Every day, research uncovers new information about medical conditions and possible therapies. Your involvement in clinical research studies could help in the development of new medication for future use. You and many other people may benefit from your willingness to become involved. Volunteering to participate in a clinical drug study is one of the best ways you can contribute to the understanding of diseases that affect people and the development of new therapies. Volunteers are important to the clinical research study phase of the drug approval process. As a volunteer, you are the most critical link in a long chain of research and testing in the development of new medications for the future treatment of a broad range of health problems.
What is a Clinical Research Study?
A clinical research study is designed to test the effects and / or safety of an investigational medication, medical treatment or device on a group of volunteers. Clinical research studies are an important step in making new medications available for future use.
How is a Drug, Treatment, or Device Approved for Testing?
The U.S. Food and Drug Administration (FDA) typically must authorize a drug company’s proposal to conduct clinical research studies. Drug companies must do years of laboratory research before they can begin testing medicines in humans.
Who Can Be in a Clinical Research Study?
People with the condition being studied as well as healthy people can volunteer to participate in a study. The FDA has strict requirements that specify which studies involve healthy volunteers and which studies involve people with the condition being studied. Each study has specific requirements such as age, sex or medical condition for participants. The physician conducting the study will review each volunteer’s medical history and the study requirements to determine who can participate. Known risks and discomforts will be explained by the study physician or research coordinators prior to participating in the study. In addition to the known risks, there may be unknown risks such as medication side effects involved in participating in a clinical research study.
What is Informed Consent?
Informed consent is the process designed to give study volunteers the information that they need to decide about participating in a clinical research study. This process allows the volunteer to ask questions and to exchange information freely with the clinical investigator. The clinical investigator is responsible for ensuring the informed consent is obtained from each research study volunteer before that person participates in the research study.
Who is the Institutional Review Board (IRB)?
The IRB is a group of healthcare professionals and members of the local community that must review and approve a clinical research study before it begins. The IRB carefully reviews study activities because its primary responsibility is to protect the safety and rights of the study volunteer.
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Once patients are enrolled in a clinical study, the emphasis shifts to retaining patients in the trial and ensuring they are compliant with all aspects and timelines of the protocol. Enrolled study participants are more likely to adhere to protocol requirements when study-related tasks are top of mind. There are many solutions available to ensure compliance with study-related tasks, including:
- Appointment scheduling and reminders via email, mail, and telephone.
- Reminders to complete patient diaries and/or interviews.
- Online patient diaries.
- Reporting mechanisms via telephone and secure Websites, as well as centralized adverse event reporting.
- Centralized communications that streamline the information flow and provide after-hours support for questions, follow up with patients, appointment rescheduling, and sharing information directly with site coordinators.