The “Fostering a European Research Area for Health” (ERA4Health) ERANet Programme recently announced the launch of the EffecTrial call, a pioneering opportunity within the field of non-communicable diseases (NCDs). EffecTrial is designed to foster collaborative, multi-country Investigator-Initiated Clinical Studies (IICS), a call format that allows for pragmatic, comparative-effectiveness clinical trials. These studies aim to assess the real-world impacts of healthcare interventions across diverse European populations. And you Nanomedicine stakeholders should take a very active role in it! Here’s why.

The primary focus areas of the EffecTrial call include:

• Cardiovascular diseases
• Metabolic disorders (including diabetes)
• Nutrition- and lifestyle-related diseases
• Non-communicable respiratory diseases (such as COPD)

What Are IICS and Why Are They Important?

IICS trials are unique in that they are typically designed by independent investigators rather than pharmaceutical companies, enabling a greater focus on real-world healthcare needs, including long-term outcomes. In the context of EffecTrial, the goal is to conduct pragmatic, randomized trials that evaluate the comparative effectiveness of existing interventions. This includes treatments already available but whose relative benefits and potential drawbacks can be further clarified through direct comparison. Unlike standard clinical trials, which often prioritize tightly controlled conditions, IICS trials take place in routine clinical settings, allowing for data that more accurately reflects daily medical practice.

EffecTrial is particularly relevant for clinical innovations with a patient-centric approach. These studies are expected to provide concrete evidence for health policy and clinical decision-making by producing results that are directly applicable to varied healthcare environments across Europe.

Call Requirements and Key Dates

To align with the call’s objectives, EffecTrial seeks proposals that are:

• Pragmatic and designed as comparative-effectiveness trials
• Conducted as randomized interventional trials
• Focused on one or more of the medical fields mentioned in the scope

Key Dates

• Publication of EffecTrial call: November 20, 2024
• Webinar Infoday: November 27, 2024 => ALL INFO HERE
• Deadline for pre-proposal submission: January 28, 2025
• Deadline for invited full proposal submission: June 17, 2025
• Expected project start: January – May 2026 (depending on national processes)

For full details, visit the ERA4Health announcement of the EffecTrial call.

ETPN’s Role: Why Nanomedicine is Highly Relevant to EffecTrial

While EffecTrial does not explicitly mention nanomedicine, solutions within nanomedicine remain fully eligible, provided they align with the call’s medical focus areas and trial criteria. Based on the recent feedback from our ETPN community consultation on IICS, we identify several ways nanomedicine can make a valuable contribution to the objectives of EffecTrial:

1. Addressing Core Medical Focus Areas Through Precision Medicine
   Nanomedicine’s innovative drug delivery platforms have clear applications in cardiovascular and metabolic diseases, non-communicable respiratory conditions, and beyond. Specifically:
   • Cardiovascular and Metabolic Disorders: Nanoparticle-based delivery systems can precisely target cardiovascular tissues, optimize the repurposing of existing drugs, and reduce systemic side effects.
   • Respiratory and Lifestyle-Related Conditions: Controlled-release nanotechnologies support sustainable, long-term treatment approaches, essential for lifestyle-based interventions and adherence.
2. Supporting Comparative-Effectiveness Through Enhanced Drug Repurposing
   One of the key insights from our consultation was the interest in optimizing existing treatments through nano-delivery systems. Although drug repurposing itself is not directly covered by EffecTrial, nanomedicine can enhance the performance of established treatments by improving their pharmacokinetics, bioavailability, and safety profiles. This aligns with EffecTrial’s goals by enabling more precise comparisons of established treatments, especially within the program’s targeted medical conditions.
3. Strengthening Patient-Centric, Real-World Trial Designs
   EffecTrial seeks pragmatic, comparative trials that bring real-world relevance to clinical settings. Nanomedicine can add value here through:
   • Multi-Drug and Targeted Delivery Systems: Nanotechnology allows for combinations of therapeutic agents to be delivered to specific sites in the body, offering better management of complex diseases with comorbidities.
   • Patient Adherence and Safety Monitoring: Advanced nanomedicine platforms can be designed for longer release profiles and monitored uptake, which is advantageous for adherence and aligns with real-world data needs.
4. Alignment with ERA4Health’s Vision for Ethical and Inclusive Research
   The call highlights the importance of Responsible Research and Innovation (RRI) principles, including inclusivity and measurable public health impact. Nanomedicine projects that prioritize these goals can further enhance the value of EffecTrial by:
   • Incorporating Comprehensive Data and Compliance Standards: Nanomedicine research often involves robust data management standards, which align well with EffecTrial’s expectations for GDPR and FAIR-compliant practices.
   • Expanding Access to Underserved Populations: Through enhanced safety and precision, nanomedicine solutions have the potential to improve treatment outcomes in diverse and underserved populations, including older adults and individuals with complex, chronic health needs.

Practical Tips for Preparing a Strong Application

To help ensure success, here are some essential tips for preparing your application for the EffecTrial call:

1. Triple-Check the Call Text! Ensure your project falls within the eligible areas, specifically cardiovascular, metabolic, nutrition- and lifestyle-related, or non-communicable respiratory diseases. Studies focused on rare diseases, cancer, infectious diseases, or any combination with these conditions are explicitly out of scope. Also ineligible are proposals on observational studies, cohort studies, basic biomedical research, development of new interventions, Phase I/II trials, placebo-controlled trials, or systematic reviews/meta-analyses.

2. Attend the Info Day on November 27th: The info day webinar is an excellent opportunity to gain insights directly from the ERA4Health team. This session can help clarify expectations, answer specific questions, and set you up for a strong proposal submission.

3. Verify Eligibility for Each Consortium Partner: Each partner’s eligibility is determined by their respective national funding agency, in line with the ERA-NET model where funding comes from national resources. Be sure to confirm that all partners meet the specific requirements of their national funding agencies, as these can vary significantly.

ETPN’s Ongoing Commitment to Supporting IICS for Nanomedicine

The ETPN remains dedicated to advancing nanomedicine’s role in European clinical research. With our community’s insights from the recent consultation, we understand the crucial impact that IICS can have on patient outcomes and public health. We will continue to support the dissemination of this call, the upcoming November 27th infoday, and additional ERA4Health activities, encouraging eligible nanomedicine projects to engage with EffecTrial.

We also encourage you to attend in November 11^th a dedicated webinar focused on these types of clinical studies feat. Dr. Frank Hulstaert, M.D., Senior Researcher at the Belgian Health Care Knowledge Centre (KCE). He will present a discussion on “Pragmatic Comparative-Effectiveness Randomized Trials: Real-World Evidence for Better Health Decisions.

Looking Forward
The ETPN is optimistic about future IICS calls that might highlight nanomedicine even more explicitly. Meanwhile, we are here to support and guide the nanomedicine community, ensuring that innovative projects align with the EffecTrial objectives and contribute meaningfully to advancing comparative-effectiveness research in Europe.

Contact information for Effectrial

• Main contact; Joint Call Secretariat (JCS) – Astrid Valencia Quiñónez and Sara García-Rodríguez (ISCIII)
  EffecTrial@isciii.es
  For more information, please visit ERA4Health’s website and stay tuned for updates on upcoming events and calls.

Explore and Join the EffecTrial Call !
If your nanomedicine project aligns with the EffecTrial objectives, we encourage you to consider applying. This call is an invaluable chance to bring groundbreaking nanomedicine solutions to real-world clinical settings across Europe.