Clinical Trial Innovation & Reform (CTIR)

iStock_000019788557_SmallWhat is the issue?

Medical device clinical trials are seen as increasingly complex, expensive, and slow. Increasingly, they are performed outside the United States. As a result, patients often have to wait longer in the United States than elsewhere for access to new medical technologies. 

What is the goal of this project?

MDIC aims to improve the efficiency and cost-effectiveness of medical device clinical trials, driving a coordinated effort to fundamentally change how medical research is conducted. Our goal is to restore the United States to a leadership role in establishing standards for clinical excellence and medical technology innovation. We want the United States to be a location of choice to conduct research for breakthrough technologies.

What makes medical device clinical trials inefficient, and what could we do to improve them?

Stakeholders in the industry, government, and patient advocacy groups have reported a variety of potential problems with the way clinical trials are conducted in the United States. These reported challenges—and their possible solutions—include:

STUDY DESIGN

Medical device clinical studies tend to be complicated. For example, case report forms—the questionnaires that study sponsors use to collect data from participating sites such as hospitals—are complex and lengthy, and they aren’t standardized from study to study, which creates opportunities for data entry error. And many clinical studies track more than one endpoint, or outcome; a study on a new treatment for heart disease might measure not only the survival rate of patients, but how many patients report feeling chest pain. Many clinical questions might be answered more efficiently through the use of alternative, innovative trial designs.

DATA COLLECTION

Researchers collect an ever-increasing amount of data. Often, a single study includes thousands of data fields. Some data is collected not because it’s needed right away, but just in case it’s useful for future research, or for answering unexpected questions from regulators. Collecting and managing data in a more targeted, thoughtful manner could save time and money on many studies.

INFRASTRUCTURE

Most medical device clinical trials have a unique build-up and tear-down—including unique detailed protocols, unique clinical study committees, and unique clinical site networks. Developing shared resources and a common platform for clinical trials could streamline many studies.

PRE- AND POST-MARKET DATA REQUIREMENTS

Medical devices are typically evaluated by asking a single question that’s tested at one point in time. The FDA and device developers are interested in exploring different models of data collection that consider data at multiple points in the development of a new product.

What is our approach?

Reform will require a sustained effort over many years and a significant investment from government, industry, and nonprofit groups. The first step is to document problems, then to define, catalog, and test possible solutions.

Currently, MDIC and its partners are working on a position paper about clinical trial reform and the importance of maintaining data quality in alternative trial designs. In 2014, project leaders are also tackling these issues:

Simplification of clinical trial designs. Many industry members believe that clinical trials are overly complex, for reasons that range from data collection practices to regulatory requirements. As a first step to addressing this concern, MDIC will gather information about whether, to what degree, and in what ways trial designs are needlessly complicated. This project may include:

  • A review of clinical trial data, including what data was collected and what data was published.
  • A catalog of alternative clinical trial designs, including designs that make innovative use of patient data registries.
  • A survey of physician societies and clinical researchers about clinical trial designs.

Reduction of barriers to early feasibility studies. Also called first-in-human studies, early feasibility studies mark the first point at which a new treatment is tested on human subjects. Early feasibility studies are a critical step in the approval process of many new medical devices. Currently, though, many of these studies are performed outside the United States. This project may include:

  • A survey to help identify barriers to conducting early feasibility studies in the United States.
  • Development of templates and best-practice guidelines to support early feasibility studies. For example, creation of a template for the applications that device developers submit to institutional review boards could help clarify the standards that a new medical device must meet in order to be approved for research involving human subjects.

Who is working on this project?

MDIC has assembled a Clinical Trial Innovation & Reform Steering Committee and working groups that consist of leaders from the industry, FDA, NIH, and academia.