Drug trial protocol redactions by industry sponsors exposed

New research published by the Journal of the Royal Society of Medicine exposes the extent of redactions in protocols for industry-sponsored randomised drug trials. Trial protocols are needed for a proper assessment of the veracity of drug trial reports. The researchers, from the Nordic Cochrane Centre in Copenhagen, found widespread redactions in the protocols for commercially sponsored trials they received from research ethics committees in Denmark. The study is believed to be the first systematic assessment of which information in trial protocols pharmaceutical companies do not wish to disclose to independent researchers.

Professor Peter Gøtzsche, director of the Nordic Cochrane Centre, said: "We wished to compare the information in the protocols with the information provided to the patients in order to evaluate whether the trials were ethical and necessary and whether essential information about the benefits and the harms of the drugs had been hidden from the patients."

It is difficult to get access to drug trial protocols so Professor Gøtzsche and his colleagues used the Danish Freedom of Information Act to request access to 78 trial protocols approved by a research ethics committee from October 2012 to March 2013. Eight protocols were excluded because they did not meet the research inclusion criteria. Only 17 of 34 protocols for commercially sponsored trials were unredacted, compared to 34 of 36 non-commercially sponsored trials.

The redactions were most widespread in those sections of the protocol where there is empirical evidence of substantial problems with the trustworthiness of published drug trials. These include the definition of patient outcomes, the detection and analysis of adverse events and the sponsor's access to incoming data while the study is running.

Professor Gøtzsche said: "The amount of redactions in the protocols we received was so vast that it made them rather useless for assessing the ethical justification for the studies and to identify discrepancies with subsequent publications.

"We could not identify any legitimate rationale for the redactions. The current mistrust in industry-sponsored drug trials can only change if the industry offers unconditional access to its trial protocols and other relevant documents and data."

Mikkel Marquardsen, Michelle Ogden, Peter C. Gøtzsche.
Redactions in protocols for drug trials: what industry sponsors concealed.
Journal of the Royal Society of Medicine. doi: 10.1177/0141076817750554

Most Popular Now

Imfinzi is the first immunotherapy to demonstrate …

AstraZeneca and MedImmune, its global biologics research and development arm, have presented data on overall survival (OS) in the Phase III PACIFIC trial of Imfinzi durin...

Sandoz Healthcare Access Challenge #SandozHACk ret…

Sandoz, the Novartis generics and biosimilars division, today announces the launch of the second Sandoz Healthcare Access Challenge (HACk). The #SandozHACk is a global co...

Global survey reveals that physicians need more in…

Results from a new global survey revealed that more than one-third (36%) of the 310 physicians surveyed do not think they have sufficient information required to make inf...

In clinical trials, new antibody therapy controls …

Thanks to improvements in antiretroviral therapy, HIV is now a manageable condition. Yet even the best drugs do not entirely eliminate the virus, which latently lingers i...

Pfizer to award more than $3 million in grants to …

Pfizer Inc. today announced the recipients of the Advancing Science through Pfizer Investigator Research Exchange (ASPIRE) Breast Cancer Research Awards. Four grants tota...

Novartis licenses three novel anti-infective progr…

Novartis announced today that it has entered into a licensing and equity agreement with Boston Pharmaceuticals for the development of three novel anti-infective drug cand...

The Nobel Prize in Physiology or Medicine 2018 was…

Cancer kills millions of people every year and is one of humanity's greatest health challenges. By stimulating the inherent ability of our immune system to attack tumor c...

FDA approves first treatment for advanced form of …

The U.S. Food and Drug Administration today approved Libtayo (cemiplimab-rwlc) injection for intravenous use for the treatment of patients with metastatic cutaneous squam...

FDA approves expanded use of Gardasil 9 to include…

The U.S. Food and Drug Administration approved a supplemental application for Gardasil 9 (Human Papillomavirus (HPV) 9-valent Vaccine, Recombinant) expanding the approved...

DNA islands effective as 'anti-bacterial drones'

Genomic "islands" that evolved from viruses can be converted into "drones" that disable Staphylococcus aureus, bacteria that are often resistant to antibiotics and pose a...

FDA awards 12 grants to fund new clinical trials t…

The U.S. Food and Drug Administration today announced that it has awarded 12 new clinical trial research grants totaling more than $18 million over the next four years to...

Pfizer announces Executive Leadership Team

Pfizer Inc. (NYSE:PFE) today announced its executive team that will report to Albert Bourla, incoming Chief Executive Officer, coincident with the commencement of his new...