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U.S. Department of Health and Human Services

Medical Devices

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WG3 - Clinical Trials Infrastructure and Methodology


Introduction

Working Group 3 was commissioned by the Japan-US HBD steering committee to promote improvements in clinical trial infrastructure in Japan and the US. This concept paper provides information on the WG3 mission and activities as envisioned by its members in response to the HBD steering committee’s direction and guidance to the working group.

Background

The United States and Japan are the largest and second largest countries in the world in terms of the use of medical devices. In both countries, however, the absence of a well-developed clinical trial infrastructure is a major impediment to the development of medical devices. In the US, these challenges have recently been outlined in the NIH Roadmap. In Japan, MHLW has recently laid out a Five Year Clinical Trial Action Plan to address clinical trial infrastructure improvements.

The clinical trial infrastructure is complex and is made up of medical devices manufacturers (who design research); contract research organizations (CROs), site management organizations (SMOs) and academic research organizations (AROs) (who coordinate research); site investigators, clinical trial coordinators (CRCs), and institutions (who conduct research) and their institutional review boards (who oversee research); government regulators (who evaluate research findings and regulate medical devices); and the public (who serve as research subjects).

The absence of a developed clinical trial infrastructure is detrimental to the medical devices industry as it leads to increased cost, longer time-lines, and the absence of predictability in device development. It may also be detrimental to patients as it may prevent the timely availability of safe and effective medical devices. The absence of a developed clinical trial infrastructure also challenges medical device regulators by limiting the availability of robust global data to evaluate the safety and effectiveness of new medical devices in pre-market evaluation.

Mission

The mission of WG3 is to facilitate the development of a robust and effective clinical trial infrastructure in the US and Japan to support the conduct of global clinical trials to allow the timely introduction of new safe and effective medical devices into the US and Japan. WG3 will identify aspects of the clinical trial infrastructure potentially amenable to modification (improvement) through proof-of-concept projects. The scope of WG3’s potential activities include all aspects of the clinical trial infrastructure including medical device manufacturers, CROs, SMOs, and AROs, clinical trial sites, government regulators, and the public. Harmonization of the clinical trial infrastructure around the world will facilitate the rapid introduction of new safe and effective devices to patients globally.

Specific Aims

The specific aims are:

  1. To identify and share aspects of the clinical trial infrastructure in the US and Japan that will improve the timely introduction of safe and effective medical devices.
  2. To identify or develop a forum to facilitate the public sharing of best practice solutions to these challenges for all stake holders.
  3. To identify high-priority challenges for the clinical trial infrastructure that might be amenable to modification through proof-of-concept HBD projects.
  4. To identify and share new best practice solutions to these challenges through proof-of-concept HBD projects.
  5. To report findings to the HBD steering committee, other HBD working groups and all stakeholders.

Deliverables

The expected deliverables include:

  1. A summary document with an itemized, prioritized list of the aspects of the clinical trial infrastructure in the US and Japan that will improve the timely introduction of safety and effective medical devices into the US and Japan. (2007-2008)
  2. Identification and / or development of a public web based forum to share best practices that address these challenges within the clinical trial infrastructure. (2008-2009)
  3. Identify a limited number (2-3) of high priority, high potential impact challenges to the clinical trial infrastructure. (2007-2008)
  4. Develop best practice solutions to these challenges and identify or develop potential proof-of-concept projects to test these solutions. (2008-2009)

Membership

Membership in WG3 will consider the general principles of HBD for symmetry and balance between Japan and the US and among government, academia and industry. WG3 will be co-chaired by academic leadership from the US and Japan. The membership of WG3 will include representatives from the stake holders in the clinical trial infrastructure. The membership of WG3 may be modified depending on the specific focus of the WG. The current membership of WG3 is included in Appendix A.

Possible Target Areas

Possible target areas include:

  1. Site identification
  2. Site contracting
  3. Budgeting and clinical site finances
  4. Investigator training
  5. CRC identification and training
  6. Institutional review board processes
  7. Japanese academic involvement in study design
  8. Public perception of clinical trial participation
  9. Clinical trial metrics
  10. Roles and responsibilities
  11. Monitoring, auditing activities
  12. Data quality assurance
  13. Public forum for sharing of best practices and educational opportunities
  14. Public relations advertising to public of clinical trial studies
  15. Access to medical records (source documents) in clinical study

Milestones

Milestones for 2007-2008 include:

  1. Develop and finalize WG3 concept paper and seek approval from the HBD steering committee.
  2. Identify appropriate membership for WG3 to address items c, d, and e below.
  3. Develop an itemized, prioritized list of the aspects of the clinical trial infrastructure in the US and Japan that could improve the timely introduction of safety and effective medical devices into the US and Japan.
  4. Identify and begin to provide content for a public forum to share best practices related to clinical trial infrastructure in the US and Japan.
  5. Identify 2 high priorities, high potential impact aspect of the clinical trial infrastructure on which to focus proof-of-concept projects.

Updated April 15, 2008