Early Phase Clinical Trials Unit (UEFP)

Since the creation of the IPO Porto’s Clinical Research Unit (CRU) in 2006, the institution has strengthened its position as a national reference center in clinical research. Urged by the accelerated evolution in the field, namely with the development of innovative clinical trial designs, and the consequent complexity and demanding operational requirements, the Early Phase Clinical Trials Unit (UEFP, Unidade de Ensaios de Fase Precoce) was formally established in 2019 as part of the IPO Porto’s CRU, with three main objectives:

– To promote patients access to innovation through clinical research;

– To implement and develop a molecular screening program to expand the opportunities of biomarker driven clinical trial access;

– To drive scientific collaboration with academic/non-commercial partners, biotech and pharma companies, focusing on translational research and early drug development;

Molecular Screening Program

The Molecular Screening Program was promptly settled within the UEFP, catalysed by the participation in the SPECTA Project from EORTC, a pan-European translational research platform (https://spectaplatform.org/projects/), but also through the implementation of the Precision Oncology Program at IPO Porto (POP-IPOP). POP-IPOP is a local tumor type-agnostic prospective observational study to evaluate the feasibility of using molecular profile-based evidence to propose individualized cancer therapy for patients with advanced/refractory rare or hard-to-treat cancers.

 

 

Molecular Tumor Board

Considered as a critical tool within the Precision Oncology strategy, IPO Porto’s Molecular Tumor Board (MTB) aims to provide access to multidisciplinary decision-making platform not only at a local but also at a national level. Therefore, are also admitted for MTB discussion (for second opinion consultation) cases of patients from other institutions who performed comprehensive genomic profiling proposed by their attending Oncologists. The MTB has an important role in the definition of standards for testing and guidance for the decision process of treatment recommendations, triggering scientific discussions and medical educational on emerging biomarkers and therapeutical targets. Ultimately, the MTB will attempt to improve patients’ referral to (innovative) clinical trials, reducing the allocation to off-label treatments. This strategy will allow patients’ access to cutting-hedge health technologies and also to attract more international resources, contributing for the national scientific and economic growth and sustainability of public health eco-system.

 

 

These strategies reinforce the Precision Oncology as one of the cornerstones of the institution and comply with the most recent ESMO (European Society for Medical Oncology) recommendations that strongly support the clinical research centres to perform multigene sequencing as part of their missions to accelerate cancer research and drug development.

 

Main Projects in Precision Medicine in Oncology
PCM4EU 

https://www.linkedin.com/company/pcm4eu/

Personalised Cancer Medicine for Europe (PCM4EU), is a project funded by the EU4Health Programme with partners from 15 countries across Europe.

The success of Precision Oncology depends on access to adequate molecular diagnostics and access to clinical trials to move towards implementation. The PCM4EU consortium aims to improve inequalities in access to PCM currently existing between and within EU countries and increase survival and quality of life of cancer patients in the EU using PCM based on best practices.

The PCM4EU consortium has an established experience in implementing molecular diagnostics coupled with investigator-initiated drug repurposing PCM trials in European countries, based on the experience of the Drug Rediscovery Protocol (DRUP) trial developed in the Netherlands. These projects effectively act as an ‘implementation device’ for PCM and aim to expand access to drugs besides generate clinical evidence; PCM4EU aims to increase the European reach of this network. This consortium will evaluate current standards and will provide best practice guidelines and recommendations on state-of-the-art genomics diagnostics, implementation and interpretation. Through harmonisation and collaboration the consortium will enable evidence generation for rare mutations/tumour types collecting data simultaneously in multiple countries to obtain faster answers and also, will facilitate interpretation of molecular and clinical data. Cross-border access to PCM clinical trials is another focus points of this consortium, together with the promotion of education for all stakeholders, including physicians, pathologists, patients and decision makers.

 

PRIME-ROSE

PRecisIon Cancer MEdicine RepurpOsing SystEm Using Pragmatic Clinical Trials (PRIME-ROSE) is the next step in the evolution of PCM4EU project, focusing on the development and implementation of investigator-initiated “DRUP-like” clinical trials in participating institutions. The main objective of these trials is to assess the efficacy and toxicity of commercially available, targeted anticancer drugs for the treatment of advanced cancer presenting a potentially actionable alteration. The trials incorporates three subsequent stages, opening according to the success of current cohorts. The main goal of PRIME-ROSE is to increase access to optimised and affordable treatment interventions that prolong life and increase cancer patients’ quality of life. This project will generate clinical evidence and evaluating effectiveness of PCM strategies, promoting evidence-based treatment interventions that improve outcomes in cancer care. Additionally this consortium will work together with regulators, policymakers, payers, healthcare providers and patient advocacy groups to implement evidence-based PCM in routine practice, facilitating implementation of the results into the healthcare system in a cost-effective way for future patients.

 

 

SPECTA: Screening Cancer Patients for Efficient Clinical Trial Access

 https://spectaplatform.org/projects/

SPECTA is a collaborative European platform from EORTC (EORTC Protocol 1553, NCT02834884), created to promote development of translational research projects in Europe, mainly focusing on the biological aspects of cancer, including molecular profiling and personalized therapy. As several sub-projects are in the Protocol pipeline, there is a constant update regarding which ones are recruiting, in the final analysis or even in development.

The opportunity to learn more about the integration of comprehensive molecular profiling in the management of cancer patients, the possibility to generate relevant translational and clinical evidence by participating within a European Collaborative Project and the opportunity to offer additional treatment strategies to our cancer patients motivated the IPO Porto team to be fully committed with SPECTA. As this Project became an important and strategic instrument, IPO Porto was even considered as SPECTA Best Recruiter in early 2020, due to the active enrolment of patients in three downstream projects (1759 AYA, 1743 Arcagen and 1828 IMMUcan).