Revitalising clinical trials in Alzheimer's Disease in Europe: exploring ways to enhance the clinical development
Patricia Paukovits, Medical Affairs Advisor, Neurology at Eli Lilly, discusses the challenges faced by the pharmaceutical industry and explores ways to enhance the clinical development of Alzheimer’s disease (AD) research in Europe.
In summary :
Improvements in Europe’s clinical trials environment are needed to make progress for patients today, especially for challenging conditions such as Alzheimer's Disease (AD), where therapeutic options are limited and the burden on patients and caregivers continues to grow. Public funding plays a crucial role in fostering innovation within the EU, yet the private sector’s involvement, particularly in clinical development, is essential.
The development of new medicines takes many years and is costly and risky, with a large proportion of drug candidates never reaching the market. The complexity and risks associated specifically with the final stages of clinical research demand substantial investments and operational capabilities. Some areas of clinical research fail more often than others, with AD being one of the riskiest with very low success rates and high costs. It is estimated that over the past 25 years, more than $24 billion has been spent on phase III AD clinical research. One of the main challenges in AD research is finding treatments that are both effective in slowing disease progression and safe to administer.
This complexity, combined with the low probability of achieving positive results, has led many pharmaceutical developers to abandon the field. However, recent progress has led to the identification of valid targets and biomarkers. This progress, coupled with refined clinical trial designs and execution strategies, has ended years of setbacks in the area, resulting in the first effective disease-modifying drugs reaching the regulatory approval stage.
To counter this trend and restore Europe’s competitiveness in AD clinical trials, benefiting both patients and health systems, the following key actions are proposed:
Harmonise clinical trial approval processes and facilitate stakeholder cooperation i.e., sponsors, sites, regulators and Ethics Committees.
Collaborate to develop measures and propose changes to break down barriers and streamline and shorten processes.
Improve regulators resourcing, foster multistakeholder dialogue and promote flexible regulatory – industry interactions.
Cut red tape to enable cross-border access to clinical trials.
Develop new approaches to raise awareness and improve access to trials.
EU-CAR 2024-150
Tags in this Article:
No categories
Related articles
EPP says EU needs Alzheimer’s plan with concrete measures and deadlines
We understand the burden that Alzheimer’s disease (AD) places on individuals, caregivers and societies, and have dedicated more than 30 years to advancing the science of this devastating disease. We continue to encourage the recognition of initial cognitive changes caused by AD and the need to arm clinicians with resources to support early and accurate diagnosis, and for policymakers to provide investment in services and access to new therapeutics that strike at the potential causes of disease.
Building a robust diagnostic pathway for Alzheimer’s Disease
To help tackle the rising burden of Alzheimer’s disease (AD), dementia services should be structured to keep people in better health for as long as possible. Lilly is calling on clinicians, payers and policymakers to place greater emphasis on practices and programs that can increase awareness and understanding of AD, support timely action when cognitive changes are first noticed and recognize the importance of an accurate diagnosis in early symptomatic AD.
Progress on Alzheimer’s Disease stagnating, warns Alzheimer Disease International CEO...
While stopping the progression of Alzheimer’s disease is not yet possible, hope is on the horizon in the form of new breakthroughs in diagnostics and new treatments. Yet scientific advances alone are not enough; public awareness, clinical practice and healthcare systems across the world must evolve in-step with scientific progress to drive confidence in what can now be achieved and deliver meaningful change for those affected.