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New research indicates that pharmaceutical companies are still failing to disclose trial information publicly, despite efforts made over the last several years to increase transparency.
Investigators examined publicly available information for 15 drugs approved by the US Food and Drug Administration (FDA) in 2012.
They found that two-thirds of clinical trials per drug were disclosed publicly, which is below legal standards.
In an attempt to fix this problem, the investigators developed the “Good Pharma Scorecard,” which ranks companies according to their adherence to transparency practices.
Jennifer Miller, PhD, of NYU Langone Medical Center in New York, New York, and her colleagues described the scorecard and reported their research results in BMJ Open.
“Selectively disclosing trial information can distort the medical evidence and challenge the abilities of physicians, prescription guideline writers, payers, and formulary decision-makers to recommend and provide the right drugs for the right patients,” Dr Miller said.
She also noted that selectively disclosing information violates the rights of human research subjects laid out in the US Common Rule, a rule of ethics that requires that human-subject experiments have the potential to contribute to generalizable knowledge.
Study details
Dr Miller and her colleagues examined publicly available information for all drugs approved by the FDA in 2012 that were sponsored by the 20 pharmaceutical companies with the highest market value.
The information was gathered from a variety of publicly available documents, including Drugs@FDA, ClinicalTrials.gov, and journals indexed in Medline.
From this information, the team identified 15 drugs from 10 companies with more than 318 associated clinical trials involving 99,599 research subjects.
Almost half of all the drugs reviewed had at least 1 undisclosed phase 2 or 3 trial. A median of 57% of trials per drug were properly registered, 20% of final results were reported on ClinicalTrials.gov, and 56% of trials were published in academic journals.
A median of 65% of trial results were publicly available—either on ClinicalTrials.gov or in the medical literature. But the investigators found “considerable variation” between companies.
Per drug, a median of 17% of trials were subject to public disclosure by the 2007 US Food and Drug Administration Amendments Act (FDAAA). Of these trials, a median of 67% were FDAAA-compliant.
A majority of the research subjects—68%—participated in trials subject to the FDAAA, and 51% of these subjects were enrolled in trials that were noncompliant with the act.
Good Pharma Scorecard
Dr Miller and her colleagues believe they have devised a solution to help fix the transparency problem—the Good Pharma Scorecard.
The scorecard ranks drug sponsors according to 5 elements of transparency:
- Trial registration
- Results reporting
- Publication of trial data in a medical journal
- Compliance with legal disclosure requirements
- Adherence with the ethics standards enshrined in the Common Rule.
“The scorecard and rankings have the potential to benefit consumers by helping assure the integrity and completeness of clinical trial information,” Dr Miller said. “Full transparency of clinical trials would also strengthen the protection of human research subjects by avoiding their unknowing recruitment into already failed experiments.”
The pilot rankings on the Good Pharma Scorecard score the largest pharmaceutical companies for drugs approved by the FDA in 2012.
But Dr Miller and her team plan to publish this scorecard annually, ranking each new group of FDA-approved drugs going forward. A ranking of drugs approved in 2015 and their sponsors is scheduled to be released in 2016. 
Photo by Esther Dyson
New research indicates that pharmaceutical companies are still failing to disclose trial information publicly, despite efforts made over the last several years to increase transparency.
Investigators examined publicly available information for 15 drugs approved by the US Food and Drug Administration (FDA) in 2012.
They found that two-thirds of clinical trials per drug were disclosed publicly, which is below legal standards.
In an attempt to fix this problem, the investigators developed the “Good Pharma Scorecard,” which ranks companies according to their adherence to transparency practices.
Jennifer Miller, PhD, of NYU Langone Medical Center in New York, New York, and her colleagues described the scorecard and reported their research results in BMJ Open.
“Selectively disclosing trial information can distort the medical evidence and challenge the abilities of physicians, prescription guideline writers, payers, and formulary decision-makers to recommend and provide the right drugs for the right patients,” Dr Miller said.
She also noted that selectively disclosing information violates the rights of human research subjects laid out in the US Common Rule, a rule of ethics that requires that human-subject experiments have the potential to contribute to generalizable knowledge.
Study details
Dr Miller and her colleagues examined publicly available information for all drugs approved by the FDA in 2012 that were sponsored by the 20 pharmaceutical companies with the highest market value.
The information was gathered from a variety of publicly available documents, including Drugs@FDA, ClinicalTrials.gov, and journals indexed in Medline.
From this information, the team identified 15 drugs from 10 companies with more than 318 associated clinical trials involving 99,599 research subjects.
Almost half of all the drugs reviewed had at least 1 undisclosed phase 2 or 3 trial. A median of 57% of trials per drug were properly registered, 20% of final results were reported on ClinicalTrials.gov, and 56% of trials were published in academic journals.
