If it
were not for drug trials, many of the lifesaving drugs we all use might not be
available today. Obviously, drug trials
are important for the development of medicines, but anyone that is entering a
trial needs to be well informed. Never
encourage anyone to enter a clinical trial for financial compensation only, as
trials should be to benefit medicines and medical technology.
What exactly is a Clinical Trial?
Clinical
trials may also be referred to as clinical studies. In a clinical trial, human volunteers agree
to be tested using potential treatments to determine if they should be approved
for use in the general population.
Treatments can consist of drugs, medical devices, vaccine, blood
product, or gene therapy. All treatments
have prior studies in animals to learn of potential toxicity, and have been
approved for human trial. The FDA
assures the public; they are protecting the participants in any trial, and
provides all pertinent information to the participant. Over the years there have been allegations
against drug trial companies regarding the participants' safety, and there are
currently petitions requesting the government regulate all drug trials. Although many safety measures are put in
place to protect volunteers, it is still a drug “trial” and all side effects
are not known. Anyone that chooses to
participate in a drug trial should read all paperwork carefully, and weigh the
possible risks to their own health.
Why Volunteer for a Trial?
Most
people participate in drug trials because it may offer hope for their medical
condition. For someone that has suffered
from a condition for a prolonged period of time, with little or no relief, it's
easy to understand why they would take their chances with a trial. Others may participate for the good of a
family member or loved one, in hopes of benefiting them with a medical
condition affecting their life. Then
there are some people that sign up for drug trials for financial
compensation. All too often, people that
sign up for financial reasons may not read all warnings regarding the
trial. This is generally when problems arise;
a reasonably healthy person may now suffer from complications as a result of
the drug trial. Patients that enroll in
drug trials for finances should be encouraged to carefully study all side
effects and risks. There is a need for
clinical trials, and it is important to test medical products within the group
of people they are intended to help.
How do Clinical Trials Work?
All
trials are orchestrated to answer certain questions. Studies are most often blind, and a
participant does not know if they are receiving the actual drug, or a
placebo. The FDA offers technical
support to the researchers conducting the trial. Clinical trial teams include doctors, nurses,
and other needed health care professionals.
The team will monitor the health of every participant and closely track
their progress with the medications administered. Trials are conducted in phases, with phase 1,
determining dosing, and to document how the drug is metabolized and
tolerated. Phase 2 trials are meant to
include participants that have the medical condition, and to determine the
drug's effectiveness on their condition.
If phase 2 participants do well with no significant side effects, the
drug moves forward to phase3. The phase
3 drug trials test more people and continue to monitor the effectiveness and
side effects. If phase 3 trials are
acceptable the drug moves forward to phase 4.
This trial is conducted after the product is approved and on the
market. Phase 4 continues to monitor the
drug for side effects and success in treating the medical condition. This is also where long term side effects are
noted, as well, as the long term success of the drug.
There are
guidelines that are followed in drug trials, no children unless special
circumstances prevail. As for each
person receiving the same drug, that does not happen, some will receive a
placebo. Studies are very controlled,
and there is no way for participants to know which drug they are
receiving. Side effects can be mild,
moderate and even severe. If severe side
effects occur in multiple participants, the trial is stopped. The risks depend on the drug, and the health
of the individual in the trial. There
are regulations in place to protect participants, however many feel they are
not strict enough.
Locations of Clinical Trials
Clinical
trials can take place in hospitals or in a specialized clinic. For trials that involve overnight stays,
patients are made to feel at home. The atmosphere is very relaxed and they have
tv's, computers, recreational activities, all the comforts of home. When the companies conducting the trial find
someone that meets the criteria. They want to do all they can to keep them comfortable
so they they remain for the duration of the study.
Clinical
drug trials have their place in society, and there is a need for them as
well. Without clinical trials, many
drugs would be in limbo and not readily available for those who need and would
benefit from them. AIDS medications have
saved countless lives, and it happens to be one of the more known drugs that
advanced to phase 4 quickly, due to the trials and the number of
participants. Clinical trials are
expected to grow in the future as new medical technology expands. Participants should pay close attention and
gather all information related to the trial.
After reading about all potential side effects a participant can then
make an educated decision on participating in the trial, safety should always
be the first concern.
A special thank you and consideration is given to all of the
people that have participated in clinical drug trials in order to expedite the
approval of life saving drugs. Today's
testing may very well save life tomorrow, or make a life worth living. Volunteering to participate in a clinical
drug trial is certainly a way of contributing to society. Volunteers should enter any study with a
complete understanding of the drug trial, which will assure safety, as the drug
being tested can move forward to benefit others.
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