Streamlining, clinical trials

Streamlining clinical trials, including advancing innovative trial designs (as discussed in Chapter 11). 

Thornquist, M.D., "Streamlining IRB review in multisite trials through single-study IRB Cooperative Agreements experience of the p-Carotene and Retinol Efficacy Trial (CARET)," Controlled Clinical Trials, 23, 80-86 (2002). 

Where a clinical trial was proposed with a marketed product then the CTMP scheme could be used. This was a streamlined process based on the fact that there were no quality issues with a product that had already been granted a marketing authorisation. The applicant submitted a copy of the trial protocol, provided information on the investigators and, depending on whether or not the applicant was the MAH, information on the procedures for reporting adverse drug reactions. It was only possible to use this procedure for UK marketed products. It did not apply to unauthorised products manufactured specifically for trial or to products, which were licensed only in countries other than the United Kingdom. 

Recommendations were also made to streamline the CTX Scheme for clinical trials and continue the CTN Scheme, with further assessment in the future. 

Both the EMEA and the EDA have recognised the need to streamline the drug development process in order to bring new medicines to patients more rapidly see for example FDA (2004) Critical Path Initiative . The FDA raise (FDA (2006) Critical Path Opportunities List ) a number of statistical issues that need to be resolved in order to help make the clinical trials process more efficient ... 

M. Hale, W. R. Gillespie, S. Gupta, N. Tuk, and N. Holford, Clinical trial simulation streamlining your drug development process. Appl Clin Trials 5 35 0 (1996). 

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