November 19, 2018

Building on the 2017 EFS project success, in 2018 the EFS Contracts working group set out, for the first time, to (A) develop an EFS-specific Master Clinical Trial Agreement (MCTA), and (B) make that EFS MCTA publicly available on the MDIC website for both medical technology and care provider EFS participants. With engagement of diverse stakeholders including industry, care provider organizations, and regulators, the goal of releasing this MCTA is to facilitate efficiencies in the EFS contracting process by developing an EFS MCTA providing (1) a starting point for contract negotiations with a priori agreement of 90% or greater, and (2) allow both parties to focus remaining legal resources on the remaining 10% (or less) of the EFS MCTA requiring negotiation. The Early Feasibility Study Master Clinical Trial Agreement (MCTA)* can be found here:

EFS MCTA (PDF) (Version 2 – 2019)

EFS MCTA (MS WORD) (Version 2 – 2019)


The authorship team acknowledged differences among state and local laws, as well as organization policies, when setting the 90% acceptability minimum threshold for the above EFS MCTA. To provide complimentary efficiency for the remaining 10% (or less) of EFS Sponsor and Institution MCTA negotiations, the authorship team recommends focusing legal resources on the following MCTA sections, and/or addressing trial-specific items in a corresponding statement of work (SOW):
1. Section 11.5: Record Retention

2. Section 15.3: Inventions

  • SPONSOR Intellectual Property
  • Other Inventions
  • Option Period

3. Section 18.3: Sponsor Review timeline(s)

4. Section 20.x: Indemnification, Insurance and Limitation of Liability

  • 1: Indemnified Parties (definition)
  • 2: Indemnification by Institution
  • 3: Obligation to reimburse, timeframe, and fair market value standards
  • 5: Insurance
    • 5.1: Amounts and/or types
    • 5.2: Term length

5. Section 22.5: Institution Audit timeline


*The Early Feasibility Study (“EFS”) Master Clinical Trial Agreement template is provided by The Medical Device Innovation Consortium (“MDIC”) as educational tools. It is neither intended, nor should be considered, to be legal advice. Applicable laws may vary in different states. Also, federal and state laws governing clinical studies are subject to change and to varied interpretations by courts in different jurisdictions. Each Institution and Sponsor entering into a clinical study agreement should consult with its own counsel to obtain legal advice on contracts for clinical studies.

November 19, 2018

A template of a patient Informed Consent Form (ICF) for adult patients considering participation in a study being conducted under an IDE through the FDA’s EFS Program was developed as part of the 2016 Blueprint for Early Feasibility Study Success.

Updated November 2020 to include an editable version (MS Word) of the CF template for EFS trials.

EFS Patient Informed Consent Form Template

November 19, 2018

To aid with the education of patients who may be eligible for a specific EFS, a brief “Introduction to Consent for Early Feasibility Studies for Patients” has been created specifically to address questions and needs patients might have in enrolling to EFS studies. This document focuses specifically on what it means to participate in an EFS. An important aspect of patient advocacy in EFS is to ensure that patients have a good understanding of EFS. The Informed Consent Form (ICF) provides details on EFS, as well as an overview of the risks associated with the specific device and EFS trial. The “Introduction to Consent for Early Feasibility Studies for Patients” is an educational aid provided to the patient prior to presentation of the ICF.

Patient Introduction to Consent for EFS

November 19, 2018

When hospital administration, research staff and IRB members have a good understanding of EFS, the time to complete study contracts, IRB approvals and patient screening and enrollment are likely to decrease. To aid with the education of these stakeholders, a brief “Background Information on Early Feasibility Studies:IRBs and Site Study Staff” has been created. This document describes points to consider when contemplating enrolling patients in early feasibility studies. It describes what an early feasibility study is and what participation means to the patient. It also discusses what types of studies and options there are under EFS and safeguards to put in place for patient protection.

 

Background Information on Early Feasibility Studies 

November 19, 2018

This Blueprint is one of the MDIC projects addressing the existing barriers for EFS. It can be considered a a best practices roadmap for navigating EFS complexities, including regulatory, ethical and legal considerations. The Blueprint covers topics including interactions with FDA, Ethics Committees and/or Institutional Review Boards (IRB)s, legal considerations including Intellectual Property (IP), and patient perspectives towards EFS.  The Blueprint is a supplement to the FDA’s Guidance on EFS/FIH Investigational Devices.  It is intended to be an overview of best practices and factors to consider for study success.

Full Blueprint 

Blueprint Appendices
Appendix 1: Sample Informed Consent Template (Updated 20-NOV-2020)
Appendix 2: Master Clinical Trial Agreement (MCTA) Template
Appendix 3: Pugh Matrix

November 19, 2018

In 2015, the MDIC formed a working group which commissioned an Early Feasibility (EFS)/First-in-Human Industry (FIH) Industry Perspectives survey of key medical device industry stakeholders. This EFS/FIH Perspectives survey was the first milestone in an ongoing effort to understand the attitudes and beliefs within the medical device ecosystem towards EFS programs in the U.S., and to ultimately facilitate an increase in the number of EFS projects initiated in the U.S. The full EFS/FIH Industry Perspectives Report (2015) is available here.

The results from that 2015 EFS/FIH Industry Perspectives survey additionally informed development of MDIC’s “Blueprint for Early Feasibility Study Success.”

November 19, 2018
November 19, 2018

The Framework proposes uniform terminology and recommendations where surrogate samples might be justifiably used in IVD validation studies. Ultimately, the goal of the Surrogate Sample Framework is to improve IVD innovation, reduce inefficient use of costly biological test materials, and ultimately improve timely patient access to safe and effective IVDs.

The framework aligns stakeholders as to the preferred surrogate sample selection by IVD performance study as well as definitions and terminology of surrogate samples and related terms.

November 19, 2018

Currently, the speed at which innovative and improved diagnostics are developed can be hampered by the difficulty in obtaining clinical specimens. This may be due to a variety of reasons, such as rare markers, lack of specimens with markers at the high or low end of the range, specimen stability, the difficulty in obtaining certain specimens due to clinical practice, or patient care taking precedence over the ability to collect specimens under defined conditions. The use of surrogate samples can foster innovation when clinical specimens are difficult to obtain.

The Surrogate Sample working group conducted an analysis of real-world examples of the use of surrogate samples to document established uses of surrogate samples to verify or validate the safety and effectiveness of an IVD medical device. The goal of the project was to establish a foundation under which the use of surrogate samples can support product innovation, with an initial focus on studies to support product submissions.