Treating drug study participants better can produce more accurate results
By Linda A. Johnson
AP Medical Writer
TRENTON, N.J. (AP) — Drugmakers are finding they can improve how drug testing is conducted— and help their own bottom lines — by giving patients a voice before testing even begins.
Pharmaceutical companies sometimes spend more than a decade trying to win approval for a new medicine, including running multiple rounds of tests on hundreds and even thousands of people. Now they are realizing that treating study participants better and listening to their concerns and insights can make the complicated process cheaper, produce results that are more accurate and help get drugs to market faster.
They’re starting to ask potential study participants how to more clearly explain the study’s purpose and what the experimental drug might do to them, and whether participation requirements are too burdensome. That can cover the amount of paperwork people have to fill out, the number of appointments needed to get the study drug, and how frequently they must undergo follow-up blood work and other testing to track their progress.
All this can help reduce costs for drugmakers and, by speeding up the testing process, give them more time to sell a drug exclusively before its patent expires and generic competition wipes out sales. It also helps drugmakers find the right patients for studies, which can be particularly difficult when testing complex drugs for rare diseases and specific subtypes of cancer.
The industry has coined a phrase for this new focus, “patient centricity,” and British drugmaker AstraZeneca recently published the first definition of it in a medical journal. The company’s drug studies now include “patient-reported outcomes” — information on how participants feel and function while taking a drug, details that regulators increasingly want to see. AstraZeneca’s also continuing to give study participants the experimental drug between the time research ends and it’s approved for sale, if they lack other treatment options.
Guy Yeoman, the company’s VP of patient centricity, recently talked with The Associated Press about the trend and his company’s efforts. The interview has been edited for length and clarity.
Q: Why do this?
A: Health care’s been paternalistic. Patients now increasingly want a voice and they want more knowledge.
Q: What was wrong with the standard way of conducting studies of experimental drugs?
A: We struggle to get enough patients enrolled in studies. A big proportion drop out and many don’t comply with the study protocol. Previously, we added more patients and (study locations) to compensate. We didn’t work with patients to understand the problems.
A couple years ago, we wanted to see what patient centricity meant to patients. So we met with European patients and caregivers and North American patients in certain disease areas. Then we engaged with online patient groups. They told us in no uncertain terms to stop focusing on what we deliver and start focusing on how we deliver. They want a relationship that is open and sustained. They want respect and compassion. They said, ‘We are not a commodity to be picked up and dropped.’ They wanted to ensure the patient and family got the experience and outcome they wanted.
Q: AstraZeneca ran a pilot program to get patient insights before finalizing the design of a study of a lupus drug you’re now testing. What did you do and what was the result?
A: We got the patient perspective on what was reasonable and what wasn’t. That produced 24 recommendations from patients, and 16 were adopted. We reduced the number of blood draws to be done during the study, to be less onerous. We reduced the time they would have to wait at the clinic after each infusion of the drug in case they have a bad reaction, because we agreed it could be safely reduced. That study is actually running ahead of schedule.
It’s not rocket science. It’s really basic, simple stuff.
Q: What other changes have you made for people participating in drug studies?
A: The consent forms were long legalese. We translated that into a simple booklet with pictures and diagrams about what happens to patients during the study. We recently launched a site with a clear two-page summary of results for patients. All future studies will have that.
Q: How will these changes benefit your company?
A: We can do studies faster and more efficiently, through quicker patient registration. The patients better understand the purpose of studies, and the study goal is meaningful for patients. They want to know how will they feel, will they be able to do more. That leads to better adherence to medication schedules. In many disease areas, patients stop taking their medicine within 12 months, so they don’t get the medicine’s benefit.
Q: Will this reduce drug prices?
A: We need to ensure there’s sufficient return on investment. I’m not promising any impact on prices.
