In a major move, a senior official at the US National Institutes of Health, one of the world’s largest funders of medical research, has announced that researchers who fail to register their clinical trials and report their results will in future no longer receive research grants.
Outsourcing-Pharma.com reports that Dr Jodi Black, Deputy Director of the Office of Extramural Research at the NIH, made the announcement in public speech at a meeting of the Association of Clinical Research Professionals in April 2018.
According to the news portal, Dr Black said that the NIH will not award research grants if it is unable to validate that the applicant registers trials and publicly reports their results, suggesting that NIH plans to actively audit grantee's track record on complying with transparency rules.
Reporting the results of some clinical trials has been a legal requirement in the US since 2007, but compliance is weak. To date, the FDA has not imposed a single fine for violations of the law. Similar transparency laws and rules also remain unenforced in other countries, undermining accountability for adherence to the ethical, scientific and legal norms governing medical research conducted with human participants.
Opacity in clinical trials harms patients, undermines public health, and slows down the development of new treatments and cures. It has been linked to the death of over 100,000 patients.
The NIH’s announcement that the age of impunity is over is a huge step forward for clinical trial transparency not only in the US, but globally:
A parliamentary committee in the United Kingdom is currently pushing government agencies to audit compliance with similar UK and EU reporting rules, and sanction universities and individual researchers who fail to report trial results. NIH’s move illustrates that there is no reason for public funders to continue bankrolling researchers and institutions that violate ethical norms and generate research waste.
Almost exactly one year ago, on 18 May 2017, major public and philanthropic funding organizations pledged to require their grantees to register and report all clinical trials, to audit compliance, and to sanction researchers who fail to adhere to WHO best practices. NIH’s move will provide a useful model for implementing these commitments in practice.
The NIH's latest move will be strongly welcomed by transparency advocates worldwide.
TranspariMED has contacted the NIH press office and asked them to post the full text of Dr Jodi Black’s speech online. This blog will be updated as soon as the full text is available.