Anyone who wishes to be part of a clinical trial should weigh in different aspects of the trial before doing so. When it comes to diseases like cancer, joining clinical trials are one of the common treatment possibilities for patients.
Medical organizations may also hire a contract research organization(CRO) to carry out the clinical trials for them. The CROs are outsourcing companies that have specific expertise to lead the trials safely and efficiently. They play a major role in all aspects of drug development, from initial discovery to market launch.
While some take part in clinical trials because they believe that these experimental regimens could very well be the cure of the ailment, others do it to help the cause and further improve the research. Be it for your personal benefit or to help future generations, there are certain things that you must know before going on a clinical trial.
Check if the goals of the trials match with what you are looking for:
The first thing to look for is the goal of the clinical trial. As a participant of the trial, you should be clear about why it could turn out to be better than standard treatment procedures in your case. You should also get in touch with the Food and Drug Administration (FDA) to get an idea of the instances when the drug(s) might not work the way it was intended to.
The patients must also understand that there are different phases in a clinical trial and it takes time to move from one phase to another. Phase 1 trials are only to identify the right dosage for humans, so if you are looking for faster results then this phase is not for you.
It is only during the phase 2 and phase 3 trials that the drug is tested for its effectiveness through medicinal chemistry. Here, you need to understand thatin certain trials, while some patients are put under trials for the listed drug(s), others are put under some other therapies to compare both the studies and get a better understanding of the trial.
The catch is that there will be times when you would not know if you are getting the experimental drug or some other therapy, so knowing it beforehand will help you.
Make sure that you’re okay with the intensity and schedule of the regimen:
Before committing to be part of a trial, you should be very clear with two things – the pain you will have to suffer, if any, and the schedule of the trials. While in some cases, participants are under constant observation, in others, they just have to visit the trial centre at scheduled intervals.
You should check if there will be any travel arrangements made for you or if there any hospitalisation involved in the process along with other such aspects. The other thing to note here is the amount of pain that you will have to go through and if this does not suit you, you should probably avoid it.
Identify the financial costs that you will have to incur, if any:
During most clinical trials, it is the pharmaceutical company that will pay for the drug and the health insurers who pay for hospitalisation. However, there might be some expenses that an insurer may not cover, like the treatment required to cure side effects of a drug or travel expenses and so on.
Therefore, it is absolutely necessary to have an idea of all these expenses before you take part in the trial.
Read the informed consent document thoroughly:
Lastly, you should definitely read the consent document thoroughly before signing the deal. Yes, it might look quite daunting to start with but you should do diligently to understand all that will take place during the trials. In fact, you should highlight the points that you do not understand take it up with the researchers before taking the final move.
These are four of the most important things to know before being part of a clinical trial to avoid any negative experience.