Friday, April 19, 2013

Clinical Operations Teams Lack Confidence in Risk Management

Study Suggests Risk Management Approaches to Clinical Research Improve Quality, But Inexperience Makes Pharma Companies Uncomfortable

By Marc Dresner, IIR

Risk assessment and risk management approaches to clinical research have created quite a bit of buzz recently, but according to results from a forthcoming industry study, neither sponsors nor providers feel adequately prepared to execute on them.
Patty Leuchten

"There seems to be a general lack of confidence at primarily the operational level within pharma and biotech companies regarding best practices, experience and comfort level with risk management,” said Patty Leuchten, President and CEO of The Avoca Group, which conducted the study.

“This is interesting to me,” Leuchten added, “because the operations team is the very group charged with determining and assessing which risk-based approaches make the most sense.”

The study—now in its 10th year—also found that while a quarter of respondents said it was too soon to tell whether or not risk assessment and management approaches have had a positive impact, the majority of respondents reported an increase in quality; however, fewer of that same group indicated that introducing risk management had improved efficiency.

Leuchten said the lower incidence of reported efficiency improvements may be due to the effort involved in implementation.

“It is actually quite a rigorous process to come to terms, for example, on risk-sharing agreements and to do all of the analysis and assessment that is required to put together a risk management approach,” she told Inside Clinical.

In this podcast interview for Inside Clinical, Leuchten discusses the study—the results will be covered in detail at the Partnerships in Clinical Trials conference next week—as well as why so many industry consortia are cropping up in the clinical space.

Listen to the podcast!
Download the transcript!

Editor’s note: Patty Leuchten will moderate a panel of industry experts on the topic of risk management and she’ll also participate on a consortium leadership panel at the 22nd Annual Partnerships in Clinical Trials Conference running April 21-24 in Orlando.

It's not too late to register! Sign-up to attend today and mention code XP1806BLOG to save 15% of the standard rate when you register!

Marc Dresner is IIR USA’s senior editor and special communication projects lead. He is the former executive editor of Pharma Market Research Report, a confidential newsletter for market researchers in the pharmaceutical industry. He may be reached at Follow him @mdrezz.

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