Medical Writing Observational Studies Regulatory submissions of non-interventional post-authorisation safety studies
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Volume 26, Issue 3 - Observational Studies

Regulatory submissions of non-interventional post-authorisation safety studies

Abstract

The post-authorisation safety study (PASS) is a pharmacovigilance activity often required as a post-marketing commitment to establish a safety profile or address specific safety concerns. An imposed PASS must be submitted in common technical document format. Comparability of observational studies to clinical trials is limited by a number of factors related to the differences in design and conduct of these studies. These include selection bias, which is harder to control in the observational setting, and typically a relatively higher extent and quality of data collection in the clinical setting. The PASS also places a strong focus on risk without collecting new formal benefit information. These factors present medical writers with some new (and not so new) challenges.
Offsetting the challenges, the PASS creates opportunities to assess the “real world” prescribing of a drug, to compare the real target population with the label population, and, because of the large scale of such trials, to assess safety across multiple sub groups with
greater certainty than possible in a clinical trial.
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References

  1. European Medicines Agency. Postauthorisation safety studies (PASS). Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000377.jsp&mid=WC0b01ac058066e979
  2. Morley G. Non-interventional postauthorisation safety studies (NI-PASS): a different type of report. Med Writ 2014;23:273-6. Available from: http://
  3. Bouvy JC, De Bruin ML, Hoekman J, Stolk P. The costs and effects of postauthorisation safety studies for new active substances. Value in Health 2014;17:A445. Available from: http://
  4. Cohet C, Rosillon D, Willame C et al. Challenges in conducting post-authorisation safety studies (PASS): a vaccine manufacturer’s view. Vaccine 2017; 35:3041-9. Available from: http://
  5. Kardos P, Worsley S, Singh D, Román- Rodriguez M, Newby DE, Müllerová H. Randomized controlled trials and real-world observational studies in evaluating cardio - vascular safety of inhaled bronchodilator therapy in COPD. Int J Chron Obstruct Pulmon Dis 2016;11:2885-95. Available from: http://
  6. Ageno W, Mantovani LG, Haas S et al. Safety and effectiveness of oral rivaroxaban versus standard anticoagulation for the treatment of symptomatic deep-vein thrombosis (XALIA): an international, prospective, non-interventional study. Lancet Haematol 2016;3:12-21. Available from: http://

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Regulatory submissions of non-interventional post-authorisation safety studies
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