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Overcoming Patient Recruitment Issues in Clinical Trials


April 4, 2012 - New York

"Pharmaceutical companies can have more success in drug development if they recruit enough of the right patients into their clinical trials," says Dr. Jeffrey Litwin, Chief Executive Officer, ERT. More time must be spent on the inclusion and exclusion criteria, so that eligible patients are not unnecessarily excluded, he adds.

From a solution provider company at the upcoming marcus evans Evolution Summit 2012, in Wheeling, Illinois, April 30 - May 2, Litwin offers his expertise into improvingpatient recruitment, clinical trial success and innovation.

- What could improve the success rate of clinical trials?

Chief Medical Officers (CMOs) have to make sure that protocols are well written, so that the inclusion and exclusion criteriado not eliminate a large number of patients who would otherwise be eligible. Criteria are often copied from another study and new exclusion criteria for that particular drug are added. Some of the exclusions that carry over from one drug to anotherare inappropriate. What often happens is a study starts and the CMO finds that many people were excluded for an inapplicable reason. Re-writing the protocol ends up being costly and time consuming.

- What is missing in clinical development today?


Companies are not sharing their data. Many are working on similar compounds, when others have already found that they do not work. There are few publications of failed studies. Pharmaceutical companies consider this information as a competitiveadvantage, but the reality is that the industry is spending billions of dollars on drugs that have proven unsuccessful. Also, if a certain compound has failed, it does not mean that it would not succeed in a better designed study or in a different formulation. At least other scientists would have some data to work from. Large pharmaceutical companies would all benefit by sharing information on their failures as much as their successes.

- What should they focus more of their time on?

Everyone is focused on drug efficacy and labeling. Of course drug approval is based on that data, but drug safety and pharmacovigilance are important to ensure that patients have adequate information on both the benefits and risks of medications. The centralized collection of data would contribute to better safety databases.

- What could CMOs take advantage of today, to enhance or nurture innovation in this field?

They have to look at the big picture, how the drug or drug development program fits into what is currently available in the marketplace and how they can create a marketing or labeling differentiation. What innovation is the drug bringing to the marketplace?

About the Evolution Summit 2012

This unique forum will take place atthe Westin Chicago North Shore, Wheeling, Illinois, April 30 - May 2, 2012. Offering much more than any conference, exhibition or trade show, this exclusive meeting will bring together esteemed industry thought leaders and solution providers to a highly focused and interactive networking event. The Summit includes presentations on the future of drug development, developing a culture of safety and maximizing return on investment.

For more information please send an email to info@marcusevanscy.com or visit the event website at www.evolutionsummit.com/JeffreyLitwinInterview

The Pharma Network - marcus evans Summits group delivers peer-to-peer information on strategic matters, professional trends and breakthrough innovations.

LinkedIn: www.linkedin.com/groups?gid=3529112&trk=myg_ugrp_ovr
YouTube: www.youtube.com/user/MarcusEvansPharma
Twitter: www.twitter.com/meSummitsPharma
SlideShare: www.slideshare.net/MarcusEvansPharma
marcus evans group - life sciences / pharma sectorportal - http://bit.ly/HEbwqQ

Please note that the Summit is a closed business event and the number of participants strictly limited.

About ERT

ERT (www.ert.com) is a global technology-driven provider of health outcomes research services andcustomizable medical devices supporting biopharmaceutical sponsors and Contract Research Organizations (CROs) to achieve their drug development and healthcare objectives. ERT harnesses leading technology coupled with unrivaled processes and scientific expertise to collect, analyze, and report on clinical data to support the determination of health outcomes critical to the approval, labeling and reimbursement of pharmaceutical products. ERT is the acknowledged industry leader in centralized cardiac safety and respiratory efficacy services and also provides electronic Patient Reported Outcomes (ePRO) and Outcomes Assessments for multiple modalities across all phases. For more information, please visit www.ert.com.

About marcus evans Summits

marcus evans Summits are high level business forums for the world's leading decision-makers to meet, learn and discuss strategies and solutions. Held at exclusive locations around the world, these events provide attendees with a unique opportunity to individually tailor their schedules of keynote presentations, think tanks, seminars and one-on-one business meetings. For more information, please visit www.marcusevans.com.

Source: marcus evans Summits

Contact:

Sarin Kouyoumdjian-Gurunlian
Press Manager,
marcus evans Summits
Tel: +357-22-849313
Email: press@marcusevanscy.com





Copyright 2012 ACN Newswire. All rights reserved.

ACN Newswire

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