Frequently Asked Questions

Frequently asked questions by study participants about clinical research

What is a clinical trial?

A clinical trial is a research study that looks to find the best way to deliver patient care. Whether the trial is studying a new drug or treatment, the end goal is to discover better healthcare practices.

New treatments help to advance medical care, but must be proven safe and effective before they are given to patients. The purpose of clinical trials is to answer the question of whether these new treatments are safe and effective.Clinical trials may be observational or interventional. In observational studies, researchers do not change patient care, but rather seek to describe a disease or disorder in its natural state. Interventional studies involve giving a group of patients a treatment or intervention, in order to determine the safety and effectiveness of that treatment.

Can everyone participate in a clinical trial?

No clinical trial can exclude a person from participating without a research-related rationale. Each study has particular patient characteristics it is looking for.

All clinical research is conducted according to plan. The plan outlines who may participate based on particular characteristics including age, medical history, diagnoses. These are called inclusion/exclusion criteria. These criteria or characteristics qualify a person for a particular study are the inclusion criteria. The characteristics that disqualify a person from a study are the exclusion criteria. These criteria are in place so that patients are kept safe and the research is designed to study the appropriate population.

Should I participate in a clinical trial?

Participating in a clinical trial can yield many benefits for patients. Participants are offered the chance to be treated by leading experts in the healthcare field.

Participants in clinical trials can play a more active role in their own health care and can gain access to new research treatments before they are widely available to the public. Participants also contribute to medical knowledge that helps improve the health of others. Participation in a clinical study is up to you. If you do decide to participate, you are a volunteer and may withdraw at any time.

What are the risks and benefits of participating?

Clinical trials offer many benefits to participants, including the opportunity: to be proactive with their healthcare, to take advantage of new treatments before they are available to the public, and to help advance new technologies or medical knowledge.

Before you participate in the study, a member of the research team will explain the potential risks and benefits to you. Researchers always try to minimize the risks involved in clinical trials.

These risks could include:

Potential discomforts associated with experimental treatments
Possible deviation from the study protocol which could result in patient harm
Failure to benefit from treatment
Side effects resulting from the treatment
Participation in a trial may be demanding and time consuming

Each particular study will have different risks which will be explained to participants before the study begins. There are also benefits to participating in clinical trials.

These benefits could include:

Gaining access to new medications and interventions prior to general availability
An ability to take a more active role in your own healthcare decisions
The opportunity to help others by contributing to your time and effort

How are participants protected and what is informed consent?

During clinical trials, the safety of patients is very important. This includes making sure that patients fully understand what will happen during any study in which they participate. All individuals have the right to know exactly why a study is being conducted, and what is expected of them upon participation.

Informed consent is the process in which potential subjects learn the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information to participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. If the participant’s native language is not English, translation assistance can be provided. The information provided to potential participants includes details such as: the purpose of the study, the duration of the study, required procedures, and key contact people involved in the study. Risks and benefits of participating are included in the informed consent document that all participants sign PRIOR to beginning the study. Informed consent is not a contract, and the participant may withdraw from the study at any time.

What are the different types of clinical trials?

There are many different types of clinical trials with each type serving a different purpose. According to the National Institutes of Health, these are the different types of clinical trials:

Natural history studies provide valuable information about how disease and health progress.
Prevention trials focus on finding out how to prevent a disease or disorder from occurring or recurring in patient populations. The prevention strategies studied may be based on medicines, vaccines, minerals, or on improving lifestyle habits.
Screening trials test the best way to detect certain diseases or health conditions
Diagnostic trials look to improve the way diseases are diagnosed, using new procedures or tests.
Treatment trials look at the benefit and hazards of new drugs or interventions.
Quality of Life trials seek to enhance the well-being or quality of life of patients with particular diseases or disorders.

Where do clinical trials take place?

Clinical Trials can take place in a variety of settings such as medical facilities, clinics, doctor's offices, and university settings. Sometimes trials may be located at only one center, or at hundreds of centers across the country or world.

