Clinical trials – Euractiv

Elon Musk expects Neuralink’s brain chip to begin human trials in 6 months

Georgi Gotev — Thu, 01 Dec 2022 06:44:42 +0000

Elon Musk said on Wednesday (30 November) he expects a wireless brain chip developed by his company Neuralink to begin human clinical trials in six months, after the company missed earlier timelines set by him.

EU wants to get back among the world leaders in clinical research

Giedre Peseckyte — Thu, 27 Jan 2022 09:00:11 +0000

The new Clinical trial regulation (CTR) - which enters into force at the end of the month - together with the Accelerating clinical trials initiative (ACT EU) aiming to gain back EU's position among clinical research leaders worldwide.

Expert: World failed in clinical research response during COVID pandemic

Giedre Peseckyte — Thu, 23 Dec 2021 09:43:27 +0000

A new Lancet publication found that most clinical trials conducted in Europe were too small and did not provide meaningful results on the COVID-19 pandemic. According to one of the authors of the publication, Herman Goossens, "the world failed in clinical research response".

EU agency examines Roche arthritis drug as possible COVID-19 treatment

admin — Mon, 16 Aug 2021 14:00:06 +0000

Europe's drugs regulator said on Monday (16 August) that it was evaluating the use of Roche's arthritis drug, Actemra, in hospitalised adults with severe COVID-19, in its latest review of a potential coronavirus treatment.

Oxford coronavirus vaccine ‘safe’ and effective, study suggests

Natasha Foote — Mon, 20 Jul 2020 18:28:43 +0000

A preliminary study investigating the safety and effectiveness of a vaccine against COVID-19 has found the vaccine to be "safe" and that it triggered a "significant" immune response in human volunteers.

New EU Commission should take on rheumatic and musculoskeletal diseases

Sarantis Michalopoulos — Fri, 25 Oct 2019 08:04:43 +0000

The new European Commission should tackle "head-on" rheumatic and musculoskeletal diseases, the president of the European League Against Rheumatism (Eular) told EURACTIV in an interview, referring to chronic diseases that affect one-quarter of all Europeans, creating healthcare and social security costs.

Would Europe be prepared for the next big epidemic? Yes, but…

Gerardo Fortuna — Fri, 21 Sep 2018 10:49:06 +0000

The EU's preparedness for outbreaks of infectious disease has increased, but member states still need to overcome ethical, administrative, regulatory and logistic bottlenecks for boosting clinical research, medical experts said at a scientific meeting in Brussels.

Health tech bill to kick off busy policy agenda in 2018

Benjamin Fox — Wed, 24 Jan 2018 06:57:14 +0000

The European Commission will propose a new law on Health Technology Assessments to kick off a busy EU health agenda in 2018.

Commission reassures ‘worried’ member states on Health Technology Assessment

Sarantis Michalopoulos — Wed, 10 Jan 2018 05:13:25 +0000

The Commission’s upcoming proposal on Health Technology Assessment (HTA) will focus on clinical aspects and leave member states to decide on economic or ethical parts, a European Commission spokesperson told EURACTIV.com.

Pharma boss: Targeting drugs won’t make healthcare systems more sustainable

Sarantis Michalopoulos — Tue, 10 Oct 2017 04:08:07 +0000

“Salami-slicing” the cost of medicines, which represent almost one-fifth of health system budgets and are subject to rigorous value assessments, won’t make healthcare systems more sustainable in the future, Nathalie Moll told EURACTIV.com in an interview.

EU agency OK’d 39 cancer drugs without evidence they work, study shows

admin — Thu, 05 Oct 2017 01:20:46 +0000

The European Medicines Agency approved 39 new cancer drugs between 2009 and 2013 despite having no evidence that they worked, unnecessarily exposing patients to toxicity, researchers said Thursday (5 October).

UK biotech boasts Europe’s best pipeline as Brexit looms

Georgi Gotev — Wed, 24 May 2017 06:57:00 +0000

Britain's biotech sector boasts the strongest new drug pipeline in Europe but industry leaders say it needs continued access to global talent, funding and regulatory clarity to thrive in the future - all of which could be jeopardised by Brexit.

