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 When registry information is inaccurate, incomplete, or outdated, patients can lose valuable opportunities to participate in research, and confidence in the research ecosystem is undermined.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