In the wake of a highly successful top-level, annual conference in Brussels earlier this month, the European Alliance for Personalised Medicine (EAPM) will be taking its messages to Madrid for a roundtable meeting at the prestigious ESMO conference – a yearly gathering of Europe’s oncologists.

High on the agenda will be the impact of data protection on research as well as the subject of clinical trials, also in relation to research.

EAPM’s recently released conference report highlights many of the barriers in the way of making personalised medicine a reality for 500 million citizens across 28 Member States

The data protection and clinical trial rules are complex, as is the whole field of regulatory affairs in the European Union. Certainly this is the case when it comes to legislating for the exciting advances and growing expectations brought about by personalised medicine, with its goal of giving the right treatment to the right patient at the right time.

The issues surrounding, for example, data protection are labyrinthine. Yet despite the complexity, this topic – and that of clinical trials - needs to be addressed swiftly and effectively in order to offer equal access for all of the EU’s patients to the best treatment available.

The topics relating to personalised medicine involve multiple disciplines, industries and other stakeholders, and understanding the nuances of these relationships while creating a regulatory environment that is satisfactory for everyone can be a struggle for legislators as they aim to create a legal framework that is up-to-date and progressive.

It is only by working together that Europe can move forward and bring personalised medicine closer to patients, thus improving Europe’s health and, by extension, its wealth.

Among the key questions to be addressed in Madrid are:

Regarding personal data and samples, how should one-time informed consent be handled to ensure that the patient understands the benefits and risks of conducting future research based on archived samples?

What are appropriate designs for clinical trials – randomised controlled trials versus basket studies versus registries? And when are prospective studies based on archived samples acceptable or preferred?

How should access to clinical trials be handled to prioritise the evaluation of technologies that have the highest potential for clinical utility to avoid exhausting valuable samples unnecessarily?

How do we maximize the cost effectiveness and streamline the performance of clinical trials while not limiting their ability to address future questions?

What standards should be put in place to ensure that multiple clinical trials addressing the same questions are comparable, both from a clinical and analytical perspective? 

These and many more questions will be debated at the roundtable meeting on Saturday, 27th September.

Source: EAPM