Clinical Trials

Safety Measures

Clinical trials are necessary for cancer research, and monitoring and ensuring safety is crucial. As a result, standards exist to protect the rights, safety and well-being of all people participating in clinical trials.

Every clinical trial is designed with several levels of safeguards and a set of rules called a protocol, which must be followed. The protocol defines the eligibility criteria, specifies the tests to be done and the procedures to be used, describes the medications and dosages and establishes the duration of the study. All participating clinics, hospitals, universities, cancer centers and medical offices, regardless of their size or location, are subject to the same protocol. Before the study begins, a scientific review panel evaluates the protocol carefully to make sure the trial is based on sound science.

These protections are overseen by three main groups: the U.S. Food and Drug Administration (FDA), the Data and Safety Monitoring Board (DSMB) and Institutional Review Boards (IRBs). Each oversees different aspects of the trials.

The FDA has regulated the conduct of clinical trials since the 1970s and is responsible for the safety, efficacy and security of drugs. It also works closely with pharmaceutical companies to ensure the integrity of new treatments and medications. Several steps in the drug development process are monitored by the FDA, which requires extensive research and applications before and after clinical testing.

The DSMB oversees clinical trials to confirm they are safe for participants. IRBs monitor clinical trials to ensure they are safe, fair and correctly designed.

The National Research Act, established in 1974 by the U.S. government, identifies three basic ethical guidelines to follow when biomedical and behavioral research involving people is conducted:

  1. Respect for people – All people, including those who require assistance to make their own decisions, should be respected and have the right to choose which treatments they receive.
  2. Beneficence – People are treated in an ethical manner by respecting their decisions and protecting them from harm and by making efforts to secure their well-being. Additionally, people should be protected from harm by maximizing benefits and minimizing risks in the research study.
  3. Justice – All people should share the benefits and burdens of research.

Additional Safety Guidelines

To ensure compliance with all scientific and ethical guidelines, all studies are conducted under the direct supervision of physicians and expert research professionals. These regulatory requirements for drug studies address safety and efficacy issues unique to the use of drugs in clinical research, and the requirements are designed to guarantee the safety of all participants in a clinical trial.

Failure to meet the FDA’s regulations can have legal and financial consequences for those conducting the research as well as for the institutions associated with the research activities.

Another safeguard is the Informed Consent process, which protects participants throughout the duration of a clinical trial. This process requires the research team to explain all the details about the trial, including the purpose, tests and treatment involved and the possible risks and benefits so you can make an informed decision about volunteering for the trial.

Benefits and Risks

All drugs 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.

A team of CDER doctors, chemists, pharmacologists and other scientists carefully analyzes the medications at various stages during the approval process. When the health benefits of a drug outweigh the known risks, approval to move forward is granted. However, when issues arise, the process is delayed or even stopped.

If any issues are identified, the CDER will send a letter of explanation to the drug sponsor (the pharmaceutical company). Upon receiving 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.

 

Additional Resources

 

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