Life Science Leader Magazine Supplements

CRO Guide 2016

The vision of Life Science Leader is to help facilitate connections and foster collaborations in pharma and med device development to get more life-saving and life-improving therapies to market in an efficient manner. Connect, Collaborate, Contribute

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LIFESCIENCELEADER.COM THE CRO LEADERSHIP AWARDS 2016 13 Learn More at SEE MORE CLEARLY GLOBAL CLINICAL RESEARCH eHEALTH SOLUTIONS MEDICAL IMAGING & BIOMARKERS OFFERING DEEP INSIGHTS INTO KEY AREAS OF THE CLINICAL TRIAL DEVELOPMENT PROCESS. perspective into the design and opera- tional implementation of our trials. We are proponents of "supplier-enabled innovation," where we actively help our key suppliers acclimate their prod- ucts and services to work in the highly complex world of industry-sponsored trials. CROs can enhance our ability to seek and utilize patient voice to guide clinical development decision making by developing needed infrastructure and services to reach out to the right patients in an efficient manner to obtain actionable insights. Vandebelt: We haven't relied on CROs much, as we've found success in either working directly with patients or trusted patient-focused organizations/patient communities. In fact, for over a year now, we've been collaborating with patients through our own internal program. The program is a collaborative framework that allows us to incorporate investigator and patient input into our study designs, enabling us to work in partnership with patients around the globe. Schneider: While I can't comment on specific examples, the way CROs help Pfizer incorporate the patient voice is by executing clinical development plans that are more consistently incorporating the patient voice. Christine Pierre: I agree that it often comes down to clinical plans. Patients can be accessed through the relationship CROs have with sites. CROs that foster partnerships with sites, as opposed to simply performing transaction-based activities, have the opportunity to leverage that site relationship to better understand the site's perspective. This will lead to greater opportunities to provide value to sponsors. The old model of patient recruitment had pharma going to a CRO, the CRO engaging with sites, and the sites and investigators recruiting patients. How much has that model changed with the advent of social media and patient advocacy groups? Pierre: Thus far, most sites are reporting that social media has not had a meaning- ful impact on patient recruitment. Part of the reason for that is sites generally do not actively engage with patient advocacy groups. However, when the sponsor or CRO works to make that connection, the results can and have been very powerful. Patient advocacy groups are in the busi- ness of actively ensuring the patient's voice is being heard, and they can provide a unique and meaningful dialogue with the research community. Shah: That model still seems to be the predominant method of patient recruitment in the U.S., but social media is complementary and is a relatively untapped arena. Social media allows for a greater audience and also personal experiences from patient to patient that can increase the interest and credibility of studies from the patient perspective. Pairing with patient advocacy groups on CROs can play a very important role in our quest to obtain patient perspective into the design and operational implementation of our trials. B E V E R L Y H A R R I S O N Janssen

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