WHO: incentives and enforcement needed to improve trial data transparency

By Gareth Macdonald contact

- Last updated on GMT

WHO HQ in Geneva, Switzerland - Organisation wants summary reports from  #Alltrials to be published
WHO HQ in Geneva, Switzerland - Organisation wants summary reports from #Alltrials to be published

Related tags: Clinical trials, Pharmaceutical industry

Publishing summary clinical trial results poses no threat to patient privacy according to the WHO, which says enforcing transparency laws and incentivising sponsors is key to making sure data from all trials is reported.

The World Health Organisation (WHO) called for summary results from all trials to be published in a policy statement last night​ in a move that brought it into line with groups​ calling for improved transparency in the clinical development process.

WHO spokesman Tarik Jasarevic told us “there is momentum through the engagement of several national authorities in recent months with the issue of results reporting. Secondly this is a logical next step from the WHO’s previous position on clinical trial registration.

Following that 2005 position there was a gradual increase in assessment of the how many clinical trials were reported. In recent years it has become increasingly well documented that a large proportion of clinical trials remain unreported​.”

Patient privacy?

Trial data publication has been a topic of debate since 2013 when the British Medical Journal and Cochrane Collaboration-backed #Alltrials group began lobbying for all past and present studies to be registered and their full methods and summary results reported.

Organisations like PhRMA, EFPIA​ and TransCelerate Biopharma​ have publicly stated support for greater transparency, although all have also voiced concerns about the impact making data available to rivals could have on sponsors as well as worries about patient privacy.

The WHO does not buy the latter argument according to Jasarevic, who said: “This WHO call is for reporting the key outcomes of clinical trials. There are no patient privacy concerns with this.​”

On the subject of competitive concerns there appears to be more common ground. Jasarevic said: “There are few incentives to publish or disclose negative trials, including ones that do not show a drug or product is effective.

He suggested that “a system of incentives and legislation will be needed to ensure compliance​” adding that “any legislation must be enforced if it is to lead to compliance with public disclosure requirements.​”

Quite what incentives would be sufficient to offset the impact publishing a failed study could have on a drugmaker is unclear as the WHO did not respond to a request for more details.

European rules

In Europe the legislative landscape is pretty clear. New rules on clinical trials on medicinal products for human use entered into force on June 16 last year and are due to come into effect on May 28 next year.

The idea is that summary results for all trials will be made public in a database managed by the European Medicines Agency (EMA), development of which is ongoing according to agency spokeswoman Orla Ni Ogain.

She told us: “Technical development of the EU portal and system is currently underway. Once all development work of the system is finalised it will be audited by independent auditors to ensure that it delivers what it is set out to do.​ 

The EU portal and database will be the backbone of the new regime for clinical trials in Europe introduced by the Regulation. The new legislation can only apply once the system is fully functional, which will be confirmed by an independent audit​.”

Related topics: Regulatory & Safety, Regulations

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