Investigator Initiated-Sponsored Research (IISR) State of the Industry and the Need for Global Standards and Metrics Alexander Kostek and DeeAnn Tinjum
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Objectives Understand the current state of IISR programs globally and the need for minimum standards and comprehensive programs Describe the current regulatory and legal environment for IISR programs and understand current industry led initiatives for IISR standards Explain the mission and vision for IISRA
What is IISR? Investigator Initiated Research/Studies/Trials Investigator Sponsored Research/Studies/Trials Physician Initiated Research/Studies/Trials Physician Sponsored Research/Studies/Trials Investigator Initiated Sponsored Research (IISR)
Current Global Environment Lack of clear, specific Regulatory Guidelines for IISR Varying global definitions of sponsorship Unfamiliarity with research by Investigators Inconsistencies in Industry policies Inconsistencies in Industry resources & support
Regulatory & Legal Considerations Food, Drug and Cosmetic Act International Conference Harmonization (ICH)/Good Clinical Practice (GCP) Guidelines US Department of Health & Human Services Federal Code of Regulations (CFR Section 21) OIG: Compliance Program Guidance Sunshine Act Federal Anti- Kickback Statute
Regulatory & Legal Considerations, cont. False Claims Act (FCA) Foreign Corrupt Practices Act (FCPA) European Unions Clinical Trial Directive European Medical Research Council (EMRC) of the European Science Foundation PhRMA and AdvaMed Codes
Proposal Submission Identify submission method Ensure transparency & availability to the public Provide templates and clear directions Document receipt Ensure completeness of proposal
Proposal Review Committee reviews using well defined criteria: Company Strategy Scientific Merit Patient Safety Fair Market Value (FMV) Expertise of the Investigator Scientific, Legal and Regulatory considerations Committee decision is documented Decision communicated to the submitter
Example of Review Process Research interest received Medical Affairs does initial review, application packet sent if warranted Denial Decision communicated to submitter Submitter completes standard IISR application form Team Review Conditionally Approved Submitter updates proposal Approved (and communicated to submitter) Submitter provided IISR Start Up Packet Deferred (IISR to be re-evaluated by team) Finalize Contract / Legal Review IISR authorized and research initiated
Proposal Review, cont. Provide a IISR packet Company specific Review Protocol Prior to IRB/EC submission Record comments Communicate to submitter
IISR Agreement Develop an IISR agreement template including: Compliance with laws and regulatory requirements Support provided by company & how it is provided IND or IDE submission, if applicable Registration of study Safety reporting Study progress reports from sponsor Publication expectations Intellectual Property Company rights for review prior to submissions Indemnification Term and termination
Overall Program Management Communicate with the sponsor-investigator Collect study progress reports Distribute funding and/or product Maintain study documents Ensure Safety Reporting Develop Metrics Obtain deliverables for internal review Perform close out
IISRA - Mission Statement IISRA is an independent association of professionals dedicated to promoting excellence in investigator initiated-sponsored research (IISR) programs. Our commitment is to support members through the development and implementation of educational activities, professional knowledge standards, and ethical practices.
Approximately 300 professionals Membership Pharma, biotech, device, academia, CROs, technology vendors, consultants Growing European Interest Benefits: Communication forum for consensus building Networking with global IISR professionals Tools and information Access to IISRA Position Statements and Guidelines Stay abreast of new trends/benchmarking Free to join: www.iisra.org.
