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Mar 15, 2009 (Vol. 29, No. 6)

Maximizing Value in Outsourcing Services

Guidance on How to Do More with Less while Maintaining High Levels of Quality

  • Adaptative Trial Innovations

    Adaptive clinical trials are nothing new, but new innovations in trial design and implementation are helping to make it a more efficient and cost-saving process, according to Imogene Grimes, Ph.D., vp, data sciences strategic services, Parexel.

    “The biggest challenge is getting the clinical trial protocol right the first time,” Dr. Grimes says. “Even if the execution is perfect, it’s no good if the design is wrong. An adaptive clinical trial is one in which there is a modification in the study based upon generated information. The necessary change could be in sample size, drug dosing, randomizing, or when there is more than one study under the same protocol.

    “A traditional saying is, ‘plan your work and work your plan.’ However, when we looked at different scenarios to see how we could change adaptive trial design to make it more efficient, we found that it was possible to combine Phase II and Phase III under the same protocol.”

    According to Dr. Grimes this innovation encompasses three major aspects. “First, you can consider reusing patients in Phase II and Phase III trials. A second dimension is to determine if you can make a decision to go with 90% of the data as opposed to 100% of the data from Phase III. Third, companies should evaluate if they have an appropriate penalty scenario built into the trial design.

    “The term alpha refers to a variable describing whether a drug works or not. Of most concern is a decision that it does work, when actually it doesn’t. Typically, the FDA allows 5% for alpha. But you must spend this wisely as error will go up unless you impose safety measures. We found you can optimize this aspect by making projections about how many patients need to be enrolled, for how long, and the resulting cost. The bottom line is that it’s important to develop protocols with and without a penalty.”

    The CRO future is bright, opines Dr. Grimes. “This is an exciting time for CROs, especially because of new and amazing technologies, a change in the regulatory attitude, and because more guidance is available now than ever before. The CRO, sponsor, and regulatory agency all must share in the process of bringing a new product to the patient.”

  • Advice from the Experts

    • Do not underestimate the importance of database integration. It is critical to work closely with your CRO from the beginning on how data is captured and processed.

    • Electronic data capture provides  straightforward and easy access to site and laboratory data coming from multiple locations.

    • Often it is most advantageous to choose one CRO for data management and a different CRO for clinical development work. This could be more efficient as you will likely get better pricing and attention since the CROs to which you are outsourcing can rely on more regular workflow.

    • Having regional contacts and affiliations may expedite the process if you are outsourcing to another country, however, there is no substitute for local presence and expertise.

    • Sometimes it is possible to combine Phase II and Phase III under the same protocol.

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