A recent study from APIFARMA (Portuguese association of pharmaceutical companies) reveals that the number of clinical trials in Portugal may increase 3.7 times per million inhabitants. The study also claims that each euro invested in clinical trials would result in double the return for the national economy. With the growing number of neurodegenerative diseases, mainly due to the ageing of the Portuguese population, it has become crucial to find new, safe, effective and innovative medicines for diseases such as multiple sclerosis (MS), Parkinson’s disease (PD) and Alzheimer’s disease (AD). As far as AD is concerned, it must be stressed that, in spite of the number of failures in clinical trials in recent years, it is important not to give up but to continue to search for new answers that may contribute to quality-of-life for those living with AD. With this in mind, a conference was organised by Alzheimer Portugal, on “Clinical Trials – For a Better Public and Patients Involvement”. In attendance, were people living with AD (as well as MS, PD and other neurodegenerative diseases), carers, pharmaceutical companies, researchers, legal experts, and the National Ethics Committee for Clinical Research (CEIC),
The conference was held in Lisbon on 24 May 2019, at Infarmed, the National Medicines Agency. During the opening session, the Chairwoman of Infarmed, Professor Maria do Céu Machado congratulated Alzheimer Portugal’s ongoing work to raise awareness about the importance of participating in clinical trials. One of the sessions, “Clinical trials with no secrets” encouraged delegates to ask any questions they might have – via an app (this allowed more people to participate, both down to reasons of efficiency and anonymity) - to help demystify trials.
Legal and ethical issues was the main focus of another session, looking at informed consent and the particular challenges it presents for people who lose their capacity. Advance directives are important tools to overcome some of the barriers of informed consent. Further discussion is needed on this issue, as Alzheimer Portugal believes the different stakeholders are not sufficiently aware of the need to respect the right of the participant to informed consent.
The main conclusions of the conference were:
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More literature is needed, to persuade people to participate in clinical trials and to avoid a situation where people make their decisions based solely on information given to them by their GPs.
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Efforts are needed to simplify the language used in informed consent files
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Patients should be invited to participate in the design of clinical studies.
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Participants want to know the results of studies in which they have taken part.
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Primary care may play an important role in the recruitment of participants.
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Stakeholders in research should develop networking, to help obtain better results.
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A global and multidisciplinary approach involving science, healthcare, ethics and law is needed to ensure the rights of current and future participants are respected.
