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Abstract

Background

Amid growing emphasis from pharmaceutical companies, advocacy groups, and regulatory bodies for sharing of individual participant data, recent audits reveal limited sharing, particularly for high-revenue medicines. Therefore, this study aimed to assess the individual participant data-sharing eligibility of clinical trials supporting the Food and Drug Administration approval of the top 30 highest-revenue medicines for 2021.

Methods

A cross-sectional analysis was conducted on 316 clinical trials supporting approval of the top 30 revenue-generating medicines of 2021. The study assessed whether these trials were eligible for individual participant data sharing, defined as being publicly listed on a data-sharing platform or confirmed by the trial sponsors as in scope for independent researcher individual participant data investigations. Information was gathered from various sources including ClinicalTrials.gov, the European Union Clinical Trials Register, and PubMed. Key factors such as the trial phase, completion dates, and the nature of the data-sharing process were also examined.

Results

Of the 316 trials, 201 (64%) were confirmed eligible for sharing, meaning they were either publicly listed on a data-sharing platform or confirmed by the trial sponsors as in scope for independent researcher individual participant data investigations. A total of 102 (32%) were confirmed ineligible, and for 13 (4%), the sponsor indicated that a full research proposal would be required to determine eligibility. The analysis also revealed a higher rate of individual participant data sharing among companies that utilized independent platforms, such as Vivli, for managing their individual participant data-sharing process. Trials not marked as completed had significantly lower eligibility for individual participant data sharing.

Conclusion

This study highlights that a substantial portion of trials for top revenue-generating medicines are eligible for individual participant data sharing. However, challenges persist, particularly for trials that are marked as ongoing and for trials where the sharing processes are managed internally by pharmaceutical companies. Data-sharing rates could be improved by adopting open-access individual participant data-sharing models or using independent platforms. Standardizing policies to facilitate immediate individual participant data availability for approved medicines is necessary.

Keywords

Individual participant data data-sharing policies clinical trials transparency

Introduction

Clinical trials are essential for determining the safety and efficacy of new medicines. Over the past decade, there has been notable emphasis by pharmaceutical companies,¹ advocacy groups,^2,3 and regulatory bodies⁴ regarding the importance of facilitating secondary access to detailed individual participant data (IPD) from clinical trials. Such access is recognized as key in facilitating independent validation of research findings, enhancing scientific collaboration, and fostering trust in the pharmaceutical industry.^2,5–9 Consequently, a majority of pharmaceutical companies now have IPD-sharing policies.^10,11

The effectiveness of current IPD-sharing policies used by the majority of companies requires evaluation. A 2018 audit revealed that only 15% of industry-sponsored clinical trials had their IPD available for sharing 2 years after publishing the primary outcome.¹² In addition, only 45% of the 304 industry-sponsored clinical trials supporting Food and Drug Administration (FDA) approval of anticancer medicines between 2011 and 2021 were eligible for IPD sharing.¹¹ Notably, the rate of IPD sharing dropped to 35% for the top 10 oncology medicines by revenue.¹¹ These findings highlight that the vital IPD that underpins the safety and efficacy of medicines used by many may not be readily accessible and that the accessibility of IPD in fields beyond oncology has not been recently evaluated. Similar challenges in data sharing have also been reported for non–industry-sponsored trials – highlighting that the issue is not just limited to industry sponsors.^13,14

This study aimed to assess the eligibility of independent researchers to access IPD from clinical trials that supported the FDA approval of the top 30 pharmaceutical medicines by revenue of 2021.

Methods

Sample and data

This cross-sectional study assessed the percentage of clinical trials eligible for IPD sharing, which contributed to the FDA approval of the top 30 pharmaceutical medicines by revenue in 2021. Our sample comprised of strategically significant medicines – those with high revenue and, consequently, high patient usage – while also ensuring a sample size of over 300 clinical trials to achieve a 95% precision level in planned statistical analyses.

