PlaceboControlled

Clinical Trials
Analytical Report
Katelyn Martinez

Table of Contents........1
Abstract.2
Introduction.2-3
Methodology3-4
Results.4
Discussion..4-5
Work Cited5
Placebo- Controlled Clinical Trials
Abstract
The purpose of the report is to describe a placebo-controlled clinical trial and how it can
affect those in the trial. These trials are conducted experiments to find new medical cures but
there are symptoms that can occur. From the study presented, a placebo-controlled clinical trial
was given permission for rheumatoid arthritis. The work describes the downfall of these trials
and how they are negatively effective on patients.
Introduction
The use of a placebo in clinical research is usually a debate in the medical community.
Some see it as unethical because there are high risks (The Regents of the University of
California, 2014). A placebo is anything that seems to be a real medical treatment, but really
isnt. A placebo can be administered in many different forms, such as a tablet, capsule, or

injection. One thing that all placebos have in common is that they do not contain an active
substance meant to affect health (WebMD, 2016). A placebo-controlled clinical trial is usually
the standard for investigating new drugs. A clinical trial of a new drug for treating rheumatoid
arthritis was argued that participants should not be exposed to the risks of placebo-controlled
trials. In 1998, the Arthritis Advisory Committee for the US Food and Drug Administration
unanimously recommended the approval of a new drug for the treatment of rheumatoid arthritis
(Chiodo et al., 2000). In clinical trials there are usually three distinct phases: phase I, II, and III.
Phase I shows the safety of a new drug or treatment. Doctors increase the dose of the drug being
studied at a slow pace. The goal is to determine what works best without causing severe side
effects. Phase II gives doctors more information about the safety of the treatment and how well it
works. This phase takes about two years and includes 30 to 120 people. Phase III starts with the
new treatment that worked well in small numbers of patients with a certain disease. These trials
are usually randomized, meaning that doctors dont choose which person gets the new treatment
or current standard treatment (American Society of Clinical Oncology, 2016). Clinical trials
frequently recruit volunteers with active disease or conditions for which treatment is normally
prescribed. The use of a placebo must be justified by analysis and subjects must be fully
informed (The Regents of the University of California, 2014).
Methodology
In a phase 3 approved trial, 482 patients with rheumatoid arthritis were included in a 1year, multicenter, randomized, double-blind, parallel-group study that compared the new drug
and a placebo. Of equal importance, 118 of the 482 subjects studied were given a placebo for one
year and closely monitored while an irreversible disease process that could be been mediated by
an approved drug was allowed to advance. The standards for a placebo controlled clinical trial

need sponsors and review boards to exhaust all possibilities for alternative research designs
before the trial is conducted. If patients were given the wrong medication by a physician and
their medical condition(s) declined, they would be justified in making malpractice claims. There
are guidelines that need to be addressed before the trials proceed. Patients are analyzed based on
a specific list of questions. The answers to the questions serve to determine whether the group is
justified.
Results
This drug was approved because of its efficiency in treating symptoms and progression.
The same percentage of patients given the placebo had improvement, but only 19% of those
given the placebo reported symptomatic relief. Damage to bone and cartilage occurred four times
faster in those who took the placebo (Chiodo et al., 2000). The placebo administered can lead to
unpleasant symptoms. Some of these symptoms include headaches, nausea, or constipation. In a
2010 review, more than 200 studies that included a placebo group along with a no treatment
group. The reviewers found that placebo treatments dont have major effects on illness.
Sometimes the placebo can make the patient feel better but they can also make them feel worse
(American Cancer Society, 2016).
Discussion
It is concluded that placebos do not cure. When effective treatments exist, participants
who have a progressive disease should be given a standard treatment rather than a placebo.
Instead of these patients being administered the placebo I believe the trial would have been more
efficient if they were given a standard treatment that was compared to the new drug. One thing

that is uncertain is if the placebo made the progress of the arthritis worse. And if so, is this
progression reversible?

Work Cited
American Cancer Society. (2016). Placebo Effect.
American Society of Clinical Oncology (ASCO). (2016). Phases of Clinical Trials.Cancer.Net
Editorial Board.
Chiodo, Gary., Tolle, S., & Bevan, L. (2000). Placebo-Controlled Trials: Good Science of
Medical Neglect? Rockville Pike, Bethesda. US National Library of Medicine National
Institute of Health.
The Regents of the University of California. (2014). Placebo- Controlled Studies. University of
California.
WebMD. (2016). What is the placebo effect? Ratini.