Clinical Trials

Clinical Trial FAQ

What is a clinical trial?

Clinical trials follow laboratory research initiatives that focus on improving public health and decreasing the occurrence of illness in people. They depend heavily on the cooperation of participants and volunteers and can be as simple as allowing yourself to be observed, or as complex as receiving new drugs, therapies, treatments, devices or surgeries.

How do clinical trials work?

The way a clinical trial is run depends largely on the type of study being performed. Depending on the study design, participants may have to meet with the researcher for tests and office visits while others may be asked to fill out questionnaires. Before participating in a study, the research team will review the protocol for the trial which clearly outlines the requirements and qualifications for participating.

What are the phases of a clinical trial?

Clinical trials are conducted in phases to ensure that the data collected accurately reflects the findings of the trial.

Phase I trials are those that are conducted in a small group of about 20 — 80 people. In this phase, researchers are evaluating the safety and setting standards for how they will administer and apply their research findings to the participants.

Phase II trials involve a much larger group (100-300) and exist to test not only the safety, but also the efficacy.

Phase III trials expand to an even larger group (1,000 — 3,000) and are used as a measure of confirmation and as a way to compare the new treatment with the one currently accepted as the standard of care. If the proposed therapy or treatment continues to prove to be both safe and effective, it progresses to the final phase.

Phase IV of clinical trials aims to extract additional information from the previous phases and move the experimental treatment into standard practice. Here researchers further evaluate the risks and benefits as well as outline the manner in which the therapy should be marketed and used.

Who sponsors clinical trials?

Clinical trials can be sponsored by a multitude of organizations, individuals such as doctors or foundations, or they can be funded federally by a federal agency such as the National Institutes of Health (NIH).

Does anyone monitor the research while it is happening?

Clinical trials are monitored by Institutional Review Boards also known as IRBs. The IRB is put in place to review the initial study plan, protocol, and ensure that the trial is being conducted in a safe and effective manner. Once approved, the IRB continues to monitor the trial at least once a year. If a researcher needs to adapt the protocol in anyway, it must be approved by the IRB and then relayed to study participants. The IRB also makes sure that participants are fully informed, treated fairly and that their privacy and confidentiality is protected at all times.

What is informed consent?

The purpose of informed consent is to outline the details of the trial to participants and protect their rights. Informed consent is issued in a document that describes in detail the goals of the study, possible risks or benefits associated with participating, the purpose, the requirements for participating, key information including the names and contact information for the researchers in charge, and the projected duration. If a participant does not speak English, the informed consent document will be translated for them.

Who is a part of the clinical trial team?

Clinical trial teams can include doctors, researchers, nurses, social workers and other health care professionals. The role of the trial team is to monitor the status of the participants’ health and record the results of the study. It is also their responsibility to ensure the comfort and safety of the participant.

What is a control group?

In clinical trials, the control group is a group of people who receive the current standard of care, rather than the experimental one being tested. For example: if the clinical trial is testing a drug to better control blood pressure, the control group would be given a drug that is the current medication prescribed by doctors.

Control groups are just as important as those receiving the experimental treatment or therapy because the results of the other group are measured against the control group. Having these two groups allows researchers to compare their results and determine how much more or less effective their research findings are.

What is a placebo?

A placebo is a pill, liquid or powder that is given to participants, but has an inactive formula. The purpose of the placebo is to form a control group that believes that they are receiving a treatment to measure the full effectiveness of the experimental drug. These studies are called single-blind trials since the participants are unaware that the medication they are receiving is not treating them. There are also double-blind trials in which neither the participant nor the researcher knows who is receiving the experimental treatment. This helps prevent researchers’ bias or beliefs from skewing the results.

What happens when the study ends?

A clinical trial usually ends for a participant when they have completed everything outlined in the protocol or if they decide to leave the study. Researchers may require additional contact with participants after the study has ended, but this should be outlined in the protocol and explained before signing the informed consent document. After the clinical trials are complete, researchers will analyze the data they have collected and publish their findings. This process could take several years and not all researchers are able to reveal the results of the trial at its conclusion. Be sure to address this with the study investigator before enrolling.