Projects
CMTP’s primary activities during the development phase are to design and begin implementation of clinical studies for three pilot project topics. As part of this process, CMTP will develop methods for priority setting among potential high value new technologies. Additionally, CMTP is working with several patient advocacy organizations and physician groups to explore collaborative mechanisms for priority setting.
Methods for Comparative Effectiveness Research
Overview
Development Process
CER Methods Projects
- Pragmatic Clinical Trials
- New Indications for Oncology Drugs
- Devices for Local Treatment of Chronic Wounds
- Non-invasive Imaging for Coronary Artery Disease
- Gene Expression Profile Tests for Early Stage Breast Cancer
- Methodological Recomendations for Comparative Effectiveness Research on the Treatment of Chronic Wounds
The primary vehicle for CMTP's work in CER methods is the Effectiveness Guidance Document (EGD), which provides clinical researchers and product developers with guidance on how to design clinical studies that will produce the evidence needed for decision making by the healthcare community. Payers and policymakers use EGDs as evidence standards that can be used when making reimbursement and coverage decisions. In addition, EGDs provide a research framework for researchers and funding agents in the area of promising medical technologies. While these guidance documents have no legal or binding effect on any decision maker, their influence derives from the transparency, credibility, neutrality, and technical accuracy of the development process.
Product developers, payers, clinicians, patient representatives, researchers, and other relevant experts participate directly in the development of EGDs through a multi-stakeholder workgroup process. Initially, the multi-stakeholder workgroup members participate in scoping the guidance document by identifying key issues and challenges associated with the technology and the conditions being targeted by the technology. Upon completion of a draft document, workgroup members serve as a review panel, and these drafts are posted on the CMTP website for a public comment period, with active outreach to all key organizations that may have an interest in the document. After one or more iterations, CMTP then posts the completed guidance document on the website. Read more...
Think Tanks and Symposia
CMTP convenes meetings to identify stakeholder views on particular medical technology issues, typically to lay the preliminary groundwork for the development of an Effectiveness Guidance Documents (EGD). The objective for these meetings is to convene relevant stakeholders and experts to exchange and understand all points of view about the types of evidence that should be developed to improve health care decision makers’ ability to adopt or manage medical technology effectively. Discussion is to concentrate on the current state of the evidence, with small breakout group discussions on focused items, such as the circumstances under which RCTs are necessary, the role of validated quality-of-life outcome measures, and the how improvements in the technology over the time of the trial should be dealt with.
Applied Policy Projects
CMTP engages in a range of activities related to the use of evidence in health and clinical policy decision making. These activities, from pilot projects to policy analyses, often focus on new and innovative solutions for incorporating comparative effectiveness research into policy and practice. For example, CMTP has developed a policy framework and model benefit language to help private health plans implement Coverage with Evidence Development policies, where coverage for promising, emerging technologies is provided on the condition of enrollment in a study that will generate the type of information medical directors need to make an informed coverage decision. Read more..
Priority Setting
While the numbers of emerging medical technologies that need evaluation far outweigh any organization’s available resources, CMTP aims to focus its efforts on addressing the most pressing gaps in evidence. As such, CMTP has developed an explicit internal process for identifying and prioritizing technologies for considered for our Effectiveness Guidance Documents and other research. Our topic selection process involves both internal and external/outsourced research into emerging medical technologies, drawing upon resources from horizon-scanning agencies and health technology assessment organizations, among others. A defined set of criteria are used to select topics, including considerations of disease burden, cost impact, the quality of current evidence, and a voting process among small working groups comprised of key decision-makers like payers, patients, and clinical experts to select priorities within a specific disease area. Read more...
Collaborative Research Projects
CMTP can coordinate clinical research studies on selected topics to generate useful information about the real world risks, benefits and costs of new medical technologies. We focus on a range of clinical research methods for evaluating comparative effectiveness. These include pragmatic trials (clinical trials for which the hypothesis and study design are developed specifically to answer the questions faced by decision makers), adaptive designs, clinical registries, and other study designs that aim to generate evidence to provide patients, clinicians and payers with a reasonable level of confidence in their decision making. In this role, CMTP can bring together relevant stakeholders (including patients and practicing clinicians) to help identify specific research questions, identify the most appropriate study design, coordinate vendors, clinical research organizations, and study sites, and assist with appropriate analysis and dissemination of data.
