CASMI Fellow Speaks about ‘Patient Participation in Melanoma Clinical Research’

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CASMI Associate Fellow Dr Sarah Garner spoke at the Joint M-icab/ESO Conference in Brussels last weekend.

Upon a joint invitation from m-icab, (Melanoma Independent Community Advisory Board), and ESO, (European School of Oncology) about 90 stakeholders – Melanoma patients and advocates, clinicians, representatives from the regulatory and Health Technology Assessment boards and the pharmaceutical industry gathered last weekend in Brussels to discuss what ‘the melanoma trial of the future’ should look like.

Bettina Ryll from m-icab, who chaired the conference, said:

Every time I meet someone involved in clinical trials, I ask them whether they would go on that trial themselves if they were a Melanoma patient. So far, no one ever said yes, so there is something wrong with the way we currently develop drugs in Melanoma!

The poignant statements from patients clearly illustrated the need for change. The conference started with a testimony from Lori Murdoch, a Stage IV Melanoma patient from the UK, who described her experience on a current clinical trial like this:

First you are told your mole is nothing, then you are told it is going to kill you and then you are told that there is a drug that can help you, but you are not going to get it

The motivation behind this m-icab conference was therefore to explore alternatives to the current system, and in particular to discuss whether adaptive licensing was a model better suited to Melanoma patients’ needs of timely access to promising therapies, a realistic evaluation of risks and benefits in a real patient population and a coordinated regulatory and reimbursement approach.

Melanoma with its desperate disease situation and extremely promising novel therapies appears to be a good candidate for an adaptive licensing pilot and conclusions will be summarized in a statement paper to be published later this year which will be the basis for the advocacy efforts for m-icab in the future.

Considering the European Medicines Agency’s call for adaptive licensing pilots from 19th March 2014, the conference was extremely timely with a program that anticipated the EMA’s call for a collaborative multi-stakeholder approach including patients. M-icab is currently in discussions with IMI (Innovative Medicines Initiative) and CASMI (Centre for the Advancement of Sustainable Medical Innovation) about follow-up educational opportunities in order to enable Melanoma patient advocates to participate constructively in the discussion.

The second day of the conference reflected the evolution of m-icab from a community advisory board towards a patient network and was de facto the foundation of the Melanoma Patient Network Europe (MPNE), which will in the future replace the Melanoma independent community advisory board. The recently launched MPNE website. MPNE intends to act as a platform for Melanoma patient advocates across Europe to exchange know-how and to collaborate effectively on European issues in Melanoma.

The network identified the need for reliable information, especially in the context of clinical trials, as top priority. The conference included a ‘Focus on’ session in which the network impressively demonstrated its existing expertise. This year’s session was ‘Focus on Romania’ where Romanian Melanoma patient advocates asked the network for advice on a number of pressing issues for Romanian Melanoma patients, among them the necessity to reach remote rural populations and how to address the stigma that is still attached to cancer in the region.

A commented version of the conference program is accessible here



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