Clinical trials

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What Are Clinical Trials?

Clinical trials are research studies conducted to evaluate the impact of newer medical, surgical, or behavioral interventions. They are the primary way that researchers determine if a new treatment, medication, or medical device is effective and free of adverse effects. Often, a clinical trial is used to learn if a new treatment is more effective and/or offers no or fewer harmful side effects than alternative treatments.

Clinical trials can be sponsored or funded by pharmaceutical companies, academic medical centers, voluntary groups, and other organizations, in addition to federal agencies such as the National Institutes of Health, the U.S. Department of Defense, and the U.S. Department of Veterans Affairs.
Sponsors design clinical trials according to rigorous scientific and ethical standards, which include oversight by an independent ethics committee and informed consent from participants.

Pros and Cons of Participating in Clinical Trials

Pros

You may be helping advance medicine and save lives.

You will have access to excellent medical care and services from top doctors and scientists in the country.

You’d be taking a hands-on role in your medical care.
You will receive treatment at no cost to you.

You may have access well before the general population to a medical drug, treatment, or device.

Some clinical trials offer compensation for participation.

Cons

You may receive the placebo in the control group of the clinical trial, meaning you wouldn’t be able to experience the drug’s beneficial effects.
However, at some point in many studies, sponsors will often treat those in the placebo control group when and if the intervention proves to be effective.

Due to side effects, you may require more medical care during and/or after the clinical trial.

You may not respond to the experimental treatment.
Every study is different.

The phases of clinical trials

Clinical trials have four phases. These phases aim to determine the appropriate dosage, test a medical treatment or drug, and search for side effects on test subjects. The FDA must approve Phases I and II before Phase 3 trials can begin. Note: Some clinical trials also have a Phase 0, which can help a research team determine whether the clinical trial should proceed.

PHASE 1

Safety Is The Top Concern

Participating in “first in human” studies is an opportunity to contribute to advancing medical research and development. As a participant, you will play a crucial role in helping researchers investigate the safety of new medications and treatments currently being studied. The results of these studies will help determine whether the medicine is safe to use and whether it can be effective in treating specific illnesses.

PHASE 2

Effectiveness Is The Top Concern

In the phase 2 clinical trial, the researchers determine the effective dosages of the investigated treatments. This phase also includes determining side effects and risk factors.

PHASE 3

Effective Options Are The Top Concern

Phase 3 clinical trials consist of an even larger group of participants (sometimes worldwide). The participation you give will help researchers get a clearer picture of the treatment’s side effects and potential effectiveness. 

PHASE 4

Public Safety Is The Top Concern

Even after a treatment is approved for use, you can still be part of clinical trials and assist researchers. These “open-label studies” assist researchers with understanding risks and potential benefits over more extended periods of time.

FDA APPROVAL

If Phase 3 proves the experimental trial was successful, the FDA may approve the medical drug, treatment, or device.

Understanding the Clinical Trial Process

Pre-clinical studies

Before a phase 3 clinical trial can begin, initial phases must determine that the intervention (medication, procedure, device) is safe and practical for humans. Pre-clinical studies include cell and animal studies.
Before a clinical trial can begin, the U.S. Food and Drug Administration (FDA) must approve early-phase clinical trials.
Before starting the trial, the research team and sponsor must obtain approval and the clinical trial participants must provide informed consent. After completing these steps, the team can begin Phase 3 of the trial.

What to expect when you participate in clinical trials

The clinical trial team must provide information to each participant in a document called “informed consent.”
This document fully describes every aspect of the trial, including what participants will be asked to do, when, and why.
Before joining a clinical study, participants must know and understand the answers to the following questions:
Why is this study being conducted?
How long will the study last?
Precisely what are the eligibility criteria for this study?
How many participants are needed to complete this study?
What medical information will I need to provide as a participant?
What will medical information be gathered to further the study?
What medical drug, treatment, and/or device will be used during the study?
What tests, procedures, and drug dosages will participants be subjected to?
*Participants must be fully aware of this important information so there aren’t any surprises or misunderstandings once the clinical trial starts.

Understanding sponsors’ needs

QLRC understands sponsors’ need to recruit a diverse audience of participants for many of their studies. To aid in that regard, we have cemented relationships with and made substantial forays into:
Local Chambers of Commerce
Local print, digital and over-the-air media
Local business groups
Local medical colleges
Local non-profits

In addition, Quality of Life Research and Quality of Life Medical Center are sister companies that share the same location. We can draw from our base of more than 6,000 patients and a new recruiting database of more than 3,000 participants.

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