November 2021: FDA looks on while major U.S. institution violate medical research rules

An article, FDA looks on while major U.S. institutions violate medical research rules, was published on TranspariMed on November 21, 2021

This article provides a comprehensive overview of FDA’s action on the Institutions violating key clinical trial disclosure law. Out of 51 large US-based companies and institutions that have failed to make five or more clinical trial results public, only three have been contacted by the U.S. drug regulator, and only one has received a final warning, FDA enforcement data show.

Between July 2020 and the end of April 2021, the FDA sent out only 54 “Pre-Notices of Noncompliance” that flagged missing trial results and instructed sponsors to make them public as required by law. When the FDA did send letters, it triggered compliance in over 90% of cases.

The article also lists all the major US-based clinical trial sponsors that have failed to make five or more clinical trial results public as required by law, and the corresponding FDA warning letters.

More information can be found here

November 2021: Transparency Scenario in Europe, United States and Canada

An article, Comparing regulatory transparency in Europe, United States and Canada, was published on TranspariMed on November 02, 2021.

This article, provides a comprehensive overview of the key laws and policies governing disclosure of data by major medicine regulators namely European Medicines Agency, the US Food and Drug Administration, and Health Canada. It also compares the data access provided to certain transparency documents by the regulators. This article was originally published by Cambridge university – Transparency of Regulatory Data across the European Medicines Agency, Health Canada, and US Food and Drug Administration

According to the article, the three major medicines regulators are providing more access to key data than ever before. The study focuses on Clinical Study Reports, highly detailed documents that contain important information on the conduct and outcomes of clinical trials that cannot be found elsewhere, but also covers Individual Patient Data plus other types of data and documentation.

The key findings of the article are:


  • Redactions – The three regulators make only “minimal” redactions to Clinical Study Reports (CSRs) to remove commercially confidential information and data that may endanger patients’ anonymity. Those redactions “generally did not hamper the interpretation of evidence”.
  • Proactive disclosure – Only Health Canada and the European Medicines Agency proactively disclose new CSRs. While the Canadian regulator makes CSRs fully public, the European regulator places restrictions on who can access them, and how. The US Food and Drug Administration has yet to start proactively disclosing CSRs.
  • Reactive disclosure – All three agencies have mechanisms that allow researchers to gain access to older CSRs and other regulatory data upon request. Health Canada provides CSRs far faster and in a more accessible format than the other two regulators do.


Access to Individual Patient Data – Access to IPD via regulators is still impossible in practice. Only the US Food and Drug Administration releases IPD on request, but it when does so, it redacts the data so heavily that they are useless. The European Medicines Agency has formally committed to making IPD accessible in future, but this is not likely to happen any time soon. Health Canada does not have an IPD sharing policy.


The three regulators differ widely in which other types of data they would release.

The article concluded that regulatory data pertinent to public health and clinical medicine, that were used to support the approval of medicines and medical devices are now available proactively or in response to information requests. Over the next decade, regulatory agencies should make Individual patient data available, and additional resources might be needed to ensure the long-term viability of regulatory data sharing programs and to encourage researchers to take advantage of the data that is — for now — more available than ever before.

More information can be found here.

October 2021: EU PAS Webinar Update

The European Network of Centres in Pharmacoepidemiology and Pharmacovigilance (ENCePP) will hold its virtual annual plenary meeting on 18 November 2021. Registration is open to ENCePP Partners (centres and networks) until 26 October 2021.

The event is for ENCePP Partners only, registration from other individuals will not be accepted.

Along with other objectives of the meet, following are the transparency objectives to be discussed:

  • To update on the work programme of the HMA-EMA Big Data Task Force and discuss the interface with ENCePP activities. Topics for discussion include the creation of curricula in Data Science, Pharmacoepidemiology and Biostatistics, the upgrading of the EU PAS Register and ENCePP Resources Database, an update on the Real-World Interrogation Network in the European Union (DARWIN EU) and the pilots for data analytics with EMA committees
  • To discuss the result of the surveys and agree on the amendments needed for the metadata and functionalities of the EU PAS Register and ENCePP Resources Database

The WebEx joining instructions will be sent to those ENCePP members who have registered via the registration form.

Related documents: 1. Registration Form   2. Meeting agenda

Additional details can be found here.

