Managing Investigator Initiated Research

Introduction

Introduction

Investigator-initiated research (IIR) is a vital aspect of the full life-cycle management of many drugs and devices, providing needed scientific and clinical information, as well as supporting the discovery of innovative uses for existing medical treatments.

However, the IIR community continues to have inconsistent industry policies and procedures and often a general lack of knowledge in setting up an IIR programme. There are also legal ambiguities surrounding safety reporting, fair market value (FMV) and the financial reporting of grants under the sunshine provisions of the Patient Protection and Affordable Care Act (PPACA).

It is therefore becoming increasingly critical for pharma, biotech and device companies to get their IIR programmes into alignment with regulatory and legal requirements.

IIR programmes can also benefit from improved processes, more meaningful measurement, and a fresh perspective on stakeholders’ roles and responsibilities.

Scope

Report Overview

Managing Investigator-Initiated Research

This comprehensive report brings together industry data, exclusive expert opinions, and a wealth of practical know-how, in one highly accessible resource.

After a thorough overview of IIR’s recent changes and challenges, the report provides actionable recommendations on every aspect of IIR, from transparent, consistent processes for registration and review of submissions; to compliant, productive sponsor-grantor communications; to clear and regular reporting of what has been achieved.

The report includes considerable input from the board members of the Investigator Initiated Sponsored Research Association (IISRA), as well as exclusive opinions from pharma and investigators.

Anyone involved with investigator-initiated research will find this report invaluable in their goal to make their IIR programmes transparent, consistent, and effective.

Highlights

Key Report Features

Puchase Reasons

Who Would Benefit From This Report?

Managers and Executives with responsibilities in:

Key Questions Answered

Key Benefits

Key quotes

“There are so many restrictions on reps now that the IIR programme is the main way to start a relationship … it’s a good relationship developer because it’s clean. We really are engaging in science. It’s a wonderful dialogue.”

– Ornah Levine-Dolberg, director, Medical Affairs, Mood & Anxiety Disorders, Lundbeck

Concern over being perceived as unduly influencing study design is strong enough that some companies are now ‘sterilising’ the grant review communications to applicants [such that] they are often reduced to a formal written communication of a yes or no grant decision. That’s a big shift from what we were seeing in this space ten to 15 years ago,”

– Anton Ehrhardt, Sanofi

“There are many legal and operational questions [small-to-midsize companies] don't know how to address, so they just make their best assumptions … It exposes both them as a pharmaceutical company and the sponsor-investigator to unnecessary risks.”

– Ran Frenkel, vice-president, International Business Development, Clinipace Worldwide

Expert Views

Table of Contents
for Managing Investigator Initiated Research

• 1. Executive summary

  2.Introduction

  2.1. Change in pharma-physician relationship

  2.2. Investigator-sponsored research

  2.3. Customers or researchers

  2.4. Investigator Initiated Sponsored Research Association

  2.5. Definitions of investigator and sponsor

  2.6. Treading a fine line

  3. Changing IIR landscape

  3.1. Multi-centre sites

  3.2. Richer IIR programmes

  3.3. IIR by therapeutic area

  3.4. Encouragement of IIR

  4.A basic IIR programme

  4.1. Legislation pertaining to IIR

  4.2. Defining the parameters

  4.3. Clarity

  4.4. Scope of the IIR programme

  4.5. The submissions process

  4.6. Certification checks

  4.7. Facilitation of ideas

  4.8. Responsibilities of sponsor and grantor

  4.9. The review process

  4.10. Review committee: members

  4.11. Review committee: criteria for evaluation

  4.12. The contracting process

  4.13. Intellectual property

  4.14. Critical components of research agreements

  4.15. START clauses

  4.16. Be as detailed as possible

  4.17. A word about safety

  4.18. Milestone management

  4.19. Fair market valuation

  4.20. How much should be paid?

  4.21. IISRA guidelines for FMV compliance

  4.22. Basic metrics

  4.23. Tracking programme performance

  4.24. Assessment of IIR programmes

  4.25. Role of the MSL in IIR

  4.26. A facilitating role

  4.27. Compliance

  4.27. Web-based tracking

  5.The future of IIR

  5.1. Academic CROs

  5.2 An uncertain future

  6.Acknowledgements

  7.Appendix

Additional Details

Publisher

FirstWord Pharma

Publisher Information

Reference

15 |

Number of Pages

74

Report Format

PDF

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