• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Email
  • Facebook
  • LinkedIn
  • Twitter
  • YouTube

International Alliance of ALS/MND Associations

  • Members' Login
  • Contact
  • Join the Alliance
  • Donate
  • Understanding ALS/MND
    • What is ALS/MND
    • Genetics
    • Diagnosis
    • Glossary
    • Navigating the Community
  • Find a Member Association
  • Support for PALS & CALS
    • Fundamental Rights for People with ALS/MND and Caregivers
    • Research
      • Clinical Trial Registry Accuracy and Maintenance in ALS/MND Research
      • Open Science
        • Open Label Extension
      • Expanded Access
      • Understanding ALS/MND Research
      • Improving Regulatory Pathways
      • Right to Try
      • US FDA Orphan Drug Designation
      • Unproven Treatments
    • Advocacy
      • Advocacy Toolkit
      • Emergency Preparedness Toolkit
      • Equitable Access to Therapies
      • Recommendations for Trial Sponsors
    • Clinical Care
      • Genetic Counselling & Testing
      • Mental Health Support
      • Nursing and Symptom Management
      • Nutrition, Swallowing and Saliva
      • Activities of Daily Living and Occupational Therapy
      • Muscles, Mobility and Exercise
      • Respiratory Care
      • Speech and Communication
      • Voice Preservation
      • Support for Family & Caregivers
      • Technology
      • Global Clinic Locator
    • Drugs in Development
      • Masitinib
      • NurOwn
      • CNM-Au8
      • ILB
      • AstroRx
      • Neuronata-R / Lenzumestrocel
      • PrimeC
      • NP001
      • Pridopidine
      • SOD1 Therapies and Trials
      • C9orf72 Therapies and Trials
      • SPG302
      • Regulatory T Cell Enhancing Therapies
      • Ulefnersen
    • Approved Drugs
      • Nuedexta
      • Radicava / Edaravone
      • Riluzole / Tiglutik
      • Rozebalamin / Methylcobalamin
      • Tofersen / Qalsody
    • Drugs No Longer in Development
      • AMX0035
      • Reldesemtiv
      • Arimoclomol
      • TUDCA
      • CuATSM
  • Support for Health Professionals
    • Breaking the News in ALS/MND
    • R.A.C.E. to Diagnose ALS/MND
  • Programs & Events
    • Calendar of Events
    • Global Day Calendar
    • Alliance Meeting
    • Allied Professionals Forum
    • “Day in the Life Of” Suite
    • Alliance Webinars
    • ALS/MND Connect
    • March of Faces
    • Patient Fellows Program
    • Alliance Fellows
    • SEED Grant Program
    • Awards
      • Forbes Norris Award
      • Humanitarian Award
      • Allied Health Professional Award
      • Student Innovation Award
  • About
    • Who We Are
    • ALS/MND Health Literacy Map
    • Board of Trustees
    • Councils, Forums & Committees
      • Scientific Advisory Council
      • PALS and CALS Advisory Council
      • Advocacy and Public Policy Forum
      • Research Directors Forum
      • Governance Committee
      • Finance Committee
    • Staff
    • History
    • Newsletter Archive
  • Members
    • Member Registration
    • Forgot Password

Clinical Trial Registry Accuracy and Maintenance in ALS/MND Research

Position Statement 

Executive Summary 

Clinical trial registries are the primary source of information used by people living with ALS/MND, clinicians, patient navigators, advocacy organizations, and trial-finding platforms worldwide. When registry information is inaccurate, incomplete, or outdated, patients can lose valuable opportunities to participate in research, and confidence in the research ecosystem is undermined. The International Alliance of ALS/MND Associations believes that accurate registry information is a research access issue and calls on sponsors, investigators, and other responsible parties to maintain accurate and current trial records on trial registries throughout the lifecycle of every ALS/MND clinical study. 

Purpose and Intended Outcomes 

This Position Statement aims to promote accurate and up-to-date clinical trial registry information as a foundation for equitable access to ALS/MND research opportunities, transparency, and accountability within the research ecosystem. Through this position, the International Alliance of ALS/MND Associations seeks to: 

  • Improve the accuracy, completeness, and timeliness of ALS/MND clinical trial registry information. 
  • Strengthen global access to clinical research opportunities and information for people living with ALS/MND. 
  • Support compliance with applicable legal, regulatory, and ethical obligations related to trial registration, maintenance, and results reporting. 
  • Increase transparency and accountability across the ALS/MND research ecosystem. 
  • Improve the reliability of trial-finding tools, patient navigation services, evidence synthesis efforts, and other resources that depend on registry data. 
  • Build confidence in the ALS/MND clinical research ecosystem among patients, families, clinicians, researchers, and advocacy organizations. 

