Clinical trials are an avenue for medical researchers and practitioners to test out new medical drugs, treatments, methods, and/or apparatuses. And for a patient who is about to enlist in one (or is contemplating on doing so), we have collated key pieces of data for you to understand what such trials entail.
Clinical Trials: What Are They?
Earlier, we’ve mentioned how clinical trials are a step towards testing out the latest innovations and/or inventions in the vast field of medicine. Most often than not, such innovations and/or inventions necessitate several, and repeated samplings and testing before they are made public. Before they are utilised for the betterment of the general population who are stricken with a particular disease that has no known cure at present.
In such a case as the latter, the newly discovered treatment will need much reviewing and studying for medical researchers to learn just how effective, or ineffective, it is. They are also required to pass global standards of safety for human consumption.
Thus, people are asked to volunteer themselves as subjects of said biomedical clinical trials. There is a regulated procedure that is to be followed, along with qualifiers not only for the medical practitioners and the trial to be conducted, but for the patients as well.
What Doctors Deem To Find Out Through Clinical Trials
*Overall drug safety
*Level of efficacy
*How quickly or slowly the treatment takes effect once administered
*Possible side effects (and their level of severity, if so)
*If the new treatment is an improvement in comparison to existing ones
The Process: 4 Phases
There are at least 4 basic phases when it comes to clinical trials. Each “phase” or stage builds up as one moves onto the next. Each phase is monitored for accurate information to be gathered from them, up until all the phases are completed.
In the event that anomalies transpire even before the full clinical trial itself is concluded, whether for reasons of any of the above-mentioned conditions (i.e. drug safety, level of efficacy, etc.), then it’s possible to discontinue the trial and terminate the proceeding of the remaining phases.
Phase I: Small Test Group
Medical practitioners and researchers target only a small group during this initial stage. Besides the safety of the drug itself, dosage quantity and safety are to be investigated closely. These, along with choosing the best ways of administering said drug.
This initial stage is also a form of preliminary screening period for possible side effects.
Phase II: Larger Test Group
If Phase I is proven successful, a larger test group will now be at the offing. Enter, Phase II. This “larger group” can tip the balance of the rate of success of the first and smaller group. It is crucial to determine that the drug and/or treatment can be just as successful when tested with a larger, more varied patient-trial group.
It might have different effects on certain types of patients and certain types of diseases.
Phase III: Varied Dosages – General Population
For Phase III of the clinical trial, multiple treatments with varying dosages will be tested on the group. Aside from this, treatment combinations will be surveyed, to further test performance.
Moreover, this stage will see testing in a broader scope— a larger part of the population, instead of small and controlled clinical test groups. Demographics will be a variable in classifying the general population.
Men and women, the young and the old, regions and geographical designations, ethnic groups, and the like shall be markers in identifying the performance of this part of the trial.
Phase IV: Actual Patients
The average patients will finally be administered the medication in this phase. Phase IV aims to check if there are side effects that may arise from the treatment that were not present in the first 3 phases.
This is the real-world administration of the drug as the drug itself was, in the first place, created for patients who have been infected with a specific and new type and/or strain of disease.
Once the clinical trials reach Phase IV, the Food and Drug Authority (FDA) gives the green light for the drug to be mass-produced and mass-marketed for the general public. It’s often referred to as the “post-marketing surveillance trial”. Phase IV is a confirmatory trial which grants the tested drug and/or medication the designated safety seal for consumption.
What To Expect: A Patient’s Pre-Clinical Trial Journey
Not everyone, no matter how willing, can be a potential test subject for a clinical trial. As much as willingness is a sentiment much appreciated especially in such areas of the medical sphere, there are qualifications patients must pass in order to be counted in.
The inclusion criteria will reveal why a patient qualifies, and the exclusion criteria, why a patient does not.
Such qualifications are different per study and per clinical trial. Other than age and gender, medical history, previous medical treatments and/or trials undergone, types of past diseases, and current health status are among the considerations. More so for trials whose treatments are complex.
You will be signed an Informed Consent. An informed consent will not merely ask for your signature. Instead, it includes information that may help you decide on whether or not to push through with the clinical trial.
Details about exactly what the treatment is for and what the trials aim to achieve, its possible effects on your body (positive and/or negative), benefits (after successful trial runs), length of the study as well as the trial itself, how the trials will be conducted, etc. The Informed Consent you are to receive should have these extensively mapped out.
Apart from allowing you greater insight into the clinical trials, this consent is meant to stand as a safeguard. Your protection through knowledge of the undertaking you are about to sign up for.
We will point out that you have every right to ask questions and clarifications about anything concerning the clinical trial. Should you change your mind about participating as a test subject, you are under no obligation of a permanent contract. You can back out of the medical procedure, at any time, and no matter the reason.