Building quality in clinical trials with use of a quality systems approach.

There is an increasing focus on having quality systems in place during the planning stages of clinical trials. Such systems require the development and implementation of standards for each step. Although this is not imposing something totally new on clinical research, a systematic approach will produce a more reliable and useful end product--high-quality data obtained without compromising the protection of human subjects' rights and welfare. A suggested quality system with standards for each step is addressed in this article.

[1]  Philip Mirowski,et al.  The Contract Research Organization and the Commercialization of Scientific Research , 2005, Social studies of science.

[2]  George W Williams.  The other side of clinical trial monitoring; assuring data quality and procedural adherence , 2006, Clinical trials.

[3]  J. Abraham.  The international conference on harmonisation of technical requirements for registration of pharmaceuticals for human use , 2009 .

[4]  Peter Sandercock,et al.  Sensible approaches for reducing clinical trial costs , 2008, Clinical trials.

[5]  Salim Yusuf,et al.  Specific barriers to the conduct of randomized trials , 2008, Clinical trials.

[6]  R. Califf,et al.  Developing systems for cost-effective auditing of clinical trials. , 1997, Controlled clinical trials.

[7]  S L George,et al.  Guidelines for quality assurance in multicenter trials: a position paper. , 1998, Controlled clinical trials.

[8]  Meredith Wadman,et al.  The quiet rise of the clinical contractor , 2006, Nature.

[9]  Paul Braunschweiger,et al.  Collaborative Institutional Training Initiative (CITI) , 2010 .

[10]  J. Adler.  Ethical and scientific implications of the globalization of clinical research. , 2009, The New England journal of medicine.

[11]  Jonathan R Davis,et al.  Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making , 1999 .

[12]  Cristián Zegers Ariztía,et al.  Manual , 2002 .

[13]  M. Shuchman.  Commercializing clinical trials--risks and benefits of the CRO boom. , 2007, The New England journal of medicine.

[14]  Douglas G Altman,et al.  Ensuring trial validity by data quality assurance and diversification of monitoring methods , 2008, Clinical trials.