Study Startup
Section 3
Additional Resources
| Resource | Description |
|---|---|
| Toolkits |
|
| Clinical Research Toolbox |
This toolkit from the National Center for Complementary and Integrative Health (NCCIH) has templates, sample forms, and information materials to assist investigators with study startup activities. |
| Clinical Research Study Investigator Toolbox | This toolkit from the National Institute on Aging (NIA) serves as a web-based informational repository containing templates, sample forms, guidelines, regulations and informational materials to assist investigators in the development and conduct of high-quality clinical research studies. |
| White Papers | |
| Considerations for Training Front-Line Staff and Clinicians on Pragmatic Clinical Trial Procedures | This document helps PCT study teams plan training for study procedures that involve front-line clinicians and staff. The content was developed by drawing on trial-specific experience from the NIH Collaboratory Trials. The document describes how training for PCTs will differ from training conducted for typical research studies, and includes a list of specific considerations, real-world examples, a checklist for PCT training design, and links to additional resources. |
| Online training | |
| Operationalizing the Trial Design | An online video training resource for researchers to learn strategies for operationalizing a trial and engaging study teams and participants. |
| Journal articles | |
| Communication is the key to success in pragmatic clinical trials in Practice-based Research Networks (PBRNs)
Bertram S, et al. J Am Board Fam Med 2013 |
Effective communication is the foundation of feasibility and fidelity in practice-based pragmatic research studies. Doing a study with practices spread over several states requires long-distance communication strategies, including e-mails, faxes, telephone calls, conference calls, and texting. Developing and ensuring comfort with distance communications requires additional time and use of different talents and expertise than those required for face-to-face communication. This discussion is based on extensive experience of 2 groups who have worked collaboratively on several large, federally funded, pragmatic trials in a practice-based research network. |
| Trials without tribulations: minimizing the burden of pragmatic research on healthcare systems
Larson EB, et al. Healthcare 2015 |
Pragmatic clinical trials are increasingly common because they have the potential to yield findings that are directly translatable to real-world healthcare settings. Pragmatic clinical trials need to integrate research into the clinical workflow without placing an undue burden on the delivery system. This requires a research partnership between investigators and healthcare system representatives. |
| A guide to research partnerships for pragmatic clinical trials
Johnson KE, et al. BMJ 2014 |
A successful pragmatic clinical trial starts with a strong partnership between researcher and healthcare system, goes through a rigorous objective evaluation of the ability of the partner healthcare system to participate, and ends with evidence about sustainable ways to improve care, as well as a long term scientific relationship. |
| Pragmatic clinical trials embedded in healthcare systems: Generalizable lessons from the NIH Collaboratory
Weinfurt, et al. BMC Med Res Methodol 2017 |
The clinical research enterprise is not producing the evidence decision makers arguably need in a timely and cost-effective manner; research currently involves the use of labor-intensive parallel systems that are separate from clinical care. The emergence of pragmatic clinical trials (PCTs) poses a possible solution: these large-scale trials are embedded within routine clinical care and often involve cluster randomization of hospitals, clinics, primary care providers, etc. Interventions can be implemented by health system personnel through usual communication channels and quality improvement infrastructure, and data collected as part of routine clinical care. |
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