Pharmaceutical giant Merck Serono and leading industry service provider Quintiles have formed a five-year clinical development partnership.

The unique collaboration aims to optimise productivity in the design and execution of clinical drug trials, speeding the development of new treatment options in Merck Serono’s core therapy areas: neurology, oncology and immunology.

Merck Serono will shape and lead the partnership’s drug development programme; Quintiles will direct the planning and conducting of clinical trials and contribute to ongoing trial design.

Quintiles will be the sole primary provider of Merck Serono’s outsourced drug development services. It will also participate in strategic decisions regarding the development of the pharma company’s portfolio.

The partnership reflects the pivotal role of contract research organisations and other service providers in the global pharmaceutical industry.

“By combining the strengths of Merck Serono and Quintiles, we are creating a new model in clinical development that will unlock the knowledge and insights of both companies,” said Annalisa Jenkins, Executive VP and Head of Global Development and Medical at Merck Serono.

“This is an innovative and unique collaboration that will help to translate the highest-quality science into efficiency and agility throughout our clinical trials, while enhancing our competitive position in an increasingly challenging environment of clinical drug development.”

Tom Pike (pictured), CEO of Quintiles, commented: “We view this as a key step forward not only for our two companies, but for the way the industry approaches the development of new therapies for the patients we ultimately serve.”

Merck Serono is the biopharmaceutical division of Merck, based in Darmstadt, Germany. Quintiles is the largest global provider of drug development and commercial outsourcing services to the pharmaceutical industry.

Patent restrictions on drug trials in the UK will be lifted, making it easier for new drugs to be compared with the standard treatment.

The new exceptions enable companies to trial a new drug or a generic version against an established brand without violating its patent.

The changes to the Patents Act could both strengthen the UK as a base for pharmaceutical R&D and improve the medical value of clinical trial findings.

Life science industry trade associations have welcomed the new regulations for the boost they offer to innovative drug development, despite potential losses to established brands.

An Intellectual Property Office consultation showed overwhelming industry support for both changes to the patent law: the ‘research exception’ for trials of new drugs and the ‘Bolar exception’ for trials of generic drugs.

Not only does the rule that head-to-head clinical trials infringe patent make it harder to establish new drugs, it has also led to widespread criticism of clinical trials that compare a new drug with placebo – which no doctor prescribes.

Most EU countries exempt clinical trials from patent infringement, and the UK law has been a barrier to clinical trial work in the UK.

“The Government is keen to create a supportive environment for pharmaceutical research and development in the UK,” said Lord Younger (pictured), Minister for Intellectual Property.

“Helping the industry get their products to market as quickly as possible will benefit patients, the industry and the economy.”

Stephen Whitehead, CEO of the ABPI, commented: “This is a welcome development that will make the UK a more attractive place in which to conduct clinical trials, which in turn will encourage pharmaceutical companies to continue operating here.”

GlaxoSmithKline (GSK) has declared its support for the AllTrials campaign, which calls for the publication of all clinical trial results.

In addition to its existing website detailing clinical trial results, the company will now publish all the clinical study reports (CSRs) it sends, or has sent, to regulators.

The support of a leading pharmaceutical company increases the momentum of the AllTrials campaign, which is supported by the BMA, the Cochrane Collaboration, and other medical bodies.

Triggered by the ‘Tamiflugate’ controversy over the non-disclosure of clinical trial data relevant to Roche’s blockbuster antiviral, AllTrials has become a key issue for the pharmaceutical industry.

According to GSK, all clinical trials sponsored by the company are registered, and the results disclosed, on a public website that has details of 5,000 drug trials.

The company has now committed to publish all the CSRs it uses to apply for approval from regulatory bodies such as the EMA.

Each CSR will appear on GSK’s clinical trials website when the drug in question has been either approved or discontinued, and the trial data have been published.

GSK will deal with patient confidentiality issues – cited by some companies as a reason for non-disclosure of trial data – by removing patient information from the CSRs before publication.

In addition, the company has said it will publish CSRs for all of its existing approved medicines. This will require work by a dedicated team over a number of years, starting with the most prescribed drugs.

Ana Nicholls, Healthcare Analyst at The Economist Intelligence Unit, noted that GSK paid a $3bn fine in the US in 2012 after admitting that it had withheld safety data on its antidepressants. “By signing up to alltrials now, GSK takes back the moral high ground,” she commented.

An open letter to the European Medical Association (EMA) calling for all clinical trial results to be published has been signed by 53 trial participants.

The fact that half of clinical trials are withheld from publication by their industry sponsors is a “betrayal of our trust”, the letter said.

