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Ethical Considerations Associated with Investigator Payments & Patient Recruitment Ginger Clasby - EVP, Business Development Promedica International Costa Mesa, CA 714-799-1617 x 25 Popular Media Headlines What the Public Hears….

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Ethical Considerations Associated with Investigator Payments & Patient Recruitment

Ginger Clasby - EVP, Business Development

Promedica International

Costa Mesa, CA

714-799-1617 x 25


Popular Media HeadlinesWhat the Public Hears…

“Drug Trials Hide Conflicts for Doctors” – NY Times, 1999

“Research for Hire: A Doctor’s Drug Studies Turn into Fraud” - NY Times, 1999

“Safety Concerns Halt Oklahoma Research” – NY Times, 2000

“Probes Targeted UCI Researcher” – LA Times, 2006


Background – Drug Development Climate1990’s Forward

  • Managed care’s strong emphasis on cost containment
  • Increased industry emphasis on new drug development (to preserve/increase revenues)
  • FDA reforms improve product review efficiencies

Background - Drug Development ClimateIndustry’s 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

Background - Drug Development ClimateInteresting 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


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
  • Finder’s fees or gifts for eligible subjects
  • Medical writing support

Median US Cost/Patient$$$$$$$$!

  • $9,800 Oncology trials
  • $9,000 CNS trials
  • $8,900 Anti-infective trials
  • $4,500 Hematology trials
  • $6,900 Endocrine trials
  • $6,500 Gastrointestinal trials

Fast Track Systems: Industry Study Cost Trends, October 2003


And SoIn 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)

Investigator ManagementFDA’s 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


FDA does not have authority to review financial agreements


Investigator ManagementSponsor’s Toolbox

  • Appropriate financial agreements
  • Formal investigator training programs
  • Study monitoring activities
  • Internal auditing program
  • Investigator termination from study

Investigator ManagementInvestigator 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


Investigator ManagementFDA 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

Investigator ManagementFDA 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

Investigator ManagementFDA 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

Investigator ManagementInvestigator 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

Investigator ManagementStudy 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

Don’t be intimidated

Address nonconformities appropriately


Investigator ManagementInternal Audits by Sponsor

  • Perform interim site audits by trained auditors uninvolved in study

Be suspicious

Expect fraud


Investigator ManagementInvestigator Termination by Sponsor

  • Terminate shipment of investigational product
  • Terminate investigator participation in study
  • Report investigator to FDA

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

21 CFR 50.25Consent 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 CFR 50.25Add’l 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

Subject Recruitment ProgramsWANTED – 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

Subject Recruitment ProgramsPrint 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

Subject Recruitment ProgramsResearch 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

IRB Review of Subject Recruitment MaterialsProhibited 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

Integrity In Corporate PracticesWhat 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