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.

Webinars

2025 Informational Webinar about the CTMC Course

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

• 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 Journal

• 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.

Specific Aims page examples

• 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.