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capsules for a clinical trial
Photo by Esther Dyson
Financial ties between principal investigators (PIs) and drug companies are independently associated with positive clinical trial results, according to new research.
The study showed a significant association between positive trial outcomes and PIs having financial ties to the manufacturer of the study drug, even after accounting for the source of research funding.
Researchers reported these findings in The BMJ.
Salomeh Keyhani, MD, of the University of California, San Francisco, and her colleagues conducted this research, analyzing a random sample of 195 drug trials published in 2013.
The team found financial ties between PIs and manufacturers of the study drug for 67.7% of the studies (n=132). In all, 58% of the PIs had financial ties to the manufacturers (231/397).
Types of financial ties included:
- Advisor/consultancy payments (39%)
- Speakers’ fees (20%)
- Unspecified financial ties (20%)
- Honoraria (13%)
- Employee relationships (13%)
- Travel fees (13%)
- Stock ownership (10%)
- Having a patent related to the study drug (5%).
PIs reported financial ties to the drug manufacturer in 76% (103/136) of studies with positive results and 49% (29/59) of studies with negative results (P<0.001).
In a multivariate analysis adjusted for the study’s funding source, a financial tie was significantly associated with a positive trial outcome. The odds ratio was 3.57 (P=0.001).
In a multivariate analysis adjusted for a range of other study-related factors as well, a financial tie remained significantly associated with a positive trial outcome. The odds ratio was 3.37 (P=0.006).
Dr Keyhani and her colleagues stressed that this analysis was observational and cannot be used to draw conclusions about causation.
However, they said, given the importance of industry and academic collaboration in advancing the development of new treatments, “more thought needs to be given to the roles that investigators, policy makers, and journal editors can play in ensuring the credibility of the evidence base.”
Authors of a related editorial said more research is needed to determine how industry funding and financial ties could influence trial results.
The authors—Andreas Lundh, PhD, of the University of Southern Denmark, and Lisa Bero, PhD, of the University of Sydney in Australia—urged trial investigators to share their data and participate in industry-funded trials only if data are made publicly available.
The authors also suggested journals could help by rejecting research by investigators who are unwilling to share their data and by penalizing investigators who fail to disclose financial ties. The role of sponsors, or companies with which investigators have ties, in the research must also be transparent.
In the meantime, trials with industry funding or investigators with financial ties “should be interpreted with caution until all relevant information is fully disclosed and easily accessible,” the authors concluded. 
capsules for a clinical trial
Photo by Esther Dyson
Financial ties between principal investigators (PIs) and drug companies are independently associated with positive clinical trial results, according to new research.
The study showed a significant association between positive trial outcomes and PIs having financial ties to the manufacturer of the study drug, even after accounting for the source of research funding.
Researchers reported these findings in The BMJ.
Salomeh Keyhani, MD, of the University of California, San Francisco, and her colleagues conducted this research, analyzing a random sample of 195 drug trials published in 2013.
The team found financial ties between PIs and manufacturers of the study drug for 67.7% of the studies (n=132). In all, 58% of the PIs had financial ties to the manufacturers (231/397).
Types of financial ties included:
- Advisor/consultancy payments (39%)
- Speakers’ fees (20%)
- Unspecified financial ties (20%)
- Honoraria (13%)
- Employee relationships (13%)
- Travel fees (13%)
- Stock ownership (10%)
- Having a patent related to the study drug (5%).
PIs reported financial ties to the drug manufacturer in 76% (103/136) of studies with positive results and 49% (29/59) of studies with negative results (P<0.001).
In a multivariate analysis adjusted for the study’s funding source, a financial tie was significantly associated with a positive trial outcome. The odds ratio was 3.57 (P=0.001).
In a multivariate analysis adjusted for a range of other study-related factors as well, a financial tie remained significantly associated with a positive trial outcome. The odds ratio was 3.37 (P=0.006).
Dr Keyhani and her colleagues stressed that this analysis was observational and cannot be used to draw conclusions about causation.
However, they said, given the importance of industry and academic collaboration in advancing the development of new treatments, “more thought needs to be given to the roles that investigators, policy makers, and journal editors can play in ensuring the credibility of the evidence base.”
Authors of a related editorial said more research is needed to determine how industry funding and financial ties could influence trial results.
The authors—Andreas Lundh, PhD, of the University of Southern Denmark, and Lisa Bero, PhD, of the University of Sydney in Australia—urged trial investigators to share their data and participate in industry-funded trials only if data are made publicly available.
The authors also suggested journals could help by rejecting research by investigators who are unwilling to share their data and by penalizing investigators who fail to disclose financial ties. The role of sponsors, or companies with which investigators have ties, in the research must also be transparent.
In the meantime, trials with industry funding or investigators with financial ties “should be interpreted with caution until all relevant information is fully disclosed and easily accessible,” the authors concluded.
capsules for a clinical trial
Photo by Esther Dyson
Financial ties between principal investigators (PIs) and drug companies are independently associated with positive clinical trial results, according to new research.
The study showed a significant association between positive trial outcomes and PIs having financial ties to the manufacturer of the study drug, even after accounting for the source of research funding.
Researchers reported these findings in The BMJ.
Salomeh Keyhani, MD, of the University of California, San Francisco, and her colleagues conducted this research, analyzing a random sample of 195 drug trials published in 2013.
The team found financial ties between PIs and manufacturers of the study drug for 67.7% of the studies (n=132). In all, 58% of the PIs had financial ties to the manufacturers (231/397).
Types of financial ties included:
- Advisor/consultancy payments (39%)
- Speakers’ fees (20%)
- Unspecified financial ties (20%)
- Honoraria (13%)
- Employee relationships (13%)
- Travel fees (13%)
- Stock ownership (10%)
- Having a patent related to the study drug (5%).
PIs reported financial ties to the drug manufacturer in 76% (103/136) of studies with positive results and 49% (29/59) of studies with negative results (P<0.001).
In a multivariate analysis adjusted for the study’s funding source, a financial tie was significantly associated with a positive trial outcome. The odds ratio was 3.57 (P=0.001).
In a multivariate analysis adjusted for a range of other study-related factors as well, a financial tie remained significantly associated with a positive trial outcome. The odds ratio was 3.37 (P=0.006).
Dr Keyhani and her colleagues stressed that this analysis was observational and cannot be used to draw conclusions about causation.
However, they said, given the importance of industry and academic collaboration in advancing the development of new treatments, “more thought needs to be given to the roles that investigators, policy makers, and journal editors can play in ensuring the credibility of the evidence base.”
Authors of a related editorial said more research is needed to determine how industry funding and financial ties could influence trial results.
The authors—Andreas Lundh, PhD, of the University of Southern Denmark, and Lisa Bero, PhD, of the University of Sydney in Australia—urged trial investigators to share their data and participate in industry-funded trials only if data are made publicly available.
The authors also suggested journals could help by rejecting research by investigators who are unwilling to share their data and by penalizing investigators who fail to disclose financial ties. The role of sponsors, or companies with which investigators have ties, in the research must also be transparent.
In the meantime, trials with industry funding or investigators with financial ties “should be interpreted with caution until all relevant information is fully disclosed and easily accessible,” the authors concluded.