Clinical Trial Disclosure and Transparency: Find this article on Pfizer.com.
Compliance with the requirement to report results on the EU Clinical Trials Register: cohort study and web resource
Twenty odd years ago if a patient or wanted to learn about new trials a it was an interesting journey. Individual academic institutions and pharmaceutical organizations around the world kept records and often eagerly registered trials to promote enrollment, the sharing of results was at times haphazard and international and national repositories aggregating thousands of trials per disease indication was slow in coming.
By 1997 the NIH in America, as well the Europeans 4 years on in 2001, and international bodies such as the World Health Organization (WHO) began offering industry and academia guidelines and structure: what to report and when, specifying exact guidelines on how many months after a trial's completion to publish results. Medical writers have been an important voice with the International Committee of Medical Journal Editors (ICMJE) in 2/2019 specifying data sharing disclosure requirements for candidate articles. For more information, an older presentation on disclosure (circa 2005) from Deborah Zarin, MD of ClinicalTrials.gov is here.
Compliance with the requirement to report results on the EU Clinical Trials Register: cohort study and web resource
By 1997 the NIH in America, as well the Europeans 4 years on in 2001, and international bodies such as the World Health Organization (WHO) began offering industry and academia guidelines and structure: what to report and when, specifying exact guidelines on how many months after a trial's completion to publish results. Medical writers have been an important voice with the International Committee of Medical Journal Editors (ICMJE) in 2/2019 specifying data sharing disclosure requirements for candidate articles. For more information, an older presentation on disclosure (circa 2005) from Deborah Zarin, MD of ClinicalTrials.gov is here.
