As we have seen with the COVID-19 pandemic, clinical trials make it possible to bring about much-needed advancements in the medical field. They help medical professionals create and test radical new vaccines, medicines and medical procedures to treat, cure and manage various ailments and illnesses.
One of the biggest limitations of clinical trials is finding volunteers. By its very nature, clinical trials are often fraught with risk. Researchers are in the process of experimenting the efficacy and safety of medicines and medical procedures through trial and error. This means, they have not yet ascertained whether these treatments are safe for use.
Fortunately, there are many people who are happy to volunteer for clinical trials. If you are planning to volunteer for any sort of clinical trial, there are a few questions you must ask prior to giving your signed consent.
Am I eligible for this clinical trial even if I have a pre-existing condition?
Medical trials are conducted on healthy volunteers as well as patient volunteers.
Though most clinical trials are conducted on healthy individuals, some patients with certain pre-existing conditions may also benefit from a clinical trial. This is especially true of anyone who has volunteered for the trial to possibly improve or treat their pre-existing condition. One common reason to sign on for a clinical trial is to see if the drug has any side effects, and see how these side effects affect any pre-existing conditions.
People with pre-existing medical conditions may be accepted or rejected based upon pre-determined criteria. Discuss all options with your physician prior to volunteering if you have a pre-existing medical condition, as medical trials may sometimes exacerbate some conditions that have been working well with more traditional medications or methods.
At what stage in development is this drug/medication in? Has it been tested on people before?
This is a two-part question, but both portions of this question are equally important. It is vital to ask what stage of development the medication or drug is in, especially if it is a new drug that has yet to be licensed or approved.
If, at any time, you do not understand anything within the paperwork or discussion of a clinical trial, ask questions. It is also vital to know whether this medication or drug has been tested on people before.
It is especially important to ask both questions if you suffer from certain allergies, are more prone to certain side effects or if you have a pre-existing condition. The research team must be informed about the patient’s health in order to be able to conduct an accurate clinical trial.
What happens if I am injured or suffer adverse effects?
The risk of experiencing adverse effects is high with clinical trials. You may be aware of this but it still pays to be informed about all the possibilities.
Read through all documentation carefully. Do not sign anything you do not agree with. Ask for all options available prior to the start of the trial, and discuss options with your own personal physician prior to volunteering for any medical trial. There should be ample documentation and discussion of necessary insurance if anything should happen that may affect you in a negative way.
If you feel your condition is worsening or you are experiencing side effects, you must contact the medial team immediately and see what steps need to be taken to drop out of the trial if necessary.
There should be some form of insurance in place to assist those who may have adverse reactions to medications or methods during the trial. When in doubt, ask.
How often will I need to see the doctors or report to the testing centre?
Participants will report to the testing centre on a regular basis which will be explained during the preliminary phase of testing. Often, participants will report to the centre’s physician and staff more often than their regular doctor, which is helpful to monitor and record not only the progress of the study, but also make note of any side effects that may occur.
Doctors and medical staff are on hand before, during, and after a medical trial, and may ask questions of participants regarding changes in condition, comfort levels, pain levels, or ask about any adverse side effects they may or may not be experiencing.
Finding out the frequency of the follow-ups in advance will help you work out a schedule that does not affect your other personal and professional commitments.
When will the results of the study/trial be released?
Once the trial period has ended, researchers will use their findings and publish them in both print and online too. Though it is often written with medical and technical jargon, many research studies are also published in newspapers and local medical or university web sites. Participants may also receive the final results of the study if they request them and sign the proper paperwork.
Read through all the documentation and paperwork prior to signing on for such studies, and as always, if you do not understand something or have any questions, ask.
May I consult with my own personal medical and legal counsel about the trial?
All participants in a medical or drug trial must discuss this step with their personal physician and also get legal counsel before making the daunting decision as to whether they may benefit from a medical trial.
Your doctor can assist you with medical terms, and a lawyer can assist you with any legal questions you may have regarding treatment or stepping away from a study if you feel you need to drop out. It is advisable to read through the paperwork with your doctor or a lawyer prior to participating, so you can have a thorough discussion both from the medical and legal standpoints.
As a voluntary participant, you may choose to not participate in any medical or research study after you have reviewed all documentation and paperwork. Any time you suspect you are at risk of serious injury or death, do not participate any further.
Medical trials are important for the health and well-being of everyone involved. Even though there will always be some risk with any sort of medical or drug trial, the general populace benefits greatly from this research and its outcomes. However, this does not mean you should put your life at risk. Asking questions is the best way to decide whether or not to go ahead and volunteer for clinical trials.