Who sponsors clinical trials?

Clinical trials may be sponsored by industry (e.g., biotechnology or pharmaceutical companies), individuals, medical institutions, foundations, or governmental agencies (e.g., National Institutes of Health).

What role does the Clinical Research Center play in clinical trials?

The Clinical Research Center is involved in all aspects of clinical trials. We have trained research coordinators and database specialists who are able to organize, facilitate, and coordinate trials.

Our staff are involved in all stages of trials from contacting sponsors to be included in studies, to writing Institutional Board Review protocols, to consenting patients, to collecting and analyzing data. If you would like to learn more about becoming involved in a clinical trial, please do not hesitate to contact us via e-mail or phone (207) 973-7175.

Terms Associated with Clinical Studies

Blinded (Masked) Study: Participants do not know whether they are in the experimental or control group in a research study.

Control Group: While one group of study participants receives the experimental therapy, the control group receives either the standard therapy or placebo.

Clinical Investigator: A medical researcher in charge of carrying out a clinical study protocol.

Double-Blinded (Double-Masked) Study: Neither the study participants nor the study professionals know which participants are receiving the test therapy and which participants are receiving standard therapy or placebo.

Confidentiality: Refers to maintaining the privacy of study participants including their personal identity and all personal medical information. The trial participants' consent to the use of records for data verification purposes should be obtained prior to the study and assurance must be given that confidentiality will be maintained.

Efficacy (of a drug or treatment): The maximum ability of a drug or treatment to produce a result regardless of dosage. A drug passes efficacy trials if it is effective at the dose tested and against the illness for which it is prescribed. In the procedure mandated by the Federal Drug Administration (FDA), Phase II clinical trials gauge efficacy and Phase III trials confirm it.

Inclusion/Exclusion Criteria: The medical or social standards determining whether a person may or may not be allowed to enter a clinical study. These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. It is important to note that inclusion and exclusion criteria are not used to reject people personally, but rather to identify appropriate participants and keep them safe.

Institutional Review Board (IRB): An IRB is an independent committee of physicians, nurses, pharmacists, scientists, ethicists, and community advocates. Every clinical study conducted in the United States requires IRB approval and monitoring to protect each participant’s rights and welfare.

Phase: Clinical trials of experimental drugs progress through four phases:

In Phase I clinical trials, researchers test a new drug or therapy in a small group of participants (20-80) for the first time to evaluate treatment safety, determine proper dosage, and observe side effects.
In Phase II clinical trials, researchers administer the study drug or therapy to a larger group of participants (100-300) to further evaluate both its safety and effectiveness.
In Phase III clinical trials, researchers administer the study drug or therapy to a larger group of participants (1,000-3,000) to confirm effectiveness, identify risks, monitor side effects, and compare and contrast study treatment safety and effectiveness with commonly used therapies.
In Phase IV clinical trials, researchers continue testing the study drug or therapy in order to measure treatment effectiveness and monitor the effects of long-term use.

Placebo: A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the treatment's effectiveness. In some studies, the participants in the control group will receive a placebo instead of an active drug or treatment. No sick participant receives a placebo if there is a known beneficial treatment.

Protocol: A protocol outlines the specifics of the clinical study, namely, study qualifications, time points, treatments, and procedures.

Side Effects: Side effects are any unanticipated actions or effects caused by the study drug or therapy.

Standard Treatment: A treatment currently in wide use and approved by the FDA, considered to be effective in the treatment of a specific disease or condition.

Study Coordinator: Study Coordinators are typically members of a research team who are responsible for such things as, recruiting, screening, and enrolling study participants, as well as ensuring the adherence to Good Clinical Practice (GCP) guidelines.

Subject: A volunteer who participates in a clinical study, either as a recipient of the experimental treatment, or as a control patient who receives the standard treatment, or as a healthy volunteer who receives no treatment.

Frequently Asked Questions