Background 

Clinical trial registries are essential infrastructure for the global research ecosystem. ClinicalTrials.gov, maintained by the U.S. National Library of Medicine, is the world’s largest clinical trial registry, with records from more than 200 countries. The WHO International Clinical Trials Registry Platform (ICTRP) aggregates records across a global network of registries, providing the most comprehensive view of worldwide trial activity. People living with ALS/MND, family members, clinicians, care teams, advocacy organizations, patient navigators, and trial-finding platforms depend on them to identify research opportunities and obtain accurate information about ongoing studies. Outdated or incomplete information propagates across every downstream system into navigation services and trial finders. 

People living with ALS/MND participate in research to advance ALS research. Accurate registry maintenance and outcome reporting are a regulatory requirement and an ethical obligation to participants and the broader community. Failures prevent participation and limit research impact. 

The Alliance is committed to improving patient access to research, supporting informed decision-making, and strengthening patient-centered research practices. As AI-enabled trial matching and international collaboration expand, registry reliability has never been more critical. 

The Position 

The International Alliance of ALS/MND Associations believes that: 

  • Accurate and current clinical trial registry information is essential for equitable access to research participation, scientific integrity, transparency, and accountability. 
  • Clinical trial registry accuracy is a patient access issue and should be recognized as a core component of patient-centered research. 
  • Clinical trial records should accurately reflect study and recruitment status, site and contact information, and study completion and results, and sponsors must comply with all applicable legal and regulatory requirements governing registration, maintenance, and reporting. 
  • Timely public reporting of all ALS/MND clinical trial results, including positive, negative, and inconclusive findings, is essential to scientific transparency, evidence-based decision-making, and respect for research participants. Maintaining accurate records and reporting results are ethical obligations that honor participant contributions. 
  • Accurate registry information strengthens the value of trial navigation services, patient support programs, systematic reviews, evidence synthesis, and future research planning. 

Call to Action 

The International Alliance of ALS/MND Associations calls upon sponsors, investigators, academic institutions, contract research organizations, and other responsible parties involved in ALS/MND clinical research to: 

  • Audit all ALS/MND trial registrations under their stewardship. 
  • Verify and maintain these public listings. 
  • Submit overdue trial results and required public reports. 
  • Establish internal processes to ensure ongoing compliance with registry maintenance. 

References 

Supporting evidence for this Position Statement includes: 

  • Food and Drug Administration Amendments Act of 2007, Pub. L. No. 110-85, § 801, 121 Stat. 823 (2007). https://www.congress.gov/110/plaws/publ85/PLAW-110publ85.pdf  
  • Clinical Trials Registration and Results Information Submission, 42 C.F.R. pt. 11 (2016). https://www.ecfr.gov/current/title-42/chapter-I/subchapter-A/part-11   
  • World Health Organization. International Clinical Trials Registry Platform (ICTRP): Policies and Guidance. Geneva: WHO. https://www.who.int/clinical-trials-registry-platform  
  • World Health Organization. Reporting Summary Results of Clinical Trials: WHO Guidance. Geneva: WHO; 2020. https://www.who.int/tools/clinical-trials-registry-platform/reporting-on-findings  
  • Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on Clinical Trials on Medicinal Products for Human Use, 2014 O.J. (L 158) 1. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014R0536  
  • European Medicines Agency. Clinical Trials Information System (CTIS): Guidance and Reporting Requirements. Amsterdam: EMA. https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/clinical-trials-human-medicines/clinical-trials-information-system-ctis  
  • International Committee of Medical Journal Editors. Clinical Trial Registration. ICMJE; 2024. http://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html  
  • FDAAA TrialsTracker. Compliance Reporting for Trials Subject to FDAAA 801. University of Oxford; 2024. https://fdaaa.trialstracker.net  

