What are informative and clinically relevant biomarkers of pulmonary hypertension (PH)?

How can NHLBI support studies that produce in-vitro assays to predict clinical response and ways to translate those results into patient therapies through novel clinical trials, including those for small patient populations and rare diseases?

Are the current methodologies for clinical trials still the best practices for conducting efficient clinical trials?

What are the metrics that can predict success of clinical trials?

What is necessary to reprogram the immune system to improve transplant outcomes of hearts, lungs, and hematopoietic cells? While NIAID is a major funder of immunology research, we are a major contributor to stem cell research. Our resources could be combined, where NIAID would support this approach for autoimmune diseases, and we would support work in tolerance for transplants. If the NCI also wants to collaborate on... more »

During this period of diminishing Federal resources and funding, what novel methods can be employed to effectively conduct clinical trials that address existing and emerging medical and public health issues?

Is an increase in macrovascular endpoints outweighed by the benefit in microvascular end points in new oral type 2 diabetes drugs?

It would go against the current regulatory paradigm in type 2 diabetes. Although drug companies do not like the current paradigm, they would prefer to go back to the pre-rosiglitazone state of affairs, in which new drugs had only to prove that they lowered blood glucose and HbA1c.

The use of win-ratio and other new statistical methods to analyze endpoints in new and existing clinical trials.

What innovative methodologies applicable to small cohorts and rare outcomes can better ensure the success of clinical and implementation studies in the rare diseases affecting heart, lung, blood, and sleep?

As the current chair of the Research and Training Division, I would like to convey that the AAAAI membership would like the NHLBI to consider the following in the development of its strategic plan:

Are the current methodologies for clinical trials still the best practices for conducting efficient clinical trials?

How can NHLBI harness the power of novel technologies involving nucleic acid delivery and gene editing for clinical therapeutics?

Although the NCRR and NIGMS used to have a mechanism to train new generation of clinical & translational scientists, this program was stopped. Why?

What is the possibility of other institutes to come up with the priority of funding resources in this regard?

There is a need to fundamentally rethink the approach to translation and dissemination of clinical trial results. The current approach relegates dissemination as a side effect to the end of a trial and does not require sufficient funds be set aside to conduct adequate outreach. As a result, it takes up to 17 years for the results of trials to be adopted and used in everyday practice. It is time for a new model which re-prioritizes... more »

Maintaining the pipeline of clinician scientists via early and mid-career awards. Promote the development of collaborative teams.

There is a need to educate the scientific community and program staff about the use of metrics, results-based accountability, and other business models to improve the science, productivity, and efficiency of clinical trials and clinical trial networks.