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Pressure mounts for patient access to investig­ational drugs

Sponsors rethinking compassionate use policies as FDA rules widen access to unapproved drugs

After University of California, Berkeley student Gideon Sofer finished a phase III trial of an experimental treatment for Crohn’s disease, he asked study sponsor Osiris Therapeutics for permission to receive the stem cell therapy on a compassionate use basis. His request was denied...

Advocacy groups use Internet to target patients for disease-specific recruitment

Matching services, patient databases bypass physicians

Patient recruitment is arguably one of the most difficult perennial problems facing the clinical research enterprise. For more than 15 years investigative sites have considered poor recruitment to be a top reason for study conduct delays. On any given clinical trial, half of all sites under-enroll or fail to enroll a single patient, while 30 percent of sites provide 70 percent of all evaluable subjects.

Eye On: Eisai

The mission of Eisai, a U.S. pharmaceutical subsidiary of Tokyo-based Eisai, is research-based human health care. The concepts of improving health-care benefits to patients and their families, and of regarding patients and their families as the most important participants in the health-care process, are so pre-eminent in Eisai’s stated philosophy that “hhc” (human health care) is its signature logo. Eisai is committed to discovery, development and worldwide marketing of its products,utilizing a global network of research facilities, manufacturing sites and marketing subsidiaries.

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