Open resource and data sharing is a core principle of the CTMC.
All webinars and other materials developed by this course are publicly available and accessible here.
2025 Webinar Series
The 2025 webinar series is open to anyone who is interested to attend (not just enrolled course participants).
Webinars will be held on Fridays from 12-1pm ET.
You can join webinars in real-time using this Zoom link.
Recordings will be uploaded after the session for asynchronous viewing.
2025 Schedule
March 21: Orientation & Elevator Pitches (Open to the 2025 cohort only)
April 4: Comparing Clinical Trial Protocols to Grant Applications - Presented by Roger Lewis, MD, PhD
April 25: Avoiding Pitfalls in Early Phase Clinical Trials - Presented by Chris Coffey, PhD, and Will Meurer, MD
May 2: What to Know About Sample Size - Presented by Sharon Yeatts, PhD
May 16: Outcomes Measures - Presented by Harold Adams, MD
May 30: Incorporating Participants’ Perspectives in Clinical Trial Design - Presented by Sophia Wang, MD
June 6, 2-3pm ET: Introduction to NINDS Networks - Presented by Chris Coffey, PhD; Valerie Durkalski-Mauldin, PhD; and Pooja Khatri, MD, MSc - *Please note the change in time (2pm ET) for this session!
June 13: Surviving Peer-review of Clinical Trial Manuscripts - Presented by Roger Lewis, MD, PhD
July 11: Specific Aims - Presented by Jordan Elm, PhD, and Robert Silbergleit, MD
July 25: Data Science in Clinical Trials - Presented by Paul Perrin, PhD; Thomas Stewart, PhD; and John Van Horn, PhD
Latest Webinars
2025 Informational Webinar about the CTMC Course - December 19, 2024
“Introductions from NINDS Networks” - June 4, 2024
Clinical Trial Resources
ADAPT-IT
The Adaptive Designs Accelerating Promising Trials into Treatments (ADAPT-IT) project was a cooperative project involving the NIH common fund, the FDA, and the Neurological Emergencies Treatment Trials (NETT) network. An overview of the project is here ADAPT-IT overview. The overarching objectives of ADAPT-IT were to identify and quantitatively characterize the ACT methods of greatest potential value in confirmatory phase clinical trials, and to elicit and understand the enthusiasms and concerns of key stakeholders that influence their willingness to try these innovative strategies.
The team developed 5 innovative adaptive trial designs. The ADAPT-IT team included clinicians planning trials (including the NETT Clinical Coordinating Center), biostatisticians from the Medical University of South Carolina (NETT Statistical and Data Management Center), biostatisticians from Berry Consultants, along with partners from the NIH and FDA.
In addition, the team conducted a 2 day, interactive design symposium in 2013 called DESIGN-IT. The videos from the sessions are here.
This work was supported jointly by the National Institutes of Health Common Fund and the Food and Drug Administration, with funding administered by the National Institutes of Neurological Disorders and Stroke (NINDS) U01NS073476. In addition, the Neurological Emergencies Treatment Trials (NETT) Network Clinical Coordinating Center (U01NS056975) and Statistical and Data Management Center (U01NS059041) are funded by the NINDS. We specifically recognize the efforts of Dr. Robin Conwit and Dr. Scott Janis, from NINDS for their work with NETT and their assistance in facilitating this project.
SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials)
The SPIRIT 2013 Statement provides evidence-based recommendations for the minimum content of a clinical trial protocol. SPIRIT is widely endorsed as an international standard for trial protocols.
The recommendations are outlined in a 33-item checklist and figure. Each checklist item is detailed in the Explanation & Elaboration paper.
CONSORT (Consolidated Standards of Reporting Trials)
An update to SPIRIT and CONSORT reporting guidelines to enhance transparency in randomized trials (Nature Medicine; 15 September 2022)
CONSORT 2010 Checklist (Word document download)
Trial Forge provides resources to trial teams to improve the efficiency of their trial through marginal gains across trial processes. They also have a series of frameworks designed to improve trial diversity.
Trials is an open-access publication that publishes articles on general trial methodology, research into trial design, as well as study protocols and statistical analysis plans. Dr. Meurer is a senior editor.
Examples of the specific aims page from 5 large clinical trials performed through the NINDS networks.
Field-specific resources
High impact journal articles (NEJM, JAMA, etc.) require study protocols to be included in the appendices. These protocols can serve as field-specific examples for monitoring adverse events, measuring outcomes, study procedures, etc. for early phase trials related to the same conditions.
NIH RePORTER and ClinicalTrials.gov can provide information about ongoing work in the specific field.
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