USA

Regulatory

The United States has one of the most complex healthcare systems in the world. The Office for Human Research Protections (OHRP), National Institutes of Health (NIH), and U.S. Food and Drug Administration (FDA) websites provide public information about clinical studies, drug development, and other health care aspects. The Good Clinical Practice (GCP) guidelines include standards on how clinical trials should be conducted, define the roles and responsibilities of clinical trial sponsors, investigators and CROs. It also includes information about protection of human rights of people participating in trials and provides assurance of the safety and efficacy of the newly developed compounds.

The US FDA is committed to protecting the participants of clinical trials, as well as providing reliable information to those interested in participating.

Official links

https://www.fda.gov/

https://www.cdc.gov/

Pharmaceutical Industry & Clinical Trials Market

The United States has captured a dominant share of the pharmaceutical market worldwide. Some of the largest international pharma companies are headquartered in the USA. The US consumers have access to one of the most advanced pharmaceutical systems in the world. Every year, the US pharmaceutical industry develops a variety of new drugs that provide valuable medical benefits. The U.S. pharmaceutical industry has made great strides over the past few decades due to a greater focus on research and development (R&D). The biopharmaceutical sector contributes close to 90% of total spending on clinical trials for drugs and equipment. Pharma companies spend approximately 20% of their revenues on R&D.

The increasing prevalence of chronic diseases, a rising number of biologics, the need for personalized medicines and orphan drugs, and demand for advanced technologies are all fueling the market’s growth.

Medical System in USA

The United States’ health care system operates differently from many others in the world with high costs for the individual as a main, distinguishing characteristic. The U.S. has historically utilized a mixed public/private approach to healthcare. In this approach, citizens or businesses can obtain health insurance from private insurance companies, while individuals may also qualify for public, government-subsidized health insurance.

In the US a large share of hospitals and clinics are owned by private non-profit organizations. While the expenditures are covered in a large share by public payers such as Federal institutions, state and local governments, they can also be covered by private insurance and individual payments.

There is no single nationwide system of health insurance, the United States primarily relies on employers who voluntarily provide health insurance coverage to their employees and dependents.

In addition, the government has programs that tend to cover healthcare expenses for the elderly, disabled and the underprivileged.