In September 2022, a list of the top 30 highest revenue-generating medicines for 2021 was compiled, using data from ‘Drug Discovery and Development’ and ‘S&P Global Market Intelligence’.^15,16 The FDA, European Medicines Agency (EMA), and Health Canada approval status of each medicine were documented. Subsequently, the most recent FDA-authorized drug labels for these medicines were obtained from the FDA Drug Database.^17,18 From these labels, identifiers of trials – such as trial numbers and study titles – with results in the labels, as well as the dates when the trial results were integrated into the drug labels, were collated. Using these identifiers, we searched ClinicalTrials.gov, the European Union (EU) Clinical Trials Register, and clinical trial publications sourced via PubMed. We matched the registry data and publications to the trials in the labels using the trial numbers and study titles. This allowed us to compile a comprehensive list of information, including National Clinical Trial (NCT) numbers/other identifiers, start dates, final completion dates, trial phases, and details of the trial sponsoring entities.

For the trial sponsoring entities, we documented their membership status with the Pharmaceutical Research and Manufacturers of America (PhRMA) and/or the European Federation of Pharmaceutical Industries and Associations (EFPIA). In addition, we searched their websites to determine if they had publicly accessible IPD-sharing policies. For trial sponsors with such policies, we gathered details about the data-sharing process, including whether it was an internal company process or external (e.g. via platforms like vivli.org (Vivli),¹⁹ clinicalstudydatarequest.com (CSDR),²⁰ or yoda.yale.edu (YODA)),²¹ as well as contact information for IPD-sharing enquiries.

Determination of IPD-sharing eligibility

Beginning on 1 October 2022, we sought to confirm the IPD-sharing eligibility for each trial audited in this study (i.e. whether a trial was in scope of sharing). A trial was deemed eligible for data sharing if it met the criteria for being ‘in scope for sharing’. This means that it satisfied the conditions required for its IPD to be shared with independent researchers in accordance with the sponsor’s data-sharing policy. Specifically, this eligibility for sharing was defined by either the identification of a public listing of the trial as being in scope for IPD sharing on a data-sharing platform website or the receipt of a positive response to a standardized enquiry (Supplemental File 1) sent to the trial sponsor (or medicine owner if different) confirming that the trial was in scope for IPD investigations by independent researchers. Ineligibility for IPD sharing was confirmed by a negative response to the enquiry (i.e. receipt of written confirmation from the trial sponsor that IPD was not sharable with independent researchers). If a trial was indicated as not eligible for IPD sharing, details of the reason(s) for ineligibility and when the trial would become eligible were requested. If no response to the initial enquiry was received, prompts were sent every 30 days after the initial enquiry. If no response had been received by the trial sponsor (or medicine owner if different) by 180 days from the initial enquiry, the trial was deemed to be ineligible for IPD sharing.

Analysis

All statistical analyses were performed using R 4.2.2.²² Chi-square tests, with statistical significance set at p < 0.05, were used to evaluate and present differences in trial IPD-sharing eligibility proportions according to trial phase, trial design, process of sharing, trial start date, time since trial completion, time since trial was listed in the drug label, and whether the IPD-sharing policy includes a criterion for trial completion.

Patient and public involvement

Our investigations into clinical trial IPD transparency have been significantly guided by the contributions of our dedicated consumer advisory group whom we have been working with for the past 7 years. For this project, we extend our profound appreciation to Mark Haseloff for his indispensable insights, spanning conception, design, evaluation, and communication.

Ethics

The research undertaken was assessed as negligible risk research and was confirmed exempt from requiring Flinders University Human Research Ethics Committee review.

Results

Sample and data

The FDA drug labels for the 30 highest-revenue medicines of 2021^15,16 included results from a total of 316 clinical trials sponsored by the pharmaceutical industry. Each of these top 30 medicines, in terms of global revenue for 2021, was also approved by the EMA and Health Canada. The sample included four vaccines (involving 39 trials), four biologic anticancer medicines (involving 76 trials), six non-biologic anticancer medicines (involving 38 trials), nine biologic medicines for non-cancer diseases (involving 102 trials), and seven non-biologic medicines for non-cancer diseases (involving 61 trials). Eight (2%) were phase 1 trials, 44 (14%) were phase 2 trials, 261 (83%) were phase 3 trials, and 3 (1%) were phase 4 trials. In total, 192 trials (61%) started before 1 January 2014, while 124 trials (39%) started on or after 1 January 2014. The results of 145 (46%) trials were integrated into the drug labels within the last 5 years, 95 (30%) trials were added between 5 and 10 years ago, and 76 (24%) were added more than 10 years ago. The 316 trials were sponsored by 20 different pharmaceutical companies, with 16 (80%) of these sponsors being among the top 20 for global revenue in 2021.²³ Of these 20 companies, 17 (85%) had a publicly available IPD-sharing policy, and they sponsored 311 (98%) of the trials included in this study. In addition, 14 companies had established relationships with data-sharing platforms such as Vivli, CSDR, and YODA.

