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Clinical Optimisation & Patient Centricity

30 September-2 October 2019
Barcelona, Spain

Vall D'Hebron Hospital has become a reference centre at the national level in Spain among the best hospitals in the nation. What role is the hospital playing in Clinical Trials and especially in Oncology, with its oncology research centre of excellence (VHIO)?

Vall d’Hebrón Hospital is the health centre with the largest number of oncology clinical trials in Spain, and among the top five oncology research centers in Europe. We have a long history in oncology research, having had a leadership role in the development of such important drugs as trastuzumab or neratinib, and we are currently among the leaders in immunotherapy trials. We emphasize initiating phase I clinical trials, allowing us to be immediately selected to subsequent phase II and phase III clinical trial when the drug shows promising activity and safety profile.

Your role at the VHIO is to coordinate, orchestrate clinical trials, usually as a pivotal person of the clinical trials gear. Communicating with sponsors, physicians, researchers and patients is your day to day activity. How do you succeed in coordinating such radically different characters that face such different challenges?

While dealing with various interests, to me, the most important thing is to be careful what information I transmit to patients. They always want to know how the other patients are doing from the same clinical trial. Telling a patient that, from the hospital experience, the clinical trial is not being effective will upset them, when it is possible that it may work for them. We always try to tell them that we are doing research, meaning that we do not know if it works or not, and that every patient is different.

We are also creating a collaborative environment with various specialists within the hospital. The new therapies being tested are antibodies and targeted therapies, which work very different than standard chemotherapy. We are currently working closely with dermatologists, endocrinologists, ophthalmologists and internists because of the side effects of these drugs. Furthermore, current clinical trials are getting more complex, combining intravenous therapy with radiotherapy, or doing intratumoral injections of the drug, requiring an ultrasound to guide the needle placement. Due to that, radiotherapists and radiologists are also part of the medical team in those trials.

The interaction with the sponsor is usually smooth, being able to routinely ask for doubts and clarifications of the protocol. However, sometimes we have to reach an agreement as to whether or not to attribute the side effects to the investigational drug, or to discontinue a patient from the trial. We also discuss the timelines for data reporting or query resolution.

Patient enrollment has become one of the critical inflexion points, as therapies become more and more specific, the patients need to be selected more and more carefully. What tools or strategies are you developing at the moment to overcome this challenge?

We are the largest hospital in the region (2nd in Spain), so we cover a broad area of Barcelona. We are also a Reference Hospital for many medical conditions, and a Reference Research Center, particularly in oncology for the entire country. Therefore, we normally get daily referrals from different hospitals to see if we can offer an opportunity to patients that have no more treatment options in their hospitals.

We are also very active in recruiting, especially due to the fact that we are moving towards personalized medicine and patients have to be positive for a specific biomarker (e. g. PD-L1), mutation (e.g. BRCA) or genomic alteration (e.g. MSI-h) in order to be enrolled in the clinical trial. We send weekly emails to our network of oncologists listing all our open clinical trials and a short description of the target population.

We work hard to give high quality medical care and personal attention to patients, which translates to most of the referred patients remaining at our hospital after participating in the clinical trial. This gives us a larger pool of patients than we should have.

Finding the right patients is undoubtedly a big challenge, but perhaps the problem is rooted in the public's opinion of clinical studies. Do you think society has an unfounded fear towards clinical trials, and if yes, how do you believe we can defeat it?

I believe that certain news has made the public fearful of clinical trials, especially when there have been unexpected adverse events in phase I healthy volunteers or pediatric patients. Unfortunately there is always a risk of something happening, even though we have informatics tools to predict interactions and toxicities, or many animal models to test the drug before humans. However, I feel people are more convinced nowadays that clinical research is necessary, and that every drug in the market needs to be tested in humans in a controlled environment before it can be approved.

In oncology, patients are very open to participating in clinical trials, because in some cases it is the last opportunity for them, and in others, it is a way to improve prognosis or have treatments with fewer side effects. As an example of this, at our Breast Cancer Unit, approximately 50% of our patients are enrolled in clinical trials. And most of the patients that are not enrolled it is because there is not a clinical trial open for their current disease status, or because they don’t meet the eligibility criteria for the ones that are opened.

An interview with:

Ángela Quintana, Oncology Clinical Trials Coordinator at Hospital Vall D’Hebron

This new marcus evans conference will dive into one of the most complex and expensive stages of the development of a novel drug, the development, management, design and organisation of clinical trials. In a time when clinical trials can cost millions, therapies are becoming more and more specific and studies are expanding internationally, there is an increasing need to create robust protocols, meticulous designs and successful partnerships. This new event will not only focus on budget and resource forecasting and controlling, risk management, site activation and CROs partnerships but will also review new trends on the rise such us blockchain, RWE, biomarkers and digital innovative solutions. Our focus will also be towards patients, who have become a pivotal element for clinical trials‘ performance and success.

We aim to bring together the voice of different experts in operations, planning, innovation and coordination of clinical trials, leverage the opinion of all stakeholders and be the catalyst of highly relevant conversations that bring solutions and enhance the performance of an essential gear of the drug development machine.

To view the Conference Agenda, click HERE! 

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About the conference

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Ángela Quintana studied Biochemistry at the University of Salamanca (Spain) and pursued a postgrad program in Applied Biosciences at the Keck Graduate Institute (Claremont, CA, USA). After graduation, she worked in the Oncology Biomarker Development department at Genentech (San Francisco, CA, USA) and in the Medical Affairs department at Grifols (Barcelona, Spain). She is currently enrolled in the PhD program at the Autonomous University of Barcelona studying the role of immune biomarkers at the onset of triple negative breast cancers, as well as understanding better the presence of tumor infiltrating lymphocytes (TILs) in this cancer. She is also engaged as a study coordinator of clinical trials in immunotherapy at Vall d’Hebron Institute of Oncology in Barcelona.

To view the Conference Agenda, click HERE! 

For all enquiries regarding speaking, sponsoring and attending this conference contact:

Yiota Andreou
Email: Yiotaa@marcusevanscy.com
Telephone: +357 22849 404
Fax: +357 22 849 394