Clinical Research - Patient Information

Patient Information

FAQs

What is a Clinical Trial?
Can Everyone Participate in a Clinical Trial?
Should I Participate in a Clinical Trial?
What are the Risks and Benefits of Participating?
What are the Phases of Clinical Trials?
What are the Different Types of Clinical Trials?
Where are Clinical Trials Done?
Who Sponsors Clinical Trials?
What is Informed Consent?

What is the Purpose of 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. These are called inclusion/exclusion criteria. The 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. Some clinical trials also make new and promising drugs available to participants before the general public has access to them. Finally, participants contribute to medical knowledge that helps improve the health of others.

What are the Risks and Benefits of Taking Part in a Clinical Trial?

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.

Researchers always try to minimize the risks involved in clincal trials. These risks include: potential discomforts associated with experimental treatments, possible deviation from the study protocol which could result in patient harm, and a failure to benefit from treatment. Each particular study will have different risks which will be explained to participants before the study begins.

When Someone Mentions "Phases" of Clinical Trials, What Do They Mean?

In clinical trials that look at the safety and efficacy of new drugs, there are several phases of testing. Phase I studies evaluate how a new drug should be taken and possible side effects of drugs in a small number of individuals (e.g., 20-100). Phase II studies look at the effects of drugs with a known dosage in a bigger sample of individuals in order to study how the drug interacts with the body. Phase III and IV studies are larger trials (sometimes involving thousands of patients) that compare the new drug to no treatment (placebo) or other, better tested drugs.

What are the Different Types of Clinical Trials?

According to the National Institutes of Health, there are four general types of clinical trials. These are:

-Treatment trials look at the benefit and hazards of new drugs or interventions.

-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.

-Diagnostic trials look to improve the way diseases are diagnosed, using new procedures or tests.

-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
-university settings

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., pharmaceutical companies), individuals, medical institutions, foundations, or governmental agencies (e.g., National Institutes of Health).

Why Do Studies Require Informed Consent?

During clinical trials, the safety of patients is very important. This includes making sure that patients understand what will happen during any study in which they participate. Informed consent is the procedure that must be followed in any clinical trial in order to ensure that participants fully understand all aspects of the study. Generally, a member of the research team will sit down with a patient who is eligible for the study, and describe what the study is about and the procedures that are involved. All patients have the right to know exactly why a study is being conducted, and what is expected of them upon participation.

What Role Does the EMMC 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 email or phone 207-973-4767.

Please visit clinicaltrials.gov for more information.