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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ROUNDTABLE leaders LIFESCIENCELEADER.COM THE CRO LEADERSHIP AWARDS 2016 14 times lower than if we had used a tradi- tional site-centric model. We often talk about how we need to give the patient a seat at the table during the trial design process. Is it important to also have the CRO, the investigator, or someone from the clinical site seated at that same table? Harrison: It is very important to have all stakeholders at the table and giving input into clinical trial design. Each has its own unique perspective, and that is vital to designing R&D programs that work — both scientifically and opera- tionally — and ensuring relevant prod- ucts that deliver value for patients emerge at the end. What one stakeholder can learn from the other in the process is equally important and can help shape and improve the individual role they play. Forums enabled by technology can greatly help to bring all these parties to the same table when it's not logistically possible to literally do so. Schneider: It's absolutely essential, especially at Pfizer where we rely on successful partnerships with leading CROs. We have CRO partners who are asking for seats at the table when we are engaging patients for insight, and we encourage them to participate. There are several "tables" where we are convening with stakeholders, including in the clinic where the patients, coordinators, investigators, and others may be brought together to simulate clinical trial protocols in a clinical setting. Pierre: Thank you, Roslyn. As someone who represents the sites, I am incred- ibly encouraged when I hear comments like that. When you think about it, sites are really an extension of the patients in many ways. The sites are the only part owners used their phone to look up a healthcare condition within the last year. This is a trend we cannot ignore. Through the internet and social media, patients also have the opportunity to share their clinical research experiences with others, including a large number of potential patients. This is an opportu- nity for many more patients, previously unknown to the sites and investigators, to be informed about a clinical trial and potentially seek additional information about participating. Harrison: The prevalence of organized patient groups has played a major role in shaping the recruitment process. Patients increasingly look to their peers for advice on care options, and peer guidance can be a big influencer of patients' decisions to participate in tri- als. It's normal now for the patients to be the ones approaching researchers — both sites and industry sponsors — ver- sus the other way around. We have a great example from a project we did in 2013 of how a digital patient community, operated by a major CRO, enabled recruitment for a research study. We ran an entirely "direct to patient" noninterventional study, whereby patients who were part of the CROs-owned patient registry were invit- ed to join a study that required submis- sion of health records and a specimen for genetic testing to 23andMe. In just 18 weeks, 1,000 patients were recruited, data provision rates were very high, and the cost of conducting this study was 50 Twitter, for example, can increase the reach to the particular patient popu- lation of interest in a relatively low- cost way. Social media will continue to increase in importance for patient recruitment and is a great tool to get the right patients into the right trial. Schneider: Christine and Tina both make good points, but from the sponsor per- spective, I also see the recruitment model changing to better identify eli- gible clinical trial participants where they are rather than where we are. Engaging patient advocacy groups early and in a disciplined way is valuable in understanding and overcoming poten- tial barriers to patient recruitment and retention. Strategies may extend beyond the "traditional" to utilize the work of patient advocacy groups, social media, community leaders, and others. Vandebelt: Those are great comments. I would just add that for many conditions, sites and investigators will typically recruit patients who are already known to them. Through the use of advertising and other relevant content, new patients unknown to the site may also become aware of the study. The internet provides the opportunity for many more patients to become aware of clinical research as a care option. Research has shown that 42 percent of the world's population uses the inter- net, the average internet user spends two hours on the web via their mobile device, and 62 percent of smartphone By E. Miseta PATIENT-CENTRICITY ROUNDTABLE: SPONSORS, SITES, AND CROs MUST WORK TOGETHER TO HEAR THE PATIENT Thus far, most sites are reporting that social media has not had a meaningful impact on patient recruitment. C H R I S T I N E P I E R R E Society of Clinical Research Sites (SCRS)

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