UNDERSTANDING THE CLINICAL TRIAL LANDSCAPE
EuroACT builds upon a research project initiated by Myeloma Patients Europe where data on clinical trials and QoL instruments over a period of 20 years was collected. The data gathered focused on myeloma in Eastern countries of Europe.
To be able to compare across disease areas, identify gaps, and overcome challenges, more evidence is needed. EuroACT expands the scope of the project to 27+ diseases areas in the WHO European Region over a period of five years.
Hypothesis: Most clinical trials are run in a few European countries and some countries are neglected
Access to clinical trials is a topic that features highly on the agenda of most European patient organisations, particularly those advocating on behalf of patients with cancer, haematologic, and rare diseases. Patient access to trials is hugely important. Clinical trials provide the option to access new and emerging therapies which can present additional options for survival, preventing, delaying, or reversing disease progression, and improving or maintaining quality of life. In addition, access to trials within a patient’s country of residence improves the likelihood of the studied medicine or therapy becoming available to patients within that country.
Often, patient organisations will engage in dialogue with pharmaceutical companies to attempt to understand and address the issue around inequities in access. Patient organisations frequently report frustrations in their efforts, particularly when asking pharma to address the question of access in Central and Eastern Europe, or outside of the “Big 5” economies (France, Germany, Italy, Spain and the UK).
Data gathered by this project will provide the evidence of the clinical trial landscape in Europe. With this evidence, patient organisations can engage in more meaningful conversations with stakeholders on challenges, patterns, and opportunities for improving access to clinical trials.
Hypothesis: Many clinical trials are conducted with meaningless or no PRO (Patient Reported Outcome) and HRQoL (Health Related Quality of Life) measurements.
When considering the issue of quality of clinical trials, patient organisations also raise concerns about the tools used to measure PRO / HRQoL in trials where collection of data takes place. An increasing number of validated generic, symptom-specific and disease-specific measures for PRO / HRQoL exist, but they are not used consistently or in a meaningful way. Patient organisations are keen to gather data on understanding not only whether PRO / HRQoL tools are used in studies, but which of those tools are utilised in clinical trials to advocate for utilisation of the tools considered meaningful for PRO / HRQoL measurement and make recommendations for best practice around PRO / HRQoL tools utilised within respective disease areas in clinical trials.