A median of 65% of trial results were publicly available—either on ClinicalTrials.gov or in the medical literature. But the investigators found “considerable variation” between companies.
Per drug, a median of 17% of trials were subject to public disclosure by the 2007 US Food and Drug Administration Amendments Act (FDAAA). Of these trials, a median of 67% were FDAAA-compliant.
A majority of the research subjects—68%—participated in trials subject to the FDAAA, and 51% of these subjects were enrolled in trials that were noncompliant with the act.
Good Pharma Scorecard
Dr Miller and her colleagues believe they have devised a solution to help fix the transparency problem—the Good Pharma Scorecard.
The scorecard ranks drug sponsors according to 5 elements of transparency:
- Trial registration
- Results reporting
- Publication of trial data in a medical journal
- Compliance with legal disclosure requirements
- Adherence with the ethics standards enshrined in the Common Rule.
“The scorecard and rankings have the potential to benefit consumers by helping assure the integrity and completeness of clinical trial information,” Dr Miller said. “Full transparency of clinical trials would also strengthen the protection of human research subjects by avoiding their unknowing recruitment into already failed experiments.”
The pilot rankings on the Good Pharma Scorecard score the largest pharmaceutical companies for drugs approved by the FDA in 2012.
But Dr Miller and her team plan to publish this scorecard annually, ranking each new group of FDA-approved drugs going forward. A ranking of drugs approved in 2015 and their sponsors is scheduled to be released in 2016.
Photo by Esther Dyson
New research indicates that pharmaceutical companies are still failing to disclose trial information publicly, despite efforts made over the last several years to increase transparency.
Investigators examined publicly available information for 15 drugs approved by the US Food and Drug Administration (FDA) in 2012.
They found that two-thirds of clinical trials per drug were disclosed publicly, which is below legal standards.
In an attempt to fix this problem, the investigators developed the “Good Pharma Scorecard,” which ranks companies according to their adherence to transparency practices.
Jennifer Miller, PhD, of NYU Langone Medical Center in New York, New York, and her colleagues described the scorecard and reported their research results in BMJ Open.
“Selectively disclosing trial information can distort the medical evidence and challenge the abilities of physicians, prescription guideline writers, payers, and formulary decision-makers to recommend and provide the right drugs for the right patients,” Dr Miller said.
She also noted that selectively disclosing information violates the rights of human research subjects laid out in the US Common Rule, a rule of ethics that requires that human-subject experiments have the potential to contribute to generalizable knowledge.
Study details
Dr Miller and her colleagues examined publicly available information for all drugs approved by the FDA in 2012 that were sponsored by the 20 pharmaceutical companies with the highest market value.
The information was gathered from a variety of publicly available documents, including Drugs@FDA, ClinicalTrials.gov, and journals indexed in Medline.
From this information, the team identified 15 drugs from 10 companies with more than 318 associated clinical trials involving 99,599 research subjects.
Almost half of all the drugs reviewed had at least 1 undisclosed phase 2 or 3 trial. A median of 57% of trials per drug were properly registered, 20% of final results were reported on ClinicalTrials.gov, and 56% of trials were published in academic journals.
A median of 65% of trial results were publicly available—either on ClinicalTrials.gov or in the medical literature. But the investigators found “considerable variation” between companies.
Per drug, a median of 17% of trials were subject to public disclosure by the 2007 US Food and Drug Administration Amendments Act (FDAAA). Of these trials, a median of 67% were FDAAA-compliant.
A majority of the research subjects—68%—participated in trials subject to the FDAAA, and 51% of these subjects were enrolled in trials that were noncompliant with the act.
Good Pharma Scorecard
Dr Miller and her colleagues believe they have devised a solution to help fix the transparency problem—the Good Pharma Scorecard.
The scorecard ranks drug sponsors according to 5 elements of transparency:
- Trial registration
- Results reporting
- Publication of trial data in a medical journal
- Compliance with legal disclosure requirements
- Adherence with the ethics standards enshrined in the Common Rule.
“The scorecard and rankings have the potential to benefit consumers by helping assure the integrity and completeness of clinical trial information,” Dr Miller said. “Full transparency of clinical trials would also strengthen the protection of human research subjects by avoiding their unknowing recruitment into already failed experiments.”
The pilot rankings on the Good Pharma Scorecard score the largest pharmaceutical companies for drugs approved by the FDA in 2012.
But Dr Miller and her team plan to publish this scorecard annually, ranking each new group of FDA-approved drugs going forward. A ranking of drugs approved in 2015 and their sponsors is scheduled to be released in 2016.