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What is a clinical trial?
Clinical research and clinical trials are important in helping researchers prove the effectiveness of new treatments, new ways of using current or known treatments, detection and diagnostic procedures and equipment. The value of a potential new treatment is weighted against possible or potential side effects with the ultimate goal for persons having better quality of life.
Clinical trials help everyone that has or someday may have a particular illness or condition by providing verification for potentially helpful treatments. Clinical trial patients are instrumental to this research. It also offers trial participants access to pre market treatments, perhaps even in the case where accepted or standard therapies were not effective and could improve their condition and quality of life or restore their health. In some cases it may be the same as standard therapy just altered delivery or strength to prove effectiveness in a different way of delivery.
What mechanisms are in place to protect patients?
There are several phases that a potential drug or treatment must pass before it is even considered for human trial. At every step, applications must be made to governing health agencies with proof or support for the proposed next step. This is in all cases including altering current known or approved therapies. Once these steps have been taken and the results indicate that it will not cause harm to humans, applications for human trials need to be made and approved.
During the course of a clinical trial, a specialist will follow a patient very closely with a strict guideline (protocol) how the trial is to be conducted with regular lab work to monitor the patient.
A third party (not related to a pharmaceutical, government agency or medical centre) called an institutional review board, independent ethics committee or ethical review board, is a committee of physicians, statisticians, patient advocates and other community members that has been formally designated to approve, monitor and review clinical trials involving humans. These boards approve or require modifications to a protocol (the method in which a trial will be conducted) and also are able disapprove proposed research to ensure the proposed clinical trial is ethical, scientific and appropriately meets guidelines. They are also able to stop a trial if it appears to be causing unexpected harm to participants, or if there is evidence that the risks outweigh the benefits.
It is generally accepted that all trials involving human participants conform to the declaration of Helsinki which is widely regarded as the cornerstone of human research ethics and outlines the code by which research is conducted in respect to participant rights and wellbeing.
What are the phases of human trials?
While there are risks in any medical treatment either standard of care or trial, anything considered for human trials has already gone through several phases of lab testing to show it is potentially safe and beneficial.
Phase 1 is a small group (20 patients) of relatively healthy patients to prove it does not cause harm to humans and that it actually has clinical benefits. Although it has been shown in pre human clinical trials it will likely not cause harm it still needs to be proved.
Phase 2 is a larger group (100 patients) to prove that it does work in a greater cross section of individuals and is safe beyond doubt.
What is the benefit and what can I expect being on a trial?
Informed consent is required, this means the protocol has to be explained and you are comfortable with the explanation and willing to participate. A clinical trial requires commitment on the part of the physician, nurses and all staff at the centre and also requires commitment from the participant. A participant must be available to visit the centre on a regular basis (as prescribed by the protocol).
There are several benefits to trials, on the individual basis a participant may be able to receive treatment for their specific conditions/illness prior to their availability on the general market and at no cost to the participant. Often times these are advancements to current accepted therapies. This is very beneficial to participants who may have not responded as hoped to standard therapies or standard of care.
On a much larger scale, trials are crucial to our populations in general as new therapies, medications or diagnostic procedures would not be possible without them. It provides a method to ethically prove that something does actually work, to what degree and benefit.