Note: This is the second blog in our ongoing healthcare series on “Data Privacy in Healthcare and The Role of Technology.” This blog series deep-dives into data privacy and transparency in the healthcare industry. It explores in detail the compliance and disclosure requirements in the global pharmaceutical industry and the international laws and regulations that guide them.
This blog series also discusses the traditional manual methods of anonymization currently prevalent, how industry 4.0 solutions can automate and vastly improve conventional anonymization, and how Gramener’s AInonymize solution can transform clinical trial disclosures and regulatory compliance in the healthcare industry.
Recap: In the last article, we introduced the concept of data privacy and general regulations on data privacy in the healthcare industry and the role of technology in it.
Precap: This article will discuss the opportunities data sharing presents to its stakeholders, the global regulatory standards EMA 0070 and Health Canada PRCI, and their role in the healthcare industry.
Check out other parts of the series:
- An Introduction to Protecting Patient Data (Part 1)
- Introduction to Handling Data Privacy Laws and Requirements in Healthcare (Part 3)
- Data Privacy Protection Techniques To Safeguard Patient Data (Part 4)
Table of Contents
Transparency and disclosure of clinical trials are regulatory requirements in most countries. While specific requirements may vary, trial sponsors are, at a minimum, required to register and publish trial results on public databases, such as ClinicalTrials.gov in the US and the Clinical Trial Registry in the EU.
The US Public Health Services Act (PHS) mandates device, biological, and drug product manufacturers to submit clinical trial registration/result information to the ClinicalTrials.gov data bank.
The Food and Drug Administration Modernization Act of 1997 (FDAMA) was the first US Federal law to require trial registration. It directed the National Institute of Health (NIH) to create ClinicalTrials.gov, a public information resource.
ClinicalTrials.gov would track privately and federally funded clinical trials regulated by the Food and Drug Administration (FDA), with the primary objective of providing better public access to clinical trial information on various conditions and diseases.
All sponsors must register their clinical trials on the ClinicalTrials.gov database within 21 days of the enrolment of their first participant and publish their statistical analysis plans, protocols, and results within 12 months of trial conclusion.
To detail industry commitments to data sharing, the European Federation of Pharmaceutical Industries and Association (EFPIA) and the Pharmaceutical Researchers and Manufacturers of America (PhRMA) jointly published the “Principles for Responsible Clinical Trial Data Sharing.”
The principles support incentives for investment in biomedical research, respect for the integrity of national regulatory systems, and enhanced data sharing without compromising patient privacy.
To penalize parties that fail to register and publish results of applicable clinical trials, the FDA issued a guidance on “Civil Money Penalties Relating to the ClinicalTrials.gov data Bank” in 2020. The first 30 days of delay incur penalties of up to $10,000.
After that, a daily penalty of up to $10,000 may be levied.
The FDA issued Acceleron Pharma the first-ever Notice of Noncompliance in Apr 2021 for failing to submit its trial results to ClinicalTrials.gov.
Less than 50% of all clinical trials publish their results within a year of completion, according to a 2020 analysis. Only 33.8% of government and academic-sponsored studies fully comply within a year of trial conclusion.
This article will explore the opportunities data sharing presents to stakeholders – sponsors, patients, and the community. We will also cover two globally recognized regulatory standards – EMA 0070 and Health Canada PRCI and their role in furthering data sharing, transparency, and disclosure in the pharmaceutical industry.
Data Sharing Considerations in Healthcare Settings
Most countries now accept the ethical and legal principles of transparency and disclosure in clinical trials. By some estimates, as many as 190 out of 253 countries maintain registries or databases for the publication and registration of clinical studies.
Commercial and non-commercial sponsors in the EU and the US must register on public databases with specific uploading interfaces. After registration, the sponsors can access their databases and publish results following the defined criteria.
Depending on the type of studies and the local laws, there are numerous requirements and regulations on the transparency of clinical trials worldwide.
For example, in its policy 0070 on the publication of clinical data for medicinal products for human use, the European Medicines Agency says that a high degree of transparency will bring regulatory decision-making closer to EU citizens. It will also promote the more informed use of medicines and benefit public health.
