Featured Research

from universities, journals, and other organizations

Clinical trials can be improved by managing the learning curve

Date:
July 30, 2010
Source:
Duke University Medical Center
Summary:
Researchers have looked for a learning curve phenomenon in the data record of a large, multi-site clinical trial. Their findings point to ways to improve the quality of future trials through better training and simulation exercises.

Practitioners of clinical medicine are familiar with learning curves, and strategies like simulation are increasingly used to minimize learning-curve effects on clinical care. Because similar learning curves have been hinted at in some clinical trials, researchers at Duke University Medical Center studied the phenomenon in the data record of a large, multi-site clinical trial. Their findings point to ways to improve the quality of future trials through better training and simulation exercises.

The team found that research conducted by investigators in the large VALsartan In Acute myocardial iNfarcTion (VALIANT) trial progressed in a way consistent with a learning curve. This trial compared long-term treatment of 12,367 patients at 931 sites with the drugs valsartan, captopril or both in high-risk patients after a heart attack (myocardial infarction).

Duke researchers found that departures from the trial protocol were more common for earlier-enrolled patients at the study sites. Departures were defined both as violations, or failure to comply with the final study protocol, and as deviations, instances of non-compliance resulting from unforeseen circumstances.

Queries -- questions about data generated in the study- were also significantly more common for patients enrolled earlier in the trial.

Protocol departures were more common at sites with less frequent enrollment -- for example, two or fewer enrollees per month -- compared to six or more subjects per month.

"We embarked on this evaluation to begin to unravel how to further improve clinical trials," said Jeffrey Taekman, M.D., co-lead author and assistant professor in the Department of Anesthesiology at Duke, and director of the Duke University Human Simulation and Patient Safety Center. "We will take these findings and incorporate them into simulation programs for study sponsors. Through a careful 'walk-through' of a study protocol we can catch and address issues prior to first subject enrollment in a trial. With the use of simulation, just like sports team members, each of the research team members will be able to practice the protocol without involving subjects. Ultimately, we hope to further improve trials through the data obtained in our research studies. "

The study was published in the Quality and Safety in Health Care journal online on July 30.

Co-lead author Mark Stafford-Smith, M.D., a Duke professor of anesthesiology, said that clinical trials that adhere to effective protocols from the very start are beneficial. "In a previous study of critically ill patients, researchers made observations suggesting a benefit for a drug, but the study didn't yield a positive finding, possibly because a learning curve affected early trial data," Stafford-Smith said.

Taekman described the two basic categories of problems with clinical trial protocols -- problems in educating or training people to run the trial effectively and human-factor problems.

Stafford-Smith said that in one instance a company that was having challenges investigating a new agent came to the Duke Human Simulation and Patient Safety Center to learn how to better conduct a clinical trial. "There was a sense that the drug wasn't working because it was tricky to learn how to use," Stafford-Smith said. A pilot simulation demonstrated potential value as a method for learning how to perform more efficiently during a clinical trial. The company was so impressed that it promptly invested in such training for further investigations of its drug, he said.

"While preparing simulations for the agent, we also uncovered human-factor concerns in the protocols -- issues that made the trial more difficult to conduct," Stafford-Smith said. "The protocols were elegant on paper but flawed in practice -- that is the human- factor error in a trial." Examples of human-factor problems in trials might be blood tests on patients that are poorly timed to show drug effectiveness, or instructions that are worded ambiguously, making the protocols hard to follow.

The team is now developing metrics to compare the effectiveness of different interventions to improve trial conduct. "Ultimately, we are interested in how our human factor and immersive education methods can impact the quality of a clinical trial," Taekman said. "Future studies may involve evaluating the best ways for trial coordinators and staff to learn, including the use of virtual environments."

Robert Califf, M.D., Duke vice chancellor for clinical research, member of the Duke Heart Center and professor of medicine in the Division of Cardiology at Duke, was senior author. Other authors include Melanie C. Wright, Barbara Phillips-Bute, and chairman Mark F. Newman of the Duke Department of Anesthesiology; Eric J. Velazquez, Mary Ann Sellers, Karen S. Pieper and Jeff Leimberger of the Duke Clinical Research Institute; Marc A . Pfeffer of the Cardiovascular Division, Brigham and Women's Hospital in Boston; Frans Van de Werf of the Department of Cardiology, University Hospital Gasthuisberg in Leuven, Belgium; and Rafael Diaz of the Instituto Cardiovascular de Rosarios in Rosario, Argentina.

This study was funded by the National Institute of Neurological Disorders, the Anesthesia Patient Safety Foundation, and the Duke Department of Anesthesiology GPRO/DCRI/Novartis Pharmaceuticals.


Story Source:

The above story is based on materials provided by Duke University Medical Center. Note: Materials may be edited for content and length.


Cite This Page:

Duke University Medical Center. "Clinical trials can be improved by managing the learning curve." ScienceDaily. ScienceDaily, 30 July 2010. <www.sciencedaily.com/releases/2010/07/100730074306.htm>.
Duke University Medical Center. (2010, July 30). Clinical trials can be improved by managing the learning curve. ScienceDaily. Retrieved September 23, 2014 from www.sciencedaily.com/releases/2010/07/100730074306.htm
Duke University Medical Center. "Clinical trials can be improved by managing the learning curve." ScienceDaily. www.sciencedaily.com/releases/2010/07/100730074306.htm (accessed September 23, 2014).

Share This



More Health & Medicine News

Tuesday, September 23, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Liberia Pleads for Help to Fight Ebola

Liberia Pleads for Help to Fight Ebola

AP (Sep. 22, 2014) Liberia's finance minister is urging the international community to quickly follow through on pledges of cash to battle Ebola. Bodies are piling up in the capital Monrovia as the nation awaits more help. (Sept. 22) Video provided by AP
Powered by NewsLook.com
Ebola Doctor Says Border Controls Critical

Ebola Doctor Says Border Controls Critical

AP (Sep. 22, 2014) A Florida doctor who helped fight the expanding Ebola outbreak in West Africa says the disease can be stopped, but only if nations quickly step up their response and make border control a priority. (Sept. 22) Video provided by AP
Powered by NewsLook.com
Global Ebola Aid Increasing But Critics Say It's Late

Global Ebola Aid Increasing But Critics Say It's Late

Newsy (Sep. 21, 2014) More than 100 tons of medical supplies were sent to West Africa on Saturday, but aid workers say the global response is still sluggish. Video provided by Newsy
Powered by NewsLook.com
Sierra Leone in Lockdown to Control Ebola

Sierra Leone in Lockdown to Control Ebola

AP (Sep. 21, 2014) Sierra Leone residents remained in lockdown on Saturday as part of a massive effort to confine millions of people to their homes in a bid to stem the biggest Ebola outbreak in history. (Sept. 20) Video provided by AP
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:

Strange & Offbeat Stories


Health & Medicine

Mind & Brain

Living & Well

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins