Clinical Trials

Safety Measures

The U.S. Food and Drug Administration (FDA) is an agency in the U.S. Department of Health and Human Services that is charged with ensuring the safety, efficacy and security of human drugs, in addition to other areas of regulatory authority. The FDA has regulated the conduct of clinical trials since the 1970s, and the protection of human participants in research is a primary focus.

Before a drug or treatment receives FDA approval, all clinical trials evaluating that drug must comply with scientific and ethical guidelines while each trial is being developed and monitored. To ensure compliance, all studies are conducted under the direct supervision of physicians and expert research professionals. Every participating clinic, hospital, university or cancer center, regardless of size or location, is subject to the same protocol. The protocol is a set of rules that outlines the eligibility criteria, specifies the tests that will be used and procedures that will be performed, describes the medications and their doses, and establishes the length of each study. These regulatory requirements for drug studies address the safety and efficacy issues unique to the use of drugs in the clinical research setting and are in place to guarantee the safety of all participants in a clinical trial. Failure to meet the FDA’s regulations can have legal and financial implications for the individuals conducting the research as well as the institutions associated with the research activities.

Safety and the FDA

Drug safety is the number one priority of the FDA, which works closely with pharmaceutical companies to ensure the integrity of new treatments or medications. Several steps in the drug development process are monitored by the FDA, which requires extensive research and applications before and after clinical testing. More than 300 new medications have been approved by the FDA over the past 10 years, and roughly 97 percent of them are still on the market and considered safe today.

Seeking approval

Regardless of how or why drugs are developed or discovered, they all must pass a series of tests and undergo a rigorous evaluation process by the FDA’s Center for Drug Evaluation and Research (CDER) to ensure they are safe and effective for human use before they’re made available to the public. The CDER regulates prescription medications as well as over-the-counter medicines, biologic therapeutics and generic drugs. Items such as fluoride toothpaste, antiperspirants, sunscreen and dandruff shampoo — all of which are classified as “drugs” by the FDA — are also subject to CDER regulation.

Safety checks

A team of CDER doctors, chemists, pharmacologists and other scientists are enlisted to carefully analyze the medications at various stages during the approval process. When the health benefits of a drug are found to outweigh the known risks, approval to move forward is granted. However, when issues arise, the process is delayed or even stopped. Some common problems that could prevent or delay a drug’s approval include the following:

  • Unexpected safety issues
  • Failure to demonstrate the drug’s effectiveness
  • Failure to follow good manufacturing practices
  • An inability to accurately mass-produce the drug (resulting in quality-control issues, for example)

If one or more of this type of issue is identified, the CDER will send a letter to the drug sponsor (the pharmaceutical company) to explain the issue(s). Upon receipt of the letter, the drug sponsor can choose to meet with a CDER official for further discussion, ask for a hearing, correct the problem(s) and submit new information or withdraw the application altogether.

Questions to ask about safety

  • What risks could I face in this trial?
  • Who is watching out for my safety?
  • Can I talk to others who have participated in previous trials?
  • Will I jeopardize my chance of getting treatment that might actually cure me?
  • How can I be sure my clinical trial follows the approved protocol?

Committed to safety

Safety for participants of clinical trials was written into law in 1974 with the passage of the National Research Act, which sought to identify basic ethical guidelines that should be followed when conducting biomedical and behavioral research involving humans. Three particular ethical principles were outlined:

  1. Respect for people – All humans should be respected and have the right to choose what treatments they receive; if they require assistance in making their own decisions, they are entitled to protection.
  2. Beneficence – People are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being. Additionally, people should be protected from harm by maximizing benefits and minimizing risks.
  3. Justice – All people should share the benefit and burdens of research.

Learn more here.


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