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Ethical Considerations Associated with Investigator Payments & Patient Recruitment Ginger Clasby - EVP, Business Development Promedica International Costa.

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Presentation on theme: "Ethical Considerations Associated with Investigator Payments & Patient Recruitment Ginger Clasby - EVP, Business Development Promedica International Costa."— Presentation transcript:

1 Ethical Considerations Associated with Investigator Payments & Patient Recruitment Ginger Clasby - EVP, Business Development Promedica International Costa Mesa, CA 714-799-1617 x 25

2 Popular Media Headlines What the Public Hears… Drug Trials Hide Conflicts for Doctors – NY Times, 1999 Research for Hire: A Doctors Drug Studies Turn into Fraud - NY Times, 1999 Safety Concerns Halt Oklahoma Research – NY Times, 2000 Probes Targeted UCI Researcher – LA Times, 2006

3 Background – Drug Development Climate 1990s Forward Managed cares strong emphasis on cost containment Increased industry emphasis on new drug development (to preserve/increase revenues) FDA reforms improve product review efficiencies

4 Background - Drug Development Climate Industrys Tactical Changes Med school research inefficiencies & patient enrollment timetables at odds with industry drug development timelines Industry develops private practitioner researchers & provides significant subject enrollment incentives Subject recruitment programs become increasingly sophisticated

5 Background - Drug Development Climate Interesting Statistics Industry investment in biomedical R&D increased from 32% in 1980 to 62% in 2000* Ave. time from IND to product approval dropped from 9.2 yr (1987 -1989) to 7.2 yr (1999-2001)** Investigator grants paid by PhRMA member companies increased from $3.2 billion (1993) to $12.2 billion (projected 2005)** Currently ~ 50,000 clinical trials taking place in US** Sources: *Business Week, **Thomson CenterWatch

6 Typical Investigator Compensation Programs $$$$$$$$! Flat fee for each subject enrolled Covers cost of exams, treatments, staff time, overhead Bonuses paid for subjects enrolled within accelerated timeframe or above target numbers Finders fees or gifts for eligible subjects Medical writing support

7 Median US Cost/Patient $$$$$$$$! $9,800Oncology trials $9,000CNS trials $8,900Anti-infective trials $4,500Hematology trials $6,900Endocrine trials $6,500Gastrointestinal trials Fast Track Systems: Industry Study Cost Trends, October 2003

8 And So In the Rush to Enroll… Subject disqualification criteria may be overlooked Subjects may not be given full disclosure regarding trial objectives Subjects may not be given full disclosure regarding associated risks Subjects may be rushed to participate (without given time to think it over)

9 Investigator Management FDAs Toolbox Investigator Agreement – Form 1572 Financial Disclosure by Clinical Investigators FDA Bioresearch Monitoring Program – Clinical Sites, Sponsors, IRBs Application of sanctions in association with violative behaviors BUT - FDA does not have authority to review financial agreements

10 Investigator Management Sponsors Toolbox Appropriate financial agreements Formal investigator training programs Study monitoring activities Internal auditing program Investigator termination from study

11 Investigator Management Investigator Agreement – FDA Form 1572 Commits to conduct study in accordance with protocol, FDA regulations & IRB conditions Commits to ensure informed consent requirements are met for all subjects (including controls) Commits to ensure that IRB reviews & approves study initially & on a continuing basis Disregard to terms of agreement may be considered a criminal offense

12 Investigator Management FDA Investigator Financial Disclosure Applies to FDA-directed marketing applications only No financial arrangements where study outcome may affect investigator compensation Investigator has no proprietary interest in tested product Investigator has no significant equity interest in company Investigator has not received significant payments of other sorts

13 Investigator Management FDA Bioresearch Monitoring Program Comprehensive program of on-site inspections & data audits to monitor all aspects of conduct & reporting of FDA-regulated research Inspections typically include clinical investigators, IRBs, sponsor &/or CRO

14 Investigator Management FDA Sanctions Exclusion of questionable quality or integrity data Restriction of parties corrupting process through misconduct of malfeasance Notification to affected parties to implement corrective action

15 Investigator Management Investigator Training Programs by Sponsor Provide detailed training on protocol implementation, study-related documentation & GCP Provide periodic training throughout study based on protocol or procedural amendments Training should be documented

16 Investigator Management Study Monitoring Activities by Sponsor Perform study initiation visits Perform interim study visits at appropriate intervals Perform appropriate study data review to ID protocol deviations, data inconsistencies, unreported safety events Review IRB submissions & responses Get technical Fill in the blanks Dont be intimidated Address nonconformities appropriately

17 Investigator Management Internal Audits by Sponsor Perform interim site audits by trained auditors uninvolved in study Be suspicious Expect fraud

18 Investigator Management Investigator Termination by Sponsor Terminate shipment of investigational product Terminate investigator participation in study Report investigator to FDA

19 The Role of the IRB Responsible for subject rights & welfare May insist on documentation of GCP training Reviews/approves study protocol & consent documents Reviews/approves most subject recruitment materials Reviews periodic study progress reports Reviews serious adverse event reports

20 21 CFR 50.25 Consent Document Must Include Study involves research; explains research purpose Known risks/benefits Alternative treatments or procedures Extent to which confidentiality will be maintained Compensation & medical tx available in event of injury or illness Contact(s) to discuss study/subject rights Participation is voluntary

21 21 CFR 50.25 Addl Consent Document Language Tx may involve unforeseeable risks Anticipated circumstances when participation may be terminated w/o regard to consent Additional costs to subject for participation Consequences associated with withdrawal of consent Commitment to provide info on significant new findings during study that may affect willingness to participate Approximate # of subjects involved

22 Subject Recruitment Programs WANTED – Study Subjects NOW! Study websites Call centers Professional referrals Community outreach In-office awareness materials Direct to patient media advertising – newspaper, radio, TV, bulletin boards, posters, flyers, etc. Financial compensation

23 Subject Recruitment Programs Print Recruitment Advertising Should Include Name & address of investigator or research facility Condition under study or purpose of research Summary of criteria used to determine study eligibility Brief list of participation benefits (including cash) Time or other commitment required of participants Location of research & who to contact for further information

24 Subject Recruitment Programs Research Subject Payments Payment amount & schedule must be approved by IRB Payment amount should be reasonable – not coercive Payment schedule should accrue - not contingent on study completion

25 IRB Review of Subject Recruitment Materials Prohibited Practices Coercive language – New treatment – Free medical treatment – Make $100! Stated or implied certainty of favorable outcome Claims of safety or effectiveness Claims of equivalence/superiority to other products

26 Integrity In Corporate Practices What Industry Can Do Be thoughtful about patient eligibility criteria Be realistic with respect to enrollment timetable Provide appropriate investigator training & oversight Follow-up promptly & appropriately on complaints

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