The High Cost and Questionable Impact of 100% SDV 

It is rare for the clinical trials industry to spend time and money on a tedious and labor intensive process when it is not required by the FDA. But that’s exactly what is happening with source data verification. FDA regulations do not require study monitors to check every source data point at each and every investigative site. But a highly conservative interpretation of FDA regulations regarding data monitoring has led to 100% source data verification (SDV) becoming standard industry practice. And drug companies are reluctant to alter that practice, believing it remains the best way to ensure the validity and integrity of clinical trial data. As sponsors’ budgetary pressures intensify, the practice of 100% SDV has been criticized for wasting time and money with no evidence it improves data quality. Many have complained 100% SDV diverts attention and resources from more critical clinical trial activities. 

By Karyn Korieth

Only 7% of U.S. investigative sites deliver on promises made in their initial study feasibility assessment. In any other industry, that would be totally unacceptable. To make matters worse, in any multi-center study, sponsors report regularly that only a small proportion of investigative sites (~20%) over-enroll and 30% meet their enrollment targets. Half of all investigative sites under-enroll or fail to enroll a single patient into a clinical trial. The challenge: How to consistently identify and engage the top enrollers. Sponsors and CROs struggle with how to find those elusive high-performing sites. Many argue site performance has far more to do with protocol quality and feasibility than the characteristics of site operations; yet, sponsors and CROs, site selection consultants and commercial database providers have all pursued predictors of site success. Various approaches have yielded some insight, but still there is no magic bullet. There is wide agreement that two factors are generally reliable predictors: Past performance and site focus.

By Suz Redfearn

Eye On Genzyme

Genzyme states its mission as offering major therapeutic advances to patients affected with serious diseases. It currently employs 10,000 worldwide and generated $4.5 billion in revenues in 2009, its success attributed at least in part to its development and application of innovative life science technologies. Genzyme products are currently in use in about 100 countries. Among its novel technologies are enzyme replacement therapy, protein and antibody therapies, polymers and small molecule therapies, cellular and gene-based therapies and biomaterials. Genzyme’s role as a global leader in R&D and providing access is apparent in enzyme replacement therapy to treat rare genetic conditions known as lysosomal storage disorders (LSDs).

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