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Who Pays for Clinical Trials???
Who pays for clinical trials? Does it matter? Do financial ties to industry matter when considering who designs the trial? Do financial ties to the cancer industry matter when considering who writes up the clinical trial?
According to Dr. James Berenson, below, bias can occur when written up by an employee of the drug company or a writer paid by the drug company.
Medical Writing Bias in Myeloma Clinical Research
I am a long-term survivor of myeloma. I’m a layman so what do I know about clinical trial bias? However, Dr. James Berenson is a board-certified oncologist and MM specialist. I think his questioning of medical bias resulting from financial ties to industry bears serious consideration by MM patients and caregivers.
Email me at David.PeopleBeatingCancer@gmail.com to learn more about managing your MM with both conventional and non-conventional therapies.
Good luck,
David Emerson
- MM Survivor
- MM Cancer Coach
- Director PeopleBeatingCancer
Patient Enrollment to Industry-Sponsored Versus Federally-Sponsored Cancer Clinical Trials
“Purpose
The conduct of cancer clinical research in the United States is supported by both private and public sponsors. Industry aims to obtain new drug approvals. Federally-sponsored trials examine a broad set of research questions that are not typically addressed by industry; these trials, which are also more commonly conducted in diverse populations, were recently shown to have contributed to gains of 14 million life-years for patients with cancer. Despite the different mandates, the proportion of patients who might participate in industry-sponsored versus federally-sponsored cancer studies is unknown.
Methods
We evaluated trial enrollment patterns from 2008 to 2022 using ClinicalTrials.gov data. The ratio of enrollments attributable to industry versus federal sponsors was estimated. A large set of estimates on the basis of different combinations of study characteristics were generated. Point estimates were determined as the mean of combinations and confidence limits by the IQR. Five-year intervals were examined to smooth annual variation.
Results
In total, N = 26,080 studies were examined. The estimated enrollment ratio from 2018 to 2022 for all industry-sponsored versus federally-sponsored trials was 8.1 (IQR, 6.2-9.9). For adult trials, the ratio increased from 4.8 (IQR, 4.4-5.3) during 2008-2012 to 9.6 (IQR, 7.4-11.8) during 2018-2022; for trials in children, the ratio increased from 0.7 (IQR, 0.6-0.7) to 2.3 (IQR, 1.8-2.7).
Despite increasing cancer incidence, enrollment counts for federally-sponsored trials were flat over the study period.
Conclusion
In the United States, there is a growing reliance on industry to conduct cancer clinical research. Underinvestment in federally-sponsored research comes at a cost for both patients and researchers, with lost opportunities for scientific, clinical, and population advances…”
Relationships Between Authorship Contributions and Authors’ Industry Financial Ties Among Oncology Clinical Trials
“Purpose
To test the hypothesis that authors who play key scientific roles in oncology clinical trials, and who therefore have increased influence over the design, analysis, interpretation or reporting of trials, are more likely than those who do not play such roles to have financial ties to industry.
Methods
Data were abstracted from all trials (n = 235) of drugs or biologic agents published in the Journal of Clinical Oncology between January 1, 2006 and June 30, 2007. Article-level data included
- sponsorship,
- age group (adult v pediatric),
- phase, single versus multicenter,
- country (United States v other),
- and number of authors.
Author-level data (n = 2,927) included financial ties (eg, employment, consulting) and performance of key scientific roles (ie, conception/design, analysis/interpretation, or manuscript writing).
Associations between performance of key roles and financial ties, adjusting for article-level covariates, were examined using generalized linear mixed models.
Results
One thousand eight hundred eighty-one authors (64%) reported performing at least one key role, and 842 authors (29%) reported at least one financial tie. Authors who reported performing a key role were more likely than other authors to report financial ties to industry (adjusted odds ratio [OR], 4.3; 99% CI, 3.0 to 6.0; P < .0001).
The association was stronger among trials with, compared with those without, industry funding (OR, 5.0 [99% CI, 3.4 to 7.5] v OR, 2.5 [99% CI, 1.3 to 4.8]), but was present regardless of sponsorship.
Conclusion
Authors who perform key roles in the conception and design, analysis, and interpretation, or reporting of oncology clinical trials are more likely than authors who do not perform such roles to have financial ties to industry…”
Who pays for clinical trials Who pays for clinical trials Who pays for clinical trials