A new EU regulation is meant to make clinical trials easier and more transparent, a pivotal tool in the fight against deadly diseases like cancer. But researchers in Germany warn that the country may lose its role as a leader in international medicine. EurActiv Germany reports.
A growing number of health and consumer advocacy organisations are urging the European Medicines Agency (EMA) to rethink its proposals to restrict the viewing of clinical trial results ahead of a board meeting Thursday (12 June).
Children with cancer are being denied access to potentially life-saving medicines because European Union rules allow drug firms to waive the need to test some drugs in paediatric trials, researchers said on Monday (10 February).
The European pharmaceutical industry association EFPIA has published new ethical commitments on clinical trials aimed at allaying accusations that a lack of transparency on how new drugs are tested is hurting patients. Critics however are unconvinced.
In a blog entry posted yesterday (24 July), the director general of the European Federation of Pharmaceutical Industries and Associations (EFPIA), Richard Bergström, rebuffed reports that the pharmaceutical industry is trying to limit transparency as it seeks to work together with patient groups on clinical trials.
The pharmaceutical industry is trying to 'mobilise' patient groups into lobbying against EU plans that will force companies to publish data from their clinical trials, according to an e-mail seen by a British newspaper.
A panel of European Parliament lawmakers gave unanimous backing on Wednesday (29 May) to new draft EU rules on clinical trials that could represent a huge step forward for research on new, life-saving drugs.
The General Court of the European Union has ordered the European Medicines Agency (EMA) not to release documents on clinical trials, after two access-to-documents were requested, at least until the Court has issued a final ruling.
The European Commission's proposed revision on the Clinical Trials Directive is an important step forward, but does not go far enough, says the Cochrane Collaboration, a healthcare NGO which advocates more transparency in clinical trials.
Since the European Commission tabled its proposal to revise the Clinical Trials Directive last July, the focus in the debate has broadly shifted from supporting European research to patient safety and transparency, suggesting health campaigners have gained the upper hand over big pharmaceutical firms. The legislation will be debated in the European Parliament’s Environment Committee on 24 April.
The most contentious political questions in the Clinical Trials Directive relate to disclosure – whether, how and when the results of clinical trials should be made public and whether pharmaceutical companies can claim ownership over the data generated by them. But if anyone owns the results of clinical trials it is the volunteers who participated, writes Jim Murray.
The European Medicines Agency, criticised in the past for excessive secrecy, is opening its data vaults to systematic scrutiny, a move that is creating tensions with drugmakers worried about preserving business confidentiality.
Too few women are taking part in clinical tests to develop new drugs, putting their lives at risk as women's bodies react differently to medicines, health experts said ahead of International Women's Day.
The lack of gender balance in clinical tests affects almost all medical sectors, but is particularly relevant in cardiovascular diseases where only 33% of trials participants are women. On International Women's Day, Marco Stramba-Badiale is calling for an update of the EU's Clinical Trials Directive to address this imbalance.
The OECD is urging its member governments to harmonise their clinical trial approval processes, citing a decline in the pharmaceutical sector in the EU, where the number of applications for clinical trials fell 25% between 2007 and 2011.
The European Commission's proposed regulation on clinical trials will help the European pharma industry to stop research centres from fleeing to Asia and America, says Philippe Juvin, a French centre-right MEP.