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Comment on the Proposed New and Revised PCORI Methodology Standards (2016)
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Washington, D.C. (March 25, 2014) -- The Patient-Centered Outcomes Research Institute (PCORI) Board of Governors today appointed 10 people as members of PCORI's new Advisory Panel on Clinical Trials. It is one of two new advisory panels whose members the Board approved at its meeting today; the other focuses on rare disease.
Members of the Advisory Panel on Clinical Trials will support PCORI's staff, Board, and Methodology Committee by providing expertise on the design and implementation of randomized controlled trials. Topics warranting their input include selection of appropriate patient-centered outcomes, informed consent of study participants, periodic evaluations of PCORI's clinical trial portfolio, and the readiness of trial results for dissemination.
Given the breadth of specialized and technical issues involved in conducting randomized controlled trials, the chairs of the panel and the Methodology Committee may work together to appoint Advisory Subcommittees as needed to address particular technical issues or specific trials. More details about panelists’ and potential subcommittees' responsibilities and activities can be found in the panel's charter.
"Randomized controlled trials, an important component of comparative clinical effectiveness research, must be conducted using appropriate designs and methodologies to yield reliable and useful results," said Bryan Luce, PhD, MBA, PCORI's Chief Science Officer. "We'll benefit greatly from the expert insights of this panel, whose members will work in concert with our Methodology Committee members to ensure that the research we fund adheres to good design and methods."
The new panelists bring together a range of perspectives. More than half are biostatisticians, epidemiologists, or others with technical expertise in conducting clinical trials. Two others represent patients, patient advocates, or family caregivers and another is an expert in the ethical aspects of such studies. A list of panelists, with brief biographies and conflict of interest disclosures, is available on PCORI's website.
The panelists and four alternates were selected from 231 applicants. PCORI staff thoroughly evaluated each candidate's personal expertise, experience and qualifications in the area of clinical trials as well as their ability to contribute to the panel’s advisory tasks and responsibilities. More information about the process is available on PCORI’s website.
PCORI's authorizing legislation allows it to appoint permanent or ad hoc advisory panels to assist it in identifying research priorities and establishing its research agenda and specifically called on the institute to establish an expert panel on clinical trial. Although not policy-making groups, advisory panels' advice and recommendations inform the work and decisions of PCORI's staff, Board and Methodology Committee.
The panel members have been notified of their appointment to the panel and are expected to respond to their invitations today. If needed, alternate members will be selected from the list also approved by the Board today. The Advisory Panel on Clinical Trials will convene for its first meeting on Thursday, May 1, in Washington, D.C.
The Patient-Centered Outcomes Research Institute (PCORI) is an independent, non-profit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers and clinicians with the evidence-based information needed to make better-informed health care decisions. PCORI is committed to continuously seeking input from a broad range of stakeholders to guide its work.
The Patient-Centered Outcomes Research Institute (PCORI) is the nation’s leading funder of patient-centered comparative clinical effectiveness research (CER). By comparing two or more health or healthcare approaches, CER generates evidence that helps people make better-informed decisions and improves healthcare delivery and outcomes. PCORI takes a holistic approach to its work, ensuring that patients and other health decision makers are engaged as partners throughout the research process, supporting dissemination and implementation of results in practice and strengthening clinical research infrastructure to advance patient-centered CER. PCORI is an independent, non-profit organization authorized by Congress.