In addition, of all clinical trial funding in the United States, nearly 75% currently comes from corporate sponsors. In addition, scientists employed by pharmaceutical companies play an important role in evaluating the effectiveness, safety and cost-effectiveness of new drugs. Unreliable clinical trials that result from the potential for bias due to the influence of large pharmaceuticals are an ongoing problem because “clinical trials for pharmaceuticals are conducted and funded by the industry,” says Dr. Carome, Director of the Public Citizens Health Research Group in Washington, DC.
But the main motivation of pharmaceutical companies is “big profits”. Therefore, they design studies and report results “in a way biased towards showing a favorable risk-benefit profile,” Carome told Drugwatch. Carome, director of Public Citizen, stated that publication bias is a “major problem”. Carome said that “The decision to publish the results of a study on a particular drug rests entirely with the researchers in the study, including pharmaceutical companies that conduct and fund clinical trials that test their drugs.
Therefore, the medical literature is a partial, and often biased, sample of all medical evidence. Funding for a clinical trial can come from different sources, including government agencies, institutions or foundations. The National Institutes of Health is the main source of government funding for trials. Government funding comes from taxes and is included in the congressional budget.
Funding can also come from companies such as pharmaceutical and medical device companies. Private companies also support research into therapies in which they have a financial interest. With government funding declining over the past 10 years, private industry is increasingly supporting clinical trials. The study sponsor (such as the government, drug manufacturers, or technology companies) typically pays all costs related to a clinical research study.
This includes the provision of the new treatment, as well as any special tests, possible additional visits to the doctor and the research costs involved in clinical trials. Each study sponsor identifies the best doctors in the country to partner with to administer the actual study with qualified patients. FDA requires clinical trial participants to receive all study-related doctor visits, diagnostic tests, and study treatments free of charge. This is in exchange for voluntarily participating in the clinical trial.
In trials funded by pharmaceutical companies, statistically significant differences in the occurrence of ADR between drug and control groups were significantly less common, and the authors of these publications (e) designated the drug as safe for use more frequently than in trials with other sources of funding (see Party. According to critics and consumer watchdogs, the influence of big pharmaceuticals on clinical trials could allow pharmaceutical companies to focus on the benefits of a drug and minimize risks for profit. According to critics, this could allow pharmaceutical companies to falsify study results or hide dangerous side effects to get their drugs approved or increase sales. ADRs, adverse drug reactions; SSRIs, selective serotonin reuptake inhibitors; RCT, randomized controlled trials; RR, relative risk; 95% CI, 95% confidence interval; FDA, U.S.
Food and Drug Administration. Seven of the studies investigated addressed adverse drug reactions (ADRs) in industrially supported drug trials (Table). Drug manufacturers spend considerable resources arguing that once the FDA approves their drug and makes a safety determination, they should be immune to product liability lawsuits filed by consumers. ICMJE, International Committee of Medical Journal Editors; RCT, Randomized Controlled Trials; ADR, Adverse Drug Reactions; OR, Odds Ratio; 95% CI, 95% Confidence Interval; FDA, U.S.
Food and Drug Administration; SSRIs, Selective Serotonin Reuptake Inhibitors. Manufacturers also don't like testing new drugs on older patients, even if this is the population that will likely use the drug once approved. According to the Food and Drug Administration (FDA), sponsors of clinical trials may be “a person who initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed. Or an industry-funded trial of a tumor drug could study a drug's ability to shrink a tumor, not its ability to prolong a patient's life or improve their quality of life.