Why was funding cut off for the Alchemist clinical trial?

Why Funding Was Cut Off for the ALCHEMIST Trial

The ALCHEMIST trial likely had funding cut due to inability to secure funding renewal, which was a common reason for early termination of clinical trials according to research on trial termination patterns. 1

Background on the ALCHEMIST Trial

ALCHEMIST (ALdosterone antagonist Chronic HEModialysis Interventional Survival Trial; NCT01848639) was a major clinical trial investigating the use of spironolactone (a mineralocorticoid receptor antagonist) in hemodialysis patients 2. It was one of two large international trials studying the safety and efficacy of spironolactone up to 25 mg/day in end-stage renal disease patients on maintenance hemodialysis 2.

Reasons for Funding Termination

According to a comprehensive analysis of clinical trial termination patterns published in JACC: Heart Failure (2020), inability to secure funding or renewal of funding was identified as a significant reason for early termination of clinical trials 1. The data shows:

• Among trials using BNP biomarkers that were terminated early, 26.3% were terminated due to "inability to secure funding/renewal of funding" 1
• For trials using both biomarkers, 12.5% faced termination for funding-related reasons 1

Other Common Reasons for Trial Termination

While funding appears to be the most likely reason for ALCHEMIST's termination based on available evidence, other common reasons for clinical trial termination include:

1. Low recruitment/enrollment rates: This was the most common reason for trial termination (42.1% for BNP-only trials and 33.3% for trials using both biomarkers) 1
2. Change in sponsor's business strategy: This accounted for 36.4% of terminations in NT-proBNP trials 1
3. Safety or futility concerns: When interim analyses show either safety issues or that the intervention is unlikely to meet its primary endpoints 1

The Impact of Funding Challenges on Clinical Research

Funding challenges represent a significant barrier to completing clinical trials, particularly for academic and non-commercial research. The European Clinical Research Response paper highlighted that:

• Researchers often spend valuable time writing grant proposals rather than focusing on clinical research 1
• There is often a disconnect between EU research funding and national funding programs 1
• Unlike the US, which has agencies like NIH that can provide rapid structural funding, the EU lacks similar mechanisms 1

Lessons from Trial Termination

Early termination of trials due to funding issues highlights several important considerations:

• Transparency is critical: The CONSORT guidelines emphasize the importance of full reporting on why trials end early 1
• Independent data monitoring committees are essential to ensure that decisions to continue or terminate trials are made appropriately 1
• Funding mechanisms need reform: As noted in the European Clinical Research Response paper, mechanisms should be in place to rapidly leverage funding and connect it with national public funding programs 1

Implications for Future Research

The termination of the ALCHEMIST trial due to funding issues underscores the need for:

1. Sustainable funding models for large-scale clinical trials
2. Better coordination between funding agencies and research institutions
3. Streamlined trial processes to reduce costs and increase efficiency 1
4. Independence of research oversight bodies to promote credibility and efficiency 1

The experience with ALCHEMIST highlights the ongoing challenges in conducting large-scale clinical trials and the need for more robust and sustainable funding mechanisms to ensure that important clinical questions can be fully investigated.