Clinical Trials

What Are Clinical Trials?


Clinical trials are designed to test the safety and effectiveness of medical interventions designed to prevent, minimize or alleviate certain symptoms and illnesses. They’re used to test whether a particular medical treatment, drug, or device can accomplish what it is claimed to do, and to evaluate any side effects or unanticipated issues. Clinical trials are aimed at a large variety of illnesses, but  cancer, cardiovascular and circulatory diseases, infectious diseases, hormone replacement and digestive diseases are among the top areas in which scientists and medical doctors continuously seek to test new medical interventions.

Clinical Trials

Understanding the Clinical Trial Process


Before a phase 3 clinical trial can begin, initial phases must determine that the intervention (medication, procedure, device) is essentially safe and practical for humans. Pre-clinical studies include cell and animal studies.

Early phase clinical trials must be approved by the U.S. Food and Drug Administration (FDA) before a clinical trial can begin. Then, the research team and research sponsor must be approved, and the clinical trial participants must provide informed consent. Once these steps are completed, Phase I can begin.


What to Expect When You Join a Clinical Trial

The team leading a clinical trial must provide information to each participant in the form of a document called “informed consent.” This document describes every aspect of the trial so that individuals who’d like to participate are fully aware and informed about all that they will be asked to do, when, and why. Prior to 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?
  • Exactly what is 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 medical information will 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 that there aren’t any surprises or misunderstandings once the clinical trial starts.

UNDERSTANDING SPONSORS’ NEEDS

QLMRC 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 co-located sister companies, which means we are able to draw from our base of more than 6,000 patients and a fresh recruiting database of more than 3,000 participants.

Pros and Cons Of Joining a Clinical Trial


Pros

  • You may be helping advance medicine and save lives.
  • You’d 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’d be utilizing a free or low-cost treatment.
  • You may have access well before the general population to a medical drug, treatment, or device that has fewer side effects and is more effective than your current or past treatment.
  • 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 beneficial effects of the drug. However at some point in many studies, when and if the intervention proves to be effective, sponsors will often then treat those in the placebo control group.
  • You may require more medical care during and/or after the clinical trial due to side effects.
  • You may not respond to the experimental treatment.
  • Every study is different.

Phases

Clinical trials have four phases. The purpose of these phases is to determine an appropriate dosage, test a medical treatment or drug, and to 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. Phase 0 can help a research team determine whether the clinical trial should proceed. A very small group of participants are tested to determine whether the medical treatment, drug, or device will work on humans.

Phase I: Safety is the top concern

Being part of these “first in human” studies, you will be assisting researchers to  investigate the safety of a medicine that is currently being investigated. You may be required to have clinical exams and lab work as well as report any problems or side effects you experience. 

Phase II: Effectiveness is the top concern

At a phase 2 clinical trial, the researchers begin determining effective dosages of the medicine being investigated. This phase also includes determining side effects and risk factors.

Phase III: effective options are the top concerns

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

Phase IV: Public safety is the top concern

Even after a medicine becomes 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 longer periods of time.

FDA Approval:

If Phase III proves that the experimental trial was successful, the FDA will approve the medical drug, treatment, or device.