Notice Number: NOT-HL-15-284

Key Dates
Release Date: November 18, 2015
Response Date: December 28, 2015

Issued by
National Heart, Lung, and Blood Institute (NHLBI)

Purpose

The purpose of this Request for Information (RFI) is to solicit public input that will be considered in developing the strategies and processes that the National Heart, Lung, and Blood Institute (NHLBI) uses to support, oversee, and administer clinical trials. The NHLBI invites comments from researchers, patient advocacy groups, patients and their healthcare providers, and others with an interest in clinical trials that NHLBI supports.

Background

The mission of the NHLBI is to provide global leadership for research, training, and education to promote the prevention and treatment of heart, lung, and blood diseases and sleep disorders with the goal of enhancing health, longevity, and quality of life. Clinical trials of various types, phases, designs, and sizes are essential to fulfilling this mission. NHLBI remains committed to supporting the full range of trials that collectively provides insights into disease processes, opens new avenues of scientific inquiry, and may inform clinical practice and shape guidelines.

Clinical trials represent a significant investment of human and material resources. When clinical trials cannot be completed, this investment and the opportunity to advance science and human health can be lost. Trials may not achieve their intended goals for a number of reasons, which may vary according to the type of disease, as well as the type and phase of clinical investigation. These reasons can include difficulty enrolling and retaining trial participants, slow site set-up, problems with product supply lines, and lack of equipoise. Some challenges are unforeseeable, but others could be anticipated and addressed in the application and review processes through an in-depth evaluation of trial feasibility and readiness to launch.

As part of its ongoing stewardship, NHLBI seeks input from the clinical trials community on ways to optimize the selection, design, planning, conduct, and management of clinical trials, including timely reporting of results, to enhance their scientific and public health impact. Changes in the research landscape and advances in technology make this a particularly opportune time to explore new strategies in this regard. In addition, there is an increasing recognition within the clinical trials community of the need to streamline and improve the management of clinical trials.

Given the importance of finding effective solutions for clinical trial oversight and management and timely dissemination of results, it will be essential to develop, in partnership with the clinical trials community, a shared understanding of the elements that are critical to the success of a clinical trial. These critical elements can then be addressed in Funding Opportunity Announcements to help guide investigators in identifying important clinical trial milestones and in developing a plan to meet those milestones in a timely manner.

Information Requested

This Request for Information (RFI) is the first in a series of solicitations of information to inform the optimization of NHLBI clinical trial enterprise. This RFI is intended to solicit input about factors that contribute to the success of clinical trials. 

The NHLBI seeks comments on any or all of the following topics:

• Characteristics of a successful clinical trial (recognizing that a clinical trial can be assessed in a variety of ways, including but not limited to advancing science and completing a trial on time and on budget).
• The best predictors of clinical trial completion.
• Types of information applicants should be encouraged to include in their application to demonstrate the methodological and operational soundness of their clinical trial proposal (i.e., that the trial could realistically be completed on time, on budget, and meet its primary endpoint).
• Performance milestones that should be addressed in clinical trial applications.
• Meaningful metrics that could be used to assess progress toward those milestones.
• Ways NHLBI can work with investigators to facilitate planning in advance of clinical trial applications.
• Ways NHLBI can work with investigators to foster successful completion of their trials.
• Ways NHLBI could engage the community when considering new approaches to the conduct and management of clinical trials (in addition to this RFI).

How to Submit a Response

All responses to this RFI must be submitted via email to NHLBIClinicalTrials@mail.nih.gov by December 28, 2015. Please include the Notice number in the subject line. Response to this RFI is voluntary. Responders are free to address any or all of the questions listed above.

Inquiries

Please direct all inquiries to:

Juanita Marner, MPP
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-1770
Email: marnerj@nhlbi.nih.gov