Clinical Trials and Transparency

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  1. EFPIA
  2. science
  3. clinical trials
  4. efpia
  5. pharma
  6. pharmaceutical industry
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Комментарии
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The European Ombudsman declared that neither clinical trial protocols, nor clinical study reports, contain commercially confidential information. The European Medicines Agency and other European regulators have also acknowledged that clinical trial data shall not be considered commercially confidential.

tim
Автор

If EFPIA is truly “willing to be more transparent”, it should support that clinical study reports, including raw data, are made available on a publicly accessible database, not just trial results “either as a publication somewhere or somewhere else.” Disclosure of full clinical trial data is essential to minimising reporting bias, which can overestimate benefits, and underestimate risks, of medicines. See our further comments about this video on our blog:

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