Showing posts with label Pharmacogenomics. Show all posts
Showing posts with label Pharmacogenomics. Show all posts

Tuesday, April 8, 2014

Three Visuals to Explain the Impact of Pharmacogenomic and Epigenetic Biomarkers in Oncology

This post was authored by Mike Madarasz of the Institute for International Research.  You can follow him on Twitter at @MikeMadarasz

In an effort to increase efficiency and streamline development of effective cancer therapies as well hold down costs associated with conducting clinical trials, drug developers have increased their investment in clinical biomarker research.  Specifically, there has been an increase in the use of pharmagenomic (PGX) biomarkers to either select or stratify patients.  Citeline recently published a white paper outlining some of the major impacts in oncology—some of which are explained in the charts below.

The increase in oncology trials selecting or stratifying by PGBX Biomarkers
The percentage of trials in this category has more than doubled since 2002


Breakdown of countries in PGX trials
The U.S. accounts for nearly 30% of these trials with Japan being the next closest at almost 15%.


Top sponsors using PGX biomarkers to select/stratify patients
The National Cancer Institute comes out as the top sponsor both in the relative     sense and in number of PGX trials.



To check out more from Citeline, download the white paper here.

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Friday, June 12, 2009

Innovative Clinical Trial Design and Management

The pharma industry is continually exploring new ways of improving drug developments and one area of focus is adaptive clinical trial designs. These innovative designs use accumulating data to guide potential modifications to the study as it progresses, without undermining the validity and integrity of the trial. The advantages of such designs include the reduced length and cost of clinical trials, lower patient numbers and the ability to stop a trial early where a drug has not shown efficacy.

'Innovative Clinical Trial Design and Management' published by Business Insights explores the major types of adaptive design and their role in dose-finding. The report investigates seamless Phase 2/3 trials and adaptive trials in pharmacogenomics, assesses the logistical implications of adaptive trial implementations and reviews the current regulatory standpoints of the FDA and EMEA. Detailed case studies of recent adaptive clinical trials are provided and the companies offering statistical expertise in this area are profiled. This report also includes a breakdown of potential cost and time savings offered by innovative designs throughout the clinical development process.

The globalization of clinical trials has arrived. As you know, the increasing use of comparator studies means that you’re playing by a new set of rules. At this critical junction, you can either evolve in 2009 to stay ahead of the curve or choose to play catch-up and try to deal with the challenges as they arise. The Global Congress on Comparator Studies conference gives you the unique opportunity to get ahead of the industry and establish your strategy for sourcing comparators and overcoming regulatory challenges in just two days.

Send an email here to find out how you can order this report and receive a 15% discount.

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