Enrolling in a clinical trial will put you in a new world with a new language. As with all professional environments, there are key terms that will be important to know. They’ll help prepare you to actively engage in your trial, understand the information presented to you, and know what questions to ask. Starting with these fifteen key terms, you’ll be better prepared for your participation right off the bat:
Adherence: Also known as “compliance,” adherence is the extent to which patients follow trial instructions. Taking medication the right way, completing forms, recording side effects, or visiting the trial’s clinic would all be examples of adherence.
Adverse Event: Sometimes called adverse effect, an adverse event refers to an unintended and undesirable effect of treatment. Ranging from mild to severe, an adverse event may be caused by a therapy used in a trial.
Clinical Research Coordinator: The clinical research coordinator’s primary responsibility is the protection and safety of the trial participant. The CRC oversees the team of clinical research associates and typically performs duties such as facilitating trial visits and serving as the primary point of contact for participants.
Dosage: The prescribed amount and frequency of a dose of a medicine or drug a patient receives.
Efficacy: The ability of a drug or other medical intervention to produce the desired effect under ideal and controlled clinical trial circumstances. Efficacy illustrates how the trial’s drug or therapy performed.
Eligibility Criteria: A term that describes both inclusion and exclusion criteria — the requirements for all people enrolled in a clinical trial. Eligibility criteria help ensure that patients resemble one another in characteristics such as age, gender, or certain aspects of medical history.
Exclusion Criteria: Factors related to age, gender, or an aspect of a medical condition that can disqualify patients from participating in a particular clinical trial. For example, being 35 years-old would be an exclusion criteria for trials seeking people aged 18 to 30.
HIPAA: The acronym for the Health Insurance Portability and Accountability Act. HIPAA is a US law protecting the confidentiality of patients’ medical records and other information provided to health care providers.
Inclusion Criteria: The requirements for participating in a clinical trial, including age, gender, the type and stage of a disease, history of treatment, and other medical conditions.
Informed Consent: A document and related conversations providing information for a patient to fully understand the risks and potential benefits of participating in a clinical trial. Informed Consent explains a trial’s purpose, how it will work, and the patient’s role.
Investigational Product (IP): A drug, biological product, device, or placebo being tested or used in a clinical trial. An investigational product is typically either not yet approved by the FDA or being used in a different way from which it is currently approved.
Principal Investigator: The person leading the clinical trial’s scientific and technical direction. The principal investigator protects the rights, safety, and welfare of trial participants and ensures all participants are volunteering with informed consent.
Randomization: A clinical trial’s technique for creating an experimental control (or comparison group) where patients are randomly assigned to a “treatment arm,” such as an experimental treatment, standard treatment or placebo. Randomization typically assigns a participant to a group using computer programs and eliminates the bias introduced when investigators select which arms participants are assigned to.
Screening Visit: The clinic site visit that determines whether a person qualifies to participate in a study. Screening visits involve meeting the trial coordinator and the principal investigator, reviewing and signing the informed consent form, undergoing a physical examination and medical history review, and, possibly, laboratory or diagnostic testing.
Sponsor: The individual, company, or organization responsible for the management and/or financing of a clinical trial as well as analysis of the data collected. Sponsors could be health care providers, research facilities, government entities, pharmaceutical companies, or nonprofit groups.
This blog is intended to be informational in nature. The information and other content provided in this blog, or in any linked materials, are not intended and should not be construed as medical advice, nor is the information a substitute for professional medical expertise or treatment.
If you have any questions or concerns, please talk to your doctor. Never disregard professional medical advice or delay in seeking it because of something you have read on this blog or in any linked materials. If you think you may have a medical emergency, call your doctor or emergency services immediately.