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Top 5 Items That Have Impacted Clinical Trial Research Technology

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  • 06 Aug
Internet: From telephone-based dial-up to cable modems to DSL to FIOS to T1 lines, the speed in which we access other computers and applications has changed the world. The Internet has changed the way we communicate, shop, play games, and access information (remember phone books?). Perhaps the largest impact to clinical trial research technology (we are now able to share data instantly); the Internet allows us to clean, review and make critical decisions earlier in the process, therefore improving clinical research. Standards: I never met anyone who thought standards were a bad idea. When zip codes were introduced in 1963, mail delivery times decreased. When CDISC CDASH standards were introduced in 2008, build time for CRFs decreased. Standards have streamlined the way we setup databases, move data around, and submit data to the FDA.
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Performance Metrics Dashboard

Operational Metrics in Clinical Trials, Part 2

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  • 04 Aug
Metrics defined by the Metrics Champion Consortium (MCC), a group of experts in clinical research, define how to measure the performance of our clinical trials and makes it easy to see where we are, and where we need to be in our study. Since the metrics are the same for all clinical studies, we are comparing apples to apples. We can see the number of subjects enrolled, completed, the number of open queries and entered pages. We can see the data by study, by site, or pool site data from multiple studies. Since we are using defined metrics, we know that the definition for ‘average time from CRF submission to verification’ is: Sum (CRF Verified Date - CRF Expected Date) / (Number of CRFs). The definitions remain consistent across different clinical studies and programs.
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FDA Logo

Ongoing Development of Imaging Biomarker Standards in Clinical Trials

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  • 29 Jul
One of the areas that I am active in is the ongoing development of standards for the qualification of imaging biomarkers. When the Prescription Drug User Fee Act (PDUFA) was renewed in 2007, the FDA agreed to develop by the end of 2011 a guidance document on “Imaging Standards for Endpoints in Clinical Trials.” Work on this is ongoing. At the recent FDA/RSNA/SNM meeting held on April 13-14, 2010 at the NIH, which I attended, Janet Woodcock M.D., Director of the Center for Drug Evaluation and Research (CDER) gave an update on the FDA’s perspective. A copy of her presentation can be downloaded here.
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PET Neurochemical Classification

The Use of Biomarkers and PET in Early Alzheimer’s Disease Diagnosis

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  • 27 Jul
Alzheimer’s disease (AD) is the most common form of dementia and is incurable, degenerative and irreversible. It affects around 4.5 million people in the United States, a number that is expected to exceed 12 million by 2050. Neuropsychological tests, such as the mini-mental state examination (MMSE), are commonly used to diagnose patients. However, cognitive impairment may be due to another disease, not Alzheimer’s. There remains an unmet need to be able to differentiate between different forms of dementia.
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