In today’s ACT Brief, we examine how sites can avoid both fear-driven and overly aggressive AI adoption, why community-based research needs sustained financial investment, and why patient access matters more than organizational size.
News|Podcasts|October 6, 2026
ACT Brief: Ibogaine Trial Design Guidance, Outsourcing Model Oversight Gaps, and Kidney Disease Partnership
Author(s)Andy Studna, Senior Editor
In today's ACT Brief, we examine FDA input sought on early-phase ibogaine protocols, why mixed outsourcing models spread faster than oversight infrastructure, and a major partnership for a rare kidney disease treatment.
This is the Applied Clinical Trials Brief—your fast track to the latest insights shaping clinical operations and drug development.
- In a
new request for information , the FDA is seeking public input on approaches to early-phase clinical trial design for ibogaine drug products, including dose selection and escalation, care setting, safety monitoring, eligibility criteria, stopping rules, and safety oversight. Comments are due by November 20, 2026, as part of a whole-of-government effort following the Trump administration's April 2026 executive order on accelerating research into psychedelic medicines for serious mental illness. - In a
new FAQ , we examined how mixed outsourcing models combining full-service providers and functional service providers are gaining ground as sponsors seek agility and resource flexibility. However, the oversight infrastructure, audit trails, and accountability structures needed to run these models well and survive regulatory inspection are consistently lagging behind adoption of the model itself. CSL and Alentis Therapeutics announced a global partnership to co-develop and co-promote lixudebart , with CSL paying $355 million upfront plus up to $1.2 billion in milestone payments. Lixudebart is a first-in-class therapy targeting claudin-1 for kidney and liver diseases, currently being evaluated in Phase II trials in patients with rapidly progressive kidney inflammation, with CSL funding completion of Phase II testing and planned Phase III trials across multiple indications.
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