• Contact
  • EPAD Academy
Top Bar Menu
TwitterFacebookYouTube
Search...
EPADEPAD
EPAD
European Prevention of Alzheimer's Dementia Consortium
  • Home
  • About
    • Welcome to EPAD
    • Project Objectives
    • Project Structure
    • EPAD Partners
    • Coordination & Management
    • EPAD Q&A
  • Our research
    • Participation in EPAD
      • Participation in EPAD Cohort
      • EPAD Study Visits
      • Trial Locations
      • Participation FAQs
    • The Participant’s Experience
      • The Research Participant Panel
      • EPAD Stories
    • The EPAD platform
      • The EPAD Platform
      • EPAD Benefits
      • Clinical Candidate Selection
      • EPAD FAQs
      • Research Resources
  • Open Access Data
    • Overview
    • Access
    • Data
    • Samples
    • MRI Images
  • News & Publications
    • Latest News
    • Newsletters
    • Publications
    • Videos
Menu back  

The Clinical Candidate Selection Process

We set up a Clinical Candidate Selection Committee (CCSC), which was a vital part of the EPAD application process. It was not only an evaluation committee but was also the first point of contact with EPAD for intervention owners, and a facilitator of the candidate nomination process.  The CCSC:

  • Maintained an open and transparent selection process.
  • Relied on regulatory authorities to ensure that interventions have met the regulatory requirements to advance to Phase II.
  • Supported de-risking the EPAD project by assuring the scientific rationale, safety, and appropriateness of using EPAD to establish PoC for a given intervention.

What were the selection criteria?

All interventions were evaluated against the following nine criteria and rated accordingly.

  1. Scientific rationale/target validation
  2. Pharmacokinetics (PK)
  3. Pharmacology requirements
  4. Safety
  5. Plans for full development/regulatory issues
  6. Develop-ability/CMC quality guidelines
  7. Biomarkers: assays available for use in the PoC

The PoC master protocol outlines our study design and requirements for all interventions.

EPAD Application Process

The application and access process contained a number of steps but was designed to be as simple as possible.

The EPAD PoC platform was open for expressions of interest from intervention owners including pharmaceutical and biotechnology organisations, academic researchers, and funders.

Before the application process could begin, all parties signed a non-disclosure agreement. The Clinical Candidate Selection Committee (or CCSC) then conducted a scientific review to ensure that the intervention was suitable for EPAD. If approved, an examination of statistical and operational requirements followed.

If all parties agreed, this stage was concluded with the signing of a letter of intent signifying the intervention owner’s commitment to the EPAD PoC.

EPAD flow

  1. Approach: The intervention owner contacted the CCSC via email, or downloads, completed and sent an Expression of Interest to the EPAD PoC team.
  2. Assess: The CCSC reviewed and identified potentially suitable interventions and had preliminary discussions with the intervention owner. The CCSC provided the template Non-Disclosure Agreement, Nomination Form, and instructions on how to apply, to the intervention owner.
  3. Submit: All parties signed the Non-Disclosure Agreement and the intervention owner submitted the Nomination Form.
  4. Review: The CCSC conducted a preliminary review of Nomination Form to determine whether additional experts were needed for the review and the formal CCSC review meeting date was set. If additional experts were required, the intervention owner consented to their involvement.
  5. Decide: The CCSC review meeting with the intervention owner was conducted and a formal decision was made. Subsequently an operational and statistical review meeting with the PoC team and intervention owner was conducted to determine if their requirements were possible within the EPAD PoC platform.
  6. Establish: If accepted, the intervention owner signed the Letter of Intent, which triggered the constitution of the Appendix Writing Group. This group was led by the intervention owner and included EPAD representatives. The Letter of Intent included the fees payable by the intervention owner for the scientific, statistical and operational resources required to complete an appendix synopsis.
  7. Finalise: The Appendix Writing Group worked on their appendix in collaboration with the EPAD team to finalise the study design elements.
  8. Review: The legal agreements and budget were reviewed per EPAD requirements and approvals received.
  9. Commence: The Appendix Writing Group reconvened as the Appendix Steering Committee to initiate study start-up activities.  Once approvals were received by the sponsor, recruitment from the Longitudinal Cohort Study begins and the trial commenced.
Share this page
FacebookTwitterLinkedInGoogle+
Latest News
  • New paper on the operationalization of the ATN classification scheme in preclinical AD has been published
    2021-04-06
  • AD Workbench
    The final EPAD dataset is now available on the Alzheimer’s Disease Workbench
    2021-03-18
  • EPAD_WordCloud
    EPAD releases its first data and sample access bulletin
    2021-03-10
  • Closing EPAD article published in the Alzheimer Europe magazine
    2021-02-24
  • Alzheimer Europe launches a report on data sharing in dementia research
    2021-02-23
View the EPAD Brochure
thumbnail of EPAD brochure
Speak to the EPAD team
thumbnail of speech bubbles
Twitter
Twitter
EPAD
EPAD
@IMI_EPAD

