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 16 systems may be engaged in a more holistic, coordinated fashion to help identify the most appropriate patients for specific trials. This approach helps ensure that patients and their healthcare teams are better prepared to consider a clinical trial as an option. Harrison: "Collectively" is the key word here. No one party can address this problem on its own; we all have to work together collaboratively. Patients themselves can help too, to spread the word to their peers, and industry, sites, and CROs can help enable this. Within Janssen, we are currently investing in a comprehensive program that will greatly enhance the accessibility of information about our sponsored trials and expect the program to go live by the end of the year. Janssen also participates actively in TransCelerate, CTTI (Clinical Trials Transformation Initiative), and other multistakeholder and industrywide forums that seek collaborative solutions to the problem of low trial participation rates. Pierre: I agree that "collectively" is the key word. For years we have conducted surveys and attempted to document the reasons why the general public does not participate in clinical trials. It is now incumbent upon us as a collective industry to tackle these very difficult and far-reaching issues. Awareness, knowledge, and accessibility all need to be addressed with the general public to change the perception of trials and the entire industry. Lastly, respect for the patients who do participate needs to be acknowledged. Study results and the patient's own clinical data should be returned to them at the appropriate time to recognize and thank them for their critical and unselfish contribution. Those contribu- tions to the general body of scientific knowledge are what will allow us to continue to bring new treatments to patients. L screening. Providers should also be armed with an easy way to connect their patients to sites, investigators, and CROs, whether it is via handouts or an email that can be forwarded to their patients. On the media end, a patient- friendly website that details available trials with links to disease websites often frequented by savvy patients would also help increase knowledge of stud- ies and enrollment. The website should be updated frequently so the informa- tion does not become stale. Partnering with disease-based organizations that have already built patient networks can further leverage the effort to inform patients of the benefits of trials. Vandebelt: Despite the low enrollment rates, many patients who participate in a clinical trial report having a posi- tive experience. Ironically, a majority of patients don't actively discuss their trial experience. Why is that? If there are ways we can enable patients to have more meaningful conversations with their loved ones, caregivers, social net- works, and physicians, then maybe we can move the needle on raising aware- ness. That is one of the reasons Lilly is exploring ways to appropriately pro- vide patients with overall trial results or even their own clinical data to enable meaningful conversations about their participation in a way that is respectful, ethical, and informative. Schneider: There are many reasons why people may not consider a clinical trial as an option, including but not limited to the lack of awareness or preconceived notions of what the clinical trial experience might be like. These are issues in both the patient and the healthcare provider commu- nities. Improving awareness of clinical trials in patient communities may be done through advocacy groups, local community, media, and social and other channels. Primary care, specialty healthcare providers, and health of the research study team that have the privilege of actively engaging with the patient. Most sites typically conduct multiple studies and, therefore, have a unique vantage point of seeing which study designs actually work and what challenges are faced by others. At SCRS, one of our goals is to provide the site's perspective to many forward-thinking sponsors and CROs to ensure the voices of the site and the patient are being incor- porated into the trial design process. Shah: I completely agree — this is very important. That qualitative piece of information, the patient voice, allows investigators to quickly know what will and won't work in practice. In order to maximize enrollment and reduce attrition, getting the perspective of all stakeholders right up front would be very helpful. The recruitment rate for trials is still very low, and a recent report stated that 85 percent of cancer patients are still not aware that clinical trials are a treatment option. What can sponsors, CROs, sites, and investigators collectively do to make patients more aware of trials and get greater involvement in them? Shah: Great question. Getting the message about available trials to patients can be tough due to the wide variation in patient use of social media, as well as patient understanding of their medical disease and what a clinical trial offers and entails. A two-pronged approach at the level of the bedside and through the internet will allow us to reach more patients. Making providers aware of relevant clinical trials for their patients is key. This should be done in a time-efficient manner with feedback and updates to providers that refer patients for trial By E. Miseta PATIENT-CENTRICITY ROUNDTABLE: SPONSORS, SITES, AND CROs MUST WORK TOGETHER TO HEAR THE PATIENT

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