Clinical Trials: Myths and Facts

Irene Blanco, MD
Assistant Professor
, Department of Medicine (Rheumatology)
Albert Einstein College of Medicine

There are more medicines in development for lupus now than ever before. In order for medicines to be available for patients, they have to be tested in clinical trials.  Without lupus patients’ participation, the medicines cannot be tested and proven effective. In this webinar, Dr. Blanco discusses what clinical trials are and why they are important. She describes different types of trials; explain how trial participants are protected, and how to find out about available lupus trials.

What is a clinical trial?
Clinical trial as a scientific study to find better ways to solve medical problems. Clinical trials help:

  • Find out how the disease progresses
  • Prevent a disease in a person who has never had it
  • Find how to detect certain conditions
  • Find the best way to diagnose a disease
  • How to best treat a disease
  • How to improve the quality of life of people with chronic diseases

There are medical research studies that include:

  • Epidemiological studies
  • Observational studies
  • Descriptive studies
  • Retrospective studies
     

Why Clinical Trials?

  • Much of clinical trials are planned once there is pre-clinical information related to a new treatment.
  • New medicines are developed in the laboratory
  • Promising treatments are studied in clinical trials
     

A clinical trial is designed to:

  1. Protect the person who is participating
  2. Give the best possible amount of information on the risks and benefits of a treatment
  3. Follows a protocol:
  • Who can participate
  • Details on analysis, doses of medicines
  • How long it will last
     

Dr. Blanco mentioned each study that investigates a new medicine has to be approved by the "institutional Review Board".

  • This is an independent Committee that is responsible for overseeing the clinical trial to protect the participants
  • Members of the committee normally are statisticians, doctors, and people in the community
  • Before participating, a person must ensure that the trial has been reviewed by the IRB
     

What is an informed consent?

  • Informed consent is the process of explaining and delivering all the information relevant to the participant prior to participating in the trial.
  • Participants are given a document that provides detailed information on the clinical trial.
  1. This document is not a contract
  2. If a person wants to leave the trial at any time there is no obligation to the director or the medical center
  3. If a participant leaves the study/trial he/she  is never denied medical treatment at the center
  • Is a continuous process
  • Translation services in other languages are available to the participant
     

Who are the Participants?

  • Participants in a clinical trial are volunteers that were provided to treat a new treatment.
  • They can be completely healthy people or they may have a disease.
     

Each clinical trial determines the type of people they are seeking.

Phases of a trial:

  • Phase I: It is a trial where a new treatment is studied for the first time only 20-50 participants.
  • Phase II: Here one begins to search for effective and tolerable doses it includes 100-300 participants.
  • Phase III: You have to complete several phase III trials before releasing a new treatment to the market. It includes 1000-3000 participants
  • Phase IV:  The FDA monitors a new treatment after it has been launched on the market
     

Treatment of Trials

  • There is a process of authorization that tries to do make the groups of participants as similar as possible.
  • Treatment trials are often "blinded" the participant and the doctors do not know if the treatment or placebo is received.
  • What is placebo?
  1. Placebo: an inactive treatment that resembles the treatment
  2. Not always used
  3. It is a quick way to know if a new treatment is effective

Benefits of participating

  • Help others
  • Access to new treatments
  • Receive medical attention regularly
     

Some questions you should ask your doctor before participating in a clinical trial:

  • Why they launched this trial?
  • Who has revised the protocol?
  • Has it been approved by the IRB?
  • How is the participant protected?
  • How much time the trial last?
  • What are my responsibilities?
  • What are the risks and benefits?
  • Who will be in charge of my medical care?
  • How will the trial affect my every day?
  • What is the cost?
     

Myths that people say:

  • There are enough volunteers so I don't have to assist as a volunteer
  • My disease is too advanced to participate.
  • If I am involved I will not have a high medical care.
  • If I participate I will get placebo.
  • There are no trials for me.
  • Participation requires invasive and painful medical tests.
  • It costs too much to participate in a trial.
  • Clinical trials are not safe, and will put my health at stake
     

The information and suggestions provided here are strictly the opinions of Dr. Irene Blanco. Please consult with your healthcare professional if you are interested in clinical trials.