EXECUTIVE SUMMARY

More clinical trials are industry-funded, with fewer funded by the National Institutes of Health, raising concerns about the potential for conflicts of interest. Some safeguards include the following:

  • better training for local research ethics committees,
  • improved scrutiny by the FDA of ethical aspects of clinical trials sponsored by industry,
  • rigorous standards of peer review and reproducibility, and
  • meta analyses on trends that might indicate a skewing of the data.

More clinical trials are being funded by industry, with fewer funded by the National Institutes of Health (NIH), found a recent study. From 2006 to 2014, the number of industry-funded clinical trials increased by 1,965 (43%), while NIH-funded trials decreased by 328 (24%).1

“The decline in NIH-funded clinical trials is, without doubt, a result of the decrease in congressional budget allocations for the NIH from 2010 through 2013,” says Ruth Macklin, PhD, professor in the Department of Epidemiology and Population Health at Albert Einstein College of Medicine in Bronx, NY.

Still, the NIH remains the largest funder of biomedical research in the world. “The pharmaceutical and biotech industries are profit-making entities, and their chief goal is to increase their revenue,” says Macklin. The more clinical trials they fund, the greater the opportunity to bring new products to market.

Andrew Childress, PhD, assistant professor at Baylor College of Medicine’s Center for Medical Ethics and Health Policy in Houston, agrees that the stagnation of government-sponsored research funding caused investigators to look elsewhere to fund their labs. “Within the last decade or so, there has been a concomitant rise in the number of academic-industry partnerships,” he adds.

The following are some concerns from ethicists involving industry-funded clinical trials:

The fact that investigators are typically reimbursed by the pharmaceutical industry to conduct these studies creates a potential financial conflict of interest.

Investigators are sometimes paid based on enrollment, or may receive incentives or bonuses related to protocol completion.

“In these cases, investigators would have a financial incentive to keep a participant in the study for as long as possible, even in light of adverse events,” explains Childress.

Some investigators also have a financial interest in the company. “While conflicts of interest are not inherently problematic, when they compromise or appear to compromise the scientific integrity of the study, then public trust in research is diminished. Patient safety may also be compromised,” says Childress.

When the sponsor is financially vested in the outcome, it calls the objectivity of the science into question, he says. Data manipulation, falsification, and ghostwriting are particular concerns. “Investigators or sponsors may be tempted to resort to these strategies to make the results appear more positive than warranted by the evidence,” says Childress.

Fairness in the allocation of resources is a concern when clinical trials are conducted for pharmaceutical interventions that are profitable, but don’t address pressing health concerns.

“This means that resources are not being spent on more pressing public health problems,” says Childress.

There may be a tendency to medicalize aspects of human growth and development that are not necessarily pathological in order to profit from treatments for these maladies.

Childress says industry sponsors are generally less interested in funding research on lifestyle modifications. These require longitudinal studies to show an effect, and resources to monitor outcomes — but likely will not translate into products that a company can sell.

“The profit motive begins to determine the research agenda,” says Childress. “This will likely lead to research that benefits only those who can afford the resulting intervention.”

Over the past couple of decades, there has been a great increase in the number of industry-sponsored trials in developing countries, notes Macklin.

“This increase has been because it is cheaper and, until recently, there has been inadequate ethical oversight over research conducted in these countries,” says Macklin. Ethical questions remain about the process of obtaining informed consent, the qualifications of contract research organizations that implement industry-funded trials, and the quality of ethical review by local institutional review boards (IRBs).

“Possible safeguards include better training for local research ethics committees, and improved scrutiny by the FDA of ethical aspects of clinical trials sponsored by industry,” says Macklin.

Childress believes rigorous standards of peer review and reproducibility can weed out bad science. Ultimately, the IRB and the academic institution are responsible for enforcing conflict-of-interest disclosure policies.

“Meta-analyses can point to trends in research that might indicate a skewing of the data toward more positive outcomes for industry vs. government-sponsored trials,” suggests Childress.

REFERENCE

  1. Ehrhardt S, Appel LJ, Meinert CL. Trends in National Institutes of Health funding for clinical trials registered in ClinicalTrials.gov. JAMA 2015; 314(23):2566-2567.

SOURCES

  • Andrew Childress, PhD, Assistant Professor, Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston. Phone: (713) 798-8164. Email: Andrew.Childress@bcm.edu.
  • Ruth Macklin, PhD, Professor, Department of Epidemiology & Population Health, Albert Einstein College of Medicine, Bronx, NY. Phone: (718) 430-3574. Fax: (718) 430-3076. Email: ruth.macklin@einstein.yu.edu.