However, the ABPI argued that clinical trial results contain “commercially confidential information” whose publication could harm investment.

The letter is part of the growing campaign for an end to industry control of medical trial data, fuelled by the ‘Tamiflugate’ scandal.

A petition with 8,000 signatories, including the Cochrane Collaboration and the Medical Research Council, calls for the inclusion of all clinical trial data in a public register to be mandatory.

According to a 2010 study by the National Institute of Health Research, half of all clinical trials are never published, and those with results supporting the use of a drug are twice as likely to be published as those with negative findings.

The Commons Health Select Committee has backed the call for a legal obligation on pharmaceutical companies to share all trial data.

The letter from 53 clinical trial participants, some of whom are seriously ill, said that the right of companies and researchers to withhold results is “dangerous and expensive” and “holds backs good medicine”.

“It is a betrayal of our trust in clinical trial regulation and the trust of the families of those patients who volunteer for trials having had a terminal diagnosis,” the letter added.

The ABPI insisted, however, that trial protocols and results are “commercially confidential information” whose publication “could undermine investment in research and development of future medicines.”

The House of Commons Health Select Committee has called for the publication of all drug trial data to be mandatory.

In a report on the role of NICE, the MPs recommended that pharmaceutical companies should have a “duty of candour” regarding clinical trial results.

David Haslam, who will become NICE’s Chairman in April, told the Committee that it was “impossible to come up with any good argument that all data should not be released.”

The report, triggered by ongoing controversy about Roche’s non-disclosure of clinical trial data regarding its antiviral Tamiflu, said the decision to withhold such data should be considered “neither legal nor ethical”.

All results from trials of licensed drugs should be publicly accessible, the Committee stated, arguing that the selective concealment of trial data undermined the role of NICE.

“This situation cannot be allowed to continue,” said Stephen Dorrell, the Chairman of the Health Select Committee.

In order to enforce this greater transparency, the Committee said, the pharmaceutical industry should introduce a new code of practice.

In addition, the General Medical Council should warn doctors that failure to comply with regulations on the conduct of drug trials could lead to their fitness to practise being legally challenged.

The ‘open data’ campaign led by the Cochrane Collaboration and the BMJ has called for a boycott of clinical trials whose publication is not guaranteed.

The campaigners have launched a public petition to discourage researchers, academic institutions, funding bodies and patients from supporting drug trials whose results may be ‘confidential’.

Other supporters of the petition include the charity Sense About Science; the James Lind Alliance, an alliance of patients and clinicians focused on medical research; the Centre for Evidence-Based Medicine in Australia; and journalist Ben Goldacre (pictured), author of Bad Pharma.

The ‘Tamiflugate’ controversy over the ongoing non-publication of clinical trial results relating to Roche’s influenza drug has fuelled the campaign. The BMJ has campaigned for the medical profession to put pressure on Roche to reveal the missing data since November 2012.

Ben Goldacre’s book claimed that pharmaceutical companies systematically distort the landscape of clinical evidence by withholding the results of less favourable drug trials.

MPs including Conservative MP Sarah Wollaston have called for a public enquiry into the £500m spent by the Government in stockpiling Tamiflu during the ‘swine flu’ crisis.

Tracey Brown, Director of Sense About Science, commented: “There have been years of foot dragging and non-compliance with requirements. We expect regulatory bodies to evaluate the best available evidence, not half of it.”

Launching the petition, the BMJ argued that patients should not participate in ‘confidential’ trials: “Participants in clinical trials assume that they are contributing to the advancement of medical knowledge; non-publication of study results negates this reasonable assumption and betrays those who have volunteered.”

Eli Lilly has resumed sole development and commercialisation rights to a new insulin analogue formerly covered by its diabetes alliance with Boehringer Ingelheim.

The alliance, formed two years ago, centred on four pipeline compounds relevant to major aspects of diabetes treatment.

The basal insulin analogue LY2605541will now progress to clinical trials under Lilly’s sole control.

The two companies are still working together to develop and commercialise three products including Trajenta (linagliptin), a drug for type 2 diabetes.

The partnership aimed to provide a broad portfolio of drugs for people with diabetes, but Lilly has now opted to shift LY2605541to its own drug portfolio.

Lilly will continue with the planned clinical trials of LY2605541, which will support regulatory submissions and evaluate the new drug’s safety, efficacy and differentiation.

Encouraged by the phase 1 and 2 clinical trial data for LY2605541, Lilly hopes to present phase 3 data and gain regulatory approval in 2014.

Enrique Conterno (pictured), President of Lilly Diabetes, said: “Boehringer Ingelheim is an important partner in our strategy to provide a broad portfolio of diabetes medicines, and our diabetes alliance remains strong.

