Regulatory texts for clinical research and reporting guidelines

News: Regulatory elements for clinical research, 2017

FAQs about clinical research on human subjects (french ministry of social affairs and health, 2016, august, 25

Jardé law : slides support of the talk given by Pr Lemaire in URC/CIC Necker-Cochin (2017, january 3th) 

Reporting guidelines

EQUATOR NETWORK (http://www.equator-network.org/)

The EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network is an international initiative that seeks to improve the reliability and value of published health research literature by promoting transparent and accurate reporting and wider use of robust reporting guidelines.

CONSORT (http://www.consort-statement.org)
Reporting parallel group randomised trials.
Extensions : reporting in conference abstract, non pharmaceutical treatments, cluster trials or feasibility study…and many more.

STROBE (http://www.strobe-statement.org)
Reporting observational studies in epidemiology (cohort, case-control studies, cross-sectional studies).
Extensions : genetic association studies (STREGA), molecular epidemiology (STROBE-ME), and much more.

STARD (http://www.stard-statement.org)
Essential items for reporting diagnostic accuracy studies

PRISMA (http://www.prisma-statement.org/statement.htm)
Items for systematic reviews and meta analysis

COREQ
Reporting qualitative research : interviews and focus groups, pdf file available here

SPIRIT (http://www.spirit-statement.org)
Defining standard protocol items for clinical trials, pdf file available here.

REMARK
Reporting recommendations for tumor marker prognostic studies, pdf file available here.

CHEERS
Consolidated Health Economic Evaluation Reporting Standards, pdf file available here.

Many other reporting guidelines have been published, discover them here.


ICH guidelines

The International Council for Harmonisation (ICH) was conceived after  discussions between Europe, Japan, the US and International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) on possibilities for harmonisation.

ICH developed ICH Guidelines on Safety, Quality and Efficacy topics. Work was also undertaken on a number of important multidisciplinary topics, which included MedDRA (Medical Dictionary for Regulatory Activities) and the CTD (Common Technical Document).

Some of them are particularly dedicated to clinical studies (efficacy guidelines) :

  • E8 : General Considerations for Clinical Trials
  • E9 : Statistical Principles for Clinical Trials
  • E10 : Choice of Control Group in Clinical Trials
  • E11 : Clinical Investigation of Medicinal Products in the Pediatric Population

 Recommendations of ICMJE (International Comitee of Medical Journal Editor)

The ICMJE is a small group of general medical journal editors and representatives of selected related organizations working together to improve the quality of medical science and its reporting. ICMJE meets annually to refine its Recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals.

  • pdf file in English available here
  • pdf file in French available here

Textes de référence (en anglais)

  • Clinical trial registration :  pdf.
  • Defining the role of authors and contributors : pdf.
  • Manuscript preparation for submission : pdf.

Other interesting links (in french)

News about medical and scientific writers and biomedical reviews : JAMA, The Lancet, BMJ, NEJM, …


 Regulatory texts (in French)

 

CNIL (National commission for informatics and data protection rights and liberties)