Clinical trials

Food industry wants common science principles to boost trust
Est. 4minThe EU's food and drinks industry has developed a set of principles for research conduct that will apply to the sector.

EU Ombudsman: Clinical trials face new transparency challenges
Est. 5minMedical researchers in Europe are facing new challenges over access to clinical trials data, according to the European Ombudsman Emily O'Reilly.
![31 drugs intended to treat cancer were approved by the European Medicines Agency (EMA) over the past three years. 2011 [Interpharma/Flickr]](https://www.euractiv.com/wp-content/uploads/sites/2/2014/06/7347518562-5706bf38f1-b.jpeg)
Cancer research at a crossroads in Germany
Est. 5minA 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.

Growing concerns over medicines agency’s proposed rules for transparency
Est. 3minA 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).

EU Ombudsman worried over lack of transparency at medicines agency
Est. 3minThe European Ombudsman, Emily O'Reilly, has written to the European Medicines Agency (EMA), expressing concern about a significant change of clinical trial data transparency policy.

EU rules ‘mean children can’t get life-saving cancer drugs’
Est. 3minChildren 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).

EU Parliament, ministers agree to more clinical trial transparency in clinical trials
Est. 2minMEPs reached on Friday (20 December) an agreement with member states on the clinical trials directive.

Ending drug trial secrecy is a boon for R&D, says EU agency
Est. 3minEurope's medicines regulator has come out fighting for greater transparency for clinical trials, arguing that its controversial policy to end data secrecy will be "a boon to drug developers".

Health experts critical of pharma industry’s new transparency rules
Est. 5minThe 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.

Pharma industry downplays lobbyism with patient groups
Est. 3minIn 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.

Pharma industry tries to mobilise patient groups in clinical trials battle
Est. 3minThe 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.

MEPs give resounding ‘yes’ to new clinical trial rules
Est. 4minA 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.

Court orders EU medicines agency to withhold clinical trial results
Est. 3minThe 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.

Health NGO pushes for more transparency in clinical trials
Est. 4minThe 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.

Clinical trials debate shifts from research to transparency ahead of EU vote
Est. 6minSince 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.

US pharma firm seeks to stop EU agency releasing drug data
Est. 2minThe 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.

Health experts urge greater gender balance in clinical trials
Est. 5minToo 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.

OECD urges harmonisation of clinical trials to save lives
Est. 3minThe 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.

Brussels seeks to simplify rules on clinical trials
Est. 4minThe European Commission proposed yesterday (17 July) new rules to make it easier for drug companies and researchers to carry out cross-border clinical trials, in a bid to cut costs and red tape.

Sufferers want EU ethics code for drug testing
Est. 3minThe European Union needs to play a stronger role in coordinating research into new drugs and should help produce a code of ethics for trials, health officials said last week.
EU to revamp Clinical Trials Directive
Est. 7minThe EU executive is planning a major overhaul of the rules governing medical research amid a growing acceptance that a directive in place since 2004 has hampered clinical trials.

EU medical trials law ‘putting brakes on science’
Est. 2minEuropean rules on medical research have decimated academic studies due to spiralling insurance costs and bureaucracy, according to a leading academic.
Pharma industry moves to improve dissemination of clinical trials’ results
Est. 2minThe innovative pharmaceutical industry has decided
to make clinicals trials data more widely
accessible after safety concerns over certain
high profile drugs resulted in withdrawals in 2004.