Best Practices

This initiative presents a multi-dimensional framework called the Innovative Research Best Practices Rubric. This process assessment tool includes core guiding principles related to evidence of success, improving patient experience, site impact, operational and technical feasibility, and regulatory and ethical compliance.

This rubric aims to:

Help researchers understand and track the success of their digital trial processes
Improve patient experience
Understand the impact of digital trials on sites, operations, and technologies
Ensure regulatory and ethical compliance

The DTRA Best Practices Evaluation Rubric provides a consistent framework by which digital trial practices may be evaluated to be considered a "best practice." Best practices are organized across the trial lifecycle:

Program Planning | Trial Planning | Trial Set-up | Trial Conduct | Trial Close and Analysis

The following best practices rubrics are not intended to be explicit instructions for use. Instead, these rubrics are intended to aid innovative trial stakeholders as they interpret and apply them to their projects and trial needs. The rubric dimensions are interrelated and need to be considered holistically.

To be considered a "best practice," expectations in the five dimensions of the rubric should be met.

1. Evidence of Success

Best practices should have measurable and demonstrable success. This dimension is meant to help teams consider whether there is a track record of successful outcomes from the use of the practice. Teams should evaluate the data to determine the fit for their situation. KPIs and tangible outcomes are at the heart of evaluating best practices for digital clinical trials.

Download the Evidence of Success Checklist >

2. Improving Patient Experience

Digital Clinical Trials, at their core, should address the needs of patients, caregivers, and therapeutic experts. Improving the experience and engagement with these key stakeholder groups should be demonstrable as a requirement for innovative trial best practices.

Download the Improving Patient Experience Checklist >

3. Site Impact

Sites will be essential stakeholders in digital clinical trial adoption. The impact on sites should be considered with any new practice, including the practical implications of adoption and change from today's working practices to increase digital trial implementation.

Download the Site Impact Checklist >

4. Operational and Technical Feasibility

Digital Clinical Trial practices will often involve the use of new operational processes and technologies. This dimension is intended to ensure that operational and technical aspects have been considered fully for ongoing support, resilience, security, integrity, scaling, and reuse.

Download the Operational and Technical Feasibility Checklist >

5. Regulatory and Ethical Compliance

Best practices should appropriately consider global and local regulations and guidance. In doing so, they should also adhere to appropriate privacy, consent, and sharing guidelines. Safeguards are essential to protecting stakeholders' sensitive or personal data and to ensure ethical conduct, safety oversight, and regulatory compliance for patients and caregivers.

Download the Regulatory and Ethical Compliance Checklist >

Best Practices Evaluation Rubric

The DTRA Best Practices Evaluation Rubric provides a consistent framework which may aid in evaluating innovative clinical trial best practices across the trial lifecycle.

The rubric dimensions are interrelated and need to be considered holistically. To be considered a best practice, all expectations of the rubric should be met.

Why Develop a Best Practices Rubric?