Major pharmaceutical companies and medical journals have agreed on 10 steps to improve the credibility of industry-sponsored clinical research.

The recommendations, developed by the Medical Publishing Insights and Practices (MPIP) group, are intended to address concerns about hidden conflicts of interest, ghost-writing and cherry-picking of positive data.

Published in the Mayo Clinic Proceedings, the 10 steps aim to improve transparency in the reporting of trial data, experimental and statistical protocols, adverse events and the professional interests of researchers.

The MPIP initiative was developed with input from GSK, Amgen, AstraZeneca and Sanofi, and is supported by six other major pharma companies.

Journals involved in the discussions included the New England Journal of Medicine and The Lancet.

The 10 steps listed are:

1. Ensure clinical studies and publications address clinically important questions.

2. Make public all results, including negative or unfavourable ones, in a timely fashion, while avoiding redundancy.

3. Improve understanding and disclosure of authors' potential conflicts of interest.

4. Educate authors on how to develop quality manuscripts and meet journal expectations.

5. Improve disclosure of authorship contributions and writing assistance, and continue education on best publication practices to end ghost-writing and guest authorship.

6. Report adverse event data more transparently and in a more clinically meaningful manner.

7. Provide access to more complete protocol information.

8. Transparently report statistical methods used in analysis.

9. Ensure authors can access complete study data, know how to do so, and can attest to this.

10. Support the sharing of prior reviews from other journals.

The authors commented: “Although framed in the context of industry sponsorship, many of these recommendations would enhance the credibility of clinical research publications in general, regardless of the funding source.”

The conclusions of the Mid Staffordshire Foundation Trust public enquiry may conflict with NHS reform policy, according to NHS Chief Executive Sir David Nicholson.

Speaking at the Patient Safety Congress 2012, Nicholson said there was a “very real” likelihood that the Francis report would recommend tighter regulation of FTs to protect safety.

Nicholson himself recommended to the enquiry that FTs failing to maintain safety should be taken back under NHS control, in direct contradiction to Government policy for FTs.

The enquiry into the Mid Staffordshire care scandal, in which hundreds of patients are believed to have died unnecessarily, has provoked urgent questions about the regulation of acute care.

In his initial report, enquiry chair Robert Francis QC said: “the evidence shows that the Board’s focus on financial savings was a factor leading it to reconfigure its wards in an essentially experimental and untested scheme, whilst continuing to ignore the concerns of staff.”

The final Francis report, including recommendations for FT regulation, was expected in May but will now be published in October (subject to DH approval).

At the end of the enquiry, Francis said he would consider such recommendations as increasing the regulation of NHS managers and merging the Care Quality Commission with Monitor.

These recommendations would conflict with the current direction of NHS reform, whereby central regulation is stripped back and Monitor’s role is shifted to economic regulation.

Nicholson told the enquiry that the DH should have the power to strip FTs of their independence – but that also, the way to prevent a recurrence of breakdowns in patient care did not lie only in regulation.

The main solution lay in better data collection and communication between NHS organisations, health workers, patients and the public, he said.

Teva has cancelled its plans to join the already crowded market for atorvastatin, the generic version of Pfizer’s fading blockbuster Lipitor.

The global generics leader will collaborate with Indian companies Ranbaxy and Dr. Reddy’s to promote the cholesterol-lowering drug in the US market, without offering its own version.

The decision, according to Teva, came down to two factors: increasing competition and limited manufacturing capability.

Since Lipitor’s patent expiry in November 2011 (US) and May 2012 (EU), eight companies (including Pfizer) have launched generic versions of atorvastatin.

In addition, the drug was likely to dominate Teva’s manufacturing facilities for active ingredients and pill formulations.

Pfizer has stopped marketing Lipitor where its patent has expired, meaning that the brand’s $13bn annual revenue is up for grabs.

Teva Americas CEO William Marth said: “It’s a tough decision, a hard decision not to launch at this time. That doesn’t mean that sometime in the future we may not launch atorvastatin.”

Referring to the challenge of manufacturing the world’s most widely prescribed drug, he added that the reason for the decision was “when we looked at our product, we only had it in the 30-tablet bottle”.

Ranbaxy has earned $600m from atorvastatin in the US under the company’s 180-day exclusivity period (now expired) as the first generic supplier. Half of that went to Teva by agreement.

India’s leading pharmaceutical company, Sun Pharma, has appointed former Teva CEO Israel Makov as Chairman.

Makov takes over the role from Sun Pharma founder Dilip Shanghvi, who will continue as Managing Director.

Having led Teva to become a world leader in generic drugs, Makov aims to help Sun Pharma expand its own major international generics business.

Israel Makov is currently Chairman of life science companies Given Imaging (endoscopy) and Micromedic Technologies (cancer diagnostics), as well as life sciences investment company BIOLIGHT.

As CEO of Teva from 2002 to 2007, Makov led the company’s meteoric rise in the global generics market and managed over 12 acquisitions.

Dilip Shanghvi said Makov was “an exceptional leader with deep knowledge and experience in globalising businesses” whose experience would help Sun Pharma “to rapidly expand its presence worldwide”.

“Sun Pharma is an exciting company poised for substantial global expansion and I look forward to working together with Dilip and his team in realising their visionary goals,” commented Makov.

Like Teva, Sun Pharma is an international generics leader that uses branded medicines to spearhead its market presence, relying on its diverse generics portfolio to soften the impact of patent expiry.