Standards and Best Practices Guidance Documents Position Statements Implementation of IISRA By-Laws Pulse on Compliance/Ethics Issues Surveys and Benchmarking IISRA Activities Leadership Presence at National Organizations/Conf. Networking Job Postings (Future) 16
2011/2012 Strategic Goals Broaden Communication Among Members Advance the Value of the IISRA Org Sustain IISRA s Growth 17
Goal: Broaden Communications Increase IISR presence and community dialogue through on-line media Accomplishments IISRA group established on LinkedIn (Jan 2011) Updated www.iisra.org website (Feb 2011) Focus IISR presence at industry conferences in the USA Accomplishments (Chair/Speaker/Moderator) Center for Business Intelligence (CBI) Standards/Best Practice Webinar_Sponsor is SteepRock (Jan 2011) Collaborative Group Initiative (Mar 2011, Oct 2011) CBI IIS Conference (June 2011) ExL Pharma IIT Conf in USA (Apr 2011, Sept 2011, Apr 2012) Q1 Productions_Medical Device in USA (Sept 2011) DIA - IIS Trial Master File (TMF) Content Model (Jan 2012) ACRP Abstract and Oral Presentation (April 2012) 18
Broaden Communications, Con t Support IISRA values Accomplishments Conduct IISRA annual elections (2011; 2012) IISRA By-Laws (July 2011) Increase exposure to non-industry partners (government, academia) Future Regulatory links and training slides for Investigators Greater interface and input with FDA 19
Goal: Advance Value of IISRA Drive the creation / completion of new position statements and guidelines Accomplishments Metrics Guidance Document (Mar 2011) IISRA surveys - future guidance topics (Apr and June 2011) Ongoing committees: Industry collaboration with Cooperative Groups Polaris initiates FMV (interviews in May 2011; draft Jan 2012) Initiating four new documents 20
Advance Value of IISRA (Con t) Expand the usages / offerings through IISRA.org Future Job postings Networking Create additional value for the biopharm and device industries, and also for government / academia Future 2012 member survey Links to portals for industry grant applications 21
Goal: Sustain IISRA Growth Achieve a target membership of 500 registrations globally Accomplishment: Membership doubled from approx 180 to 300 members Increase presence in Europe, Asia/Pacific & emerging markets Accomplishments: DIA_Europe: Intro of IISRA to EU community (Mar 2011) Q1 Productions (Frankfurt, Germany) Chair/Speaker IISRA Board increased from one to four EU members Plan and execute at least two (2) IISRA general sessions 2012 annual meeting via conference attendance and webinar Build strategic partnerships (FDA, Medical Affairs) 22
Initiatives With Other Organizations National Organization s National Cancer Institute (NCI) Clinical Trials Network (CTN) Inter- National Conferences Industry Leaders Technology Vendors Industry_Posting of Grant Applic. Links Committees for Position/Guidance Docs Polaris SteepRock DIA (USA) DIA (Europe) MedNet Solutions ACRP ExL Pharma IIT CBI ISS CBI Coop Groups Q1 Prod (USA) ExL Pharma IIT (Europe) Q1 Prod 23
IISRA Board of Directors (2012-2013) Chairperson: Officers: Karen Bartels (AstraZeneca) President: Anton Ehrhardt (Sanofi) Vice President: Ran Frenkel (Clinipace_Europe) Treasurer: Nader Molavi Secretary: Patricia Westergren (MedNet) Executive Committee: Executive Director: Alex Kostek (Pfizer) Members: Dan Bromberg (Polaris) Jocelyn Ulrich (HGSI) Ornah Levine-Dolberg (Lundbeck) Jonathan Chambers (Pierre-Fabre) Ouadah Hadjebi (Editor, IST Journal) 24
IISRA Guidance Documents / Position Statements 25
Guidance Documents and Position Statements Completed Documents - Currently Available on the IISRA Website (www.iisra.org) IISRA Mission Statement Standards and Best Practices Metrics Guidelines Setting Up an IISR Program Statement on Fair Market Value Future Documents - IISRA conducted a survey at the ExL Pharma and CBI Conferences in 2011 to determine topics of interest 26
Survey Results: Desired Topics New Committee Initiatives: Fair Market Value (FMV) - Initiated Collaborative Initiative with NCI - Initiated Contract Bottlenecks Publications CTMS System for IISR Programs Sunshine Act 27
A thank you for their contributions! Cynthia Barbitsch Karen Bartels Shiferaw Kibriye Michael Montgomery Wendy Moore Matthew Silverman DeeAnn Tinjum Mary Voehl Pat Westergren