Die verandering van die manier waarop die EU kyk na kliniese toetse

Deur Europese Alliansie vir Persoonlike Geneeskunde (EAPM) Uitvoerende Direkteur Denis Horgan 

Clinical trials are vital to patients and the advancement of cures for myriad diseases, but the issues surrounding countrywide and, even more so, pan-European trials and their application in modern-day medicine are complex.

As a follow-up to a high-level, multi-stakeholder meeting at the ESMO congress in Madrid last autumn, die European Alliance for Peronalised Medicine (EAPM) has taken discussions to the next stage by setting up a Consensus Group on Clinical Trials consisting of multi-disciplinary experts from a broad base of countries across the EU.

The initiative also came on the back of an extensive stakeholder survey carried out by the Alliance.

The consensus panel will attempt to define how personalised medicine cancer clinical trials should be organized to direct patients to most appropriate research and address important unmet needs.

During the ESMO Congress, stakeholders agreed to try to address how Europe can stay at the forefront of clinical trials in cancer, focusing on personalised medicine to support the delivery of the right prevention and/or therapeutic approach to the right patient at the right time.

One key objective is to increase collaboration among stakeholders to conduct the best possible clinical trials in Europe, to introduce innovative personalised medicine approaches and increase the value and quality of patient care across EU health care systems.

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Critical is the question of how clinical trials should best be organized to maximize the effectiveness of precision medicine initiatives which optimize access for appropriate patients.

A main aim is also to determine how to organize cross-border clinical trials by enabling collaboration and minimizing regulatory burdens.

Yet another goal is to determine how to solve the problem of ensuring that clinical trials can be organized and financed in the most efficient way possible.

It is a complicated area and, as clinical trials are addressing smaller patient groups, more efficient approaches need to be implemented to match the right patient with the right trial.

This is not just a European problem. In the US there have been calls for the FDA to “turn the clinical trials paradigm on its head” in order to create a better environment for personalised therapies to thrive.

Increasing the speed by which personalised medicine discoveries are translated into clinical practice requires appropriately conducted clinical trials with early input from relevant regulatory authorities, health care providers and policymakers.

Since ideal clinical trials require new approaches, relevant stakeholders need to align on how to best organize these studies to establish the right evidence by tailoring access to smaller populations who may benefit from a particular treatment.

In the same way, health technology assessment agencies need to understand how to best introduce new therapies and diagnostics into today’s health-care systems, especially given the current economic situation.

In the end, it is all about the welfare of a potential 500 million patients across 28 member states and these patients need to play an active role in the development of personalised clinical trials methodologies.

In addition, EAPM believes that patients should have access to cross-border clinical research approaches which are relevant to their disease and it is vital that these studies are conducted to the same high standard across the European Union.

Also, as clinical trials get more complex, there is an increased need for appropriate and clear informed consent. Patients need to better understand how their data may be used for research, based on current and future privacy regulations.

It is clear that all stakeholders need to agree on what evidence relating to quality, safety and effectiveness is necessary and how clinical research should be better organised to support personalised medicine, thus bringing them more into clinical practice.

Personalised medicine is evolving quickly, so there needs to be alignment by different stakeholders on new clinical trial approaches that can accelerate the appropriate introduction of effective and safe therapies into the EU.

The work of the Consensus Group starts now.

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