Scarce quality assurance documentation in major clinical trial registries for approved medicines used in post-marketing clinical trials

Author:

Doua Yorokpa JoachimORCID,Dominicus Hanneke,Mugwagwa Julius,Gombe Suzelle Magalie,Nwokike Jude

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Medicine (miscellaneous)

Reference25 articles.

1. Hannan EL. Randomized clinical trials and observational studies: guidelines for assessing respective strengths and limitations. JACC Cardiovasc Interv. 2008;1:211–7.

2. Juni P, Altman DG, Egger M. Systematic reviews in health care: assessing the quality of controlled clinical trials. BMJ. 2001;323:42–6.

3. Newton PN, Green MD, Mildenhall DC, Plancon A, Nettey H, Nyadong L, et al. Poor quality vital anti-malarials in Africa - an urgent neglected public health priority. Malar J. 2011;10:352.

4. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonized Tripartite Guideline. Guideline for Good Clinical Practice E6(R1). 1996. www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf . Accessed 10 Oct 2017.

5. World Health Organization. Forty-ninth Report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations. 2015. http://apps.who.int/iris/handle/10665/176954 . Accessed 10 Oct 2017.

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