Adverse event: a negative change in a patient’s condition that takes place during the study or sometime after the study has ended. The cause of the change may or may not be because of the treatment given during the study.
Allocation: method used to assign volunteers so a specific arm of a study; can be randomized or nonrandomized
Arm: group or subgroup of patients in the study who may or may not receive treatment depending on the study protocol.
- Active comparator: group of volunteers that receive the treatment and is considered effective
- Experimental: group of volunteers that receive the treatment and are the study’s main focus
- No Intervention: group of volunteers that do not receive any treatment during the course of the clinical study
- Placebo comparator: group of volunteers that receive a placebo during the clinical study
- Sham comparator: “A group of participants that receives a procedure or device that is made to be indistinguishable from the actual procedure or device being studied but does not contain active processes or components”
Baseline characteristics: data gathered at the beginning of a clinical study for all volunteers and arms of the study. Data include demographics and study-specific measures (such as medical history).
Certain agreements: an explanation of the agreement between the Sponsor of a clinical study and the principal investigator (PI) in which the PI is not allowed to discuss or publish the results of the clinical study once it has ended
Clinical study: Clinical studies, also commonly referred to as clinical trials, are research centered around people. Each has a separate goal or objective that may focus on better ways to prevent or diagnose cancer, or on how to improve cancer treatment.
Closed studies: clinical studies no longer accepting volunteers because they have enough volunteers, the study has ended or has been stopped. Recruitment statuses for closed studies include:
- Active, not recruiting
- Enrolling by invitation
- Temporarily not available for expanded access
- No longer available for expanded access
- Approved for marketing
- Unknown (study record has passed its completion date and the recruiting status has not been verified on ClinicalTrials.gov within the past 2 years)
Collaborator: organization besides the Sponsor that offers support, including funding, design, reporting, etc, for a clinical study
Controlled study: a type of clinical study where observations made during the treatment are compared to the traditional method, or the control
Cross-over design: groups of volunteers receive two or more interventions in a specific order.
Data monitoring committee (DMC): group of individual scientists who observe the safety and scientific integrity of clinical studies. The group reports any findings that may be impeding the study to the study Sponsor
Double-blind masking: two or more groups involved in the study don’t know which volunteers have been assigned to which interventions
Eligibility criteria: requirements for individuals who choose to volunteer for a study must meet. Includes both inclusion and exclusion criteria.
Enrolling by invitation: studies where select participants are chosen by researchers in advance. Not open to all participants.
Exclusion criteria: the factors restricting someone from participating in a clinical study
Expanded access: process monitored by the FDA where certain manufacturers can administer new treatments to patients with serious conditions and illnesses who cannot participate in a clinical study
FDA: Food and Drug Administration
Funder type: organization that supplies necessary funds for the clinical study. Also referred to as Sponsors or Collaborators. Four main types of funders include:
- National Institutes of Health (NIH)
- Other U.S. Federal Agencies
- Industry (pharmaceutical and device companies)
- All others (private individuals, universities)
Genders eligible for study: the physical gender (Male, Female or Both) who may participate in a clinical study
Health authority: a national or international health organization that has jurisdiction over a clinical study
Human subjects review board: group of experts whose focus is the human participants’ well being by looking over, approving and observing the clinical study protocol.
Inclusion criteria: the factors, or rationales, for allowing someone to partake in a clinical study
Informed consent: a process by researchers used to relay information to new and current research participants about the clinical study. Its main focus is protecting the participant. Researchers must provide all important information to patients, make sure he or she understands all the risks and benefits associated with the study, and assure the current or future participant that the clinical study is a voluntary study and that he oro she may withdraw at any point.