If you're attending #BNA2021, check out the pre-registration poster from @GregorySarah introducing the SPeAk study. Participants of this new study must have previously enrolled in the @IMI_EPAD LCS or CHARIOT Pro study at @CenDemPrevent. #biomarker #Alzheimer’s disease #dementia twitter.com/CenDemPrevent/…

reply retweet favorite
10:18 am · 2021-04-14
Twitter
EPAD
EPAD
@IMI_EPAD

Check out the last @IMI_EPAD publication on the application of the #ATN classification scheme in the first 1500 participants consented in the EPAD Longitudinal Cohort Study. ep-ad.org/2021/04/06/new… @silvia_ingala @IMI_JU @EFPIA @EU_H2020 pic.twitter.com/3HhgMcBDN0

reply retweet favorite
8:15 am · 2021-04-13
Twitter
EPAD
EPAD
@IMI_EPAD

The @IMI_EPAD Bioresource consists of over 100,000 samples consisting of blood, CSF, saliva and urine that have been collected annually from research participants throughout their participation in the Longitudinal Cohort Study. #OpenAccess ep-ad.org/2021/03/10/epa… twitter.com/IMI_EPAD/statu… pic.twitter.com/dRjuI1opFi

reply retweet favorite
7:16 am · 2021-04-12
Twitter
EPAD
EPAD
@IMI_EPAD

The ATN classification has been added for public use to the analytical database of the @IMI_EPAD Longitudinal Cohort Study, hosted by @aridhia . ⬇️ ep-ad.org/2021/04/06/new… twitter.com/IMI_EPAD/statu…

reply retweet favorite
5:56 am · 2021-04-07
Twitter
EPAD
EPAD
@IMI_EPAD

In this article, the #ATN classification was operationalized in the first 1500 participants consented in the @IMI_EPAD cohort, a deeply phenotyped cohort of individuals who do not have #dementia. ep-ad.org/2021/04/06/new…

reply retweet favorite
7:08 am · 2021-04-06
Copyright © 2015-2021 EPAD | Created by CMAST and Aridhia
  • Acronyms
  • Legal Notice
  • Privacy Policy
Bottom Menu

efpia-logo EU imi logo

This work has received support from the EU/EFPIA Innovative Medicines Initiative Joint Undertaking EPAD grant agreement nº 115736

This website uses cookies to improve your experience. Accept Read More
Privacy & Cookies Policy

Privacy Overview

This website uses cookies to improve your experience while you navigate through the website. Out of these, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may affect your browsing experience.
Necessary
Always Enabled

Necessary cookies are absolutely essential for the website to function properly. This category only includes cookies that ensures basic functionalities and security features of the website. These cookies do not store any personal information.

Non-necessary

Any cookies that may not be particularly necessary for the website to function and is used specifically to collect user personal data via analytics, ads, other embedded contents are termed as non-necessary cookies. It is mandatory to procure user consent prior to running these cookies on your website.