Life Science Leader Magazine Supplements

CRO Supplement 2015

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7 LIFESCIENCELEADER.COM THE CRO LEADERSHIP AWARDS 2015 CRAIG LIPSET: I continue to monitor the proliferation of digital tools (mobile, social, and health information technol- ogy), the increasing role of the patient as a participant in healthcare, and the changes in health delivery infrastructure from retail clinics to integrated health networks. Our innovation priorities for clinical trials are anchored around data- driven and structured protocols, making studies easier for investigators, improving clinical trial participant experience, and streamlining the capture of study data. JEFF KASHER: Those are all good com- ments. I would add how effectively and consistently RBM is implemented across the industry (both within and outside the U.S.). We also have to consider the econom- ics of clinical research. Early data I have seen indicates that clinical trials reduce an institution's cost per patient and results in improved patient outcomes. Finally, wear- able devices and patient-friendly ePRO apps will have a great impact on trials and patient recruitment/retention. What are a few of the larger trends you are monitoring that could significantly impact clinical trials? FRANCES GROTE: There are a number of trends that could potentially have a major impact on how we conduct clinical trials within the next few years. A few of these are fairly widely acknowledged, such as using a risk-based approach to monitoring and fully leveraging remote data capture, while others are in earlier stages of evalu- ation or adoption. Some of the key ones in this latter group are obtaining patient input into clinical trial design, maximiz- ing site relationships with a core group of investigators, and various mechanisms to "virtualize" clinical trial conduct through the use of novel data collection modalities like wearable monitoring devices, apps, and use of EMR data. It's exciting to see our industry becoming more open to real- time innovation, but we still have lots of opportunity to move the needle farther towards innovation. What do you feel will be the larger disruptors in the conduct of clinical trials in the next five years, and will the driving force tend to be sponsors or CROs? KASHER: This ties in with the previous com- ments about the role of the patient. I believe the larger disruptions in the conduct of clinical trials in the next five years will be driven by neither sponsors nor CROs…it will be driven by the patients and research sites. Clinical research must become a "treatment option," which means patients will have a large voice in the design/fea- sibility of trials. Patients, along with their physicians, will match to the trials in which they want to participate. They will discuss the trial, sponsor, and physician on social media and in patient groups, if they are not doing so already. GROTE: In addition to the novel areas of trial conduct I mentioned above — and no doubt some we haven't even envisioned yet — one of the greatest disruptive forces our J E F F K A S H E R President, Patients Can't Wait, LLC F R A N C E S G R O T E Senior director, clinical operations vendor oversight, Biogen Idec. Innovation is a critical topic in the pharmaceutical industry. It is what will help the industry keep on top of quality issues, develop new products, speed needed medicines to patients, and bring down the cost of the entire process. However, identifying where it can best happen and then making the vision a reality is also one of the toughest challenges that sponsors face. I assembled a panel of some of the best innovative minds in the industry to discuss the trends happening in regard to innovation, and what we can expect to see change in the coming years. The panel included: C R A I G L I P S E T Head of clinical innovation, Pf zer

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