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Understanding Clinical Trials
So you have been asked to participate in a clinical trial... What should you know and what questions might you want to ask your doctor?
What is a clinical trial?
Improvements in health care for patients require painstaking effort. A clinical trial is an orderly process
to assess if a particular way to prevent, detect, or treat an illness is better. Sometimes, it can also be that a new treatment is
equally good but with fewer side effects. New tests, drugs, techniques or a combination of these are involved. Doctors and researchers
involve patients in the clinical trial process. Hence there it is important that there is organization, responsibility and efficiency.
Clinical trials should try to make sure that participants are not unfairly disadvantaged by their participation.
Copyright of AxisMed Research Pte Ltd, updated 30 Jan 2012
What are the different types of treatment trials?
Clinical trials that test new treatments are of a few types.
Phase 1 trials look at
the safety of a new treatment. They look at the appropriate dosing of a particular medicine and how it should be administered.
Phase
2 trials explore the range of disease that the new treatment is useful for and at the same time continues to collect information on
its safety. For example, after phase 2 testing, a new cancer medication might be found to be useful for breast cancer but not so useful
for colon cancer.
Phase 3 trials require further evaluation of a medication that seems safe (from phase 1 studies) and effective (from
phase 2 studies) in a particular medical condition. Now the test is in comparison with the current “standard” treatment. Investigators
would want to know if the new medication is better, worse or the same as the current available treatment. Phase 3 trials often involve
many more patients and may require placebo control, blinding and randomization.
What is placebo control, blinding and randomization in clinical trials?
As humans, we are often bias without us realizing
it. We may like coffee better than tea or even a certain type of coffee better than others. If we were to be given a particular coffee
drink and not told its origins, we might perhaps make decisions on its taste not clouded by other issues such as cost.
In clinical
trials, testing of new medications compared to standard medications sometimes requires investigators to not tell let participants
know which they are taking (blinding) or if they are even taking any active ingredient (placebo). Even the trial investigators might
need to be blinded in some cases to the treatment being administered. Allocation to new medication or standard arm is also often randomized
to avoid bias.
Who can be in a clinical trial?
This depends on the trial. Trials try to answer a research question and should compare apples
with apples and not with oranges. In other words, the clinical trial needs to compare subjects of the same or similar condition as
much as possible. For example, a trial might be looking for cancer patients with no prior treatment given. These patients are likely
to be healthier than patients with multiple previous treatments. The eligibility to enter a trial is usually set out and participants
may be required to answer a series of questions or even undergo some tests. So, in addition to selecting the trial a person might
want to participate, the trial also selects you!
What are the possible benefits of being in a clinical trial?
Not everyone is driven by altruism to contribute to medical knowledge
and advance medical science for the benefit of humanity. However, there are many participants who join clinical trials just knowing
they are helping others. Trials also help them learn about themselves and about research.
For participants with a medical condition,
a clinical trial is a chance to get a new treatment which might not be available yet. Clinical trials have fairly rigorous protocols
to follow and subjects are often comforted knowing they are being watched closely by expert doctors.
Finally, knowing that one
has a certain medical condition can be a driving force to contribute to improving medical knowledge and treatments for that condition
through the clinical trial process.
What are the possible disadvantages of being in a clinical trial?
Any new treatment may have unknown or unexpected side effects.
Sometimes these may be affecting only a few patients on the treatment and will only come to light after a number of people have taken
it.
In some instances, a new treatment which might be promising may not work as well as the current treatment, or it might not
work at all. Some larger trials have a built in interim measure of the treatment’s effectiveness and will be halted if the monitoring
committee feels that continuing the trial will be futile to show a benefit.
In randomized trials, a subject may not get the
new treatment. They do not get to choose which treatment to take. If a placebo (sugar pill) is used, a subject may not be getting
an active treatment. Placebos are used when the researchers are not sure if the new treatment is better off than no treatment or when
there is no good standard treatment for that condition. Some studies allow the participant in the placebo arm to “crossover” to the
new treatment arm when the disease progresses.
Thinking it through…
Each person intending to participate in a clinical trial needs to know that:
The decision to participate
in a clinical trial is an individual one. There is no compulsion to join one if you should decide not to participate. Not participating
should not compromise the medical care you receive. The doctor’s role is to explain the details of the trial to you and answer questions
that you might have. If you are agreeable to the trial, you will be asked to sign a consent form.
Trials are scrutinized by experts
before and during for safety to participants. In Singapore, there is a requirement for a review board to separately evaluate the protocols
that decides how a trial is conducted. Periodic safety reports are also often submitted.
During the trial, there is a requirement
for subjects to follow instruction related to visits, medications, tests and evaluations. Generally, clinical trial related expenses
are covered in Singapore, although some may not cover everything, especially if it is not trial related procedures. You should be
willing to comply with trial related procedures. At any time, when you or your doctor feels that the clinical trial is not helping
you, the trial may be terminated.