Of the 316 trials audited, eligibility for IPD sharing was publicly listed for 106 (34%) on data-sharing platforms. For the remaining 210 (66%) trials, an inquiry to the sponsor was necessary to establish their eligibility for IPD sharing, and the median response time from the initial inquiry was 42 days.

Eligibility to share

During the assessment window from 1 October 2022 to 1 April 2023, the IPD-sharing eligibility of 316 clinical trials was evaluated. Out of these, 201 (64%) trials were confirmed eligible for IPD sharing, 102 (32%) were confirmed ineligible, and for 13 (4%) trials, the sponsor indicated that a full research proposal was required to assess the IPD-sharing eligibility (i.e. the sponsor would neither confirm nor deny whether the trial was in scope for IPD sharing without the submission of a full research proposal) (Figure 1).

Figure 1.

Diagram summarizing the IPD-sharing eligibility outcomes of the 316 industry-sponsored clinical trials.

Overall, among the top 30 medicines by global revenue for 2021, 19 were confirmed to have over 50% of their clinical trials, as presented in their FDA drug labels, eligible for IPD sharing (Figure 2). In contrast, Pembrolizumab, Rivaroxaban, Nivolumab, and Sitagliptin/Sitagliptin-Metformin each had less than 50% of their clinical trials with results presented in their FDA drug labels eligible for IPD sharing. Furthermore, Tozinameran, Elasomeran, Apixaban, and Lenalidomide had none of the trials eligible for IPD sharing.

Figure 2.

The percentage of IPD eligible for independent researcher request for the industry-sponsored clinical trials with results presented in the FDA-approved drug labels of 2021’s top 30 highest-revenue medicines.

Table 1 presents the proportion of trials eligible for IPD sharing according to key descriptive subgroups. Notably, trials listed in drug labels within the last 5 years had lower eligibility rates (56%) compared to those listed 5 to 10 years ago (77%) and those listed over 10 years ago (75%) (p < 0.01). Similarly, trials yet to pass the completion dates were much less likely to be eligible for IPD sharing (32%) compared to those recently completed (75% of those completed within the last 5 years, 90% of those completed within 5 to 10 years, and 70% of those completed greater than 10 years ago, p < 0.01). In addition, older trials (started before 1 January 2014) showed higher IPD-sharing eligibility (76%) than those started more recently (52% for trials started after 1 January 2014, p < 0.01). IPD-sharing eligibility was also observed to vary with trial phase, with phase 4 trials shared at the highest rate (sharing for phase 1, 2, 3, and 4 trials were 25%, 61%, 68%, and 100% respectively, p < 0.01).

Table 1.

Breakdown of IPD-sharing eligibility according to key descriptive subgroups.

Category		Companies (n)	Trial eligible for IPD sharing		p*
Category		Companies (n)	No	Yes	p*
Trial phase	Phase 1	3	6 (75%)	2 (25%)	0.03
	Phase 2	11	17 (39%)	27 (61%)
	Phase 3	18	79 (32%)	169 (68%)
	Phase 4	2	0 (0%)	3 (100%)
Trial design	Nonrandomized	11	17 (40%)	26 (60%)	0.37
Trial design	Randomized	18	85 (33%)	175 (67%)	0.37
Process of sharing	External	14	57 (25%)	171 (75%)	<0.01
	Internal	2	42 (58%)	30 (42%)
	None identified	2	3 (100%)	0 (0%)
Trial start date	<1 January 2014	14	44 (24%)	138 (76%)	<0.01
Trial start date	≥1 January 2014	17	58 (48%)	63 (52%)	<0.01
Trial has passed final completion date	<5 years	14	20 (25%)	61 (75%)	<0.01
	5–10 years	11	6 (10%)	54 (90%)
	>10 years	10	27 (30%)	63 (70%)
	Not passed	14	49 (68%)	23 (32%)
Time since trial listed in drug label	<5 years	17	63 (44%)	79 (56%)	<0.01
	5–10 years	12	22 (23%)	72 (77%)
	>10 years	8	17 (25%)	50 (75%)
IPD-sharing policy includes a criterion for trial completion	No	8	21 (30%)	50 (70%)	0.03
	Yes	8	78 (34%)	151 (66%)
	Has no online policy	2	3 (100%)	0 (0%)

IPD: individual participant data.

