On 25 September at the ESMO-ECCO congress in Vienna, the European Alliance for Personalised Medicine will hold a second annual event on clinical trials to build on the work from last year, and its high-level meetings held in between.

The meeting in Austria will seek to priortise several issues, and possible solutions, identified by EAPM and its partners and reach consensus on key policy asks that the oncology community should focus on for the next two years.  

A crucial area of the work undertaken by EAPM concerns clinical trials and patient access to them.

One of the Alliance’s main aims is tackling the broader issues of personalised medicine in terms of clinical trials, biobanks, data sharing and more while looking towards the EU’s Horizon 2020 initiative.

Last year’s roundtable at the 16,000-strong congress, held in Madrid, was organised to set up a working group with the aim of helping MEPs and European Commission officials to understand that biobank samples and data from clinical trials is vital in order to progress research for the benefit of 500 million citizens in the EU’s 28 Member States.

Among the key questions addressed in Spain were: 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?

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?

And 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?

Traditionally, the randomised clinical trial has been the bedrock upon which practice changing clinical advances in medicine have been founded.

However, times are changing, and the clinical trials team has produced a series of papers for a special issue of Public Health Genomics.

Among other matters, the papers discuss the key question of whether the classical clinical trial approach (comparing Regimen A with Regimen B) is still the most optimal in the era of personalised medicine.

Clinical trials must address the needs of all stakeholders in a comprehensive and transparent fashion.

There is a need to set the efficacy bars much higher than they are currently at the start of the trials process and introduce the concept of efficacy being linked to cost.

At a European level, this has the potential to allow more equitable price negotiations to be conducted, which translates to more equitable access to innovative therapy for cancer patients.

A well-defined biomarker strategy is also crucial and must be embedded into the clinical trial process, with appropriate regulatory review and implementation based on best international practices.

In the special issue, a series of stakeholders have been challenged to respond to the title “Cancer Clinical Trials; Changing the Paradigm” and to propose a new framework in order to derive maximum benefit for patients.

As medicine moves away from a one-size-fits-all approach to cancer-care delivery, it is necessary to adopt the same principles in modern-day clinical trial design, particularly as tumour disease biology increasingly segments or stratifies patients into different clinical subgroups.

EAPM believes that the framework must be comprehensive but flexible, addressing relevant issues such as clinical trial access, biomarker validation and integration, the complex data challenges, the regulatory landscape, the cost-versus-value issue and the views and experiences of patients.

There must also be collaboration to a high degree, bringing together all relevant stakeholders (healthcare professionals, patients, researchers, industry, payers, policymakers and regulators) in an added-value partnership, allowing barriers to be faced and solutions formulated that deliver optimal cost-effective care for cancer patients.

Specifically, this month’s meeting in Austria will set out to tackle several issues, such as finding ways to optimise research to better address the objectives of different stakeholders with competing interests, optimising the finite opportunities to address important clinical questions in research, increasing cross-border collaborations especially among different stakeholders and incentivising the successful development of biomarkers.

Other discussions will cover what solutions can be offered to optimise information sharing regarding existing research to avoid suboptimal clinical decision making.

The latter can delay the implementation of best practices in clinical research and practice.

This year’s meeting will be held in the Johann Meeting Room at the Nestroy Hotel, Rotensterngasse, in Vienna, Austria.

Source: EAPM