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New research has revealed a lack of public information regarding protocols for industry-sponsored, randomized drug trials in Denmark.
First, researchers found it difficult to obtain protocols for commercially sponsored trials, with some sponsors taking legal action in an attempt to keep protocols private.
When the researchers did receive protocols, many had widespread redactions.
The researchers reported these findings in the Journal of the Royal Society of Medicine.
“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,” said study author Peter Gøtzsche, MD, director of the Nordic Cochrane Centre in Copenhagen, Denmark.
To that end, Dr Gøtzsche and his colleagues used the Danish Freedom of Information Act to request access to 78 protocols for randomized trials that were approved by a research ethics committee from October 2012 to March 2013.
The researchers said several companies refused to provide protocols and involved their lawyers. In fact, Sanofi-Aventis sued the National Committee on Health Research Ethics but lost.
Three years after this project was started, the researchers were able to obtain all the protocols they had requested. Eight protocols were excluded from analysis because they did not meet the research inclusion criteria.
Seventeen of 34 protocols for commercially sponsored trials were unredacted, compared to 34 of 36 non-commercially sponsored trials.
The researchers said 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.”
This includes data analysis, the handling of missing data, the detection/analysis of adverse events, the definition of patient outcomes, interim analyses and premature study termination, the sponsor’s access to incoming data while the study is ongoing, ownership of the data, and investigators’ publication rights.
“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,” Dr Gøtzsche said.
“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.” 
New research has revealed a lack of public information regarding protocols for industry-sponsored, randomized drug trials in Denmark.
First, researchers found it difficult to obtain protocols for commercially sponsored trials, with some sponsors taking legal action in an attempt to keep protocols private.
When the researchers did receive protocols, many had widespread redactions.
The researchers reported these findings in the Journal of the Royal Society of Medicine.
“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,” said study author Peter Gøtzsche, MD, director of the Nordic Cochrane Centre in Copenhagen, Denmark.
To that end, Dr Gøtzsche and his colleagues used the Danish Freedom of Information Act to request access to 78 protocols for randomized trials that were approved by a research ethics committee from October 2012 to March 2013.
The researchers said several companies refused to provide protocols and involved their lawyers. In fact, Sanofi-Aventis sued the National Committee on Health Research Ethics but lost.
Three years after this project was started, the researchers were able to obtain all the protocols they had requested. Eight protocols were excluded from analysis because they did not meet the research inclusion criteria.
Seventeen of 34 protocols for commercially sponsored trials were unredacted, compared to 34 of 36 non-commercially sponsored trials.
The researchers said 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.”
This includes data analysis, the handling of missing data, the detection/analysis of adverse events, the definition of patient outcomes, interim analyses and premature study termination, the sponsor’s access to incoming data while the study is ongoing, ownership of the data, and investigators’ publication rights.
“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,” Dr Gøtzsche said.
“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.”
New research has revealed a lack of public information regarding protocols for industry-sponsored, randomized drug trials in Denmark.
First, researchers found it difficult to obtain protocols for commercially sponsored trials, with some sponsors taking legal action in an attempt to keep protocols private.
When the researchers did receive protocols, many had widespread redactions.
The researchers reported these findings in the Journal of the Royal Society of Medicine.
“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,” said study author Peter Gøtzsche, MD, director of the Nordic Cochrane Centre in Copenhagen, Denmark.
To that end, Dr Gøtzsche and his colleagues used the Danish Freedom of Information Act to request access to 78 protocols for randomized trials that were approved by a research ethics committee from October 2012 to March 2013.
The researchers said several companies refused to provide protocols and involved their lawyers. In fact, Sanofi-Aventis sued the National Committee on Health Research Ethics but lost.
Three years after this project was started, the researchers were able to obtain all the protocols they had requested. Eight protocols were excluded from analysis because they did not meet the research inclusion criteria.
Seventeen of 34 protocols for commercially sponsored trials were unredacted, compared to 34 of 36 non-commercially sponsored trials.
The researchers said 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.”
This includes data analysis, the handling of missing data, the detection/analysis of adverse events, the definition of patient outcomes, interim analyses and premature study termination, the sponsor’s access to incoming data while the study is ongoing, ownership of the data, and investigators’ publication rights.
“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,” Dr Gøtzsche said.
“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.”