Glossary

Clinical Research Coordinator

A Clinical Research Coordinator, also known as a Coordinator (herein called a “Coordinator”) is a research professional working under the direction of the study doctor or Principal Investigator (PI). The Coordinator is responsible for screening and recruiting trial participants and collecting trial data.

Clinical Trials

A clinical trial is also known as a medical research study. For purposes of this website, we will refer to a research study as a “trial”. A trial is intended for human subjects to determine the pharmacological, pharmacokinetic and/or pharmacodynamic effects of an investigational (not yet approved) medication, device or vaccine and is carefully designed to include specific criteria for participation. Trials may also test new methods of screening, prevention, diagnosis or treatment of a disease. Trials are also designed to answer questions about new therapies or new ways of using known therapies or treatments to determine whether new drugs or treatments are safe and effective.

Study participants (or “study volunteers” or “study subjects”) will be screened to see if they qualify for a particular study. Qualified participants may be asked to take an investigational medication or vaccine or, in some cases, use an investigational device, under the supervision of a Principal Investigator which is a study doctor or a physician or other research professional who is qualified to conduct the study.

Studies must be reviewed by an Institutional Review Board (IRB) or Ethics Committee (EC). An IRB or EC is a group that is responsible for helping to protect the rights and welfare of study participants. The IRB or EC will assure that each study participant is receiving the standard of care. Every study participant is closely monitored before, during and, sometimes, after the study.

CRO

A sponsor may transfer responsibility for any or all of the obligations to a Clinical Research Organization (CRO). (See “Sponsor” below.)

Clinical Trial/Trial Phases

Trials are usually done in three (3) phases, sometimes followed by a post-marketing study.

Phase 1 Trials

Phase 1 trials (first time in humans) focus on determining the safety of a new or investigational medication. This phase involves a small group of healthy participants. While healthy participants are targeted, there are some Phase I trials where specific populations such as Cancer patients and HIV patients are included when it is likely that the trial medication would make a healthy participant ill. Phase I trials are designed to assess how the medication is absorbed, metabolized and excreted when introduced to the human body. Phase I trials also include dose escalation to determine the best and safest dose. Many Phase 1 trials involve overnight stays in order to be closely monitored.

Phase 2 Trials

Phase 2 trials continue to focus on safety and also test the medication’s efficacy (to assess whether the drug has any biological effect). This phase involves participants with a particular medical condition and involves a larger group of participants which may involve several hundred participants.

Phase 2 trials are sometimes divided as follows:
Phase 2A – Designed to assess how much drug should be given (dosage)
Phase 2B – Designed to assess how well the drug works at the dosage level prescribed.

Phase 3 Trials

Phase 3 trials focus on a more comprehensive understanding of the effectiveness of the trial medication, the benefit to the participant and understanding of side effects and reactions to the trial medication. Phase 3 trials are randomized and controlled. This phase involves several hundred to several thousand participants.

Phase 4 Trials

Phase 4 trials are also known as Postmarketing studies. Phase 4 trials are not required, but may be conducted in order to test a new indication for an already approved medication, to compare a proprietary drug with a competitive drug, to monitor or detect any rare or long-term adverse effects, to determine the cost-effectiveness compared to other conventional or novel therapies, etc.

Informed Consent

An informed consent is a document that describes the purpose, procedures, duration, risks and discomforts of the trial. It will also describe alternative procedures that may be available, any compensation or costs that are part of the trial and your right to withdraw from the trial at any time. It is important that you read the informed consent and ask any questions before you decide to participate in the trial.

IRB

An Institutional Review Board (IRB) is a board, committee or other group that reviews research involving humans as subjects, to approve the initiation and conduct of such research. An IRB is established to help protect the rights and welfare of trial participants. To participate in a trial, you will be given an Informed Consent document that will include contact information for the IRB should you have any questions about your rights, concerns or complaints about the research trial.

Principal Investigator

The Principal Investigator (PI) is the trial doctor who is responsible for ensuring that trial participants are adequately protected and is in compliance with federal regulations. The PI must be appropriately qualified by training and experience to conduct the clinical trial. The PI ensures the research is conducted according to the research designed that was approved by the IRB (see Institutional Review Board).

Site

A site is the location where the clinical trial is being conducted. It may be a physician’s office, medical center, hospital or other site.

Sponsor

A company or person who initiates a clinical trial but does not actually conduct the clinical trial. In most cases, the “Sponsor” is a pharmaceutical, device or other such company. The sponsor has several responsibilities including, but not limited to, selecting qualified Principal Investigators, ensuring proper monitoring of the study and ensuring prompt reporting of significant new findings to proper authorities. The sponsor may transfer responsibility of any or all of the obligations to a Contract Research Organization (see “CRO” above).

Trial Participant

A trial participant is an individual who is or becomes a participant in research. A trial participant may be either a healthy person or a patient. Trial participants may also be called “trial subject”, “human research subject”, etc.