Medical Research: Participation Issues

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2 Medical Research: Participation Issues

3 Key Points Types of medical solutions vary Various factors influence support & adoption Clinical trials are a critical, expensive piece of the approval process Threat to medical research is with basic elements: ensuring participants & securing qualified physician investigators Community based strategies are required to enable the medical research process & the adoption of new medical solutions

4 Research & Acceptance of New Medical Solutions Medical Procedures Medical Devices Drugs & Biologics Studies funded by NIH Studies funded by Sponsor Studies funded by Sponsor FDA Regulated FDA Regulated IRB Approval for Studies IRB Approval for Studies IRB Approval for Studies Utilization driven by coverage (e.g, medicare, insurance) FDA Approval for Marketing Utilization driven by sales, marketing & coverage FDA Approval for Marketing Utilization driven by sales, marketing & coverage

5 Macro Issues Regulatory: FDA approval time need it fast but safe Lack standards for testing procedures Lithotripsy, Gamma Knife late to US Political Who has the voice will votes drive Research acceptance by source

6 Macro Issues Economic: Who pays for new solutions - patient? Will Medicare raise the bar create acceptance Cultural & Structural Health delivery models Japan MD dispenses Primary physicians not involved with research on new medical solutions Public neutral to negative on medical research

7 Focus of this Presentation Cultural & Structural Primary physicians not involved with research on new medical solutions Public neutral to negative on medical research WITHOUT PHYSICIAN INVESTIGATORS AND PATIENTS WE HAVE NO DATA FOR THE FDA & THE SCIENTIFIC COMMUNITY

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10 Drug Development Process Basic Research (2-4 years) Development (3-6 years) Clinical Trials (6-8 years) FDA Review & Approval (1-2 years) Commercilization * Target ID * Target Validation * Screening * Optimization * Preclinical * Phase I * Phase II * Phase III * Submit Ne Drug Application (NDA) * Phase IV studies * Outcomes studies * $400M * NIH (Target ID) * Pharma/Biotech * $210M * Pharma/Biotech * $290M * Pharma/Biotech

11 Clinical Trial Overview Pre-Clinical: Lab & animal studies (3-4 yrs) File Investigational New Drug Application (IND) w/ FDA Phase I: Safety & dosage (1 yrs) Phase II: Effectiveness & side effects ( 2 yrs) Phase III: Verify efficacy & monitor safety (3 yrs) File New Drug Application (NDA) w/ FDA (2-3 yrs) Phase IV: Approved meds - special populations

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13 Number of FDA Approvals

14 Clinical Research Facts & Challenges 60,000 trials conducted in US annually 10,000 research centers & 33,000 investigators 50% of all study delays are due to enrollment 80% of studies must extend enrollment by 2 months 2.2 million subjects in trials in ,000 gap of subjects needed vs. enrolled <10% of eligible patient participate in trials >$500 million spent on recruitment in 2001

15 Clinical Research Facts & Challenges Expected short fall of investigators in 2005 is 15% Actual use, primary care setting is needed (FDA, etc.) Ethnic groups are underrepresented in trials - Latinos are 13% of populations - but only 3% of study participants Subjects rely mostly on their physicians to learn about studies (46%)

16 Conduction of Phase II-IV FDA Based Studies Pharma Research Centers CROs (Contract Research) SMOs (Site Mgt.) Research Centers SMOs Research Centers

17 Required Elements of Research Patients Data Raw Material of Research Study Visits & Data Collection Usable data for FDA submissions or other purposes Study Execution Investigators CRCs Research Staff Ancillary Services IRB Study Sponsor

18 Traditional Research Site Advertisement Advertisement Research Site Patient Database (1,500) Direct to Patient (Main Source) Community MDs No Access

19 Potential Solutions Develop research training for community based physicians increase participation Develop viable links between investigators and community physicians Community physicians will drive acceptance by patients where the loyalty resides Involve more ethnic groups - educate Provide a mechanism for human subject protection build trust in system involve primary care physicians

20 James Brown Effect Bangladesh Mortality United Kingdom Morbidity Canada Mobility France Quality of Life United States Feel Good

21 Hospital Mission Statement Old World Order To get our greedy little hands on the sickest insured patient people so we can do every billable thing to them known to mankind beyond the point that improves their health status.

22 Hospital Mission Statement New World Order To get our greedy little hands on the healthiest people we can so we can get as much money as possible without having to do the messy and unpleasant work of caring for sick people.

23 Canada Possibility Reality American know how British Ethics French Culture American Culture British Know how French Ethics

24 2003 Health Care Definitions Managed Care - It s the British National Health Service only it s run by Morgan Stanley. Physician Hospital Organizations Over paid specialists and high tech hospitals getting together for income preservation. County Health Care Systems Fee for service medicine meets the Department of Motor Vehicles.

25 2003 Health Care Definitions Continued Health Care Patient Service The Basil Faulty School of customer service, the customer is scum. CIGNA Call In Get No Answer Managed Care organized system of health care financing and delivery that takes the excess profits of hospitals, and drug companies and gives them to consultants.

26 Views of Death Europe death is imminent Canadians - death is inevitable Californians death is optional

27 Views of Death Rights Privileges Europe Healthcare Guns United States Guns Healthcare

28 Unicorns They re a really nice idea but they don t exist in nature.

29 Political Obstacles Not invented here syndrome Examples: Germany- Lithotripsy Phil Jackson Kidney Stone Procedure < 1969 FDA approved 1984, Brazil- Pitanguy buttock ptosis and breast reduction Russia- Radial Keratotomy begun in Japan 1940 s and 1950 s introduced from to the United States from Russia in Sweden- Gamma Knife 1967 introduced in Pittsburgh 1987.

30 Political Obstacles Not invented here syndrome Examples (continued): Australia- Helicobacter Pylori discovered as cause of gastric ulcer, delay and skepticism and ridicule before acceptance in the United States. Japan Heart Transplants the last heart transplant, carried out in 1968, led to murder charges law defined brain-death and 1999 the first legal transplant is performed. Hong Kong Doctors as Rx dispensers