Applied Clinical Trials - September 2013 - Supplement - (Page 3)

What Does the Future Hold for Clinical Monitoring? Andrew Schafer Current commercial forces are working to accelerate the adoption of adaptive monitoring designs. hen you are through changing, you are through.” So says Bruce Barton. Bruce who? Think Betty Crocker. She’s Barton’s creation. So are the enduring household reputations of Campbell Soup, Revlon, General Motors, and General Electric. Barton is among the most successful advertising executives in American history—some insist, the best. A real forward thinker for most of the 20th century. If Barton were alive today, he would be all over the results of a recent Industry Standard Research (ISR) Study* evaluating what clinical monitoring might look like in 2015. Why? We know that the biopharma industry is not what it was five years ago as financial pressures continue to mount. Second, we know that clinical monitoring can account for approximately half the costs of later stage clinical development projects, so if companies are going to cut costs, they might as well target the biggest bucket. That being said, survey results reinforced that traditional clinical monitoring will not go away. It can’t. Its scope is a critical component to help ensure squeaky clean data and utmost patient safety. Yet, according to study results, if sponsors and service providers are to relieve stubborn industry-wide financial pressures and meet growing industry demands, clinical monitoring must begin to morph into more of a hybrid model—at least in the later phases of clinical trials. As one respondent aptly put it, “There is a large area of opportunity to improve how clinical trials are conducted. Hopefully the combination of new W September 2013 technologies and alternative models can help to improve monitoring and data quality.” What’s in it for sponsors and CROs? Consider these study results a wake-up call to action. The report details the overall awareness, interest, and likelihood that alternative models would be adopted for clinical monitoring; it exposes the barriers to adopting these models; it outlines appropriate phases of development for the various mix of monitoring models; analyzes the best pricing models for this highly outsourced activity; and broadens the industry’s understanding of how the clinical monitoring environment will likely change over the next few years. Merging industry forces lead to change While the biopharmaceutical industry can be slow to change, current commercial forces are working to accelerate the adoption of adaptive monitoring designs. These forces (a struggling economy, lack of novel drugs in the pipeline, mega mergers, sub-par financial performance, and the patent cliff) will impact clinical monitoring, just as it has impacted other facets of biopharma. Many companies saw the handwriting on the wall early on. In the late 1990s, Novella Clinical began to test new monitoring models, utilizing EDC for both data capture and remote review. Today, Novella utilizes a combination of onsite and centralized monitoring to effectively monitor clinical studies. On-site monitoring allows monitors to assess study documentation, appliedclinicaltrialsonline.com APPLIED CLINICAL TRIALS 3  http://www.appliedclinicaltrialsonline.com

Table of Contents for the Digital Edition of Applied Clinical Trials - September 2013 - Supplement

Applied Clinical Trials - September 2013 - Supplement
Contents
What Does the Future Hold for Clinical Monitoring?
Risk-Based Monitoring: A Primer for Small to Mid-Size Sponsors
Targeting Source Document Verification
Triggered Monitoring
Overcoming the Concerns Associated with Risk-Based Monitoring

Applied Clinical Trials - September 2013 - Supplement

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