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Quality in FDA-Regulated Clinical Research

With eager anticipation of the excellent educational content provided at the Section (and Committee) meeting events scheduled for this year's NYSBA Annual Meeting (Jan 28-Feb 2), I noted that our Health Law Section will focus on "Medical Malpractice, Quality Assurance, and Fraud: Emerging Trends" for a full day.

For a bird's eye view about Quality in FDA-Regulated Clinical Research, you might want to take a look at one of their 2007 Concept Papers.(1) One problem they put into context concerns random errors (sloppiness). They describe it as a critical destruction affecting the quality of data and it biases the data--it obscures differences between treatments and tends to undermine a showing of effectiveness or more generally of a difference between treatments. Biased data or fraudulent data is a major concern of regulators as it is designed to lead to the wrong conclusion.

The FDA inspects and performs oversight for the dual purposes of ensuring safety and welfare of trial subjects and as well the reliability and integrity of the trials and data generated from such trials now. But their role is not so static. The Concept Paper notes that clinical trials have evolved dramatically and are no longer conducted primarily at a single center-- not only are they multi-centered but multi national and trial conduct has become much more complex, both administratively and scientifically. And we need clinical trials to answer an increasing number of questions about the benefits and risks of therapies, about the best intervention to use in a given medical condition and about the best choice of therapy in a particular individual. So, FDA has undertaken the Human Subject Protection/Bioresearch Monitoring initiative (HSP/BIMO) for a comprehensive evaluation of the policy and regulatory framework informing FDA's oversight of clinical trials. It will further the goals of the Critical Path initiative.

Also of interest, see the recently issued draft FDA guidance annex(2) to a larger parent guidance document for the International Conference on Harmonization (ICH) which discusses a minimal approach and an enhanced approach regarding different aspects of pharmaceutical development and life cycle management of their products. In this document, there is of course technical industry language but throughout it as well they discuss overall approaches to pharmaceutical development for products designed to meet patients' needs and the intended product performance. Descriptions of the various approaches are condensed nicely into a comparative chart in Appendix 1. The complexity and challenges drug companies and regulators, and really all of the stakeholders involved face in this regard, are amazing.

(1) http://www.fda.gov/oc/initiatives/criticalpath/clinicalresearch.html
(2) http://www.fda.gov/cber/gdlns/ichq8pharmann.pdf

Major issues about the Quality of FDA regulated research are cited in the Concept Paper as:

-Can research and regulatory communities develop consensus definitions of "quality" of clinical data? for conduct of clinical research?
--Can clinical research achieve both high quality and efficiency?
--Can the research and regulatory communities develop a "desired state" for achieving the above?
--Can the research and regulatory communities agree on concrete actionable steps to move towards the desired state?

They point out that a wide range of elements are involved in regard to quality in research-- comprising a scientifically valid protocol, meaningful informed consent,appropriate attention to patient safety, complete and accurate recording of results, proper performance of tests and evaluations, and appropriate record verification and retention.
Once a suitable study is designed and thoroughly reviewed, assurance of quality is dependent on the behavior of the clinical investigator which is affected by training and integrity.

This process is supported by appropriate monitoring which provides a direct assessment of certain aspects of quality.

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This page contains a single entry from the blog posted on January 15, 2008 10:56 AM.

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