farmacisti spital, exprima îngrijorarea cu privire la EMA accesul la informațiile referitoare la studiul clinic

The European Association of Hospital Pharmacists (EAHP) has written to the Board of the European Medicines Agency (EMA) expressing concern about proposals to restrict the viewing of clinical trial results to an ‘on screen only’ version. Such access would exclude the possibility of individuals being able to print, distribute, or transfer the information, making scientific analysis of clinical study data highly problematic.

EAHP has joined the voices of other organisations such as the European Ombudsman, the British Medical Journal, the AllTrials campaign, the European Consumer Organisation and Health Action International in urging a rethink by the EMA. EAHP’s intervention comes ahead of an EMA Board Meeting on joi 12 iunie, at which the proposed draft policy on ‘proactive publication of and access to clinical trial data’ could be finalised.

The development of new policy by the agency on clinical trial transparency comes as the result of intensive advocacy efforts by transparency campaigners, and after over a year of consultation by the EMA with patient groups, health care professionals and the pharmaceutical industry.

EAHP President Dr Roberto Frontini said: “Transparency in the reporting of clinical trial results matters. It matters because it is important in avoiding duplicated effort. It matters because patients participating do so on the basis that they are assisting wider scientific understanding of medical issues. It matters because independent secondary scrutiny of clinical trial results frequently yields new insights.

"Therefore, whilst we congratulate the European Medicines Agency on its efforts so far on trial result transparency, the news that access could be restricted to “on screen only” comes as a disappointment. Transparency is needed for the purposes of scrutiny. Yet if individuals may not print, distribute or transfer the information, it is hard to see how the purpose is served. Its an important moment for the Agency and its Board and we hope it will listen to what the European Ombudsman and stakeholders are saying: the transparency policy should go further.”

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