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Klinische proeven regels geeft hoop aan miljoenen patiënten

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3-klinische onderzoeken-EuropaOp 2 april stemde het Europees Parlement voor een breed pakket aan transparantiemaatregelen voor gegevens van klinische onderzoeken, maatregelen die hoop geven aan patiënten die aan zeldzame ziekten lijden.

Glenis Willmott MEP, Labour’s leader in Europe and rapporteur for the clinical trials regulation, said: “I am delighted the overwhelming majority of MEPs backed the deal I reached on the clinical trials regulation. It will make trials more transparent, give hope to patients needing new and better treatments, and boost the number of skilled research jobs here in Europe.

“The new law offers hope to the millions of people in Europe suffering from rare diseases by making cross-border trials much easier to conduct.

“There are simply not enough patients in one country alone to develop new or improved treatments for rare diseases, and by working at European level we can reduce the huge cost and burden of conducting trials across borders.

“Currently around half of all clinical trials are not published, which is unacceptable.  This legislation will change that by ensuring all trials report a summary of results to a publicly accessible database, as well as the full clinical study reports once a medicine has applied for authorization.”

De nieuwe regelgeving zal ook onderzoeksbanen in heel Europa beschermen en creëren.

Willmott added: “Over the past few years Europe has been losing jobs in research as clinical trials move elsewhere in the world. By streamlining the rules, whilst keeping patient safety at heart, we can be more competitive, create new jobs and ensure Europe remains a world leader in medical research.”

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