An optimal adaptive design to address local regulations in global clinical trials.

After multi-regional clinical trials (MRCTs) have demonstrated overall significant effects, evaluation for a region-specific effect is often important. Recent guidance from regulatory authorities regarding evaluation for possible country-specific effects has led to research on statistical designs that incorporate such evaluations in MRCTs. These statistical designs are intended to use the MRCTs to address the requirements for global registration of a medicinal product.

FDA review practices and priorities for drugs used in cancer treatment.

The Federal Food, Drug, and Cosmetic Act and related regulations (21 U.S.C.

Phase I trial of orally administered pentosan polysulfate in patients with advanced cancer.

Tumor angiogenesis is critically important to tumor growth and metastasis. We have shown that pentosan polysulfate (PPS) is an effective inhibitor of heparin-binding growth factors in vitro and can effectively inhibit the establishment and growth of tumors in nude mice. Following completion of our Phase I trial of s.