Green Key Blog

News for the way you work

Changes Are Needed In Clinical Development To Improve Outcomes

March 14th, 2016
Martin GiblinDrug development is expensive and lengthy, averaging 10 years and $2.6 billion. Much of the time and expense is wrapped up in clinical trials which become more complex every year. At the same time, too many trials fail, creating a productivity challenge for the industry.

In a report on the 5th Annual CROWN Congress in Philadelphia earlier this year, Ed Miseta, Chief Editor of Clinical Leader, wrote that the introductory remarks, "Painted a bleak view of some of the challenges currently facing the world healthcare system, and the pharma industry as well."

Martin Giblin, VP of Data Science, Safety and Regulatory Operations for Quintiles, told the clinical leaders at the conference, that as drug therapies become more focused and targeted, clinical studies become more difficult.

"Too many of our therapies are failing in Phase 3, which is extremely expensive and wasteful," Giblin told the gathering. "Although there has been some improvement in recent years, many of those successes are targeted and narrow. So while the number of approvals is going up, the number of patients impacted by them may not be increasing.”

In his remarks as chairperson of the conference, Giblin offered several suggestions for improving the process. Focus first on the patient, identifying the right patient for the right trial in a timely way. Harvest the data the industry already has, as well as the data collected in every trial and "learn how to use that data more effectively."

Pharma companies must "become more competent with data management, including the analysis, control, and reuse of the data," said Giblin. "That will have to be a core competency in the future.”
Tags: pharma

Leave a Reply

comments powered by Disqus