Clinical Trial Recruitment Process Randomized Clinical Trials. Source: Cary P Gross. Annals of Internal Medicine. July 2, Vol. 137, Number 1.

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1 Cancer Clinical Trials (CCT) Attitudes and Awareness Among Cancer Survivors Clinical trials are essential for the identification of effective therapies in modern medicine. A number of studies have found that only 4% of adults diagnosed with cancer enter a clinical trial. Source: Coalition of Cancer Cooperative Groups. Enhancing Cancer Treatment Through Improved Understanding of the Critical Components, Economics and Barriers of Cancer Clinical Trials.

2 Clinical Trial Recruitment Process Randomized Clinical Trials Source: Cary P Gross. Annals of Internal Medicine. July 2, Vol. 137, Number 1.

3 Best Practices for Patient Recruitment Use technology to facilitate the gathering and dissemination of accurate and up-to-date study information Conduct formative research to determine the best way to reach the patient population Brand a clinical trial to unify communications and help your study stand out Use research-based and highly targeted strategies to recruit hard-to-reach populations Implement a prescreening program to alleviate recruitment burden for study sites Consider retention a fundamental part of your patient enrollment efforts to ensure evaluable study participants Source: Research Practitioner, Best Practices in Patient Enrollment Volume 6, Number 1.

4 Enrolling Patients in Clinical Trials A recent poll conducted by Research!America indicates that only 6% of patients say their doctors have ever suggested they participate in a clinical trial. Another study by the Coalition of Cancer Cooperative Groups revealed that when informed about a clinical trial by their doctor, 40% of cancer patients either enrolled or tried to enroll.

5 Enrolling Patients in Clinical Trials About 81% of all clinical trials are delayed at least one to six months due to difficulties in patient enrollment, with another 5% postponed six months or more, according to CenterWatch.

6 There is no national mechanism for obtaining information about all of the clinical trials taking place, including how to become involved and the eligibility criteria for specific trials. Finding out about a specific clinical trial may be a hit-or-miss process, dependent on a patient's doctor, location, and access to informational resources rather than on appropriateness/eligibility criteria.

7 Source: Coalition for Cancer Cooperative Groups

8 Source: Coalition for Cancer Cooperative Groups

9 Source: Coalition for Cancer Cooperative Groups

10 Source: Coalition of Cancer Cooperative Groups

11 EmergingMed s Personalized Interactive Service Advocacy Groups Cancer Patient Cancer Centers Family/ Friends EmergingMed Clinical Trial Specialists: Prescreening & Referrals IRB-Approved Clinical Trial Site Physicians/ Nurses Where to find information? Internet Rx Companies 1. Match to relevant clinical trials 2. Facilitate access to matched trials Informed Consent Patient Screening and Selection States 3. Provide phonebased support and education

12 EmergingMed Facilitates Patient Recruitment 1 Patient or physician completes disease- specific profile via phone or Internet 2 Patient profile compared to structured match criteria Patient Profile Match Criteria 3 Unbias ed Match Results Patient selects trial matches & cities; and with permission 4 EmergingMed s Clinical Trial Specialists speak to every matched patient. Average 5 follow-up calls per patient. Patient calls trial site directly. Source: Courtney Hudson. EmergingMed Navigator A Personalized Service Connecting Patients & Physicians to New Therapies in Development EmergingMed. 5 Ongoing follow-up provides: Update/review patient profile Site contact details Fulfillment Referral guidance Trouble-shooting Education & referrals Outcomes tracking

13 EmergingMed s Growing Partner Network Advocacy Groups Cancer Centers States Pharmaceutical Companies Source: Courtney Hudson. EmergingMed Navigator A Personalized Service Connecting Patients & Physicians to New Therapies in Development EmergingMed.

14 Reach and Educate Patients and Physicians Increase awareness of new therapies in development and inform patients, caregivers and physicians about clinical trials Support outreach to diverse patient populations (i.e. elderly, minority, underserved) by providing access via the Web and phone Communicate with patients while remaining compliant with regulatory and privacy requirements Source: Courtney Hudson. EmergingMed Navigator A Personalized Service Connecting Patients & Physicians to New Therapies in Development EmergingMed.

15 Source: John Walsh. Alpha-1 Foundation.

16 Source: John Walsh. Alpha-1 Foundation.

17 Source: John Walsh. Alpha-1 Foundation.

18 Source: John Walsh. Alpha-1 Foundation.

19 Source: John Walsh. Alpha-1 Foundation.

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21 Problems in Clinical Trials Poorly designed trials Slow to accrue Inferior drugs No physician/patient interest Arduous bureaucracy Slow process and increases cost It s NOT the FDA; it s the drug development process!

22 One-Stop Shopping / Organized for Efficiency Sloan-Kettering: Coordinating Center Centralized Protocol Composition/Review Central data repository (electronic) Overall regulatory responsibility Protocol tools; Common data elements Standardized clinical trial contracts Uniform consulting agreements Our way or the highway

23 DOD Clinical Trials Consortium for Prostate Cancer

24 Metrics Accrual targets Reduction in average time to clinic Cross-Center collaboration is required Minimum number of trial ideas established

25 Results at 1.5 Years 27/35 ideas approval Protocols 26 protocols open 100% of initial sites are leading at least 1 trial 14 industry; 4 NCI; 9 investigator - initiated

26 Future Goals Create a sustainable financial model that supports investigator studies All prostate cancer trials come to consortium for vetting, execution Insure that all trials are: Designed appropriately Implementation is swift Experimental agents are scientifically important