Primary Sidebar

  • Yolanda Armendariz, Mexico

    Yolanda Armendariz, Mexico

  • Phil Rossall, UK

    Phil Rossall, UK

  • Angelique van der Lit-van Veldhuizen, Netherlands

    Angelique van der Lit-van Veldhuizen, Netherlands

  • Cath Muir, UK

    Cath Muir, UK
    Cath

  • Leon Ryba, Argentina

    Leon Ryba, Argentina

  • Ann Nicol, USA

    Ann Nicol, USA

  • Art Eggert, USA

    Art Eggert, USA

  • Jean

    Jean
    jean

  • Bob Spurrier, USA

    Bob Spurrier, USA

  • Eric Von Schaumburg, USA

    Eric Von Schaumburg, USA

  • Steve

    Steve

  • Liam Dwyer, England

    Liam Dwyer, England

  • Jette Odgaard Villemoes, Denmark

    Jette Odgaard Villemoes, Denmark

  • Chen Chun-Chin, Malaysia

    Chen Chun-Chin, Malaysia

  • Ian Roberts, Australia

    Ian Roberts, Australia

  • Camilla Heiberg Freiberg, Denmark

    Camilla Heiberg Freiberg, Denmark

  • Mirca Bersani, Italy

    Mirca Bersani, Italy
    MircaBersani

  • Guido De Mets, Belgium

    Guido De Mets, Belgium

  • Orlando Ruiz, Colombia

    Orlando Ruiz, Colombia

  • David Watson, Scotland

    David Watson, Scotland

  • Irene McCaughey, Australia

    Irene McCaughey, Australia

  • Danny Reviers, Belgium

    Danny Reviers, Belgium
    DannyReviers

  • Imelda Arenas, Colombia

    Imelda Arenas, Colombia

  • Animesh Kumar, India

    Animesh Kumar, India

  • Lucy Lintott, Scotland

    Lucy Lintott, Scotland

  • Catherine Pearce, Australia

    Catherine Pearce, Australia

  • Margarita Pizarro, Argentina

    Margarita Pizarro, Argentina

  • Joanne Pratt, Australia

    Joanne Pratt, Australia

  • Jean Waters, UK

    Jean Waters, UK

  • Alberto Baez Murillo, Colombia

    Alberto Baez Murillo, Colombia

  • Michel Perrozzo, France

    Michel Perrozzo, France

  • Claudia Cominetti, Italy

    Claudia Cominetti, Italy

  • Olga Cosentino, Argentina

    Olga Cosentino, Argentina

  • Steven Spencer, New Zealand

    Steven Spencer, New Zealand

  • Ian Gale, Australia

    Ian Gale, Australia

  • Emilienne Verhaegen, Belgium

    Emilienne Verhaegen, Belgium

  • Shay Rishoni, Israel

    Shay Rishoni, Israel

  • David Bishop, UK

    David Bishop, UK

  • Jo Knowlton, Scotland

    Jo Knowlton, Scotland

  • Frank Taylor, USA

    Frank Taylor, USA

  • Inta Grubb, Australia

    Inta Grubb, Australia

  • Malu Araujo Ribeiro, Brazil

    Malu Araujo Ribeiro, Brazil

  • Maria Santos Garcia Tellez, Mexico

    Maria Santos Garcia Tellez, Mexico

  • Verónica Isabel Castro Molina, Argentina

    Verónica Isabel Castro Molina, Argentina

  • Gisli Jonasson, Iceland

    Gisli Jonasson, Iceland

  • Ching-Liang Chu, Taiwan

    Ching-Liang Chu, Taiwan

  • Rosie Riley, USA

    Rosie Riley, USA

  • Ada Garrido Benavidez, Mexico

    Ada Garrido Benavidez, Mexico

  • Michael Lee, Australia

    Michael Lee, Australia

  • Jon Newsome, USA

    Jon Newsome, USA

Learn more about the March of Faces

Footer

Stay connected to the global ALS/MND community.

Subscribe to receive our newsletter and updates on how to get involved across the Alliance network.

 
This field is for validation purposes and should be left unchanged.
  • Email
  • Facebook
  • LinkedIn
  • Twitter
  • YouTube
Return to top of page

Contact | Disclaimer | Privacy Notice & Cookies | Sitemap

Copyright © 2026 The International Alliance of ALS/MND Associations. All rights reserved.


Registered in England: Charity Number 1079504 · Site built by graphics.coop · Powered by WordPress · Members' login