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Abstract
A number of decisions in the health care field rely heavily on published clinical evidence. A systematic approach to evidence development and publication planning is required to develop a portfolio of evidence that includes at minimum information on efficacy, safety, durability of effect, quality of life, and economic outcomes. The approach requires a critical assessment of available literature, identification of gaps in the literature, and a strategic plan to fill the gaps to ensure the availability of evidence demanded for clinical decisions, coverage/payment decisions and health technology assessments. The purpose of this manuscript is to offer a six-step strategic process leading to a portfolio of evidence that meets the informational needs of providers, payers, and governmental agencies concerning patient access to a therapy.
Transparency
Declaration of funding
There was no funding for development of this process and resultant paper.
Declaration of financial/other relationships
M.R.W. and M.J.W. have disclosed that they are employees and stock shareholders of Medtronic, Inc. A.M.C. has disclosed that she is the Chief Manager of Data Intelligence Consultants, LLC, a health services research organization, and is a consultant/advisor to Medtronic. Neither organization made payment to the authors to prepare this manuscript nor has there been any payment by a third party.
Some peer reviewers receive honoraria from CMRO for their review work. Peer reviewer 1 has disclosed that he/she is an employee of a communications agency and a board member of ISMPP. The other reviewers disclosed that they have no relevant financial relationships.
Acknowledgment
The authors participated in writing this manuscript; no others contributed to the preparation of this manuscript.