Chi-square evaluation of the distribution between trial eligible for IPD sharing ‘No’ and ‘Yes’.

Beyond trial characteristics, the proportion of trials eligible for IPD sharing was also associated with characteristics of the sponsoring companies’ data transparency policy (Table 1). Notably, trials sponsored by companies with no IPD-sharing policies had the lowest proportion of trials eligible for IPD sharing (0%). Companies with policies that shared data via independent external platforms had a greater proportion of trials eligible for IPD sharing than compared to companies that managed their policies and processes internally (external processes 75% vs internal processes 42%, p < 0.01).

Table 2 presents a breakdown of the reasons provided by sponsors for the 115 (36%) clinical trials for which the eligibility to share IPD was not confirmed. The three most common reasons provided for confirmed ineligibility were: not in scope for sharing per policy (29 trials, 9%), the study is still ongoing (27 trials, 9%), and the clinical trial initiation or completion date predates the companies IPD-sharing policy (9 trials, 3%).

Table 2.

Breakdown of clinical trials for which eligibility to request IPD was not confirmed.

Reasons provided	Total assessed = 316
Clinical trials confirmed as ineligible for IPD request	102 (32%)
• Not in scope for sharing per policy	29 (9%)
• Study is still ongoing	27 (9%)
• Clinical trial initiation or completion date predates IPD-sharing policy	9 (3%)
• Consent form issues	8 (3%)
• IPD under embargo, 18 months have not elapsed since trial completion	8 (3%)
• Phase 1 trials are out of scope	7 (2%)
• Results have not been published in a public registry/peer-reviewed journal	5 (2%)
• Sponsor does not share IPD	3 (1%)
• Co-development/contractual constraints	3 (1%)
• Ongoing regulatory activities	3 (1%)
Clinical trials unable to be confirmed eligible/ineligible for IPD request	13 (4%)
• Full research proposal required to assess eligibility to share IPD	13 (4%)

IPD: individual participant data.

Data specified as number of trials (% of the total number of trials assessed).

Supplemental Table S1 lists the characteristics of the 30 evaluated medicines and the respective proportion of eligible trials for IPD sharing. The raw data set generated and analysed in this study is available in Supplemental File 2.

Discussion

This study evaluated the eligibility of independent researchers to access IPD from clinical trials supporting the FDA approval of the top 30 pharmaceutical medicines by revenue in 2021. Of the 316 trials examined, 201 (64%) trials, involving over 280,000 patients, were confirmed eligible for IPD sharing. However, 102 trials (32%), involving over 230,000 patients, were confirmed as ineligible for IPD sharing. Particularly concerning was the lack of IPD-sharing eligibility for Tozinameran, Elasomeran, Apixaban, and Lenalidomide and that Sitagliptin-Sitagliptin/Metformin, Nivolumab, Rivaroxaban, and Pembrolizumab had less than 50% of their trials eligible for sharing.

Recognizing the importance of clinical trial data sharing, many pharmaceutical companies have committed to promoting transparency and collaboration by sharing de-identified IPD over the past decade.¹ Prior to this study, the largest structured assessments of independent researchers’ eligibility to request industry-sponsored trial IPD were conducted by Murugiah et al.,²⁴ Hopkins et al.,¹² and Modi et al.¹¹ In 2016, Murugiah et al.²⁴ found that IPD were eligible for sharing from ~25% of large cardiovascular trials. In 2018, Hopkins et al.¹² broadened the scope beyond the cardiovascular setting, documented that ~15% of clinical trials were eligible for IPD sharing 2 years after publication of the primary results. Positively, Modi et al.’s 2022 study indicated that IPD-sharing eligibility was ~45% for trials that underpinned the approval of anticancer medicines in the preceding decade. Nevertheless, it was a point of concern that IPD-sharing eligibility for the highest revenue-generating anticancer medicines was notably lower at 35%.¹¹ Significantly, this study demonstrates that 64% of clinical trials supporting the FDA approval of the top 30 pharmaceutical medicines by revenue in 2021 are eligible for IPD requests, indicating substantial growth in the data-sharing ecosystem, while also revealing room for improvement.

