Research and Clinical Trials
Getting Involved in Research
Getting Involved in Research
The patient’s perspective is necessary to ensure that research projects and clinical trials are truly designed with the objective of either improving or saving the lives of people living with breast cancer.
Europa Donna’s recommendations for advocates involved in this area include:
- Making sure that the patient perspective is considered and respected
- Being prepared to provide input and allocate time and effort to fully participate as an equal partner
- Acquiring knowledge and credibility in order to interact as equals with researchers and experts
- Making sure the research/clinical trial protocols are designed according to guidelines for good clinical practice, as described in the EU Clinical Trials Regulation, the European Medicines Agency (EMA), and with the ethical principles set out in the Declaration of Helsinki
- Ensuring that the outcomes and endpoints explored are relevant to patients, including providing input into the draft protocols and subsequent reviews, and requesting updates on progress status and results
- Making sure all patient documents are comprehensive and drafted in clear lay language so that all participants are properly and fully informed and protected
Europa Donna has developed a series of publications, including a training module for advocates who serve on trial committees, to ensure that advocates are well informed about research and clinical trials.
A guide entitled Clinical Trials and Breast Cancer
explains how clinical trials are conducted, the requirements for participation, the risks and potential benefits of participating, and where and how to find them (eg, the EU Clinical Trials website). The booklet also includes a list of questions women can ask before deciding to participate in a trial (eg, What is the aim of the trial? Where will I undergo treatment? What info will be collected and how often? What type of long follow up does it involve? What happens if I decide to leave the trial early?)
The Advocates Guide to Understanding Breast Cancer Research provides an overview of common medical terms and concepts that are necessary to understand and interpret the scientific literature, such as epidemiological studies in breast cancer. It helps provide the health literacy required for advocate to interact with researchers, clinicians, all and the players involved. A glossary outlines basic medical terminology.
Exploring the Role of Advocates in Breast Cancer Research explains what advocates can do and how they can get involved in breast cancer research and make a difference. For example, it explains the clinical trial process, the roles of steering committees and ethics committees, the roles advocates can have on various committees, questions advocates need to ask and the procedures that must be in place for a trial to have a useful impact that truly benefits patients.
Breast International Group (BIG)
This EU Research and Innovation programme designated nearly €80 billion of funding over 7 years (2014 to 2020). Europa Donna continues to participate as the patient advocacy representative on the following funded research projects:
MESI-STRAT Research Project (MEtabolic SIgnaling STRATification): This project is exploring the role of metabolites in biological samples as markers of resistance to endocrine therapy, and relapse. A representative of Europa Donna is a member of the Advisory Board.
More info: https://mesi-strat.eu/
BOUNCE (Predicting Effective Adaptation to Breast Cancer to Help Women to BOUNCE Back project): An interdisciplinary consortium of experts from Italy,
Finland, Israel, Greeceand Portugal is researching factors that influence breast cancer patients’ resilience and ability to return to normal/everyday life and work after breast cancer treatments. A representative of Europa Donna is a member of the External Advisory Panel.
More info: https://www.bounce-project.eu/
MyPEBS (My Personal Breast Screening project): This research project is assessing the effectiveness and feasibility of a personalised approach to breast cancer screening compared with standard breast cancer screening. A representative of Europa Donna is a member of the Independent Ethics and Data Monitoring Committee.
More info: https://mypebs.eu/
PREFERABLE (Project on Exercise for Fatigue Eradication in Advanced Breast cancer to improve quality of life): This project is aiming to generate solid and conclusive evidence of the beneficial effect of structured, individualized exercise on cancer-related side effects and patients’ quality of life. Europa Donna is highly involved in this project, acting as the Project Director, the Project Administrator and the Project Overseer.
More info: https://www.h2020preferable.eu/
INSPIRE (INnovative tools for Safety Pharmacology for Integrated cardiovascular safety assessment to REduce adverse events and late stage drug attrition): This multidisciplinary project aims to identify methods to better screen for cardiotoxicity potential among drug candidates while they are in the preclinical development stage. Europa Donna is a member or the Scientific Advisory Board, provides the patient’s perspective on cardio-oncology, and helps to support the dissemination of research results geared toward patients.
More info: https://cordis.europa.eu/project/id/858070
CARDIOCARE (An Interdisciplinary Approach for the Management of the Elderly Multimorbid Patient with Breast Cancer Therapy Induced Cardiac Toxicity): This multidisciplinary project is using eHealth applications and individualised care plans in elderly patients with breast cancer and cardiovascular comorbidities with a view to identifying biomarkers and improving patients’ quality of life. A representative of Europa Donna is a member of the External Advisory Board.
More info: https://cardiocare-project.eu/
This is the EU’s next Framework programme, a key funding programme for research and innovation with a budget of €95.5 billion. For the years 2021 to 2027, it has five main mission areas, one of which is cancer research and innovation. Europe’s Beating Cancer Plan is part of this mission.
As part of projects funded by this programme, Europa Donna serves on the External Advisory Board of the “4D PICTURE Project-Design-based Data-Driven Decision-support Tools: Producing Improved Cancer Outcomes Through User-centred Research”. This project aims to address gaps in patient involvement in treatment decision-making by creating digital tools that cancer patients and their families and clinicians can use to help support treatment decisions.
Early Breast Cancer Trialists Collaborative Group (EBCTCG)
The main purpose of the EBCTCG is to bring together the worldwide evidence from clinical trials in early (ie, operable) breast cancer to obtain the most reliable possible assessment of the benefits and risks of different treatments. Europa Donna has two representatives on the EBCTCG Steering Committee.
International Breast Cancer Study Group (IBCSG)
Europa Donna has a representative on the Ethics Committee of the IBCSG, a non-profit breast cancer research organisation that performs clinical trials, translational research, and database studies. Patient welfare and quality of life are key research topics.
Innovative Medicines Initiative – OPTIMA
Organisation for Economic Co-operation and Development (OECD) Patient-Reported Indicator Surveys (PaRIS)
Europa Donna participates in regular working group meetings of this initiative aiming to develop and implement standardised patient-oriented measures of health-care performance, including patient-reported experience measures (PREMs) and patient-reported outcomes measures (PROMs), such as patient satisfaction measures following breast cancer surgery.
The OECD Health At A Glance provides data comparing health system performance in OECD countries.
EU Clinical Trials Regulation
The EU Clinical Trials Regulation (CTR) entered into application on 31 January 2022 and harmonises the processes for assessment and supervision of clinical trials throughout the EU. It centralises the clinical trial application system so that applications and approval to run a clinical trial are processed via a single online platform, the Clinical Trials Information System (CTIS), run by the European Medicines Agency (EMA). The public can also search for clinical trials using the EU Clinical Trials website. The CTIS includes strict measures to protect personal data. The EMA is a decentralised EU agency responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU.
The Clinical Trial Regulation was first published in 2014. Europa Donna has been involved in promoting the application of this regulation via activities at the European Parliament.