Engaging Patients in Research to Increase Efficiency and Generate Real-World Data
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1 Engaging Patients in Research to Increase Efficiency and Generate Real-World Data Chris Kula-Przezwanski Partnering Director Quintiles Digital Patient Unit
2 2 THE ENVIRONMENT
3 Research Challenges 2005: PRNewswire reported that patient recruitment was the leading cause for missed timelines in clinical trial deadlines 2007: a survey by Centre Watch reported that of 25,000 studies in the USA, 90% cited patient recruitment as a reason for missing study deadlines 2009: Datamonitor reported that around 90% of clinical trials are delayed because of patient recruitment problems, and this is particularly acute in large studies such as those involving cardiovascular or central nervous system disorders 2011: PMLive reported that Industry sources believe that up to 95 per cent of the delays in completing clinical trials are caused by slow and inefficient recruitment So where do we go from here? 3
4 Clinical Trial Naïve Patients Unfamiliar with Studies, but Recognise Importance Community-based patients are unfamiliar with clinical trials Up to12% have previously participated in a study 64% not at all or a little familiar Yet studies are recognised as important to development of new medications 93% rate as very or extremely important Most patients don t participate because they are unaware of study opportunities Why Haven t You Participated in a Study? (n=75) 0% 25% 50% 75%100% Not aware of CTs Concern about investigational med Travel distance Don't want to discontinue meds Concern about placebo Visits require too much time 8% 6% 2% 2% 16% 68% 4 Source: MediGuard UK member survey, May 2011, n=150 (50 England, 50 Scotland, 50 Wales).
5 5 QUINTILES SOLUTION FOR ENGAGING PATIENTS
6 Rapid Adoption of the Internet Has Resulted in the Emergence of the Patient as a Key Stakeholder for Research Patients are increasingly seeking information on their conditions/medications A study by PEW in 2011 showed that ~60% of all patients are searching for health/medical information on-line This trend will continue to grow as: The population ages Technology continues to expand internet access (PCs, Tablets, Smartphones, Apps, The Cloud) How does this affect clinical research? Patients are empowered to influence care decisions and to participate in research without their personal physician Internet allows for rapid access to large pools of patients allows for cost-effective, bi-directional communication (information push, pull for data capture/screening) 6
7 Quintiles Has Invested in a Secure Platform and Front-end Services to Engage with Digital Patients Profiled patients who have consented to participate in research activities ~3.0 million members across the US, UK, France, Germany, Spain, Australia and Brazil 13,000+ in the France Asia Pacific next Global platform for messaging and data capture (bi-directional) 7 Proven techniques for patient outreach
8 Security Digital Patient Platform Leveraging Quintiles Technology to Deploy Private Labeled Services Fully customisable front end services (including Quintiles DPU sites) Patient relationship management tools used in more than 28 million patient interactions Nearly 2 billion data fields and 3 million clinically profiled patients MediGuard.org Custom Patient Communities API Tags Global Gift Fulfillment Survey Tool Über Query Tool Enigma Data Token Tool ClinicalResearch. com Custom Patient Programs Patient Knowledge Warehouse Admin Site/ Security Messages ( , SMS, fax) Enrollment Channels The industry s leading, privacyprotected, global environment from which to host unique patient communities and the tools and processes to operate them 8
9 Digital Patient Solutions Research enabled by going direct to patient 9 Clinical Studies Feasibility: Optimise your protocol before first patient enrolled. Recruitment: Save time and money by engaging digital patients for referral to sites. Retention: Engage with patients to boost retention and maintain relationship post study. Observational Research Real-World Outcomes: Collect observational data more efficiently. Measure burden of illness Justify market value Compare product effectiveness Validate PRO instruments Disease Management Program Design & Evaluation: Leverage patient feedback to create and continuously improve upon tailored programs. Patient Adherence: Maintain a two-way dialog with your patients to help ensure compliance and persistence. Patient Portal: Integrate PRO data with EMR to improve patient outcomes and demonstrate meaningful use to physicians and payers.
10 MediGuard Patient Survey Experience, Condition Studies Patients Patients Country Completed Screened Enrolled CNS (depression, bipolar, ADHD) 42 10,901 1,356 US,UK Metabolic (diabetes, obesity) 48 6,749 3,627 US,UK Arthritis (RA, OA, psoriatic, gout) 39 8,686 2,574 US,UK CV (AF, CHF, cholesterol, HTN) 44 9,086 2,401 US,UK Neurology (PD, AD/Dementia, epilepsy, RLS) 32 5,991 1,136 US,UK Respiratory (Asthma, COPD) 17 7,235 1,124 US,UK GI (GORD, Crohn's, UC, constipation) 20 7,723 1,348 US MS 24 3,555 2,563 US,UK Women's Health (contraception, osteoporosis, menstruation) 12 2, US,UK Infectious disease (Hep C, HIV) 12 1, US Pain 11 2, US Cancer 13 1, US Chronic Kidney Disease 7 1, US Allergies 5 1, US,UK Lupus US Dermatology (psoriasis, dermatitis, CIU) US 10 As of July 16, 2012
11 11 PARTNERSHIP EXAMPLE
12 Partnership Example American Diabetes Association s Private Labeled Site Launched in June 2012, Quintiles Digital Patient Unit partnered with American Diabetes Association to develop My Medicine Tracker to support patients with diabetes in: Tracking and printing a list of all their medications, both prescription and OTC Viewing safety information regarding side effects and contraindications Receiving alerts and updates on important safety information about medications Interacting with other members to share experiences such as tolerability issues Participating in research studies 12
13 Working Together to Further Research Options for a Partnership Around Digital Patients Potential Touchpoints Co-branding Quintiles services to support patients within the Partner catchment area MediGuard.org (medication monitoring) ClinicalResearch.com (clinical trial matching) Developing a Partner Clinical Trial Alumni Community to maintain relationship with previous clinical trial subjects Patient portal to capture PRO data and integrate with EMR to evaluate meaningful use for physicians and payers Joint clinical, observational, and disease management research programs Benefits Ongoing connectivity with patients Expansion of support services provided beyond hospital and/or physician visits Increased patient engagement and participation in research Expansion of the types of research programs possible through direct connection with patients Enhanced reputation of institution by patients 13
14 Engaging Patients in Research THANK YOU 14
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