Our study highlights several factors that could significantly improve IPD-sharing practices. Notably, companies using independent external platforms for IPD sharing had a higher proportion of eligible trials compared to those using internal processes or without any IPD-sharing policies (75% vs 42% vs 0%, respectively; p < 0.01). In addition, our analysis identified a significant variance in IPD-sharing eligibility based on the completion status of trials as indicated on ClinicalTrials.gov. Specifically, trials not yet marked as completed were substantially less likely to have their IPD eligible for sharing compared to those marked as completed (32% vs 78%, respectively; p < 0.01).

The implementation of public data-sharing policies by most pharmaceutical companies over the past decade is a positive step towards transparency. However, the effectiveness of these policies hinges on their ability to ensure access to key IPD. While phase I and II trials are not always essential for regulatory approval, this study only includes trials that had their results presented in the FDA²⁵ drug label, signifying their importance to the regulatory review process of drug efficacy and safety. Therefore, we believe that the trials we examined, regardless of phase, are important to the drugs in question, as they contain key results that contributed to the approval of the evaluated medicines by the FDA, EMA, and Health Canada. Furthermore, while extended follow-up in clinical trials is essential for comprehensive safety and efficacy data, this should not be used as a pretext for delaying or denying access to the IPD that has already played a role in a medicine’s approval – again herein we reinforce that the trials audited had results presented within the FDA drug label.^9,11 Any hindrance in accessing these data undermines the very purpose of public data-sharing policies designed to promote transparency. Accordingly, our study points to a necessary standardization in data-sharing policies – a clear need for policies to stipulate that all IPD, especially that which underpins the results outlined in drug labels, should be immediately available for sharing upon the medicine’s registration. Moreover, our findings reveal that data-sharing efficacy was higher among companies that engaged external parties in their data-sharing processes. This finding aligns with current discussions in the literature about mechanisms to improve data-sharing practices by both industry and non-industry trial sponsors.⁹ Such discussions often advocate for either the adoption of open-access IPD-sharing models to minimize bureaucracy burdens or the implementation of processes managed by external parties as a means to minimize conflicts of interest and thus potentially improve IPD-sharing rates.^4,9,26

The strength of our study lies in its focus on high-revenue medicines, offering valuable cross-sectional analysis of medicines with high patient usage that are supported by substantial funding. This approach facilitates an insightful evaluation of IPD-sharing practices among major pharmaceutical companies, equipped with resources to facilitate data sharing. This study focused on the top 30 pharmaceutical medicines by revenue for the year 2021, as at the time the study was initiated, this was the most recent expenditure data available. Nonetheless, the high-revenue status of most of the evaluated medicines persisted into 2022, further supporting the relevance of our findings.²⁷ However, this specific focus on high-revenue medicines may have narrowed the scope of our findings, as they may not encompass the data-sharing practices for all medicines or represent the practices of smaller pharmaceutical companies. Furthermore, it should be noted that for 13 trials (4%), the ability to indicate the eligibility to share IPD was contingent upon submitting a research proposal. In these instances, our study was unable to determine their current sharing eligibility. This ambiguity underscores the importance of emerging literature and recommendations from the International Committee of Medical Journal Editors (ICMJE) recognizing the importance of transparent data-sharing plans as part of trial registration.³ While 76% of the trials audited that started before 1 January 2014 were confirmed eligible for IPD sharing, it should be acknowledged that the 24% confirmed ineligible had start dates predating many existing data-sharing policies and recommendations.^1,5 Due to the age of these trials and the generally forward-focused nature of data-sharing policies and recommendations,^1,5,28 sharing data from these trials may not be possible.