African Union EU rep: ‘Africa shouldn’t just be a spectator to global decisions’

Nicole Sagener — Thu, 04 May 2017 11:50:37 +0000

The African Unions EU representative, Ajay Bramdeo, told EURACTIV Germany that plans for a Marshall Plan for Africa are fundamentally good but warned that the continent needs to be the focus and that healthcare must be the priority.

Allowing patients to choose could save billions

Fred Roeder — Wed, 03 May 2017 12:35:55 +0000

The Commission’s recent musings on the social dimension of Europe touches on common drug pricing among member states. But it misses out on solutions for faster access to medicine, Fred Roeder.

The Commission’s innovation confusion

Philip Stevens — Wed, 15 Mar 2017 11:37:54 +0000

Unless the European Commission changes its attitude, the innovation gap between Europe and the US will likely increase, and it could be overtaken soon by China, with dire consequences for living standards, warns Philip Stevens.

Rare cancers: A headache for policymakers

Hannah Black, Sarantis Michalopoulos — Tue, 07 Feb 2017 05:32:58 +0000

The complexity of diagnosing and treating rare forms of cancers like sarcomas can be addressed by a multi-level approach and better coordination among member states, insist experts in the field.

Lawmakers warn EU pharma industry about drug pricing

Sarantis Michalopoulos — Thu, 02 Feb 2017 05:59:32 +0000

Pressure is mounting on pharmaceutical companies to reconsider the way they do business by refocusing their efforts on meeting patient needs and health outcomes rather than their own profits.

Germany votes to ease access to medical marijuana

Daniel Mützel — Thu, 19 Jan 2017 15:30:54 +0000

The German Bundestag today (19 January) unanimously passed legislation granting seriously ill patients easier access to medical marijuana. EURACTIV Germany reports.

Tattoos could pose health risk says new Commission report

Samuel Morgan — Wed, 11 Jan 2017 10:42:59 +0000

Ink used in tattoo parlours can contain low-purity pigments that are not meant to be applied to the skin and may pose a health risk, according to a European Commission report. EURACTIV Spain reports.

Alzheimer Europe chief: Holistic approach needed to tackle dementia

Sarantis Michalopoulos — Thu, 03 Nov 2016 05:28:01 +0000

Alzheimer’s disease and other forms of dementia remain underdiagnosed in most European countries, Jean Georges told EURACTIV.

Andriukaitis: Health Technology Assessment will make EU healthcare ‘sustainable’

Sarantis Michalopoulos — Fri, 21 Oct 2016 05:14:49 +0000

EXCLUSIVE / National healthcare systems should embrace the digital era and use Health Technology Assessment (HTA) to become truly sustainable and cost-effective, European Commissioner for Health and Food Safety Vytenis Andriukaitis told EURACTIV.com in an interview.

EU’s sunbed safety assessment clouded by bias

Frank Harbusch — Thu, 01 Sep 2016 08:00:02 +0000

An upcoming assessment by a European Commission committee on the risks of UV radiation and sunbeds is hamstrung by in-built bias and a failure to comprehensively address all the issues, warns Frank Harbusch.

Brexit casts doubt over Uganda development project on lung disease

Jack Barton — Tue, 23 Aug 2016 11:17:10 +0000

The UK's vote to leave the European Union has come at a crucial moment in the development of an international medical project that throws into sharp relief the state of flux Brexit has cast over collaborative research, says Jack Barton.

EU drugs agency to unveil results on ‘early medicines’ project this week

Sarantis Michalopoulos — Mon, 01 Aug 2016 04:42:38 +0000

The European Medicines Agency (EMA) will this week publish the much-awaited results of a pilot project on the early marketing authorisation of drugs, EURACTIV has learnt.

Pharma expert: new ‘value added medicines’ offer cheaper, customised treatment

Sarantis Michalopoulos — Tue, 26 Jul 2016 04:37:53 +0000

A new breed of drugs, called “value added medicines”, could help patients improve their everyday life while in treatment, without increasing healthcare budgets, Christoph Stoller said in an interview with EURACTIV.com

New medical devices rules should avoid ‘unnecessary’ red tape, industry says

Sarantis Michalopoulos — Mon, 13 Jun 2016 04:34:35 +0000

The implementation of new rules on medical devices should avoid extra burdens and unnecessary bureaucracy, health industry officials have told EURACTIV.com.