“There is no group of patients with whom Lilly has a deeper history than those impacted by diabetes. If approved, this basal insulin analogue will be an important addition to the Lilly portfolio.”

Eli Lilly, the first company to commercialise insulin, has a long history of innovation in diabetes treatment.

The National Institute for Health and Clinical Excellence (NICE) has been drawn into the ongoing row over Roche’s failure to disclose clinical trial data.

The British Medical Journal’s Editor in Chief, Fiona Godlee, has asked NICE to withdraw its recommendation for antiviral drug Tamiflu (oseltamivir) until the missing data are available.

NICE’s Chairman, Sir Michael Rawlins, has said that Roche could be reported to the General Medical Council (GMC) if the company is found to have withheld data relevant to the NICE appraisal.

The BMJ is campaigning for the release of data from at least 123 clinical trials which, according to the Cochrane Collaboration, were promised by Roche in 2009, when Tamiflu received marketing authorisation in Europe.

The Cochrane researchers recently rejected a proposal from Roche to form a joint panel that would discuss what clinical trial data were needed, in order to balance commercial confidentiality with public interest.

Godlee’s letter to NICE proposed that the regulator withdraw its guidance on Tamiflu until it “has received and reviewed the full clinical trial data”.

She also accused NICE of “colluding with the status quo” by failing to insist on seeing the missing clinical trial data at the time of its approval – and pointed out that the FDA has not given the same approval to the drug because it has “performed a more thorough assessment of the trial data”.

Rawlins replied that if the missing data supported the use of Tamiflu then “patients would be damaged by precipitate withdrawal of our guidance” – thus implying a Catch-22 situation.

However, he noted, if Roche’s medical director had “knowingly” withheld relevant data then NICE would report the matter to the GMC.

Clinical trials for new drugs in the UK are becoming too expensive for companies to carry them out, according to a new report.

The strong tradition of NHS clinical trials is growing weaker: the number of clinical trial applications in the UK fell from 1,484 in 2004 to 947 in 2011.

The study, produced for Novartis by Europe Economics, blames this decline on a lack of national organisation and poor support from hospital trusts.

A clinical trial in the UK now costs an average of €9,758 (£7,890) per patient, compared with €7,232 in Germany, €7,310 in Spain or €5,810 in Italy.

The reason for the higher UK cost, the report argues, is that trusts draw out negotiations and charge additional fees on top of the costing template.

In addition, the lack of a national system means that recruiting participants in UK drug trials is difficult: only 55% trials reach their target recruitment rate of 90%, compared to 100% in Spain and 77% in Poland.

The report calls for a “cultural shift” in the NHS towards recognition that supporting clinical trials is a responsibility for all organisations.

At present, the report argues, hospital trusts trend to see clinical trial approval as “someone else’s job” – or else to charge a high price for getting involved.

One possible solution proposed by the report is a ‘hub and spoke’ model of trial organisation, with a national centre providing the administration and hospital trusts recruiting local participants.

Sue Webb, UK Country President at Novartis, said: “We invest over £2m a week in R&D and clinical trials in the UK. We want to work with the NHS, government, and academia to make the UK an attractive place for clinical trials, which ultimately helps patients get access to innovative medicines.”

A leading researcher for the Cochrane Collaboration has called for doctors to boycott Roche over its failure to release clinical trial data on Tamiflu.

Peter Gøtzsche, head of the Nordic Cochrane Centre in Copenhagen, also argued that European governments should sue Roche for the funds spent on the drug.

His comment was made in response to an open letter from BMJ editor Fiona Godlee, accusing Roche of stepping “outside the circle of responsible pharmaceutical companies”.

The Cochrane Collaboration is the leading global authority for medical drug evaluation, known for its emphasis on randomised controlled trials.

Roche claims that it was unable to supply the Cochrane group with certain clinical data because its members refused to sign a confidentiality agreement.

However, the Collaboration insists that no such confidentiality agreement was offered to them at the time.

The antiviral Tamiflu (oseltamivir) was heavily stockpiled by European governments during the ‘swine flu’ crisis, on the basis of assurances from Roche that clinical data proving its efficacy existed and would be supplied.

Gøtzsche commented: “Roche has withheld data that purports to show that Tamiflu has dramatic effects. We all wonder why it is so difficult to get these data from Roche and why Roche has not published them if it is really true that they show these effects.”

He recommended: “European governments should sue Roche, which might have the effect that the hidden trial results come out in the open. Furthermore, I suggest we boycott Roche’s products until they publish missing Tamiflu data.”