The policy mentioned above mandates sponsors to make an extra effort to combine the complex activities of clinical research with the spirit of transparency. This includes private and public sector investments that produce benefits beyond compliance with a set of rules.
The following sections explore how data sharing, transparency, and clinical trial disclosure policies present unique opportunities for sponsors, patients, and the community.
Sponsors
Clinical trial disclosure and transparency are opportunities to describe how researchers and physicians investigate the safety and efficacy of new medical devices and drugs. It also makes this information more accessible.
To increase public access to clinical trial information, the drug manufacturer associations in the US (PhRMA) and the EU (EFPIA) adopted the joint document Principles for Responsible Clinical Trial Data Sharing in Jul 2013.
Many pharmaceutical companies have already established clinical trial disclosure and transparency policies, with almost all of them posting their clinical trial results.
Industry leaders like Bristol-Meyer Squibb, Johnson and Johnson, and GSK adopted similar policies in 2015, with the rest of the players in this space following suit shortly after.
A Jul 2018 study found that 68.1% of commercially sponsored trials posted their results, as opposed to only 11% of trials with non-commercial sponsors. According to a UK House of Commons Feb 2019 Report, pharmaceutical companies have complied vastly better than universities.
As per a report by Clinical Trial Transparency at European Universities, about 83% of the clinical studies sponsored by 30 European universities do not comply with the European transparency rules.
The report detailed that:
- 14 universities across 7 countries did not publish any results.
- Out of 13 other universities, the highest percentage of published clinical studies results were only 33%.
- Only 3 universities published more than 80% of their clinical studies results.
By committing to making their clinical trial results public, sponsors can improve their public perception and credibility with patients. They can also demonstrate the tolerability, safety, and efficacy of their products and highlight the quality of their R&D processes.
Data sharing can help sponsors build public trust in their drugs often eroded due to lack of information.
Patients
Article 25 of the Declaration of Helsinki on human experimentation says that individuals who can provide informed consent can only participate in medical research voluntarily. Individuals capable of giving their consent but not free to participate cannot be placed in a clinical trial.
Despite this, before the advent of European and US-based clinical trial public databases, patients faced significant challenges in accessing the results of the clinical studies in which they had participated.
Public databases like the EU Clinical Trial Register and ClinicalTrials.gov offer patients direct access to their results. According to a joint study by Cochrane, The Collaboration for Research Integrity and Transparency (CRIT), Transparency International (TI), and TranspariMED, patients are harmed by the lack of transparency in clinical trials.
If the information about the medical devices and drugs generated through research is incomplete, distorted, conditioned, or missing, the risks or benefits associated with them cannot be evaluated or fully understood.
Well-documented and numerous examples have demonstrated how insufficient transparency of clinical trials has harmed large groups of patients.
During its five years in the US market, the arthritis medicine rofecoxib, also known as Vioxx, is estimated to have caused up to 140,000 heart attacks, 40% of which were fatal.
A Canadian study found that the drug caused gastrointestinal bleeding among the elderly, leading to hospitalizations. The clinical trial evidence analysis showed an unacceptable risk profile long before the recall of the drug from the market in 2004.
Had this information been made available to the public in advance, countless lives could have been saved.
Patients can now access the results of studies, thanks to transparency and disclosure rules. For instance, current EU regulations extend anonymization guarantees to all healthcare personnel, ensuring better protection of patient privacy.
Community
The objective of EMA Policy 0070 is to bring citizens closer to clinical trials. The EU Clinical Trial Regulation 536/2014 provides that sponsors will initiate publications of layperson summaries for all clinical trials conducted under the new regulation six months from the release of the new Clinical Trial Information System (CTIS) platform.
The regulation allows sponsors to submit a single application on the CTIS platform to seek approval to run clinical trials across multiple European countries. It also enables EU member States to ratify said applications more easily using the CTIS platform.
The regulation fosters innovation and research by facilitating large clinical trials that span multiple EU and EEA countries. It also improves information sharing, transparency, and collective decision-making and ensures the safety of participants in clinical trials.
