Life Science Leader Magazine Supplements

CRO Supplement 2015

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THE CRO LEADERSHIP AWARDS 2015 LIFESCIENCELEADER.COM 26 TRIAL DESIGN Patient-centricity And why is the adoption of this paradigm not moving ahead at a faster pace? Wicks believes there are three primary reasons. WHY CHANGE WHAT YOU'RE DOING? "I believe the first reason is inertia," says Wicks. " When something has always been done a certain way, it is very easy for people to keep doing it the same way. I think there is also a belief that some of those internal stakeholders speak on behalf of the patients, particularly the physicians. But while physicians are clearly experts in the disease and the treatments, they are not experts in having to live with the disease. A clinician may have views on whether or not a pathway, molecule, or side-effect might be disrup- tive, but they are not going to have insight into how a woman with a job and a child in school will be able to fit weekly clinical visits for an MRI scan into her schedule." Asking executives, regulators, or scien- tists to try and understand a trial from the patient perspective might be an impossible task. However, with the digital technologies currently available, it is easier to get patients to answer those ques- tions themselves. "Imagine a cell phone he whole topic of patient centricity is really about bringing people togeth- er," says Paul Wicks, VP of Innovation for patient network PatientsLikeMe. "Although engaging patients early on in the design process is still in the early stages, listening to patients as if they were partners is going to be a significant paradigm shift for the industry." The trial design process involves answering a lot of questions, such as what should go into a trial, what should be measured, what logistical difficulties will be faced, and how many patients should be recruited. There are a lot of decision- makers involved in answering those questions, including executives, scien- tists, clinicians, and representatives from legal. Ironically, the only stakeholders who generally seem to be missing from that table are the people who are going to benefit from the medication, who will decide whether or not to take part in the study, and will then decide whether or not to stick with it. Why has pharma not gotten patients more involved in the trial design process? company trying to design a new device for young people and doing so without talking to the users," notes Wicks. "Or perhaps they just talk to the parents of the users. Parents might be able to discuss all of the features they would like to see on the device, but their opinion would be a poor proxy for the ultimate user. While that model is a nonstarter in the consumer world, in clinical trials it is simply how we have always done things." LEGAL, SAFETY, AND REGULATORY ISSUES Another reason sponsors might not interact with patients relates to legal, safety, and regulatory issues. These are definitely real issues, according to Wicks. If a patient showed up and started talk- ing about the side effects of a drug, that information would have to be reported to the drug safety department and reports would have to be filed in a timely manner. There are also issues around companies potentially paying patients to take part in surveys or sitting on advisory commit- tees. Sponsors have to be careful not to cross any lines, particularly if the drug is not yet on the market. Wicks notes there are also issues By E. Miseta WHY ARE MORE PATIENTS NOT SITTING AT YOUR DECISION TABLE? Why Are More Patients Not Sitting At Your Decision Table? E D M I S E T A Executive Editor @OutsourcedPharm Although patients are learning more about clinical research and getting more involved in clinical trials, they oftentimes are still not invited to meetings at the trial design level. This occurs, despite the fact that both sponsors and patients have valuable information that could be shared with each other. T

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