Life Science Leader Magazine Supplements

CRO Supplement 2015

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17 LIFESCIENCELEADER.COM THE CRO LEADERSHIP AWARDS 2015 ing with the local regulations that dictate rules around consenting and monitoring of that consent. The FDA just released its guidance, Use of Electronic Informed Consent in Clinical Investigations, and while this should help normalize per- spectives on this subject, there are many countries where research takes place and the industry has to be careful to stay within the regulations of every country. eConsent providers can consider redi- recting marketing resources in order to generate high-quality legal opinions that help the industry better understand these implications around the world. DAVIS: Currently there are a limited number of organizations that specialize in the adoption of eConsent processing as a commercial opportunity. At present the results from the first industry pilot stud- ies are only just coming to the attention of the broader audience. Additionally, they are typically focused on the English lan- guage versions in the first instance (as any language requirements for multina- tional studies are adding complexity to the mix) and the focus is still very much on the U.S. market. However, eConsent has been gaining momentum in the last couple of years as organizations are becoming more confident in it and as people are starting to make the case for change in their own companies, and it's set to become more prevalent particularly with the recently released draft guidance on eConsent by FDA. Which mobile technologies do you believe will have the biggest impact on trials? STEEL: The trend will be toward trial-spe- cific interactive patient engagement tools. An app that reminds patients to take their study medication and about upcoming appointments, gathers data from wearable devices and provides a knowl- edge base of information regarding the study in a patient-friendly format will study. Therefore, reducing cost is more about qualifying patients and reducing the number of screen failures. The other major cost is time. With data manage- ment, the question is whether we can decrease the electronic data capture (EDC) build time and database lock time. If so, we can start sooner and faster. However, this is harder to put into prac- tice than it sounds. We have built EDC systems in six-and-a-half weeks, but doing so requires strong support from the entire project team. Are companies adopting eConsent in trials? What challenges are holding up adoption, and how can they be overcome? KIM: While I see more and more com- panies adopting eConsent, challenges still remain. A major challenge revolves around the debate between provision- ing devices versus allowing sites to BYOD. While this obviously drives cost, the ghost of EDC past comes to mind as well — many of us still remember the days when stacks of thick, heavy lap- tops accumulated at the site, each one provisioned for a separate study. At the time, cloud computing had not caught up with EDC, and so this was arguably a necessity. This may not need to be a con- straint today. Another challenge is align- impact the overall patient experience, resulting in increased retention and compliance. Patients who are supported throughout the study with meaningful engagement tools will go on to advocate to others about their positive experience, helping to improve not only retention but recruitment as well. DAVIS: The rise of electronic patient reported outcome (ePRO) tools, especially those implemented through everyday mobile technology, has transformed how CROs and sponsors approach patient engagement in clinical trials. SMS mes- saging, emails, and in-app notifications now allow sponsors to incorporate a range of reminder, educational, and motivational interventions within study protocols, where previously patients typi- cally would have been left with no support between site visits. Additionally, research sponsors are able to monitor safety, manage compliance (including visit atten- dance, medication, correct preparation for procedures, home-based actions, etc.), and more closely ensure patient retention throughout the study period. This has not only made clinical trials an easier and more useful experience for patients but has also enabled researchers to collect and process comprehensive data quickly, accurately, and reliably. KIM: While I will not comment on the specific research or products of other companies, what I can say is that Lilly is committed to transforming clinical devel- opment — for science, for innovation, and for those suffering from disease. Part of this transformation includes thinking about new ways to support patients in their successful participation, devel- oping the right medicines for unmet needs, and measuring their efficacy in ways that are meaningful to regulators, healthcare providers, payers, and, most importantly, patients. We are excited to see how aesthetically pleasing, easy-to- use technology can potentially help play a role in enhancing the way research is conducted. L Listening to the patient during drug development and partnering throughout their clinical trial experience … is now seen as vital to pharmaceutical R&D success. T I M D A V I S

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