Introduction: The World Health
Organization strongly urges the publication of all study results – including
negative findings for which the null hypothesis is sustained.
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WHO Calls for all Clinical
Trial Results to Be Published
April14, 2015 -- The World
Health Organisation (WHO) made it unambiguously clear today that researchers
have an ethical imperative to make results from all clinical trials – including
past trials – publicly available. Its Statement
on Public Disclosure of Clinical Trials Results:
- says results from clinical trials should be publicly
reported within 12 months of the trial’s end,
- calls for results from previously unpublished trials to
be made publicly available, and
- calls on organisations and governments to implement
measures to achieve this.
This is a strong statement from the WHO. It
has been welcomed by patients, doctors and researchers worldwide. The best
available evidence shows that around half of all the clinical trials that have
ever been carried out have never reported results. This means that doctors,
patients and medical regulators cannot make informed decisions about which
treatments are best. It means that hundreds of thousands of patients have
volunteered to take part in clinical trials where results have been kept
hidden. It means that information about the medicines we use every day is at
risk of being lost forever.
Congratulations to the hundreds
of people and organisations who wrote to the WHO to set out in their
own words why the WHO should call for old information to be made available.
Today’s great news only came about because of you.
Please share this news on Twitter and
Facebook and with your friends, family and colleagues.
Of course, although it is an influential
organisation the WHO has no legislative power. It will be up to companies,
research groups, funders, regulators and legislators to take up the challenge
laid down by the WHO today. In an invited commentary, published in PLoS Medicine alongside the WHO
statement, Ben Goldacre has set out a series of practical suggestions to drive
up standards and prevent trial reports being withheld. The AllTrials campaign
wants to hear from everyone who can help progress these suggestions and your
ideas on how to implement them. Please get in touch.
Responses from campaigns, doctors,
patients and consumer groups:
Síle Lane, Director of Campaigns,
Sense About Science, co-founding organisation of the AllTrials campaign:
This is the first time the WHO has
taken a position on reporting of clinical trial results. That it’s such a
strong position is a fantastic acknowledgement of the thousands of patients,
doctors and researchers who have been urging everyone who has a role in
clinical trial reporting to do what they can to make all clinical trials count.
The WHO has stated unequivocally that the era of secrecy around clinical trial
results must end.
Richard Stephens, cancer patient and
clinical trial participant:
The call from the WHO for old
information to be shared is hugely welcome. Patients who choose to take part in
clinical trials believe that by doing so, we are helping other patients in the
future. We do not expect the knowledge to be kept secret or the help for others
to be denied. It is immoral to recruit patients to clinical trials and then not
report or share the results. We hope the call from the WHO will be taken up by
everyone who can help uncover hidden information.
Dr Ben Goldacre, author and
co-founder of the AllTrials campaign:
This is a very positive, clear
statement from WHO, and it is very welcome. But withheld trials are already in
breach of multiple existing codes, declarations, and even laws: delivering
change will require more than good intentions. We need individual
accountability, from robust public audit. Only this can show us exactly which
researchers, companies, institutions, funders and treatments are the best – and
the worst – for withheld data. With this individually accountable data we can
finally reward good practice, learn from the best performers, and ensure that
those withholding information are held fully to account.
Dr David Tovey, Editor in Chief,
Cochrane Library, co-founding organisation of the AllTrials campaign:
The announcement by the WHO to make
available all previous unpublished studies is a substantial step forward. For
Cochrane this means that our researchers would have access to more of the data
they need, in order to inform decision making by consumers of health care,
health professionals and policy makers more effectively.
Dr Virginia Barbour, chair of the
Committee on Publication Ethics, member of the AllTrials campaign:
The statement from the WHO is a really
welcome signal of concrete and specific leadership in public disclosure of
clinical trial results. Crucially, the statement specifically recognises that
access to past trials is as important as future trials. It won’t be possible
now for any organisations or individuals involved in trials to have a
legitimate excuse to not engage with this important issue.
Professor Carl Heneghan, Director,
Centre for Evidence-based Medicine, Oxford
The WHO position statement on reporting
of results is an important step forward in the trial transparency campaign.
Significantly, the WHO’s statement also includes publically disclosing the
results from older clinical trials, which remain unpublished and the trial
identifier should always be included in publications. These two steps will
allow easier identification of trials and allow better assessment of the
effectiveness of both older and newer drugs. The WHO’s International
Clinical Trials Registry Platform (ICTRP) provides the means to publish summary
results, and there are now no reasons, or barriers, to not publishing clinical
trial results within the stipulated 12 months time frame.
Professor Heneghan is on the advisory panel
of the WHO’s ICTRP
Fiona Godlee, editor in chief, The BMJ, co-founding
organisation of the AllTrials campaign, told The BMJ:
This statement definitely changes
things. It sets a new international norm by making it clear that failure to
publish the results of clinical trials can no longer be considered acceptable.
What we now need are mechanisms to make this real. Regulators, ethics
committees, funders, journals all have a role to play, and academic and
commercial interests must not be allowed to stand in the way. We will keep
pushing for what patients and the public have a right to, which is full access
to the results of all trials of treatments in current use.
Ilaria Passarani, Head of the Food
& Health Department, the European Consumer Organisation, BEUC:
The WHO’s revised statement is a
landmark move for consumers. All data disclosure policies should make past
trials’ reports available. Complete, accurate and easy-to-understand
information about medicines is essential to empower consumers so they can
choose their treatments knowingly. It is truly the only way consumers can have
objective information about most of the medicines they are prescribed or
purchase over the counter today.
Sascha Marschang, Policy Manager for
Health Systems, European Public Health Alliance
EPHA is pleased with the WHO statement
since patients who take part in clinical trials would like this research to be
available for the future benefit of society. In order to avoid costly
duplication of work and prevent selective reporting of results, it is crucial
for all trials to be reported and for old trial data to be accessible,
regardless of whether they were completed or not. From a public health
perspective, transparency and access are key prerequisites for making clinical
trials as productive and inclusive as possible as they ultimately serve to
improve population health.
Alison Lightbourne, Policy Manager,
International Alliance
We welcome these steps towards greater
transparency in clinical trial results. This further opens the door for
patients to access accurate, relevant information that helps them make informed
decisions about their healthcare. Without this, patients can lose control of
key choices that affect their lives.
We call on governments, the healthcare
industry and healthcare professionals to follow the WHO recommendations by
actively publishing and communicating full clinical trial information in clear
and unambiguous language. This supports meaningful patient involvement in
policy and decision-making at all levels of national health systems, clinical
trials, reporting and treatment.
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