JHU-Tufts Trial Innovation Center Design Lab - Call for applications

The JHU-Tufts Trial Innovation Center is looking for investigators who are interested in pursuing innovative clinical trial designs to participate in a Design Lab. The Design Lab, jointly run by the Tufts Institute for Clinical Research and Health Policy Studies and the MIT Center for Biomedical Innovation, will explore innovations in clinical trial design in the context of the full treatment development pathway, with a particular focus on innovative clinical effectiveness trial design. The Design lab will take place June 29-30, 2020 Two examples of innovative designs explored in recent Design Labs include efficacy-to-effectiveness (E2E) trials and efficacy and effectiveness too (EE2) trials, as outlined below.

Efficacy-to-Effectiveness (E2E) Trials

• Innovative trials that begin with an efficacy trial, which tests how a treatment works under ideal conditions, and then seamlessly transitions to an effectiveness trial, which tests how the treatment works in usual care settings, by expanding eligibility and endpoints while the drug is under regulatory review.

Efficacy and Effectiveness Too (EE2) Trials

• Innovative trials that incorporate both efficacy and effectiveness trials into a single trial, with a study sample that includes a cohort to address efficacy as well as a wider range of patients.

The Design Lab is to explore approaches to clinical effectiveness evidence development, with a focus on different stakeholders, including patients, payers, regulators, healthcare providers and others. The Design Labs are organized according to the needs of the project being discussed. The Lab may be a half or full day session that involves a presentation by the investigator and team, and a robust discussion by a diverse multi-stakeholder group of participants.

Investigators will develop a briefing book that outlines their proposed project, with input from Tufts and MIT. The book will be distributed to Design Lab attendees, under confidentiality agreements if required. They should include:

1. the traditional development and marketing plan with expected outcomes and metrics
2. a non-traditional scenario with the same metrics and a comparison of expected outcomes between the two scenarios.

Timeline:

• Application form returned by January 30th, 2020
• Selection on February 6th, 2020
• Design Lab on June 29th and 30th, 2020

Please answer the questions on the application, limiting your response to two pages (excluding appendices), save your responses as a .pdf, and submit them to This email address is being protected from spambots. You need JavaScript enabled to view it. no later than 5pm EST on January 30th, 2020.