Managing Legal Risks in Structuring & Conducting Clinical Trials

September 23, 200810:15am

10th National Hotel, Boston

Tuesday, September 23, 2008 to Wednesday, September 24, 2008

Program Details:


Structuring Proper Incentives and Payments for Sites, Healthcare Professionals, and Trial Participants

Recruiting and Compensating Sites and Subjects and Evaluating Interactions With Healthcare Professionals

  • Examining the legal constraints applied to clinical site and subject recruitment and the practical difficulties that can impede clinical site and subject recruitment
  • Structuring funding to clinical sites and incentives to subjects so as to comply with legal requirements and achieve business objectives
    • what constitutes fair market value to a clinical site?
    • offering recruitment incentives to subjects
    • structuring payments to a clinical site
    • negotiating "overhead" with the PI and making payments to PIs
  • Site selection for trials
    • reimbursable expenses
    • avoiding appearance of kickbacks
    • evaluating authenticity of payments relating to overhead
  • Analyzing common forms of compensation
    • payment for participation
    • time spent in study visits
    • travel expenses
    • childcare
    • flexible clinic hours
  • Interactions with healthcare professionals
    • avoiding improper payments to physicians
    • examining relationships with Key Opinion Leaders (KOLs)
    • meeting disclosure requirements and alleviating enforcement concerns
    • factoring in applicable state legislation and a new federal bill targeting industry gifts to physicians

Conflicts of Interest as Recruitment Constraints

  • Improving conflict of interest (COI) identification, disclosure, and management
  • Ensuring full disclosure of a COI to all appropriate parties
  • Mitigating the conflict's impact on the conduct or results of the trial
    • modifying interest/commitment
    • using the "Chinese wall" strategy
  • Avoiding liability based on conflicts of interest through proper management

Emerging Trends in Informed Consent and Their Impact on Recruitment

  • Examining impact of recent guidance and proposed regulations in the informed consent realm
  • Translating complex legal obligations into understandable language covering the investigational procedure and related risks; alternatives to participation; and realistic benefits
  • Factoring vulnerable populations into the equation