Apr 17, 2015

NIH cites European precedent in call for disclosure of clinical trial data

The aim of publishing more clinical trial data has been introduced beyond Europe. In this way, every researcher of the U.S. National Institutes of Health (NIH) will have to publish a complete report of the results of their work, regardless of whether the trial succeeded or failed.

This is focused on correcting publication bias, since negative results are never included, according to the NIH. Definitely, this measure will stop useless duplicate research and could help scientists in future investigations. Moreover, the NIH requires sharing other kind of results (genomic projects data, for example). However, clinical trials have been forgotten.

There is a common issue in Europe of clarifying clinical trial data from companies. The NIH considers that a data bank (similar to EudraCT) could solve this problem.

These political determinations are looking for transparency in Europe with some controversy. The equalization of data between EudraCT and ClinicalTrials.gov reduces the validity of one of the technical objections proposed by the NIH. The NIH claims that it should be easy to add new data to the European system, as well as to ClinicalTrials.gov.

The NIH is accepting feedback on the proposal until February 19.

America’s Institute of Medicine says sharing data from clinical trials should “become the norm” 

A recent study from the Institute of Medicine claims that sharing clinical trial results should be considered as a part of the research, including all the work of scientists, pharmaceutical companies, patients, ethics committees, journals and professional bodies.

The study concludes that revealing this type of information is a challenge and despite personal preoccupations and the risks that imply some wrong analyses, there aren’t any problems with sharing clinical trials data.

The report also includes specific recommendations:

  •  Data sharing plans are registered with before the trial begins
  •  Summary results are published within a year of a trial’s end
  •  Full data sets from a clinical trial should be shared within 18 months of the trial’s end
  •  Data sharing initiatives should be overseen by independent panels of experts and the public, and should be as transparent as possible

The director of ClinicalTrials.gov, Deborah Zarin, states that researchers and their sponsors must have shared the results by the end of the investigation. The report also encloses a number of opinions and affirmations considering the negative sides of sharing clinical trial data. Here are some of the them:

Dr Ben Goldacre, author of Bad Pharma and co-founder of the AllTrials campaign, said:

“Data sharing is vital if we are to make truly informed decisions with patients about which treatment is best for them. It helps us spot when trials have been misleadingly or incorrectly analyzed. It helps prevent trials being repeated unnecessarily. It allows us to combine all the information, from large numbers of studies, and so produce the clearest possible picture of which treatments work best overall. It also helps us identify which treatment will work best for each individual patient. 

The risks of data sharing have been greatly overstated, by a dwindling number of senior figures in pharma who think that secrecy is necessary to protect their work, and their reputation. In reality, these people have inflicted enormous avoidable harm on the reputation of their industry, and on medicine as a whole. Modern medicine is built on clear information, transparency, and informed patients. There is no way back.”

Tracey Brown, Managing Director, Sense About Science, co-founding organization, AllTrials campaign: 

“No one now has any excuse not to commit to sharing clinical trial data. This report straightforwardly addresses specific challenges to data sharing with specific recommendations. It confirms what some companies, research institutions, funders and regulators are already doing. The only people who are still saying that challenges to data sharing make it impossible are the ones who are not sharing results.”

Professor Carl Heneghan, Director, Centre for Evidence Based Medicine, Oxford and co-founder AllTrials campaign: 

“This report is welcomed as it clearly indicates that sharing data benefits science and patients alike and should be the norm. When the Institute of Medicine states there are ‘compelling justifications for sharing clinical trial data to benefit society and future patients,’ you would expect robust recommendations too. But some of its recommendations are disappointingly weak. Providing metrics that are actionable, accessible and auditable is the key to effective data sharing. What is omitted from this report is a recommendation that trial sponsors and institutes should regularly audit their compliance with data sharing, which could provide a notable measure of quality of responsible sharing of clinical trial data. 

The IOM is right to point out that the ‘the costs of data sharing are borne by a small subset of sponsors, funders, and clinical trialists.’ There now needs to be concerted efforts to make data sharing affordable and feasible.” 

Harlan Krumholz, Director of the YODA project told Forbes:

“It is gratifying to see the IOM come out strongly for data sharing. At this point, they are codifying what is an emerging consensus and unstoppable growing momentum for open science in medical research. How we ever developed a culture that favored researchers over society is a good question – but the good news now is that we are firmly on our way to a better, more responsible scientific culture. It is no longer just the voices of those outside the power structures that are calling for change.”

Written by Dr. David Alcantara and Paula Ruíz for The All Results Journals.

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