In conclusion, our study shows that 64% (201 of 316) of clinical trials supporting the FDA approval of the top 30 revenue-generating medicines in 2021 are eligible for IPD sharing. This finding indicates substantial progress in the pharmaceutical industry’s data-sharing practices over the past decade. To build on this progress, we advocate for key strategies: first, the adoption of either open-access IPD-sharing models or the management of IPD-sharing processes by independent parties; and second, ensuring the immediate eligibility for sharing of primary outcome IPD critical to medicine approvals. Implementing these strategies aims to enhance the accessibility of essential data, and uphold the commitments made to clinical trial participants, who often join trials understanding that, while they may not benefit directly, their participation will help in advancing patient care. Therefore, it becomes a collective duty among all involved stakeholders to respect this commitment by maximizing the potential for scientific discovery and advancement.

Supplemental Material

sj-docx-1-ctj-10.1177_17407745241286147 – Supplemental material for The state of individual participant data sharing for the highest-revenue medicines

Supplemental material, sj-docx-1-ctj-10.1177_17407745241286147 for The state of individual participant data sharing for the highest-revenue medicines by Natansh D Modi, Lee X Li, Jessica M Logan, Michael D Wiese, Ahmad Y Abuhelwa, Ross A McKinnon, Andrew Rowland, Michael J Sorich and Ashley M Hopkins in Clinical Trials

Supplemental Material

sj-xlsx-2-ctj-10.1177_17407745241286147 – Supplemental material for The state of individual participant data sharing for the highest-revenue medicines

Supplemental material, sj-xlsx-2-ctj-10.1177_17407745241286147 for The state of individual participant data sharing for the highest-revenue medicines by Natansh D Modi, Lee X Li, Jessica M Logan, Michael D Wiese, Ahmad Y Abuhelwa, Ross A McKinnon, Andrew Rowland, Michael J Sorich and Ashley M Hopkins in Clinical Trials

Footnotes

Author contributions

N.D.M. and A.M.H. had full access to all the data in the study and take responsibility for the integrity of the data collection,accuracy,and its analysis. All authors contributed to the study design,data analysis,data interpretation,and drafting of the manuscript. All authors have read and approved the final version of the manuscript. The corresponding author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted.

Declaration of conflicting interests

The author(s) declared the following potential conflicts of interest with respect to the research,authorship,and/or publication of this article: A.R and M.J.S. are recipients of investigator-initiated funding for research outside the scope of the current study from AstraZeneca,Boehringer Ingelheim,Pfizer,and Takeda. A.R. is a recipient of speaker fees from Boehringer Ingelheim and Genentech outside the scope of the current study. The author team have no other support,financial relationship,or other relationship activities that could appear to have influenced the submitted work.

Funding

The author(s) disclosed receipt of the following financial support for the research,authorship,and/or publication of this article: N.D.M. is supported by a Postgraduate Scholarship from the National Health and Medical Research Council,Australia (APP2005294). A.M.H. is supported by an Emerging Leader Investigator Grant from the National Health and Medical Research Council,Australia (APP2008119). M.J.S. is supported by a Beat Cancer Research Fellowship from Cancer Council South Australia. The funders had no role in considering the study design or in the collection,analysis,interpretation of data,writing of the report,or decision to submit the article for publication.

Ethical approval

The research undertaken was assessed negligible risk research and was confirmed exempt from requiring Flinders University Human Research Ethics Committee review.

Disclosures

During the preparation of this work,the authors used ChatGPT and Grammarly AI to assist in the formatting and editing of the manuscript to improve the language and readability. After using these tools,the authors reviewed and edited the content as needed and take full responsibility for the content of the publication.

Patient consent

Not applicable.

Transparency

The lead author (the manuscript’s guarantor) affirms that the manuscript is an honest,accurate,and transparent account of the study being reported;that no important aspects of the study have been omitted;and that any discrepancies from the study as planned have been explained.

ORCID iDs

Natansh D Modi

Jessica M Logan

Data sharing

The raw data set generated and analysed in this study is available in Supplemental File 2.

Supplemental material

Supplemental material for this article is available online.

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Supplementary Material

Please find the following supplemental material available below.

For Open Access articles published under a Creative Commons License, all supplemental material carries the same license as the article it is associated with.

For non-Open Access articles published, all supplemental material carries a non-exclusive license, and permission requests for re-use of supplemental material or any part of supplemental material shall be sent directly to the copyright owner as specified in the copyright notice associated with the article.

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