Clinical Trials

Safety Measures

Strict regulations and rigorous guidelines are among the many levels of safeguards that protect people who take part in clinical trials. Clinical researchers rely on these volunteers, and their safety throughout the entire clinical trials process is the number one priority. Protecting patient rights and well-being is crucial.

Another safeguard is a set of rules called a protocol. It defines a clinical trial’s eligibility criteria, specifies the tests and procedures, describes the medications and dosages, and establishes the duration of the study. Before the study begins, a scientific review panel evaluates the protocol carefully to make sure the trial is based on sound science. Regardless of their size or location, all clinics, hospitals, universities, cancer centers and medical offices that conduct clinical trials must follow the same protocol.

Groups Provide Oversight

These safeguards and protections are overseen by three main groups, and each is responsible for different aspects of the trials.

The U.S. Food and Drug Administration (FDA) is responsible for the safety, efficacy and security of drugs and has regulated them since the 1970s. It monitors several steps in the drug development process, which requires extensive research and numerous applications before and after clinical testing. The FDA also works closely with pharmaceutical companies to ensure the integrity of the new treatments and medications.

Institutional Review Boards (IRBs) review each clinical trial’s protocols before the study begins and monitor the trial’s ongoing progress from beginning to end. Members are in charge of reducing the risk of harm when compared with possible benefits to participants. An IRB may consist of scientists, doctors, nurses, social workers, chaplains, patient advocates and other health care or community professionals.

Data and Safety Monitoring Boards (DSMBs) review the progress of a clinical trial while monitoring the participants. They also review data on the effectiveness of the trial interventions. Each trial has only one DSMB, and it is usually composed of doctors, statisticians and others who are independent of the people, organizations and institutions that are sponsoring, organizing and conducting the clinical trial. Members are experts in clinical research and clinical trials, and they can stop a trial early if safety concerns develop.

In addition to safety oversight from these groups, the government passed the National Research Act in 1974, which ultimately led to the creation of three basic ethical guidelines for clinical trials.

  • 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.
  • Beneficence – People are treated in an ethical manner by respecting their decisions, protecting them from harm and making efforts to secure their well-being. Additionally, people should be protected from harm by maximizing benefits and minimizing risks in the research study.
  • 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 directly supervised by physicians and research experts. These regulatory requirements for drug studies address safety and efficacy issues unique to the use of drugs in clinical research and 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.

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 before they’re made available to the public. A team of CDER doctors, chemists, pharmacologists and other scientists analyze the medications at various stages during the approval process.

Another safeguard is the Informed Consent process, which protects participants throughout the clinical trial (see Overview, page 2). 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 people can make an informed decision about volunteering for a trial.

Understanding The Four Phases of Clinical Trials

Traditionally, clinical trials have been designed in four phases, and each phase adds another building block to the study’s foundation of knowledge. This approach allows researchers to ask and answer questions in a way that produces the most reliable information and provides the greatest protection of trial participants. The process also ensures that only treatments that have been rigorously studied are approved for the public.

  1. Phase I evaluates a new drug (or other type of treatment) to see if it is safe for use in people. The goal is to determine how the drug should be given, how often and at what dosage to be most effective for killing diseased cells while causing the fewest side effects.
  2. Phase II determines how well a treatment works and how safe it is in a greater number of patients.
  3. Phase III compares the new treatment with the current standard of care to see if it is more effective or has fewer side effects.
  4. Phase IV tests a drug that has already been FDA approved to gather more information about its effect in different populations and learn about long-term side effects.

The time it takes for the FDA to approve new therapies has been shortened considerably. Previously, approvals took about 10 years. Recently, based on successes of other trials, researchers have begun investigating and conducting seamless trials that begin in earlier phases. Today, the FDA considers approvals at any phase of research, including as early as Phase I trials, and frequently approves therapies before many other countries’ organizations. These advances give patients access to lifesaving treatments sooner.


Key Takeaways

  • The number one priority of clinical trials is the safety of participants
  • Many levels of safeguards are in place to protect participants’ rights, safety and well-being.

Additional Resources


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