Thursday, May 13, 2010

Data Quality and Validity in Clinical Trials, Presubmission and Clinical Submission

During development, presubmission and clinical submission, investigational therapies and drugs are tested in a clinical setting with human subjects, providing data and assessments that must be reviewed with regulatory rigor, viewed with public confidence and assessed by pharma and FDA for safety and effectiveness. The importance of informed consent, human subject protection, data integrity and quality in clinical trials and clinical submission has been widely discussed over the last 50 years. It is well accepted that human subjects must not be needlessly exposed to risk in clinical trials that fail to yield data. There is widespread agreement among pharma and FDA that data from clinical trials and clinical submission must be of high quality.

Current processes for assuring data quality and validity were developed individually, by pharma companies, clinical investigators and FDA in response to various problems or crises rather than in a comprehensive quality management framework. Although the current system is successful, it has its flaws and is relatively expensive and time intensive. There is no consensus definition of "quality" as it applies to data from clinical trials and clinical submission. If you doubt that fact, please go to the CFR and check. Many changes pertaining to clinical practice, clinical trials and clinical submission, including the widespread use of automated systems, programming validation, computerized data entry, contract research organizations, increased multinational clinical trials, declarations, WHO and health care delivery systems affect data quality and validity.

Data quality and its validity must be managed, processed and controlled for all phases of clinical development, presubmission and clinical submission data. Approached early and with strict go/no regulatory decisions and data and quality management plans, human subjects are protected and data will be credible, consistent and concise.

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