EU project hopes to phase out animal-testing

Nicole Sagener — Fri, 15 Jan 2016 14:37:02 +0000

When chemicals are considered too dangerous to be tested on humans, animals have long been the answer to some scientific quandaries. The EU project ToxRisk will act as Europe's flagship for safety assessments that do not require the use of animals. EURACTIV Germany reports.

Food industry wants common science principles to boost trust

Henriette Jacobsen — Fri, 20 Nov 2015 13:25:29 +0000

The EU's food and drinks industry has developed a set of principles for research conduct that will apply to the sector.

Ben Goldacre: Pharma industry has destroyed its own reputation

Frédéric Simon — Wed, 22 Oct 2014 08:49:54 +0000

EXCLUSIVE: The great tragedy for the pharmaceutical industry is that it keeps denying that it lobbies against transparency in clinical trials, says Ben Goldacre.

EU Ombudsman: Clinical trials face new transparency challenges

Henriette Jacobsen — Tue, 30 Sep 2014 08:58:30 +0000

Medical researchers in Europe are facing new challenges over access to clinical trials data, according to the European Ombudsman Emily O'Reilly.

Cancer research at a crossroads in Germany

Dario Sarmadi — Thu, 19 Jun 2014 08:16:09 +0000

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.

Growing concerns over medicines agency’s proposed rules for transparency

Henriette Jacobsen — Wed, 11 Jun 2014 16:07:06 +0000

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).

EU Ombudsman worried over lack of transparency at medicines agency

admin — Wed, 21 May 2014 08:24:53 +0000

The 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’

admin — Tue, 11 Feb 2014 07:46:54 +0000

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).

EU Parliament, ministers agree to more clinical trial transparency in clinical trials

Nikita Chudjakov — Fri, 20 Dec 2013 17:48:08 +0000

MEPs 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

admin — Tue, 22 Oct 2013 08:30:16 +0000

Europe'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

Henriette Jacobsen — Thu, 29 Aug 2013 08:26:04 +0000

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.

Pharma industry downplays lobbyism with patient groups

admin — Thu, 25 Jul 2013 08:13:20 +0000

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.

Pharma industry tries to mobilise patient groups in clinical trials battle

admin — Tue, 23 Jul 2013 07:45:19 +0000

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.

MEPs give resounding ‘yes’ to new clinical trial rules

Henriette Jacobsen — Thu, 30 May 2013 08:09:02 +0000

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.

Court orders EU medicines agency to withhold clinical trial results

Henriette Jacobsen — Thu, 02 May 2013 16:07:15 +0000

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.

Health NGO pushes for more transparency in clinical trials

admin — Tue, 30 Apr 2013 18:29:07 +0000

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.

Clinical trials debate shifts from research to transparency ahead of EU vote

Henriette Jacobsen — Fri, 19 Apr 2013 08:21:45 +0000

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.

Clinical trials directive: The Parliament’s political dilemna

Frédéric Simon — Thu, 04 Apr 2013 17:15:43 +0000

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.

US pharma firm seeks to stop EU agency releasing drug data

admin — Mon, 11 Mar 2013 08:33:58 +0000

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.

Health experts urge greater gender balance in clinical trials

Henriette Jacobsen — Fri, 08 Mar 2013 08:53:57 +0000

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.

Medical director: Women under-represented in clinical tests

Henriette Jacobsen — Fri, 08 Mar 2013 07:56:09 +0000

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.

OECD urges harmonisation of clinical trials to save lives

admin — Tue, 26 Feb 2013 07:49:11 +0000

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.

MEP: New clinical trial rules will boost EU pharma research

Evan Lamos — Thu, 19 Jul 2012 08:58:06 +0000

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.

Brussels seeks to simplify rules on clinical trials

admin — Wed, 18 Jul 2012 08:37:04 +0000

The 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

march — Tue, 14 Dec 2010 08:41:51 +0000

The 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

admin — Thu, 22 Apr 2010 08:47:47 +0000

The 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’

admin — Tue, 25 Aug 2009 08:45:00 +0000

European 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

admin — Tue, 11 Jan 2005 08:50:00 +0000

The 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.

A cure for clinical trials

admin — Mon, 29 Apr 2002 00:00:00 +0000

A cure for clinical trials “Pharma companies often miss their deadlines when testing new drugs. The use of marketing techniques to manage the recruitment of patients for clinical trials could speed things up considerably.” The McKinsey Quarterly, 2002 Number 2...