GAO critical of FDA’s clinical trial oversight

By Nick Taylor

- Last updated on GMT

Related tags: Clinical trials, Clinical trial, Food and drug administration, Fda

The GAO has criticised the FDA’s efforts in overseeing clinical trials, with the agency accused of failing to implement recommendations that were made as far back as 2001.

Weaknesses in the US Food and Drug Administration’s (FDA’s) ability to monitor clinical trials have been identified by the US Department of Health and Human Services (HHS).

These include a failure to provide sufficient oversight to ensure the protection of patients participating in clinical trials. In particular the HHS reported that data limitations prevent the FDA from effectively managing clinical trials conducted through its Bioresearch Monitoring Program.

Inspection of clinical trial sites is another area the Government Accountability Office (GAO) has been monitoring after the HHS reported that only one per cent had been checked between 2000 and 2005.

The GAO’s own investigation into the FDA’s activities has highlighted a failure to analyse how gender and age affects the safety and effectiveness of particular drugs.

A recommendation was made by the GAO in 2001 that the FDA “consistently and systematically discuss gender differences in their written reviews of new drug applications​” but the agency has failed to implement this.

In addition the GAO is concerned the FDA is not analysing the impact age has on the safety and efficacy of drugs even when the product is treating conditions that are commoner in the elderly.

The GAO’s investigation into the FDA’s ability to oversee clinical trials started in January 2007, when the area was identified as being “high-risk”. These are classified as areas vulnerable to fraud, waste and mismanagement or those in need of significant changes to address major challenges.

Related news

Show more

Related products

show more

How clinical trial software can optimize trials

How clinical trial software can optimize trials

Formedix | 09-Jun-2021 | Technical / White Paper

This article explains the different types of clinical trial software available, and how it can be used to optimize the end to end clinical trials design...

Adapting supply chains to new ways of working

Adapting supply chains to new ways of working

World Courier | 01-Jun-2021 | Technical / White Paper

COVID-19 has changed the way we operate. We have adapted our supply chain solutions to meet our clients’ requirements while following World Courier standard...

What are the building blocks of DCTs?

What are the building blocks of DCTs?

Medable | 26-Apr-2021 | Technical / White Paper

How to create a seamless experience across eConsent, eCOA and more.

Over the past year, tremendous progress was made toward digitizing and...

How a clinical metadata repository helps with data

How a clinical metadata repository helps with data

Formedix | 22-Mar-2021 | Technical / White Paper

This article covers the various ways a clinical metadata repository helps with data quality, and in turn, with data quality in the clinical trials process....

Related suppliers

Follow us

Products

View more

Webinars