Pharmacy Residency (PGY1)

Parkland Research

What are clinical trials?

Clinical trials are an important part of medical research and are at the heart of all medical advances. Clinical trials (or clinical studies) look at new ways to prevent, detect or treat disease. Treatments might be new drugs, new surgeries or devices, or new ways to use existing treatments. The goal of clinical trials is to find out if a new test or treatment works and is safe. Clinical trials can also answer questions about ways to improve the quality of life for people with chronic illnesses.

Clinical trials are carried out according to a plan called a research protocol. The protocol describes what types of patients/volunteers may take part in the study and how the investigational drug or device will be tested. The protocol explains the schedules of tests and procedures, the length of study as well as the results that will be measured.

Every clinical trial is led by a principal investigator who is often a doctor. Clinical trials also have a research team that may include doctors, nurses, social workers and other healthcare workers.

Clinical trials at Parkland

At Parkland, clinical trials may be available in certain areas of the hospital or clinics. Each clinical trial has requirements for those who want to participate. The best way to find out about clinical trials that you may qualify for is to ask your physician or care provider.

Why are clinical trials done?

Many clinical trials are done to see if a new drug or device is safe and effective for people to use. Clinical trials are also done for other reasons. Some compare existing treatments to determine which is better. The current, approved treatments are called “standard treatments.” Sometimes clinical trials are used to study different ways to use the standard treatments so they will be more effective, easier to use and/or decrease side effects.

What are the different types of clinical trials?

  • Treatment trials test experimental treatments, new combinations of drugs or new approaches to existing treatments.
  • Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vaccines, vitamins, minerals, or lifestyle changes.
  • Diagnostic trials are conducted to find better tests or procedures for diagnosing a disease or condition.
  • Screening trials test the best way to detect diseases or health conditions.
  • Quality of life trials (or supportive care trials) explore ways to improve comfort and the quality of life for people with a chronic illness.

Why do people join clinical trials?

Patients take part in clinical trials for many reasons:

  • Interest in advancing science and medical care
  • Interest in gaining access to new, experimental drugs or treatments – especially if all of their other treatment options have failed
  • Interest in learning more about their medical condition

By volunteering to take part in clinical trials, people help advance what we know about medical treatments and medicines. In doing so, clinical trial participants can play an important role in getting new drugs and devices approved for use in treating other patients.

Who can be in a clinical trial?

It is important to remember that the main purpose of clinical trials is to study new drugs or devices, or new uses of approved drugs or devices, and not to treat patients. Often, drugs or devices must be tested under very specific conditions, so not all patients with a disease will be able to join a clinical trial.

For each clinical trial, the protocol will outline the requirements to be in the study. Not everyone will be accepted. Volunteers may be excluded based on the eligibility criteria and/or limits on the number of people who can take part.

What is informed consent?

Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to be in a trial. To help someone decide, the doctors, nurses and research coordinators involved in the trial explain the details of the study. Informed consent continues throughout the study to provide information for those who take part in the study.

An informed consent document provides written details that were discussed about the study, such as its purpose, the length of the study, the required procedures and key contacts. Risks and potential benefits are explained in the informed consent document. The patient/volunteer is given a chance to ask questions and make a decision about whether or not to be in the trial and to sign the document. Signing the document indicates the individual understands that the trial is research and understands the risks and possible benefits, that participation is voluntary and also formally documents their consent to participate. Informed consent is not a contract, and the person may withdraw from the trial at any time.

If the individual’s preferred language is not English, translation assistance can be provided.

What should I think about before joining a clinical trial?

The following questions might be helpful for someone who is considering taking part in a clinical trial.

  • What is the purpose of the study?
  • Who is going to be in the study?
  • Why do researchers believe the experimental treatment being tested may be effective? Has it been tested before?
  • What kinds of tests and experimental treatments are involved?
  • How do the possible risks, side effects and benefits in the study compare with my current treatment?
  • How might this trial affect my daily life?
  • How long will the trial last?
  • How often will I have to visit the hospital or clinic?
  • Am I required to stay in the hospital?
  • Who will pay for the experimental treatment?
  • Will they pay my other costs?
  • What type of long-term follow-up care is part of this study?
  • How will I know that the experimental treatment is working? Will results of the trials be provided to me?
  • Who will be in charge of my care?

How can I find a clinical trial?

The best way to find a clinical trial is to ask your physician or care provider.

You can also find clinical trials through ClinicalTrials.gov and search for studies by disease, drug or location.

Where can I find more information about clinical trials?

You can learn more about clinical trials through:

ClinicalTrials.gov 
National Institutes of Health (NIH) 
US Food and Drug Administration (FDA) 

You can find information about cancer clinical trials through:

A guide to clinical trials for cancer – English. 
A guide to clinical trials for cancer – Spanish. 
National Cancer Institute: Clinical Trials Information for Patients and Caregivers – English 
National Cancer Institute – Spanish