Clinical Trial Excellence Campaign (CTEC)
The Clinical Trial Excellence Campaign (CTEC) aims to scale tried and tested operational improvements to the clinical trial activation process.
Clinical trials are foundational to discovery and treatment development in human research. To start or “activate” a clinical trial at UCSF requires strong collaboration across multiple stakeholders and application of best practices.
Units within the Office of Research have been working behind the scenes to identify these best practices to optimize clinical trial activation. We now know what operational changes can make your research journeys easier and more effective and are making it a priority to introduce these optimizations to more study teams.
Campaign Goals
The campaign is an ongoing and iterative process aiming to improve internal and external engagement, knowledge and satisfaction of key stakeholders including study staff, investigators, sponsors and CROs.
Initial goals are to:
- Shorten activation times* and improve the overall activation process
- Improve communication and transparency on the activation process
- Develop a culture of shared responsibility between operational units, study teams, and external stakeholders including sponsors and CROs
*A key metric of performance in the campaign is the time from first submission of a protocol into the system (IRB or OCTA) through to contract execution. The campaign aims to achieve an institutional median of 90 days for this metric.
Campaign Elements
Below are four key elements that study teams can engage with as the campaign begins. Please note that some elements may be more relevant to your research than others.
| What this means |
Improved Result |
Resources |
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Study teams now benefit from a single budget and coverage workflow to obtain approval in one touchpoint.
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This reduces steps in review and sign-off processes for budgets and coverage analysis and streamlines communication between OCTA and the study team.
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NEW: Monthly Advanced Trainings for Study Staff:
NEW: Combined CA/Budget Review Guide for PIs and Study Teams
NEW: PI Proxy approval of the draft coverage analysis and internal budget. Delegation of this responsibility is at the discretion of the PI and their department. The above training courses are required for any staff.
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| What this means |
Improved Result |
Resources |
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Study teams will use tools and checklists to guide the submission process. Process guidance will also be given to Sponsors to elucidate the offices and analysts working on different aspects of activation.
Sponsors will be able to review and approve mandatory informed consent language before the study team drafts the ICF.
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This reduces back and forth with Sponsors on document prep and review and provides greater transparency of the steps within the activation process. |
NEW: Study Team Guide for UCSF Industry Clinical Trial
Activation
NEW: Sponsor Guide for
UCSF Clinical Trial
Activation
|
| What this means |
Improved Result |
Resources |
| Study teams will be prepared to submit materials to various systems simultaneously, rather than submitting in a serial fashion. |
This reduces the number of days between system submissions and optimizes the opportunity for central units to process the contract, budget/coverage analysis, and regulatory review in parallel. This will also help maintain version control across units. |
NEW: Study Team Guide for UCSF Industry Clinical Trial
Activation
NEW: Sponsor Guide for
UCSF Clinical Trial
Activation
|
| What this means |
Improved Result |
Resources |
| In cases where it is deemed to be beneficial, PIs may be invited to attend IRB Committee meetings during which their study is being reviewed to address any questions and concerns. |
Near 50% reduction in median time to IRB approval, compared to clinical trials that did not apply this method.
"Attending the IRB meetings as Principal Investigator has facilitated addressing potential queries in real-time as well as gaining a deeper understanding and appreciation for the specific issues that are considered by the IRB during the trial activation process. I see this as a valuable step in the trial activation process particularly for investigator-initiated trials."
Rahul Aggarwal, MD
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NEW: To support strong UCSF IRB applications and reduce IRB approval time use the UCSF IRB Initial Submission Checklist |
New in 2024
Additional campaign elements will be rolled out starting in Q1 of 2024, including:
- Optimizing activation when recruiting non-English speaking populations
- Focus on activation workflow challenges at ZSFG
- Improving the activation process by providing additional tools, new and updated training courses, and best practices to a variety of study designs and sponsorships
- And more!
Get Involved
The campaign is now in a phase where we need your collaboration! As you start to use the new campaign offerings, or engage in parts of the new activation process, we encourage your feedback to enrich this iterative process and make these changes even better.
What our central teams will offer:
- Operational scaling of initiatives shown to be effective
- Training, resources, and support for CTEC initiatives
- Outreach to study sponsors
- Continual internal effort and initiatives for process improvement
Requests from study teams, sponsors and CROs:
- Engagement with our new processes and trainings
- Feedback on what is working well and what is not working well
- Commitment to collaboration
Are you a study Sponsor or Clinical Research Organization (CRO) that wants to get involved or learn more about this initiative? Contact us at [email protected].
Meetings
| Date & Time |
Speakers & Topics |
Recording |
|
March 7, 2024
12 pm – 1 pm
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- Dominica Randazzo, Associate Director for CTO
Industry Clinical Trial Activation Guide for study teams
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Recording |
| Date & Time |
Speakers & Topics |
Recording |
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October 16, 2023
11 am – 12 pm
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|
Recording |
Frequently Asked Questions
You may find some campaign elements more useful than others depending on the nature of your research. Please contact us at at [email protected] to get in touch with the unit(s) responsible for the optimizations that will be most useful for your work.
Our initial metric of success is shorter activation time for study teams, meaning that teams will be able to bring their idea to fruition in a shorter amount of time and using a more streamlined and efficient process.
This is only the beginning! The CTEC plans to introduce even more elements starting in Q1 2024, including:
- Enhancing studies recruiting non-English speaking populations
- Focusing on challenges at our affiliate sites with variable workflows
- Providing central support (e.g., navigator, liaison) to point teams towards needed resources
- Providing additional tools, training courses, and best practices to a variety of study designs and Sponsorships
- And more!
The CTEC is rooted in the following values to foster the best outcomes for all stakeholders in the clinical trial activation process:
- Engagement, collaboration, and synergy
- Equity and diversity across participants, PIs, and study teams
- Service and responsiveness
- Shared responsibility and accountability
- Transparency, trust, and open dialogue
We recognize the time a protocol spends in the activation pipeline does not account for the time that study teams and sponsors and other stakeholders spend in start-up for a clinical trial. Throughout the campaign, tools, guides, and training will be available to support study teams and sponsors. Many of these will directly support the pre-submission process and streamline the activation pipeline for central processing.
