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Participating in Clinical Trials

What is a Clinical Trial?

A clinical trial is a study with the purpose of determining whether a treatment improves a clinical condition or a disease. The study is designed to test the specific idea that a treatment is effective and safe.

Volunteers are randomly assigned to receive either a ‘treatment’ or an alternative. The ‘treatment’ could be an investigational drug, prescription or over-the-counter medicine. The alternative may be a pill, which has no active ingredient, known as a placebo, or it may be a comparison treatment.

What is the purpose of a clinical trial?

Medical knowledge is in a constant stage of evolution and expansion. New medications, devices, operative and surgical procedures require years of testing and refining. Researches need to prove that new remedies introduced are safe and are improvements over existing therapies.

Not all clinical trials are done on investigational products, sometimes doctors do studies to compare different treatment regimes in order to compare known forms of therapy to see which is superior.

They do this by designing trials according to strict guidelines (known as protocols) in compliance to regulatory standards.

Should you participate in a clinical trial?

Researchers are unable to guarantee if the experimental treatment is going to be effective (reason the trial is being conducted in the first place). Hence, an individual’s decision to enter a clinical trial is a very personal one and there could be a variety of reasons for taking part in a study. Having hope for a future cure, feeling better and contributing to research and society are some personal reasons participants enter trials.

Participants who enter clinical trials also receive new treatments before they are readily available to the public. Some patients who are unable to derive benefits from currently available treatments may want to see if a new experimental treatment might be able to help them.

Some studies include a fee payable to participants, often covering also the cost of the study medications, tests, examinations and follow up consultations. Some participants may be enticed by these extras.

There are strict ethical guidelines enforced by the regulators and no participant will be enrolled in a trial without his prior understanding and consent.

Defining the study

Inclusion and Exclusion criteria

Each clinical trial has a set of inclusion and exclusion criteria to ensure that only people with the right conditions are included in the study. For e.g. In a study for a heart failure medication, people with congestive heart failure might be eligible only if their ejection fraction is below 35%. This pre-fixed criterion will assure that the study results will not be compromised by people with adequate pump functions.

A clinical trial may also exclude people with certain medical conditions or those taking other medication, to avoid any serious safety problems or to insure that the efficacy can be measured. For example, in a clinical trial of Alzheimer’s disease, participants who also have a stroke are excluded because the benefit provided by the drug may be masked by the problems caused by the stroke.

‘Randomized, Double-blind, Placebo-controlled’

A placebo is an inactive substance (often a sugar pill) that looks just like the study drug. Study volunteers are split into different groups, often with one group receiving the study drug and the other- the placebo. The group who received the placebo serves as the control group to compare against the treatment group.

In a Randomized, double-blinded, placebo-controlled trial, neither doctors nor patient knows who has received the active medication and placebo. External researchers who are not directly involved in the dispensing and care of the patient have the code to analyze the results.

This sophisticated system allows doctors to know for sure that any effects observed in actively treated patients really came from the drug and not due to any biasness from either researchers or subjects.

Are there any risks to participating in a clinical trial?

There may be both small and large risks associated with clinical trials. Small risks might be discomfort associated with laboratory tests or inconvenience associated with frequent visits to participate.

Other risks such as side effects from the treatments may also exist. With new treatments there may be unknown risks or side effects.

One protection is by providing complete information about the study. All of these risks are carefully and completely described in a consent form, which all participants must sign before beginning a clinical trial.

Patient Consent

All clinical trials conducted in Singapore, unless exempted under the Medicines (Clinical Trials) Regulations, must be approved by the Ministry of Health and comply with the Singapore Guidelines for Good Clinical Practice (GCP). The Singapore GCP guidelines is based on an international ethical and scientific standard for designing, conducting, recording and reporting of trials that involves the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected.

The patient consent form will provide information on the known side effect(s) of the study medication that has been gathered from previous studies.

Doctors are obliged to reveal any information from ongoing research throughout the duration of the trial.

Signing the consent form indicates your willingness to be enrolled in the study, it does not however, bind you to completion and you can withdraw at any point in the study without any penalty.

References:

1. Participating in Clinical Trials: What you need to know. Christine Weber, Ph.D. and Mary Sano, Ph.D., Gertrude H. Sergievsky Center Columbia University. http://www.ec-online.net/Knowledge/Articles/clinicaltrials.html

2. Mayo Clinic Heart Book 2^nd Edition. Bernard J Gersh. P374-377.

3. National University Hospital Singapore. Clinical Trials Unit; Volunteers FAQs http://www.nuh.com.sg/medicalProfessionals/medicalResearch/clinicalTrialsUnit/medicalProfessionals_ctu_faq_volunteers.htm