Monthly Archives: January 2018

First produced in June 1996, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (GCP) is an internationally agreed standard that ensures ethical and scientific quality in designing, recording and reporting trials that involve human subjects. The objective of the standard is to ensure thatRead more

In recent years, there has been unprecedented acceleration in the development of novel therapies in hematology, such as ex vivo hematopoietic stem cell gene therapy for severe combined immunodeficiency (SCID), AAV-mediated gene transfer for hemophilia B, and p-selectin monoclonal antibody for the prevention of pain crises in sickle cell disease. The August 2017 FDA approvalRead more

Since the mid-1990s, researchers have struggled to enroll sufficient numbers of patients in their trials for Alzheimer’s disease (AD) therapies. As a result, few new therapies have actually come to market—which is tragic for the 47 million people currently living with the disease. Three key strategies, executed in concert, may help overcome recruitment issues inRead more

An effective team is critical to the success of any clinical study. And when your product is destined for a market valued at $4-16 billion—such as the AVR (transcatheter aortic valve replacement) and TMVR (transcatheter mitral valve replacement) markets—you want to ensure a particularly strong foundation for your study. You build that foundation with yourRead more

Clinical trial sponsors and the clinical research organizations (CROs) supporting them have more clarity from the U.S. Federal Food & Drug Administration (FDA) on how to better select trial participants and design precision-based clinical trials for targeted therapies. New direction is contained in two new agency draft guidance documents recently published by the agency. TheyRead more

Unfortunately, not all oncology trials succeed. In fact, the phase success and likelihood of approval (LOA) rates for oncology are the lowest across major therapeutic areas. Although there are many reasons for these relatively poor success rates, issues determining dose, schedule, and regimen in early phase trials are among the most prominent. Why and WhereRead more

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