Written by:
Dr. Liz O’Brien, Therapeutic Expert, Oncology & Women’s Health, Drug Development Solutions, ICON
World Cancer Day’s campaign theme is “united by unique”. It invites the world to see people living with cancer as “more than a disease, more than a statistic”. For oncology sponsors it is a day to reflect on progress made on evidence and treatment access. While each patient’s experience is unique, their access to new treatments should be equitable.
World Cancer Day is also a timely point to consider how the EU Joint Clinical Assessment (JCA) is changing oncology studies since it came into effect just over a year ago.
What is the EU Joint Clinical Assessment (JCA)?
This is a European Health Technology Assessment (HTA) initiative implemented in January 2025 for oncology products and advanced therapy medicinal products (ATMPs). The JCA process includes 27 EU countries plus Norway, Switzerland, Ukraine, and the UK. The aim of this regulatory change is to ensure that clinical effectiveness assessments are harmonized and fair across Europe. However, its consequences have spread beyond Europe, changing the design and execution of global trials. It aims to accelerate access to medical products for patients across Europe. The new process streamlines the procedure for applicants, improving coordination across member states. The rollout of the JCA will continue with rare disease treatments in 2028 and all medicinal products by 2030.
How JCA is Changing Trial Design and Protocols
The change in regulations is compelling sponsors to answer more difficult questions, and to do so earlier in their research. It changes the focus of trial design and protocols from the historic model of designing trials for the FDA, with Europe considered afterwards. That approach will no longer work; comparator choices must now withstand pan-European scrutiny. Studies now have a single, central, clinical value assessment shared across 27 EU member states and the additional four non-EU countries. Europe should be viewed as a prospective influencer on evidence generation rather than a late addition to protocol or clinical development programs (CDPs).
What JCA Means for Patients
Underpinning JCA assessment is the formulation of a defined research question using the Population, Intervention, Comparator(s), Outcomes (PICO) framework. Patients and their experiences are central to everything. JCA ensures that access to clinical trial participation and new treatments is equitable across the participating countries. For a long time, oncology patients in one part of Europe did not get the same treatment as their counterparts elsewhere. With JCA, that is changing. The focus on clinical value encompasses quality of life and the patient experience. Comparator justification must be relevant, accepted and reflective of current clinical practice. When implemented early, this changes everything that follows for the patient. A shared JCA reduces the duplication of assessments across countries, potential resulting in faster access to new treatments and reducing the postcode lottery and other disparities. National payer bodies will still decide which new treatments to reimburse based on health economics outcome reporting (HEOR ), but the JCA makes it easier for new treatments to cross borders to reach more patients sooner.
Patients are now, as they should always be, at the center of oncology trial design.
It is no longer enough to show that a new oncology treatment is as effective and safe as other available treatments. It must be clinically meaningful and an advancement from the patient perspective. Endpoints still include traditional oncology markers such as survival and progression. In addition, patient-focused endpoints once viewed as nice-to-haves are now must-haves, including time to next treatment (TTNT) and patient quality of life.
Early Planning and Engaging with Patient Groups
For effective JCA submissions, clinical value must be demonstrated much earlier in drug development, ideally from phase 2. Early planning is crucial to anticipate JCA expectations. Draft PICOs should be shared with patient groups, key opinion leaders and other stakeholders. The input from patients and stakeholders should be captured in the JCA. This necessity will lead to strengthening patient and clinician networks to ensure their engagement and accurately reflect their inputs. This offers sponsors an opportunity to listen and understand oncology patients and see the drug development process through their eyes.
JCA One Year Later
A year is not a very long time in drug development. However, one year after JCA, implementation patterns are emerging in oncology drug development. More patient reported outcomes (PROs) are being integrated into studies. HEOR teams in clinical research organizations (CROs) are deeply engaged in cross-functional work with oncology drug development teams. For oncology patients a year can be the difference between illness and regained health, or indeed between life and death. An additional year means more time to spend with the people they love and being able to enjoy life. People with cancer enable clinical trials through their participation and they have the highest stakes in the complex world of developing oncology treatments and ATMPs.
As drug developers and researchers, we need to remember those people, united by unique, every day of every year, not just on World Cancer Day.