Clinical Trials

Safety Measures

One area of concern patients may have about volunteering for a clinical trial is whether they will be safe throughout the process. Rest assured, guidelines have been established to ensure every patient who joins a clinical trial is protected. Clinical trials rely on volunteers, and protecting their rights, safety and well-being is the top priority for clinical researchers.

To keep patients safe, several levels of safeguards and a set of rules called a protocol must be followed for every clinical trial. A protocol 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.

These safeguards are overseen by three main groups.

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. The FDA monitors several steps in the drug development process, which requires extensive research and numerous applications before and after clinical testing. It also works closely with pharmaceutical companies to ensure the integrity of the new treatments and medications.

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.

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.

Additional Safety Guidelines

All studies are directly supervised by physicians and research experts. This extra safety measure is designed to ensure compliance with all scientific and ethical guidelines. 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. Every trial also has a local principal investigator whose name and phone number are on every trial and can be contacted. In addition, all investigators have required training and periodic updates of training.

Another safeguard is the Informed Consent process, which also protects participants throughout the clinical trial. The Informed Consent form contains all the details about the trial. You will be given that form when you are considering a specific trial so you can make an informed decision about volunteering.

A member of your health care team should explain the Informed Consent information in easy-to-understand language. That explanation should include details about the purpose of the research, including your role in the trial, how the trial will work, risks, benefits, expectations, protocols, alternative beneficial procedures or treatments, the research subject’s rights, where more information can be found and answers to additional questions about the research.

The document will include some of the following information:

  • The trial and its goals.
  • Possible risks and benefits.
  • How the participant will be monitored and what side effects to expect.
  • The best standard regimen of care for the stage of your disease, regardless of the doctor or institution.
  • The safeguards in place. All clinical trial participants are protected by rules that apply nationwide to all facilities.
  • How to withdraw from the trial. You may choose to leave the trial at any time and for any reason.

To ensure you fully understand, you are required to review the form. You should have a reasonable amount of time to review the trial’s information and ask questions before giving your consent.

Before signing it, check with your insurance providers to determine the procedures that are covered and those you will be expected or required to pay out of pocket. Although many components of the trial may be covered, other expenses may be your responsibility. It is important for you to have this information before you begin participating in the trial.

Keep in mind that participants in a clinical trial are not guaranteed to benefit. And, as with any type of cancer treatment, potential risks as well as benefits may occur.

 

National Research Act

The U.S. government passed this act in 1974, which ultimately led to the creation of these 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.

 

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