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The Perfect Circle


By William Claypool

Oct. 16, 2006 | Three converging factors are rapidly transforming the concept of adaptive clinical trials from the realm of "theoretically possible" to - dare I say it - "hot"? (see Real-Time Trials, Bio-IT World, June 2006) These three elements are creative statisticians, willing regulators and company managers, and enabling technology.  The dynamic driving all this interest? A huge potential for improvements in time, cost and safety.

Careful selection of the enabling technology supports and accelerates the creativity and effectiveness of the other two factors. Imaginative statisticians and a progressive FDA are increasing the opportunities to sharpen patient stratification and decision-making criteria, with the help of newer biomarkers and baselines, plus treatment-evolving genomic signals. Epidemiologic data mining can provide additional context and insight to these observations. With the right technology, the speed and quality of clinical answers will accelerate in direct proportion to the creativity of those asking the questions for future drug development.

The central technology for supporting adaptive a trial design is electronic data capture (EDC), but EDC alone is insufficient to maximize the full benefits of adaptive trials. When the right EDC system is coupled tightly with other technologies such as Interactive Voice Response (IVR) systems, just-in-time clinical supply labeling and packaging inventory control and real-time site performance assessment systems, tremendous improvements in study conduct can be expected. Combined in this way, operations and statistical staff can create studies that spare patients unnecessary exposure to experimental drugs and save sponsors significant time, money and effort.

EDC systems and the companies supporting them have matured greatly in recent years.  Most systems are reliable, scalable and, given individual tastes, user-friendly. It may sound like circular logic, but what distinguishes systems for use in adaptive trials is their "adaptability." The most compatible EDC systems provide real time data transfers to whomever the sponsor requires and allow sponsors to rapidly modify the study design.  Additionally, these systems provide highly customized, distributed and selective (e.g. fully blinded, grouped, un-blinded, partial or complete) views of the data within and outside of the company. These systems can easily segregate source verified data from unverified data as needed; acquire, catalog, and consolidate disparate data types (e.g. routine labs, digital or X-ray images, free text drawings, binary outputs such as electrocardiogram displays); and provide threaded discussion platforms for making the best decisions about the study.

Savings and Integration
Beyond traditional EDC, the study database should also incorporate all the elements of the IVR system. This allows a single display of all data, integrated in a manner most useful to the sponsor statistician and to the regulator or senior company manager. These IVR data may be randomization data and logistics reporting or electronic Patient Recorded Outcome data (e-PRO). By tightly coupling the EDC data with the IVR data in a single database, the reporting is quicker, and therefore, the decision-making is much more robust.

A flexible and integrated Clinical Trial Supply labeling and packaging system is also required to properly support adaptive trials. These logistics are often supported using a separate software application but they can do more than simply reduce the cost of drug supply overages. Directly interacting with the EDC/IVR system, these systems offer a just-in-time inventory approach that minimizes both on-site storage issues and concerns of expired supplies.

Integrating all of these technologies into a Clinical Trial Management framework can yield additional long-term advantages. Integration not only supports the storage and evaluation of historical data, but also benefits future study conduct by optimizing recruiting and site selection. Quality metrics extracted from this framework will allow sponsors to focus on smaller numbers of high recruiting sites and reduce the resources necessary to manage a study.

The savings derived from adaptive trials can be impressive. In the ideal trial, data arrive in near-real time and in near-perfect cleanliness. Results can be analyzed almost instantaneously, resulting in faster decisions and, ultimately, more rapid study locks, reports and submissions. The greatest savings are amassed by treating only patients who will benefit from the intervention with the optimal dose, administered for the optimal time. By refining the subjects, doses, and duration, it may be possible to even combine Phase II and Phase III studies. Significant savings also accrue from better in-study site selection adjustments based on both productivity and quality. Fewer sites to monitor and less frequent monitoring visits per site yield additional savings.  Most importantly, trials benefit by minimizing subjects' exposure to unnecessary risk and unproductive interventions.

With the most current technologies accelerating adaptive trial designs, the future holds great promise. 

William Claypool, M.D., is Chairman and CEO of Phoenix Data Systems. Email: bclaypool@pdsedc.com

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