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Publish all clinical trials, say pharma doctors

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Unpublished clinical trials risk the possibility of research then being repeated unnecessarily

All clinical trials should be registered and published according to a recent survey conducted by the Faculty of Pharmaceutical Medicine.

Out of the 400 Faculty of Pharmaceutical Medicine (FPM) members asked, nearly all (95%) suggested that trials should be registered, with 73% stating that clinical trials should be published within one to two years of completion.

The FPM, a part of the Royal College of Physicians, is made of doctors who hold a Diploma in Pharmaceutical Medicine. 

The end of salesmanship?

Published on 18/08/14 at 07:54am
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Although my specialism for the last 35 years has been clinical research, I actually started in the pharmaceutical industry as a salesman. The first thing I learned was that there is not a thing on this earth that anyone buys, that somebody doesn’t have to sell.

Now when I graduated as a biologist  we had recently been through the drug  scandals of the 1960s, including the  thalidomide disaster and – more relevant to this piece – the massive over-selling of benzodiazepines by Roche.

Boehringer launches new transparency regime

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Boehringer is making good on its 2013 promise to release more clinical trial data to researchers with the launch of a new website designed to ensure more disclosure.

The new policy aims to make clinical study data and other related documents more widely accessible for approved products, or after termination of a drug development programme.

The website access allows clinical study reports (CSRs) and other clinical documents to be requested from the firm dating back to 1998.

NICE chair: pharma must show how it prices drugs

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Professor David Haslam (Credit: Financial Times Live)

The pharmaceutical industry must be willing to show the public how it prices its drugs - or face losing its trust.

This is according to the chairman of NICE Professor David Haslam, who tells Pharmafile that currently no one outside the boardroom of a pharma firm knows how it evaluates a drug’s worth.

“If we could have greater transparency about pricing, then a lot of problems could be bypassed - it’s not just that drugs are expensive and NICE says no, it’s about the cost-effectiveness of
these medicines. 

EMA delays data transparency

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EMA headquarters

The European Medicines Agency has delayed its much-trailed plan to launch a clear policy on making clinical trial data publically available at the end of this year.

Europe’s drugs regulator now admits that it will not know when the start date will come - but says it will miss the 1 January deadline.

The vexed question of data disclosure encompasses a range of issues - among them patient and commercial confidentiality - and has been a subject of great debate.

Unpublished trials ‘violates ethical obligation’ to patients

A new study published in the BMJ has found almost one in three (29%) of large clinical trials remain unpublished five years after completion.

And of these well over two-thirds (78%) have no results publicly available, according to the research by US-based authors.

They say this means an estimated 250,000 people have been exposed to the risks of trial participation without the societal benefits that accompany the dissemination of their results.

LEO Pharma to release clinical trial data

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LEO Pharma has announced that it will start releasing clinical trial data from studies dating back to almost 25 years ago.

The Denmark-based firm said it is using this as a “Declaration of its support for the increased global calls for transparency coming from many quarters”, which includes patient groups, researchers and think tanks.

UK trial rules tightened up

Anyone wanting to conduct clinical trials in the UK will have to register their research in order to receive a ‘favourable ethical opinion’ before they can begin, according to new rules to be introduced at the end of the month.

The Health Research Authority (HRA), whose remit is to protect and promote the interests of patients and the public in health research, is bringing in the plan from 30 September to ensure that UK trials are put onto a public database. 

Pharma groups want limited data release

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The two main US and European pharma lobby groups have released a joint statement saying they welcome independent reviews of study data, but are still resisting full disclosure.

Both EFPIA and PhRMA have published new commitments this morning which they say will see biopharmaceutical companies “dramatically increase the amount of information available to researchers, patients, and members of the public”.

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