October 2021: What’s New on

Below update was posted on What’s New section on October 08, 2021:

  • Train-the-Trainer Materials Available: The materials from the August 2021 Results Database Train-the-Trainer virtual workshop are now on the Training Materials page. The topics covered in the workshop included an Overview of the Clinical Trial Disclosure Landscape, a PRS System Overview, NIH Requirements for Clinical Trials Registration and Reporting, PRS Results Module Introductions, and Example Studies for Results Data Entry.
  • Glossary Term Updates: Definition for Results First Posted with QC Comments is now available in the Glossary and the terms, Results First Posted and First Posted, have been updated for clarity. In addition, the Results First Posted with QC Comments date is added to the Key Record Dates.

August 2021: US Regulatory Update

FDA Takes Action For Failure to Submit Required Clinical Trial Results Information to

The FDA issued a Notice of Noncompliance on August 31, 2021, to Andrey Petrikovets, M.D. (responsible party) affiliated to University Hospitals Cleveland Medical Center, for failing to submit required summary results information to The company failed to update the study results for their applicable clinical trial (ACT) within 30 days after the first notice was issued. The company’s applicable clinical trial compared ICE-T postoperative multimodal pain regimen to the Standard regimen in patients undergoing same day vaginal pelvic reconstructive surgery.

The prenotice was issued on July 20, 2020, alerting Andrey Petrikovets to potential noncompliance with the requirement to submit clinical trial results. Although the trial’s results were made public in a medical journal, journal publication does not satisfy disclosure requirements. On November 30, 2020, Andrey Petrikovets responded, stating that they were very busy with the “Covid surge” and were short staffed. FDA recognizes the unique circumstances that the pandemic presents, and believes they have provided ample opportunity to submit the required results information. The Notice of Noncompliance gives Andrey Petrikovets 30 days to submit the required summary results information. The FDA is authorized to seek civil monetary penalties for Andrey Pretrikovets’s violation, including additional civil money penalties if Andrey Petrikovets fails to submit the required information within the 30-day period.

The Notice of Noncompliance has been posted to the FDA’s website and information about the noncompliance has also been posted on the study record on by NIH. NIH will continue to update the records for applicable clinical trials that are the subject of a Notice of Noncompliance with information regarding whether the noncompliance has been corrected and the amount of civil money penalties assessed if any.

For more information, please refer to the Letter of noncompliance on the FDA Website: Non-compliance letter

June 2021: Japan Registry Update

Updated Field of jRCT

A pre-registration content check sheet was posted on June 29, 2021 on Japan Registry of Clinical Trials (jRCT).

For registration items of “Other Clinical Studies” and “Clinical Trials”, an input check at the time of registration is added. If the items in the check sheet are not met, the registration can be remanded.

Please click here to go to the original update.

June 2021: What’s New on PRS

The below update was posted on the What’s New section of PRS Test, which will go live on June 27, 2021:

Late Results Problem Detection: The Late Results problem notification is now removed upon initial release of results rather than when results are posted. Similarly, the Incomplete Results problem notification is now removed upon the first release that includes all primary and secondary outcome measures.

February 2021: Japan Regulatory Update

Japan Clinical Trial Registration System Unification to jRCT

Official notification was published on Center for Clinical Trials, Japan Medical Association (JMACCT) regarding unification of Japanese clinical trial registries into jRCT, in February 2021.

As per the new notification i.e.  August 31, 2nd year of Reiwa (i.e. 2020), Pharmaceuticals and Herbal Medicines 0831 No. 9, the following changes will be applicable to clinical trials after September 01, 2020:

  • The registration of all clinical trials is unified to one center – jRCT (Japan registry  of Clinical Trials)
  • The clinical trials involving  Phase 1 (except bioequivalence studies), phase 2-4 would be registered
  • The language for disclosures information would be made mandatory in English and Japanese
  • The information on the physicians and the medical institutions would be added to enable better accessibility to the public, these details are to be registered in a timely manner

Please click here to go to the original update.

February 2021: Japan Regulatory Update

Updated Fields of jRCT

Below updates were made to the jRCT system for “Specific clinical research”, “Other clinical research (non-specific clinical research only)”, and “Regenerative medicine research” on February 01, 2021:

  • Added the following 4 items in the initial application, change application, and minor change application (regeneration only): about ‘Plan to share IPD’, ‘Plan to share IPD’, ‘Explanation of plan’, and ‘Plan description’
  • Removed the selection of ‘Undecided’ from “Plan to share IPD data” in the end notification, and only “Yes” or “No” needs to be selected
  • Removed the selection of ‘Undecided’ from “Plan to do” and made only “Yes” and “No” for ‘IPD data sharing’ of Plan to share IPD data of ‘Other clinical research’ and ‘Clinical trial’ in initial application, change application, minor change application (other than clinical trial), completion notification.

Please click here to go to the original update.