Can FDA Accelerate Clinical Trial Timelines and Completion Using Documented cGMP Processes?

October 2013

In this Policy Forum, Usala and Di Spirito argue that not requiring quality control systems in regulating clinical trials has led to submission of contradictory data to FDA, increased drug development costs and increased the timelines for Phase II study completion.  Usala and Di Spirito explain that successfully implementing quality control that resemble current Good Manufacturing Processes (cGMPs) at Physician Investigator Sites will increase site efficiency and improve the quality of data, leading to faster approval by FDA and safeguarding patient safety.  Further, the authors assert that implementing cGMP-like controls will decrease clinical trial costs by ensuring that processes are completed as intended.
 
Citing to these benefits, Usala and Di Spirito recommend that FDA provide an accelerated study review option to sponsors if clinical trial data is obtained at investigative sites using internal quality control systems demonstrated to meet FDA requirements.  The authors also recommend providing Principal Investigator (PI) Site Specific Contact Research Organization (SS-CRO) Business Associates the option to assume responsibility for operations and quality systems implementation, as these individuals have expertise in quality systems implementation that physician PIs or other medical subject experts may not.  Usala and Di Spirito conclude that implementing these proposals would increase confidence in data credibility and safety while decreasing costs, without further compulsory legislation.


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