Protecting People Everywhere
Pharmaceutical Executive
Washington, DC-More countries are hosting pharma's R&D efforts, creating a research environment ripe for abuses of patient safety because FDA cannot ensure the same protection in foreign trials as in domestic ones. A recent study by the US Health and Human Service's office of the inspector general (OIG) found that regions with less research experience-including Eastern Europe, Latin America, and East Asia-have become more desirable locations for US-based companies and contract research organizations' clinical trials. In fact, the number of countries producing data for FDA submissions jumped from 28 to 79 between 1989 and 1999. And that trend shows no
Washington, DC-More countries are hosting pharma's R&D efforts, creating a research environment ripe for abuses of patient safety because FDA cannot ensure the same protection in foreign trials as in domestic ones. A recent study by the US Health and Human Service's office of the inspector general (OIG) found that regions with less research experience-including Eastern Europe, Latin America, and East Asia-have become more desirable locations for US-based companies and contract research organizations' clinical trials. In fact, the number of countries producing data for FDA submissions jumped from 28 to 79 between 1989 and 1999. And that trend shows no signs of slowing.
Currently, foreign institutional review boards (IRBs) oversee the ethical treatment of patients, but they have been widely criticized by the pharma industry, national regulatory authorities, the National Bioethics Commission, and the World Health Organization for their lack of experience and insufficient monitoring practices.
IRBs are known as ethical committees-there to protect the populations' safety-says Basil Burke, PhD, vice-president of drug discovery and development for Clinimetrics, a global CRO. Whether they are doing that is a pivotal question that FDA must face. Right now, it is up to CEOs to recognize and stop shortcuts on patients' rights.
The issue has heated up since the Washington Post ran a series of articles in late 2000, questioning Pfizer's treatment of Nigerian children participating in its 1996 clinical trials for the meningitis treatment Trovan (trova-floxacin) and inspiring OIG to conduct the study.
Yet companies will probably continue to seek emerging regions for clinical trials because it makes business sense: Large numbers of eager participants and naïve subjects-patients untreated for the disease being studied-save companies money by speeding trial recruitment, and testing in another country allows extended market development. Enabling the trend is FDA's acceptance of international data in line with the standardized procedures laid down at the 1990 International Conference on Harmonization.
In the report cover letter, inspector general Janet Rehnquist issues her recommendations for FDA and the Office for Human Research Protections to help ensure foreign protections are at least equivalent to US regulations. They include:
- develop an international accreditation system for institutional review boards
- obtain more information about individual practices of foreign IRBs
- help IRBs build more competency
- encourage better research monitoring and greater researcher commitments to ethical standards.
Addressing Disparities in Psoriasis Trials: Takeda's Strategies for Inclusivity in Clinical Research
April 14th 2025LaShell Robinson, Head of Global Feasibility and Trial Equity at Takeda, speaks about the company's strategies to engage patients in underrepresented populations in its phase III psoriasis trials.
Beyond the Prescription: Pharma's Role in Digital Health Conversations
April 1st 2025Join us for an insightful conversation with Jennifer Harakal, Head of Regulatory Affairs at Canopy Life Sciences, as we unpack the evolving intersection of social media and healthcare decisions. Discover how pharmaceutical companies can navigate regulatory challenges while meaningfully engaging with consumers in digital spaces. Jennifer shares expert strategies for responsible marketing, working with influencers, and creating educational content that bridges the gap between patients and healthcare providers. A must-listen for pharma marketers looking to build trust and compliance in today's social media landscape.
Pfizer, GSK Gain ACIP Recommendations for RSV and Meningococcal Vaccines
April 18th 2025The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted to expand access to Pfizer’s respiratory syncytial virus vaccine Abrysvo for high-risk adults in their 50s and voted in favor of GSK’s meningococcal vaccine, Penmenvy, for streamlined adolescent protection.