US legislation does not require the publication of lay summaries.
The lack of clinical trial transparency increases public costs. In the absence of precise information, it is difficult for regulatory agencies to make informed decisions or determine the effectiveness of drug or device candidates, resulting in the loss of public funds.
In the following sections, we discuss two globally recognized regulatory standards and how they are helping to democratize data sharing, transparency, and disclosure in healthcare.
Overview Of Key Regulations Regarding Disclosure
The EMA Proactive Transparency Policy (EMA Policy 0070)
The European Medicines Agency (EMA) launched policy 0070, also known as the “publication of clinical data for medicinal products for human use” in 2015. This policy aims to meet the increasing stakeholder demand for additional transparency in clinical data used in critical regulatory decision-making.
Under policy 0070, regulatory documents can be accessed worldwide for non-commercial reasons. Clinical data defined under this policy includes clinical study reports (CSRs), summaries, and clinical overviews.
It also includes CSR appendices – protocol, protocol amendments, sample case report form(s), and documentation of statistical methods or clinical study statistical analysis plan (SAP).
Policy 0070 allows clinical data to be published in an anonymized portable document format through central regulatory applications. Anonymity ensures that the public disclosure of data does not lead to the reidentification of trial participants using the information in these documents.
This policy helps people, including academics and researchers, to access direct information from the CSRs submitted to the EMA by the pharmaceutical companies that pertain to the marketing authorization applications for new medicines.
The original policy document had the following two phases:
- Phase 1 comprised the publication of CSRs only
- Phase 2 comprised the publication of individual patient data (IPD)
However, the 2019 policy revision covered IPD and CSRs under “clinical data.”
With such refined transparency initiatives, the EMA hopes to promote the well-informed use of medicines by bringing EU citizens and regulators closer to each other. Future public health will also benefit from access to clinical data.
This policy has facilitated the development of more efficient medicine, creating a platform and enabling drug developers to learn from past experiences. Using this clinical data, original research can be further analyzed to assess the regulators’ position.
EMA is the first regulatory body worldwide to open access to clinical data submitted by companies for marketing authorization applications.
This proactive transparency policy has persuaded other global regulators, including Health Canada and the US Food and Drug Administration (USFDA), to drive their transparency initiatives.
Health Canada PRCI
In March 2019, Health Canada released the guidance document known as the Public Release of Clinical Information (PRCI) to make anonymized clinical information in medical device applications and drug submissions publicly available.
Under the Privacy Act of Canada, this document allows industries, the public, healthcare professionals, and other stakeholders to make appropriate health-related decisions and understand clinical aspects better.
It also fosters new research queries, facilitates Health Canada’s Regulatory review process completion, and enables independent data re-analyses.
In line with the amendments to the Medical Devices Regulations (MDR) and the Food and Drug Regulations (FDR) that came into effect on 28th Feb 2019, the PRCI document authorizes Health Canada to publicly release the clinical information in medical device applications and drug submissions that cease to be Confidential Business Information (CBI).
These regulatory amendments describe how to protect personal information from public release, procedures to remove CBI information, and the scope of clinical information eligible for public release.
As is amply evident, data anonymization is an indispensable aspect of data sharing, transparency, and disclosure. To comply with globally accredited healthcare regulations, sponsors must anonymize confidential and sensitive patient information and clinical trial data.
Gramener’s AInonymize solution can help strike the right balance between data transparency and protection, helping sponsors leverage AI-powered anonymization techniques to submit CSR documents exponentially faster without compromising patient privacy.
Our AInonymize solution is industry-tested and has helped global healthcare leaders meet the aggressive timelines of EU and US-based regulations.
Conclusion
This article covered an overview of data sharing, transparency, and disclosure requirements in the healthcare industry. We also explored the opportunities data sharing presents to key stakeholders and discussed two globally recognized regulatory standards – the EMA 0070 and Health Canada PRCI.
Don’t miss the next blog in this series, where we deep-dive into data privacy in the healthcare space and further explore the transparency and privacy requirements of Health Canada PRCI and EMA 0070.
See you soon!
