Communication is key to an effective partnership as well as to the success of a clinical development program. A CRO who works with a biotech company as an extension of that company's team will ensure the success of the collaboration. This model lends itself to consensus development.

Frequent contact is essential between the CRO and the biotech company, not only to ensure that study protocols are adhered to and targets are met, but also to help the CRO if a problem arises. A CRO must have excellent communication systems in place with its personnel (including top management) being easily accessible and engaging. It should hold regular meetings with its partners — including third-party partners such as labs — and use secure email connections to maintain contact at other times. Meetings should be reinforced with regularly scheduled reports and other written documentation that are consistently provided to all parties involved (e.g., the biotech sponsor, third-party partners, contractors, etc.). Apart from this, the maintenance of detailed documentation is necessary to comply with Good Clinical Practices (GCPs) and other regulatory agency requirements. One key component of an excellent communication system is to have an experienced project manager from the CRO become fully engaged — acting almost as an internal team member of the biotech company. This ensures an efficient, seamless integration of the clinical team into the biotech company.

The CRO should share your corporate culture and values.

Many biotech companies tend to be small. Working with a CRO who operates as a small company may result in higher quality implementation and management of clinical studies. A CRO should have a service-oriented philosophy and a determination to do whatever is necessary to achieve the sponsor's objectives.

The CRO should understand the challenges and demands that new targeted biological therapies present for clinical trials.

While new technologies have lead to significant breakthroughs at the front-end of the drug development process, the same has not happened at the drug trial stage. A recent report by FDA states, "Not enough applied scientific work has been done in creating new tools to get fundamentally better answers about how the safety and effectiveness of new products can be demonstrated, in a faster timeframe, with more certainty, and at lower costs." ⁷ To address this problem, FDA outlined in its March report a goal of developing new, publicly available scientific tools such as assays, standards, computer modeling techniques, biomarkers, and new clinical trial endpoints designed to make the drug development and testing processes more effective. A potential CRO partner should be aware of these tools and have experience collaborating with third parties who use them, as well as have experience with new trial endpoints.

It is important for the CRO partner to help the biotech company select appropriate patients for targeted therapies. This leads to an establishment of key measurable clinical endpoints and more robust trials. For example, an oncology trial should be conducted in patients whose tumors are turning on a target or in certain tumor-specific cancer patients, in which the target is driving the malignancy.

Adopting new biomarkers or surrogate endpoints for effectiveness can speed up clinical development. For example, the adoption of CD4 counts and subsequent measures of viral load as surrogate markers for anti-HIV drug approvals, allows for the rapid clinical trial program completion and approval of life-extending antiviral drugs, with time from human studies to market being a short 3.5 years versus the average of 8 to 12 years.

A biotech company will increase its efficiency in the overall trial process — saving money and time — by finding a CRO partner who is ahead of the curve in understanding some of the potential new and emerging technologies (e.g., pharmacogenomics, proteomics, computer modeling, etc.) to incorporate into biotech trials, while being cognizant of the regulatory issues related to biotechnology. Narrowing the focus of biotech clinical trials will no doubt lead to improved quality and success.

Wendy Porter is president of Endpoint Research, 2595 Skymark Avenue, Suite 210, Mississauga, Ontario, L4W 4L5, 416.626.0299, fax 416.626.2063. info@endpointresearch.com
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Susan Krivacic is founder and consultant of PBG Consulting, LLC, 3571 Far West Blvd., #76, Austin, Texas 78731, 512.795.0055, fax 512.795.2344. susan@pbgconsulting.com
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REFERENCES 1. Voisin, Emmanuelle and Schroeder, Manfred. Anticipating New Regulatory Hurdles. Applied Clinical Trials. May 2004. pg. 56.

2. Engel, Styli and King, John. Pipeline Gaps. Can Biotech Fill Them? R&D Directions. July/August 2004. pg. 42.

3. Ernst & Young's 18th Biotechnology Industry Annual Report. 2004.