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You are here: Home / Gerald Batist
The Urgent Need for Clinical Research Reform to Permit Faster, Less Expensive Access to New Therapies for Lethal Diseases

The Urgent Need for Clinical Research Reform to Permit Faster, Less Expensive Access to New Therapies for Lethal Diseases

October 14, 2015Written by David J Stewart, Gerald Batist, Hagop M. Kantarjian, Joan Schiller, John-Peter Bradford, Razelle Kurzrockin Articles

High costs of complying with drug development regulations slow progress and contribute to high drug prices and, hence, mounting health care costs.  If it is exorbitantly expensive to bring new therapies to approval, fewer agents can be developed with available resources, impeding the emergence of urgently needed treatments and escalating prices by limiting competition.  Excessive regulation produces numerous speed bumps on the road to drug authorization.  Although an explosion of knowledge could fuel rapid advances, progress has been slowed worldwide by inefficient regulatory and clinical research systems that limit access…

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Redefining cancer: a new paradigm for better and faster treatment innovation

Redefining cancer: a new paradigm for better and faster treatment innovation

February 23, 2014Written by David J Stewart, Gerald Batistin Articles

Common cancers may arise from several different mutations, and each causative mutation may require different treatment approaches.  There are also several mechanisms by which malignancies may become resistant to therapy, and each mechanism will also require a different therapeutic strategy.  Hence, the paradigm of devising therapies based on tumor type is suboptimal.  Each common malignancy may now be regarded as a collection of morphologically similar but molecularly distinct orphan diseases, each requiring unique approaches.  Current strategies that employ randomized clinical trials (RCTs) in unselected patients carry a high risk of misleading results.  Available data suggest that…

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