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U.S. Department of Health and Human Services

Medical Devices

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WG1 - Global Cardiovascular Device Trials

Introduction

Working Group 1 was commissioned by the HBD steering committee to promote the convergence from parallel clinical trials in Japan and the U.S. toward single clinical trial protocols that advance toward global device evaluation. Successful execution of single protocol clinical trials is intended to facilitate more rapid and cost effective generation of more informative clinical data sets for pre-market, and potentially for post market, device evaluation in both the U.S. and Japan. This concept paper provides information on the WG1 mission and activities as envisioned by its members in response to the HBD steering committee’s direction and guidance to the working group.

Background

Since the U.S. and Japan are two of the largest consumers of medical devices, clinical plans that are conducted in a coordinated and simultaneous way in both countries are likely to facilitate more rapid generation of useful clinical data.

Clinical data for a single product obtained from trial sites in the U.S. and Japan may be rendered non-poolable due to various factors including differences in study design, choice of primary endpoint, controls, follow-up duration, differences in medical practice, or patient genetics or other demographics.

Convergence toward the implementation of a single prospectively designed clinical protocol has the potential to allow sponsors to conduct global clinical studies in a cost effective and least burdensome way. Similarly, a single protocol can facilitate the review of such clinical trials by government regulatory agencies. Single protocol evaluations can also provide more interpretable, and therefore more informative, data on both safety and performance of new devices. All of these features comprise the basis for the most important “mission” of single Japan-U.S. clinical protocols, e.g. to promote faster patient access to safe and effective innovative therapies.

Mission

The mission of WG1 is to improve the communication between MHLW-PMDA, FDA, academia, and industry, and to provide a forum to identify, discuss, and develop solutions to barriers to single protocol clinical trials in the U.S. and Japan, in order to facilitate the timely and more cost effective global introduction of new device technologies. The scope of WG1 is to encourage convergence toward the design of prospective clinical trial plans for single U.S.-Japan protocols and to identify proof of concept programs that execute steps along the path of such convergence. Such programs must not abrogate current regulations of MHLW-PMDA and FDA, and should be aimed to improve the efficiency of device approval decisions in both countries.

Specific Aims

The specific aims are:

  1. To clearly define what a single prospective clinical plan constitutes;
  2. To identify roadblocks to combined clinical plans whether they constitute one single trial or parallel simultaneous studies;
  3. To find solutions for the problems identified;
  4. To identify proof-of-concept protocols and define how they are initiated and how they are earmarked;
  5. To illustrate convergence goals through proof-of-concept projects and WG1 meetings;
  6. To report findings to the HBD steering committee, other HBD working groups and all stakeholders;
  7. To identify overlaps/key interactions with HBD WG 2-4;
  8. To promote educational programs that supports the above.

Deliverables

The expected deliverables include:

  1. Definition of what a single clinical plan constitutes;
  2. Summary of barriers that may be encountered when conducting a U.S.-Japan study, including regulatory, academic and industry perspectives;
  3. Identify other unique risks for industry in conducting a U.S.-Japan endeavor;
  4. Propose solutions (recommendations, suggestions, or points-to-consider) to the problems identified in b) and c);
  5. Reports (identification and summary of proof-of-concept studies);
  6. Follow-up on implementation of the proposed solutions;
  7. Educational programs in support of these deliverables.

Membership

Membership selection will consider the general principles of HBD for symmetry and balance between the U.S. and Japan, among government, academia and industry, and among all stakeholders and constituencies.

The chairmanship of WG1 will be held jointly by designated representatives chosen by the steering committee in a rotating basis as necessary.

Possible Target Areas

Possible target areas include:

  1. U.S.-Japan clinical trials already conducted (for identification of differences or issues surrounding poolability of data);
  2. Devices for which prospective U.S.-Japan parallel or single-protocol clinical trials are planned;
  3. Devices in the cardiovascular domain, but with potential to move outside of cardiovascular devices in future efforts.

Business Plan and Milestones

Business plans and milestones for 2007-2008 include:

  1. Finalize WG1 concept paper with approval from the HBD steering committee;
  2. Define key features and barriers around convergence toward prospective single clinical protocol plan;
  3. Continue to identify proof-of-concept projects and develop action plans to facilitate proof-of-concept projects;
  4. Plan and execute educational meetings or symposia in support of the above.

Summary

The mission, specific aims, deliverables, membership, possible target areas and business plan/milestones set forth above are intended to promote feasible, incremental steps toward improving the potential for global clinical studies, and in particular, a single clinical protocol acceptable to regulators and viable to industry. Consistent with the overall objectives of HBD, achieving this objective would offer substantial benefit to physicians and patients in both Japan and the U.S.