Notice Number: NOT-HL-12-002
Release Date: January 6, 2012
Responses Due By: Friday March 2, 2012
National Heart, Lung, and Blood Institute (NHLBI)
In December 2010 the NHLBI convened a Working Group on Value of Information (VOI) modeling to identify how VOI might help NHLBI evaluate the potential usefulness and economic impact of proposed large-scale NHLBI clinical studies (http://www.nhlbi.nih.gov/meetings/workshops/info-modeling.htm). As the NHLBI and the cardiovascular research community consider how best to allocate clinical study research efforts and funding, VOI modeling may help inform these decisions. Investigators considering large clinical studies may benefit from understanding how to use VOI in both designing and demonstrating the value of planned clinical studies to NHLBI and other potential sponsors of research.
A single clinical study may commonly cost anywhere up to tens of millions of dollars or more. Currently, the NHLBI decision-making process on whether to support large clinical studies relies on expert knowledge to assess potential impact and design of proposed clinical trials and studies. VOI modeling and analysis has the potential to supplement this expert knowledge and help NHLBI improve its ability to evaluate the scientific focus and design of proposed clinical studies and trials.
VOI analysis uses many of the measures used by cost-effectiveness analysis to identify where the largest improvements in health outcomes and (if desired) costs can be obtained by investments in research. The VOI approach has been used successfully in other countries. For example, in the UK, VOI has been used to inform and support research recommendations, as well as the cost effectiveness of screening and treatments for various diseases for The National Institute for Health and Clinical Excellence (NICE) (http://content.healthaffairs.org/content/24/1/93.full, and http://www.york.ac.uk/media/che/documents/papers/researchpapers/rp4_Pilot_study_of_value_of_information_analysis.pdf). Thus, VOI could serve as an additional tool to aid decisions made by the NHLBI for allocating funding for research within and across disease areas, and to ensure the most effective and economical study designs.
The possibility exists that multi-disciplinary VOI research centers could assist in performing similar functions for the NHLBI and for the cardiovascular research community. The NHLBI is potentially interested in the use of multiple, highly collaborative VOI research centers that would interact with clinical research centers and the NHLBI to evaluate proposed clinical studies and their design using novel VOI modeling strategies. This RFI aims to gather information on critical gaps, challenges, and potential strategies in how value of information research may be used to aid in the study design, success, and economic impact of clinical studies sponsored by the NHLBI.
Definitions: For the purpose of this initiative, Value of Information is defined as analyses that estimate the expected value of alternative studies and study designs. This approach compares and weighs the merit and outcomes of these alternative strategies to inform a more quantitative assessment, by studying what is expected with current information to the outcomes and costs that would be expected if a given study were performed. VOI analysis evaluates the extent to which new evidence might improve expected benefits by reducing the chance for error, and compares that improvement with the cost of the information (written exactly from: http://content.healthaffairs.org/content/24/1/93.full).
This RFI seeks information on critical gaps and challenges and potential approaches in the application of VOI to facilitate clinical research Members of the scientific community, scientific organizations, healthcare professionals, patient advocates, and the public are invited to respond to any, or all of the following:
To assure consideration, comments must be received by Friday March 2, 2012.
Individuals, groups, and organizations interested in commenting on how Value of Information can advance clinical studies at the NHLBI, as outlined in this RFI, may submit comments to this RFI.
Responses must be submitted emailed to: VOI@NHLBI.NIH.GOV.
For further information contact:
Dina Paltoo: firstname.lastname@example.org
Jennie Larkin: email@example.com
This Request for Information (RFI) is for planning purposes only and is not a solicitation for applications or an obligation on the part of the United States (U.S.) Government to provide support for any ideas identified in response to it. Please note that the U.S. Government will not pay for the preparation of any information submitted or for its use of that information.
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