Clinical & Translational Science Pilot Program

The CCTS supports translational science pilot projects that align with the CCTS mission of accelerating the translation of research into improvements for human health and healthcare delivery. Projects must be focused on translational science – the generation of generalizable innovations that are applicable to a broad range of diseases and conditions and address translational barriers, such as those that*:

• Lack of patient/participant/community involvement in the advancement of health interventions
• Ineffective clinical trial recruitment
• Failure/inability to retain participants
• Lack of novel clinical trial design (e.g. adaptive designs)
• Lack of novel endpoints for clinical studies/trials (e.g. behavioral endpoints)
• Complexity of study protocols
• Complexity in management of multi-site studies
• Clinical trials not completed on time or budget
• Translation of evidence-based interventions between populations (e.g. adult to pediatric)
• Lack of rigor, transparency, and reproducibility (e.g. clinical to real-world settings)
• Lack of data interoperability and transparency
• Challenges to data acquisition, integrity, and analysis
• Failure to utilize existing data for research (e.g. electronic health records, national cohorts)
• Challenges in testing new therapeutic modalities and drug repurposing
• Failure to correctly predict drug toxicology or efficacy
• Failure to technically execute complex mechanistic studies
• Lack of access to biospecimens
• Lack of common solutions across research on a range of diseases and conditions
• Lack of incentivization for collaboration
• Lack of training research teams
• Lengthy regulatory approval processes (e.g. participant consent content/process)
• Failure to disseminate evidence-based interventions, health practice or system updates
• Failure to implement evidence-based interventions, health practice or system updates

* Not listed in order of priority.

Clinical Translational Research vs. Clinical Translational Science

*Ensure applications are within the scope of a pilot project, which are intended to assess “Can this be done?” and NOT “Does the intervention work?”. See Pilot FAQs.

What is a Pilot Project?

• Pilot projects are small projects often done to assist in the preparation of a larger, more comprehensive study.
• Study aims focus on assessing feasibility (of recruitment, consent, randomization, data collection), scalability, acceptability, fidelity, or estimating parameters needed for a larger study.
• While pilot projects consist of planned methods to collect and analyze data, descriptive statistics are generally utilized (e.g. mean, range, standard deviation, frequency).
• References and Suggestions:
  • David Redden, PhD, Research Methodologist, discusses “Designing & Conducting Pilots”
  • NIH NCCIH “Pilots: Common Uses and Misuses”
    • Spoiler: Pilot projects are intended to answer, “Can I do this?”, not “Does the intervention work?”.
  • What are NOT pilot projects?
    • A pilot project is NOT a repackaged, underpowered version of a larger study.
    • A pilot project is NOT intended to test a hypothesis. Therefore, a pilot project is NOT designed to evaluate the effect (sizes) of an intervention on the participants (see Clinical Trial Decision Tool Question 3) and inferential statistics are NOT appropriate (e.g. T-tests, ANOVA, Chi-Square, Regression).
    • A pilot project should NOT be the basis of a sample size calculation for a main trial, as the minimum important difference (MID) should be based primarily on clinical judgement rather than statistics (doi:10.1136/bmj.i5239).

What should every pilot proposal address?

• How will the proposed work inform the next study?

Translational Barrier: Lack of patient/participant/community involvement in the advancement of health interventions

Development of health interventions often overlooks the very individuals the interventions are intended to help, leading to unforeseen ‘fatal flaws’ in the study design. To address this gap, a CCTS pilot study systematically assessed the patient and their caregivers’ knowledge and needs to inform the development of a home-based health program. The information gathered during this pilot, such descriptive statistics characterizing participants, inform the recruitment strategy for future mixed methods research studies focused on identifying perceived barriers and facilitators to participation and adherence of a home-based program intended to improve frailty and post-operative outcomes.

Translational Barrier: Fidelity of Remote Data Collection

Remotely delivered health interventions represent a relatively new era of clinical research. However, remote measurement of health represents a barrier to larger utilization and participation, particularly for individuals with transportation challenges. A CCTS pilot project aimed to validate a method to remotely measure health outcomes, which is expected to increase the enrollment and retention of healthy and physically disabled participants

Translational Barrier: Novel Clinical Trial Design

In several clinical settings, physicians lack evidenced-based methods to predict health outcomes, especially at the point of care, which represents a major translational barrier towards examining the efficacy of health interventions. To address this barrier, a CCTS pilot project sought to identify clinical predictors of poor health outcomes. Using sepsis survivors as the initial use-case, the study team will conduct an observational, prospective study to assess if physical function recovery trajectory and rehospitalization events can inform the development of post-intensive care unit recovery subgroups. Establishment of these subgroups could inform a novel approach to clinical trial design within and beyond the context of sepsis.

Translational Barrier: Implementation of evidence-based interventions, health practice or system updates

Remembering information from clinical visits is a common challenge that can limit the success of healthcare interventions and health practices. Poor recall can lead to medication errors, difficulties with self-management, and unmet care needs, especially for patients with complex conditions. Healthcare systems are increasingly using ambient audio recordings to support tasks such as clinical documentation and billing. These recordings may also help patients better remember and use information discussed during their visits. A CCTS pilot project will evaluate the feasibility and acceptability of providing patients with access to recordings of clinical visits in spinal cord injury care, an example of complex care. The project will identify important, modifiable factors that will help inform the translation of ambient recordings of clinical visits into routine practice.

Translational Barrier: Implementation of evidence-based interventions, health practice or system updates

Psychological distress is a leading driver of workforce attrition, which negatively impacts an organization’s ability to implement and sustain operations. In the context of healthcare, nurses experience higher levels of psychological distress than other healthcare workers, and are leaving the profession in record numbers, which represents a barrier towards implementation and sustainability of health practice. To address this challenge, a CCTS pilot project sought to engage nurse perspectives to inform the implementation of an evidence-based stress reduction strategy into clinical workflows as an approach to sustain the healthcare workforce.

Translational Barrier: Implementation of evidence-based interventions, health practices or system updates

The Emergency Department (ED) represents a uniquely challenging clinical unit to implement and sustain healthcare practices. A prime example is implementation and sustainment of ED-based urinary tract infection (UTI) diagnostic stewardship, which seek to prevent overdiagnosis of UTIs and misuse of antibiotics. Shortcomings in education and electronic medical record alerts have failed to provide lasting impact. The CCTS supported a pilot study seeking to identify factors that influence UTI diagnostic stewardship through the lens of ED care providers to inform the development of a UTI diagnostic stewardship as part of routine clinical workflows, an approach that may be applied to other ED workflows.

With modest pilot support, investigators can systematically and proactively address barriers in research design, thereby developing more predictive and successful health interventions.