Life Science Leader Magazine Supplements

CRO Supplement 2015

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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Page 13 of 51

THE CRO LEADERSHIP AWARDS 2015 LIFESCIENCELEADER.COM 14 ROUNDTABLE leaders great care when selecting the technology used and manage the programming and validation very well so that you can with- stand the audit questions that will follow. If you are using a visual analog scale that needs to have a precise screen display, then using a Web interface will not provide the control that is needed. If your data collected has less strict requirements or only uses text displays, then it may be possible to use a vari- ety of consumer-type devices instead of a locked-down or purpose-built device. This is a brief description of the decision area that you have to be concerned about. If you have more critical and strict requirements, your time and cost will increase to match the risk of the project and importance of the data. STEEL: There are a number of factors that I think need to be considered. At a minimum, I believe any technology should be patient-friendly, applicable to the protocol, a fit for the patient popu- lation under consideration, and able to perform remote monitoring. Additionally, it should have the ability to report adverse events to a live person and customized to the country it will be used in. KIM: Well, there's mobile health and then there's mobile health. If we are talking about new ways to measure a primary endpoint using mobile tech or a wearable device — which in simple, but exciting terms is about moving a traditional end- point away from an "asking" perspective to one of "measuring" — a body of evi- dence and credible scientists will need to support this shift. While this could mean more expensive trials, it also could translate into smaller, faster trials. The challenge for a clinical trial team will be to consider how to deploy mobile health technologies for use in clinical trials without any additional challenges than it already takes to manage a study. I do rec- ommend we find a way to practice use of any new technologies before using them in an actual clinical trial, as a way to learn and create best practices. What are the most important factors that should be considered when deciding on the use of mobile health technology for a clinical study? DAVIS: As patient-centricity is now seen as vital to pharmaceutical R&D success, the simplification of methods to capture and report patient data obtained dur- ing a clinical trial is critical, helping to facilitate continuous patient engagement for the duration of the study. Therefore, putting the patients and their needs at the center of each solution should be the prime consideration when deciding on the use of mobile technology in clinical studies. Giving particular consideration to the needs of the study population up front can ensure that the technology used to capture and disseminate clinical assessments is both practical and effec- tive in addressing protocol requirements, and is also engaging and convenient for study participants. BORBAS: The main factor is whether the data is being collected for the primary or secondary endpoints. This will determine how much validation and programming is needed and what type of technologies to use. For example, collecting prima- ry efficacy data that is critical to the success or failure of the analysis of the study means that you need to exercise Patient recruitment and retention has been a challenge in trials for years. What advancements do you see having the biggest impact on patients? KIM: There are several factors to consider as we strive to advance the development and implementation of clinical studies. In general, we would look to industry to improve raising awareness, increasing Web traffic, using technology, and creating patient-friendly trial designs. In addi- tion, regulations in transparency will be incredibly important to help better edu- cate potential study participants about clinical research. Embracing notions of transparency and turning it into a way to delight our volunteers has the poten- tial to empower individuals to become research advocates. We want to create a community so that those living with a disease and their loved ones not only have a support system, but have information at their fingertips so they can participate in applicable clinical trials. New technology is not necessarily the answer to fix the challenges associated with patient recruitment. Instead, industry needs to work to continue to raise awareness of clinical trial opportunities in addition to telling the story of the value of clinical trial participation in a way that resonates with patients. STEEL: As technology becomes more sophisticated, and pharmaceutical com- We are seeing an increased demand for speed and targeted enrollment of the best patients. D A V E B O R B A S The biggest breakthrough in clinical development will be the increase in patient-centric studies. A B B E S T E E L By E. Miseta TECHNOLOGY AND DATA COLLECTION: WHAT HAS THE POTENTIAL TO TRANSFORM CLINICAL TRIALS?

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