descriptive data to help ensure greater equity about trials are all very sensible but appear to be telling us what we already know and should be doing. It i likely that obtaining more complete data on trials activity globally will confirm what is presented in this report.

- The main issue appears to be the lack of trials and trials reporting in low income countries where the burden of disease is highest. This article should focus much more on these specific issues and how to address them.  One useful method is for experienced centres in higher income countries to be funded by WHO or other non commercial emtities to partner with academic centres in lower income countries to develop clinical trial expertise and capacity.  This could boost clinical trial activity and quality in lower and lower-middle income countries through training schemes and exchange of knowledge which in turn will help to train the next generation of researchers and trialists.

- I was not sure how useful figure 3 was for example the profile for Africa and Americas looked quite similar but we assume the number and composition of the trials would be quite different.

Does the paper provide a comprehensive overview of the policy and the context of its implementation in a way which is accessible to a general reader?

No

Is the discussion on the implications clearly and accurately presented and does it cite the current literature?

Yes

Are the recommendations made clear, balanced, and justified on the basis of the presented arguments?

Yes

Reviewer Expertise:

Cardiovascular Clinical Trials and Epidemiology, acute coronary syndromes, heart failure

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

Zhang Wei Research for Health, World Health Organization, Geneva, Switzerland

Competing interests: No competing interests were disclosed.

 3 6 2026

This is a useful report on the international clinical trials landscape with a focus on regulatory oversight and number of trials conducted in relation to socio-economic status of countries. Unsurprisingly lower income countries appear to have less regulatory oversight and overall very few registered clinical trials and of these a lower proportion of academically led trials compared to North American and Europe.  The report also points out limitations of clinical trial registration data in particular the difficulties obtaining information on ongoing or completed trials in the lower income countries. 

Response: Thank you for the comments and acknowledging the usefulness of this work.

Some comments:

- authors should provide a bit more detail about WJHA 75.8 as the current description is a bit vague and generic.  What are the key gaps to be addressed?

Response: Thank you for the suggestion. We have expanded the introduction adding gaps highlighted in the resolution.

- authors should acknowledge that establishing clinical trials as a useful method to test new treatments strategies has been academically led, and industry has adopted these methods as they are well accepted for evaluating evidence and for promoting their products.

Response: Thank you for the comments and we appreciate the insights. However, our objective of this scope review and its data analysis had focused on landscapes of clinical trial policy, funding sources and capability.

- Clinical trials activity, both non-commercial and commercial, depends on the strength and depth of academic trials leadership and the extent of collaboration with national and international clinical networks. Many non-commercial and commercial trials rely on international networks of investigators in different income countries but as the report rightly suggests the presence of these trial in low income countries is relatively low.

Response: Thank you for the comments. We generally agree. However, our review objectives and analysis are not designed to inform such assertions.

- the aim of complete clinical trial registration and reporting is well established and if this is not happening in lower income areas then the issue is likely related to local governance, resources and academic capacity to address these issues.

Response: Thank you for the useful insights. We have added in these perspectives on strengthening local governance, resource and capacity in the recommendation to emphasize their importance.

- I think the Actionable Recommendations about descriptive data to help ensure greater equity about trials are all very sensible but appear to be telling us what we already know and should be doing. It i likely that obtaining more complete data on trials activity globally will confirm what is presented in this report.

Response: Thank you for the comments. We appreciate the reviewer’s confirmation of this observation and recommendation.

- The main issue appears to be the lack of trials and trials reporting in low income countries where the burden of disease is highest. This article should focus much more on these specific issues and how to address them.  One useful method is for experienced centres in higher income countries to be funded by WHO or other non commercial emtities to partner with academic centres in lower income countries to develop clinical trial expertise and capacity.  This could boost clinical trial activity and quality in lower and lower-middle income countries through training schemes and exchange of knowledge which in turn will help to train the next generation of researchers and trialists.

Response: Thank you for the useful insights. We have added in the importance of directing investment in the conclusion to highlight that it is a key objective for clinical trial transparency.

Thank you for suggesting possible solutions for addressing research capacity development. Our review objectives are to highlight gaps in the clinical trial landscape. Specific solutions will come later following comprehensive consultations with relevant stakeholders.

- I was not sure how useful figure 3 was for example the profile for Africa and Americas looked quite similar but we assume the number and composition of the trials would be quite different.

Response: Thank you for pointing out the needed improvement in clarity. We have added in a new table (Table 2) with number of trials presented for each WHO region and in each category of sponsorship. And corrected the caption of Figure 3 to present ‘percentages’.

10.5256/f1000research.183335.r428489 Reviewer response for version 1 Marshall John C 1 Referee St. Michael’s Hospital, Toronto, Canada

Competing interests: No competing interests were disclosed.

 22 11 2025 Copyright: © 2025 Marshall JC 2025 This is an open access peer review report distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. recommendation approve-with-reservations

This manuscript discusses limitations in our understanding of the global clinical trials landscape, and makes a series of recommendations to address these.  It addresses an important topic, but could be improved through several modifications.

1. The work is based on a scoping review, but there are no details on the methods or sources used.  There is a link, however this does not provide information beyond the specific database to which the link is directed.  An understanding of sources would be valuable.

2.  The definitions used to define sponsorship are unclear. 

3.  In Figure 3, the categories are unclear.  What is meant by education, by healthcare.

4. In the recommendations, more focus could be placed on establishing and curating durable sources for information on clinical trials.  Given that trials are the foundation of medical knowledge, a mechanism - an archive, a library, or something analogous - would be important, and seems an important step beyond merely registering what one is doing.  Additionally harmonizing registries would be an important advance, if we are unable to settly on a single global registry.   

Does the paper provide a comprehensive overview of the policy and the context of its implementation in a way which is accessible to a general reader?

Yes

Is the discussion on the implications clearly and accurately presented and does it cite the current literature?

Yes

Are the recommendations made clear, balanced, and justified on the basis of the presented arguments?

Yes

Reviewer Expertise:

Clinical trials; Host-microbial interactions;

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

Zhang Wei Research for Health, World Health Organization, Geneva, Switzerland

Competing interests: No competing interests were disclosed.

 3 6 2026

This manuscript discusses limitations in our understanding of the global clinical trials landscape, and makes a series of recommendations to address these.  It addresses an important topic, but could be improved through several modifications.

Response: Thank you for the reviewer’s comments and recognition of the importance of this work.

1. The work is based on a scoping review, but there are no details on the methods or sources used.  There is a link, however this does not provide information beyond the specific database to which the link is directed.  An understanding of sources would be valuable.

Response: The source documents were quite variable, but all were found using Google web search. Due to challenges such as languages, we do not have more analysis on whether the document or information was housed on a government website vs. other sites.

2.  The definitions used to define sponsorship are unclear. 

Response: Thank you for pointing out the needed improvement in clarity. We have added in a footnote to explain the sponsorship.

3.  In Figure 3, the categories are unclear.  What is meant by education, by healthcare.

Response: Thank you for pointing out the needed improvement in clarity. We have added in a notes in the figure caption to explain the education and healthcare categories.

4. In the recommendations, more focus could be placed on establishing and curating durable sources for information on clinical trials.  Given that trials are the foundation of medical knowledge, a mechanism - an archive, a library, or something analogous - would be important, and seems an important step beyond merely registering what one is doing.  Additionally harmonizing registries would be an important advance, if we are unable to settly on a single global registry.    

Response: Thank you for the very helpful insights and suggestions. We have highlighted the importance of having international common standard in trial registry data and reporting in the first recommendations.