Increasing the Impact of Clinical Research on Human Health

Program Rationale

NCATS (NIH National Center for Advancing Translational Sciences) requires all Clinical and Translational Science Centers, including Harvard Catalyst, to use translational science methodologies to identify and mitigate roadblocks impeding health-related research at their local institutions.  Through multiple outreach formats across Harvard University schools and affiliated hospitals, Harvard Catalyst identified multiple roadblocks that faculty and other employees felt limited the breadth and impact of research on human health. These formed the basis for initiatives proposed in Harvard Catalyst’s current NCATS award and several are addressed by this pilot opportunity.

Description

In accord with the above mandate, this RFA seeks studies that explore or demonstrate how a range of processes, assessments, models, or modifications can inform clinical translational research more generally, rather than asking for proposals focused on a specific aspect of a highly-defined clinical question or setting.

General guidance from NCATS includes:

• Development of new research methodology and/or new technologies/tools/resources that will advance clinical translational science (CTS) and thus increase the efficiency and effectiveness of translation.
• Early-stage development of a new therapy/technology with generalizable application to an identified translational roadblock.
• Demonstration in a particular use case(s) that a new methodology or technology advances translational science by making one or more steps of the translational process more effective or efficient.
• Dissemination of effective tools, methods, processes, and training paradigms.
• Feasibility/proof of concept studies to support future CTS projects.
• Secondary analysis of existing data (e.g., projects using the National COVID Cohort Collaborative (N3C) Data Enclave).

The Translational Roadblocks

Innovative pilot proposals should address one of the roadblocks below. Under each roadblock, you will find examples of responsive topics. These are only examples and are not intended to limit the range of applications.

Research and clinical data need to be connected, and their access democratized

• Pilot approaches to new ways of consolidating or integrating available public databases for research purposes – e.g., publicly available clinical trials data (YODA website), Federal or institutional data and other potential sources of more closely held organizational, corporate, or statewide data.
• Projects integrating EPIC-based data with external data source(s).
• Approaches to data reutilization.
• Novel integrations of clinical data from wearables, e.g., with geographic or other data streams.
• Novel uses of data from ClinicalTrials.gov or NIH data streams/datasets such as the COVID Collaborative NC3 Data Enclave referred to above.

The clinical translational research (CTR) workforce is not sufficiently diverse and must be grown in all domains

• Multidisciplinary pilots that integrate non-health services researchers into design or analysis of translational research questions (e.g., climate scientists, commercial advertising experts, public school educators or curriculum developers).
• Development or assessment of new (e.g., certificate, degree or industry-based) training programs or existing opportunities (e.g. academic or other employer programs) preparing healthcare allied or adjacent colleagues for clinical research opportunities.
• Novel evaluation tools that leaders can use to assess and address the competencies and weaknesses of individuals and potential teams (e.g., experience, training, problem-solving and communication skills).

Insufficient mechanisms exist to support implementation of CTR evidence into practice

• The proposed addition of a generalizable translational science component to an existing clinical trial (e.g., studying why patients cancel/miss required study appointments or characterizing physical or socioeconomic aspects of participation that are challenging or limiting).
• Studies that validate or pilot deployment of existing or novel aids, interventions or other supports for those with physical or socioeconomic constraints on research participation, with the goal of increasing. the capacity to access, consider, consent, and participate in clinical trials.
• Studies of novel approaches that address participation in clinical trials or the validation of trial results in special populations, e.g., prisoners, pregnant women, those suffering from neurocognitive disease.
• Pilot studies examining the role of inclusion and exclusion criteria, for common conditions and their therapies, on pharmacokinetics, trial outcomes, results communication and adoption.
• Pilot studies or models for incorporating life-choice (religious beliefs, dietary practices, exercise) and common existing physiologic variables (e.g., menopause or menstrual cycle, HgbA1c levels) on treatment tolerance, study adherence and completion and clinical outcomes.

Translational Science

The term “translational science” and its relation to “translational research” may be new or unclear to many potential applicants. These differences are defined by NIH/NCATS as “translational research is the endeavor to traverse a particular step of the translational process for a particular target or disease. Translational science is the field of investigation focused on understanding the scientific and operational principles underlying each step of the translational process. Whereas translational research focuses on the specific challenges associated with a particular target or disease, translational science is focused on the general hurdles applicable to any target or disease. A key tenet of translational science is to understand common causes of inefficiency and failure in translational research projects (e.g., incorrect predictions of the toxicity or efficacy of new drugs, lack of data interoperability, ineffective clinical trial recruitment).” A more extensive statement and an example of the difference between translational research and translational science is provided in the Application Guide below.