Sandy Kennedy is an executive at Quintiles Transnational, where she is charged with making sure that studies testing new medicines follow federal and industry regulations and guidelines.
Kennedy’s job duties will receive much attention at public education workshops Saturday at N.C. Central University in Durham. The workshops are hosted by the Center for Information and Study of Clinical Research Participation as part of the nonprofit’s East Coast campaign to get more people, particularly more minorities, interested in participating in clinical trials.
About 25 percent of all clinical trials are run by contract research organizations such as Quintiles, but over the next few years drugmakers are expected to farm out as many as 35 percent of all trials.
North Carolina’s Research Triangle area is home to more CROs than any other place in the U.S. Quintiles, which is based in Durham, is the largest CRO in the world and a strong supporter of CISCRP. Kara Lemons, a quality assurance manager at Quintiles, will participate on one of the workshop panels.
Kennedy told Science in the Triangle why the workshops, billed as Clinical Research Education Day, are so important.
Q: How big a problem is patient recruitment for clinical trials?
A: Difficulties in recruiting enough patients to enroll in clinical trials is the main reason why trials don’t start on time and trial results are delayed.
A lot of scary stories have been published about what can go awry in clinical trials. “I don’t want to give the impression that this doesn’t happen. But the scary stories aren’t always balanced. Controls are in place to govern clinical trials.”
There isn’t one big solution to make patient recruitment easier. The workshops are aimed at providing information about who oversees and monitors clinical trials and about patients’ rights to make people more comfortable about participating in clinical trials.
Q: What do you hope people will take away from the workshops?
A: “I would love to see the clinical trial experience demystified. If they want to participate in a clinical trial, there is so much information out there.”
Multiple regulatory layers exist to ensure patients’ safety and to protect their rights and their welfare. The layers include Food and Drug Administration inspectors, independent review boards and internal auditors at clinical research companies.
I hope the workshops raise public awareness about what it means for patients to have the right of informed consent. “So many people think of informed consent as a document you sign. It’s really a process that includes a lot of dialog.”
As part of that dialog, patients should be able to ask questions – What procedures will they undergo during the trial? What is the chance of getting the experimental medicine? What are the known or potential side effects of the drug? – and receive answers.
As a patient, “you must be able to make a decision without coersion.”
Q: Two studies published in the past week raise concerns that clinical research still lacks transparency. One study found that the results of fewer than half of the clinical trials sponsored by the pharmaceutical industry are published. Another study found that the published results of clinical trials oftentimes are different from what the trial was supposed to show. Any comments?
A: I haven’t read the studies and can’t comment on them. What I can say is that Quintiles follows all the requirements of publication of clinical trials.
Q: Why do people participate in clinical trials?
A: Some people feel it’s the only way to gain access to a new treatment. Others do it to serve the greater good, to help other patients. I participated in a clinical trial because I wanted to learn what it is like to be a patient.
“Everybody is doing it for different reasons. But you have to make sure it’s right for you.”