Posted on 13 Nov 2019


Docket FDA-2019-N-2012 Update – Perspectives Vary on FDA’s Proposed Integrated Review Template

You may recall that FDA Docket “New Drugs Regulatory Program Modernization: Improving Approval Package Documentation and Communication” was opened in summer 2019. Comments were invited on FDA’s proposed Integrated Review Template as a possible alternative or addition to the publication of redacted clinical documents adopted by some authorities (e.g. EMA and health Canada). Mine and Art Gertel’s comments are posted here on the FDA Docket (as well as on the CORE Reference website).

A total of 22 sets of comments are posted. These make interesting reading; I encourage you to read them for yourself in full. In the meantime, below are my ‘take home points’ on perspectives of interested stakeholders including:

Industry associations

  • PhUSE’s Data Transparency Working Group
    • Suggest that reidentification attack risk is higher in the proposed FDA Integrated Review compared to the redaction approach taken by EMA and HC - as applied directly to publication of clinical documents
  • PhRMA
  • Biotechnology Innovation Organization
    • Both support the use of the FDA Integrated Review, and suggest to abandon the publication of redacted clinical documents
  • Combination Products Coalition
    • Request publication of discipline-specific review memos, in addition to the proposed FDA Integrated Review

Publications professionals

  • Cochrane
  • BMJ and PLOS (joint comments)
    • All support providing the CSR, protocol and SAP in addition to the proposed FDA Integrated Review document

Pharmaceutical companies

  • Leo Pharma
    • Point out the non-alignment of redaction approach with some other health authorities [EMA, HC]. Support the proposed FDA Integrated Review

Data and analytics company interested in real-world data

  • Flatiron Health
    • Suggest that totality of evidence, including any consultative reviews, are included in the proposed FDA Integrated Review


  • Lupus Foundation of America
  • Cancer Support Community
    • Both want patient experience data considered in the decision-making process

ISO14155 (GCP for Medical Devices) Update

The new ISO14155 GCP update is here and transparency is one of the key additions for medical devices with postings required in a publicly accessible database. Read Raquel Billiones’ summary here of this critical update.

Generation of Synthetic Clinical Trial Data

I am pleased to share Replica Analytics' Webinar materials from 4th October 2019 on the generation of synthetic clinical trial data. Please find below the links to the webinar materials:
The complete set of slides can be downloaded, together with a recording of the webinar.
Feel free to distribute this information to your colleagues and others in your network. Spread the word about synthetic data, how it is generated, and its benefits.

Given the necessary protections around 'real' clinical trial data, we should understand about upcoming alternatives.

Recent Clinical Trial Transparency Publications

Baronikova et al remind us that improvements in clinical trials disclosure are needed in their publication Commitments by the biopharmaceutical industry to clinical trial transparency: the evolving environment in BMJ Evidence-Based Medicine.
Nature Medicine aligns with International Committee of Medical Journal Editors guidelines in requiring prospective registration of interventional trials in a publicly available database as a pre-requisite to publishing papers on clinical trials in this October 2019 Editorial 'Raising the bar on Clinical Research'.