What is a clinical research study?
Before a pharmaceutical or biotech company can bring a new drug to the marketplace, they must test the new drug to determine the safety and effectiveness of the new medication. This testing involves people who volunteer to participate in the clinical research study. People that volunteer to participate in clinical research study are referred to as volunteers or study participants.
The clinical research study is conducted by a doctor or a team of doctors and their medical staff who have been provided with strict procedures, rules, and guidelines, for conducting the study, by the U.S. Food and Drug Administration (FDA) and the pharmaceutical or biotech company.
What are the benefits of participating in a clinical research study?
Clinical research studies are the basis for the development of new drugs used to treat diseases and illnesses. People that volunteer to participate in clinical research studies do so for various reasons to include:
- the ability to take an active role in their own health care while learning more about their condition or illness
- gaining access to new treatments before they are widely available to the general public
- receiving the satisfaction of knowing that they are assisting in the development of new treatments that may help themself and others
- access to free health care, exams, and procedures
- access to medications that may help treat their illness or disease
- compensation for their time and travel
Who can participate in a clinical research study?
Every clinical research study indicates in detail the eligibility criteria for the study. Some studies seek participants that have a specific illness or condition while others seek healthy participants. The criteria required to participate in a clinical research study is called the inclusion criteria whereas the factors that disqualify someone from participating in a study are called exclusion criteria. Inclusion and exclusion criteria are based on factors such as age, gender, the type and stage of the disease, previous medical history, and other medical considerations. The medical staff conducting the clinical research study will help the participant determine his or her eligibility for the study.
How long do clinical research studies last?
Clinical research studies vary in length of time depending on the illness or condition being studied. Some studies have extensions which are in effect another study that begins after the initial study has ended. The participants are always told how long a study will last prior to enrolling in the study.
What should I expect as a volunteer in a clinical research study?
Each study is different and has its own unique set of procedures, rules, and guidelines that have been reviewed and approved by the U.S. Food and Drug Administration (FDA). Before you begin any study, you will be provided with a document called the informed consent. The informed consent thoroughly outlines everything that is involved in the clinical research study. It provides information on the study’s purpose, duration, an explanation of all study related assessments and procedures, a schedule of events for all activities that will take place during the study, the participants responsibilities, an explanation of the potential benefits and risks associated with the study, details of compensation for participating in the study, the confidentiality of all study participants, and the participants right to withdraw from the study at any time.
After reviewing the informed consent, the prospective participant decides whether or not to participate in the study. If the decision is made to participate in the study, the prospective participant signs the informed consent which acknowledges that the prospective participant received and read the informed consent. However, it should be noted that the prospective participant’s signing of the informed consent does not create a contract, therefore, the study participant can withdraw from the study, at their sole discretion, at any time.
How is the safety of the study participant protected?
Throughout the clinical research study, every effort is made to maintain the safety and protect the rights of the study participants. First, the doctor that leads the clinical research study has an ethical and legal code, as a doctor, to always act in the best interest and safety of his patient/study participant.
Second, the study participant is always provided with an informed consent which is a document that outlines, in detail all that is involved in the clinical research study. The informed consent is provided to the study participant so that the participant knows what to expect throughout all steps involved in the study. Based on the information presented in the informed consent, the prospective participant makes the decision whether or not to participate in the clinical research study. Further, even after making the decision to participate in the study, the study participant can at any time make the decision to withdraw from the study.
Third, the U.S. Food and Drug Administration (FDA) must approve all clinical research studies prior to the start of the study. Even after the study has been approved, the FDA continues to monitor and oversee the study to ensure that all procedures, rules, and guidelines are closely adhered to ensure that the study participants’ safety and rights are protected.
Fourth, the pharmaceutical or biotech company that sponsors the clinical research study has their representatives that continuously come to the research site, throughout the course of the study, to monitor the participant’s records. These representatives are required to adhere to the strict procedures, rules, and guidelines set forth by the U.S. Food and Drug Administration (FDA) that includes maintaining the safety of all study participants.
Finally, every clinical research study is overseen by an Institutional Review Board (IRB). The IRB is an independent committee made up of doctors, statisticians, and members of the community who ensure that the clinical research study is ethical and that the rights of the participants are protected. Each clinical research study must be approved and monitored by an IRB to ensure that risks are minimal and worth any potential benefits derived from the clinical research study.
Based on the information above, clearly every effort is made to protect those that volunteer to participate in clinical research studies. This is important because the participants’ involvement in the clinical research study is critical and essential to the further advancement of medicine. Without their willingness to participate in clinical research studies, the clinical research required to look at new ways to detect, prevent, and treat diseases would be significantly limited.