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Driving oncology research progress through access to early-phase trials

By Emiliano Calvo, MD, PhD, and Victor Moreno, MD, PhD, The START Center for Cancer Research

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The START Center for Cancer Research represents a global team of leading investigators in medical oncology, driven by a commitment to improving clinical trial access for patients treated in community oncology centres.

Emiliano Calvo, MD, PhD, and Victor Moreno, MD, PhD, serve as Directors of Clinical Research at START Madrid-CIOCC and START Madrid-FJD, respectively.

As Spain has become an increasingly important player in the clinical research landscape, Drs Calvo and Moreno have experienced first hand the value of accessible clinical research in advancing cancer treatments.

In this article, they share their perspectives and experiences in Spain’s growing landscape of early-phase oncology trials, how a strong clinical trial infrastructure serves patients and researchers alike, and how stakeholders can continue this momentum.

What does the oncology treatment landscape look like in Spain, and how do patients typically get involved with clinical trials? 

While Spain has a robust public healthcare system, and roughly a quarter of citizens also hold private coverage, it can be difficult to get reimbursement for the newest or most specialised oncology treatment options, such as novel immunotherapies.

Clinical trials can be a path to accessing novel therapies within the public or private system.

Fortunately, clinical trials are a massive part of cancer care in Spain, largely due to strong collaborative efforts between our healthcare system and the pharmaceutical industry.

Spain is first in Europe and second globally, behind only the United States, for oncology clinical trials.

Oncology residency programs in Spain have a mandatory rotation in Phase I clinical research units, making our providers well-acquainted with the trial experience.

There is strong coordination and communication throughout the healthcare system, so even though clinical research is conducted mainly in large academic hospitals in major cities, patients outside of these areas are readily referred to trials. 

Why is patient access to Phase I clinical trials so important? 

Clinical trial access is vital to expanding patients’ opportunities and alternatives for care.

Phase I trials, in particular, can open doors to the most innovative, ground breaking therapeutic candidates.

Every approved drug started in a Phase I trial – these studies form the foundation of every improvement in cancer care and our understanding of safe and effective therapies.

For many cancer patients, participating in a Phase I clinical trial may be their only feasible option for accessing a potentially successful treatment.

In these cases, access to a trial can be a much-needed source of hope.

Increasing access to these trials also benefits the oncology research community as a whole and has been an instrumental part in bringing so many clinical trials to Spain.

Successfully recruiting and retaining patients in studies at our public or private medical centres shows sponsors that these sites can support high-quality research.

By building this strong track record, we can attract more research funding, make clinical research an accessible treatment option for even more patients, and play a more prominent role in driving drug development forward.

How does START Madrid exemplify the value of wider patient access in clinical research?

Since the first START Madrid location opened in 2009, we have worked to make Spain a leader in oncology research.

At our inception, very few Phase I oncology trials were conducted in Spain.

START worked closely with regulators and pharmaceutical companies to bring more trials to Madrid, which, in turn, led other centres to build more substantial Phase I research programs after seeing the growth of START’s model. 

The “revolution” in clinical research in Spain over the last decade has transformed patients’ access to novel and experimental therapies, brought more specialised trials to large public and private hospitals, and strengthened the culture of clinical research across the country.

More advanced studies, such as cell therapy trials, require a multidisciplinary approach with precise coordination between every part of the research team.

Now that Spain has that level of clinical research infrastructure, we can commit to supporting more innovative and sophisticated trials and making novel therapies accessible to more patients.

What are some of the most exciting developments in oncology research? 

While immunotherapies were a primary focus in oncology research roughly a decade ago and it is still an area of continuous innovation, we are now pivoting to more targeted therapies tailored to the unique molecular profiles of patients’ cancers, as antibody-drug conjugates.

In Spain, 30 per cent of all personalised medicine clinical trials are now in oncology.

There’s a major research push to expand cell therapy from haematological applications to successfully target solid tumours. T-cell receptor (TCR)-focused therapies are exciting for this area.

TCRs are capable of recognising intracellular tumour-associated antigens, which opens a broad new range of possible solid tumour targets.

Additionally, antibody-drug conjugates are extremely promising as a way to deliver cytotoxic drugs directly to a tumour site while sparing normal, healthy cells. 

How can stakeholders in the clinical research community continue to drive trial success and therapeutic innovation? 

It’s become clear that the clinical trial landscape is changing across indications, and we must adapt to keep up.

Efforts that support a robust clinical trial infrastructure, such as sophisticated data management systems, will be key in maintaining our momentum in clinical research and ensuring we can reach as many patients as possible.

Investing in our infrastructure will also help to facilitate decentralised trial activities and make research participation more accessible and patient-friendly. 

In oncology research, referring physicians are often the first point of contact for patients and play a pivotal role in identifying eligible candidates for clinical trials.

Fostering strong relationships with referring oncologists can ensure a steady flow of patients into our trials, which is essential for the advancement of new therapies and providing hope for patients who have failed standard of care.

By continuing to advocate for clinical trials and build strong records of clinical research excellence, we can continue to attract interest in trial funding and show sponsors that our centres can conduct high-quality research with a large patient population.

At START, our collaborative relationships with biopharmaceutical companies and referring physicians have enabled us to build a strong foundation of research success and provide cutting-edge treatment options to our patients.

We are proud to continue our contributions to driving innovation in oncology and improving the lives of those affected by cancer. 

Emiliano Calvo, MD, PhD, is currently a senior clinical investigator at START Madrid-CIOCC (Centro Integral Oncológico Clara Campal) hospital, in Madrid, Spain, and its director of Clinical Research since its launch in 2008, as well as the President of START Europe.

He is also the President and co-founder of the non-profit organisation Investigational Therapeutics in Oncological Sciences (INTHEOS) Foundation.

In addition, he is Full Professor (Profesor Catedrático) in Oncology and Director of the Oncology PhD/Doctorate Program at Universidad CEU San Pablo in Madrid, Spain.

Victor Moreno, MD, PhD, is Director of Clinical Research at START Madrid-FJD.

Dr Moreno has been a recipient of several awards and grants including 2011 ASCO Merit Award and Grant in 2011 for the 13th Joint ECCO – AACR – EORTC – ESMO Workshop on “Methods in Clinical Cancer Research” and is a member of the Executive Committee of the +MIR group in the Spanish Society of Medical Oncology (SEOM).

He has co-authored more than 40 scientific papers published in such medical journals as New England Journal of Medicine, Lancet Oncology, Journal of Clinical Oncology, Clinical Cancer Research and Nature.

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