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Medical writing tips for simplifying disclosures and redactions

  • Writer: catherine evans
    catherine evans
  • Jan 13
  • 5 min read

Clinical trial transparency will continue evolving in 2025. (1) While publication of trial results has been standard practice for several years, (2) initiatives to broaden transparency have been recently revitalised. (3) Documents behind marketing authorisation applications (MAAs) are also now accessible for some medicines in the EU, and the scope of these disclosures will expand further next year. (1) Trial sponsors are adapting to the challenges that these changes bring and I've summarised some key tips for medical writers below.

What are the changes?

EMA Policy 0070 currently applies to MAAs for medicines containing a new active substance reviewed by the EMA from September 2023 onwards. (4) The documents released include clinical study reports, protocols, sample case report forms and statistical analysis plans. (3) The scope includes MAAs that failed the Committee for Medicinal Products for Human Use (CHMP) review process or were withdrawn, as well as applications for significant changes to existing medicines, such as indication expansions. (1)

It is possible that future scope expansions will encompass all medicines with a known active substance, not just new active substances. (5)

What impact could this have?

As the documents give anyone* extensive information about the design of clinical studies, as well as study data, these disclosures could improve research efficiency and also help build trust in the EMA’s decision and review processes (Box 1). Ultimately, greater transparency in clinical research can improve public health — more medicines could be produced but also existing evidence could be explored more easily so that current medicines help broader patient groups or people with other conditions. The public, patients and healthcare providers can have access to the evidence behind the approval of medicines and see accountability in the process.

*Anyone who logs into the portal after first creating an EMA account, here: http://clinicaldata.ema.europa.eu


Box 1: How can increased disclosures improve public health?

Increased innovation

Independent re-examination of data by anyone outside the sponsor company, e.g. academic or clinical researchers and other pharmaceutical companies, can give a deeper understanding and broader perspective of trial design and results. This might generate new evidence for using existing medicines with broader patient groups and indications.

Reduced research waste

Protocols that are unapproved and withdrawn will be public and can be evaluated to avoid unnecessary duplication of similar weaknesses in trial design.

Improved accountability and trust

Independent analysis and verification can build trust in the EMA’s scientific review and decision-making processes.




What are the challenges?

The policy brings challenges for sponsor companies (Box 2) — the identity of trial participants must be protected and commercially sensitive details should also be secured. Specific information can be blacked-out in the documents, but these redactions can be a difficult process with large, complex and intertwined documents, especially under time pressure. Redactions can also be rejected if the utility of the information is lost.


Box 2: Challenges of disclosures and redactions for clinical trial sponsors


Protecting participants’ identities

Trial sponsors are responsible for keeping participants anonymous. Indirect identifiers in patient narratives, such as treatment dates, medical history and adverse events, make this harder. Even more so with rare diseases.

Securing commercially sensitive information

Most information in clinical reports is not considered commercially relevant by the EMA and so redactions may well be rejected.

Retaining data utility

As more and more information is redacted, the usability of the document decreases. Each redaction must be justified to the EMA in an anonymisation report form



What role do medical writers have?

With foresight, medical writers can ease these challenges. We can proactively reduce future work load by using lean writing techniques and by minimising the need for redactions.


Here are 12 medical writing tips for simplifying disclosures and redactions:


  • Limit protected personal data (PPD)

    • Use age ranges rather than exact ages of patients

      • e.g. ’50–59 years’ rather than ‘53 years’

    • Group minority ethnicities with an overarching term

      • e.g. ‘White European’ rather than ‘Sami’

    • Generalise participants’ geographic locations to larger population areas

      • e.g. ‘Germany’ rather than ‘Marburg’

    • Reword verbatim expressions in patient narratives to MedRA terms when possible

      • e.g. ‘fall’ rather than ‘slipped on a banana skin’

    • Use study days rather than real dates

      • e.g. ‘Day 31’ rather than ‘5 December 2024’

    • Use generic medicine names in medical histories rather than brand names that may reveal a territory

    • Create new participant IDs rather than reuse trial randomisation numbers

  • Limit commercially confidential information (CCI)

    • Be aware that the EMA may reject CCI redactions that are not well supported

    • Communicate early with patent experts in the team to identify potential CCI

    • Query if specific CCI can be omitted without jeopardising the purpose of the document

  • Simplify formatting and structure

    • Organise tables to allow block redaction of whole columns so that separate redactions across many multiple cells are not needed

    • Restrict PPD and CCI to specific sections and cross-reference as needed to avoid multiple redactions


If you are looking for a freelance medical writer to support with your regulatory documentation, get in touch with me.



Resources for medical writers:

If you want to learn more about upskilling as a medical writer, here are some resources related to this article:



References

  1. Revised Scope and updated Toolkit. EMA, 14 November 2024. Accessed 11 December 2024. https://www.ema.europa.eu/en/documents/presentation/presentation-clinical-data-publication-revised-scope-updated-toolkit-k-quigley-ema_en.pdf.

  2. Posting of clinical trial summary results in European Clinical Trials Database (EudraCT) to become mandatory for sponsors as of 21 July 2014. EMA, 19 June 2014. Accessed 11 December 2024. https://www.ema.europa.eu/en/news/posting-clinical-trial-summary-results-european-clinical-trials-database-eudract-become-mandatory-sponsors-21-july-2014.

  3. Clinical data publication. EMA, 31 January 2023. Accessed 11 December 2024. https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/clinical-data-publication.

  4. Clinical Data Publication: Questions and Answers (Q&As) on the External Guidance on the implementation of the European Medicines Agency policy on the publication

    of clinical data for medicinal products for human use (Policy 0070). EMA, 26 July 2023. Accessed 11 December 2024. https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/questions-and-answers-qas-external-guidance-policy-0070-clinical-data-publication-cdp_en.pdf.

  5. Reply of the European Medicines Agency in response to the letter of the European  Ombudsman concerning “[t]he proactive transparency of clinical trial data” (Case  SI/3/2023/MIK). EMA, 29 September 2023. Accessed 11 December 2024. https://www.ombudsman.europa.eu/pdf/en/176095.


If you are looking for a freelance medical writer to support with your regulatory documentation, get in touch with me.




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