Challenges and opportunities for Multi-National Investigator-Initiated clinical trials for ALS: European and United States collaborations

Abstract

An inherent challenge to clinical trials that aim to test the efficacy of experimental therapeutics for patients with amyotrophic lateral sclerosis (ALS) is the relative rarity of the disease. A promising solution to this problem is a multi-center approach that ideally includes sites distributed across a broad geographic area. In support of such an approach, the European E-RARE program and the United States National Institutes of Health (NIH) partnered to support the investigator-initiated ROCK-ALS trial (Eudra-CT-Nr.: 2017-003676-31, NCT03792490) as a multinational collaboration between centers in Europe and North America that is led by European investigators. During the setup of this international trial, however, a number of unanticipated legal, administrative, and financial complexities emerged that required significant adaptation of the proposed trial scheme. Here, we report our experience navigating these obstacles and describe the potential solutions that we explored. Our experience may inform future efforts to implement multinational investigator-initiated trials that involve both European and United States centers.

COVID-19 associated coagulopathy: A bibliometric investigation

“…Because authorship has grown exponentially but the number of joint publications has only climbed linearly, it is suggested that connection is deepening. Changing cooperation patterns in Europe are believed to be a result of the European Commission's Framework Programmes' cohesion elements, which promote multi-national collaborations regardless of scientific quality [ 43 ]. VOSviewer was used in this study to visualize the co-authorship between authors.…”

When innovation outpaces regulations: The legal challenges for direct‐to‐patient supply of investigational medicinal products

“…In extension to UK–EU database recognition, there is also a need for regulatory acceptance of equivalent international databases, facilitated through the World Health Organization International Clinical Trials Registry Platform, 61 to include guaranteed and accepted standards for anonymity protection for the personal data of patients and trial participants between the UK and the US. 62 , 63 …”

Operational complexities in international clinical trials: a systematic review of challenges and proposed solutions

“…21 24 This required additional administrative steps. 24 To overcome these challenges, INSIGHT (International Network for Strategic Initiatives in Global HIV Trials) established coordinating centres in several countries that were geographically closer to sites, familiar with local regulatory requirements and fluent in local languages which improved the contract negotiation process. 23…”