Clinical trials are experiments that aims to assess the safety, efficacy and effectiveness or new drugs and medical devices by studying them and observing their effect on human.
All current medication we safely use in our hands and pharmacies have went through this experimenting process in laboratories then tested on animals then on human, which is called Clinical Trials.
Clinical Trials Go Through 4 Phases:
Phase 1:
Which is testing the new investigational product on human for the first time in order to determine the safest dose in a closely monitored environment, this process requires a highly equipped unit and special regulations, the participants in this phase are mostly healthy volunteers.
Phase II:
Which requires enrolling patients to assess the investigational product efficacy and monitor the side effects
Phase III:
In this phase usually a comparison is made between the investigational product and other drugs and continue the monitoring of the side effects, it requires a large number of participants.
Phase IIII:
It is a continuation of monitoring the investigational product's safety and efficacy on larger number of patients and usually on different populations.
Based on this process you can see that drugs development is a long complicated process that takes from 10-20 years, so participating in such trials give participants the advantage of receiving drugs that are not yet in the market.
The community's support and participant’s involvement in clinical trials are a corner stone in the process of developing new drugs to be in the hands of the patients who need it the most. There are a lot of drugs that failed to reach the scientific evidence to obtain the necessary approvals due to not meeting the sample size (lack of participants) which give you a hint on how important it is to participate in clinical trials that tries to find therapies to diseases.
Is it possible to safely consume drugs that didn’t go through the process of clinical trials?
No, because they are not approved by the regulatory authorities for lack of scientific evidence of their safety and efficacy.
What do I benefit from participating in clinical trials?
It depends on the type of study you're participating in, if the study is a phase I clinical trial that test the drug for the first time on human then the benefit is limited, except for the personal reward of enhancing the science and developing a new drugs that may save lives and eliminate human suffering in the future. As for other phases of clinical trials, the clinical trial participant will have a closer follow up on his health as per the study protocol, and the study drug might help cure his condition.
What could happen to me in terms of side effect?
Although one of the main objectives of clinical trials is to assess the drug safety and side effects, it goes through close monitoring by highly qualified and trained team and a safe protocol that is approved by the ethics committees and regulatory authorities. For example, in phase I clinical trials the drug dose is determined by previous studies in the lab and on animals that could take years. The test on human starts with the low doses then increases according to a calculated formula until we reach the proper dose based on diagnostic labs and special medical monitoring and based on the later phases of the clinical trial we will have a clearer knowledge on the drug's safety.
Keeping in mind that all drugs have some type of side effect like headache, nausea, diarrhea etc.. but they are mainly minimal and disappears by the time you stop taking the drug or lower the dose. In addition to that, there is a special committee called the Data Safety Monitoring Board that works to assess the safety of the drug under study.
What are the steps to take to participate in clinical trials?
1- Pre-screening:
The study team will contact participant or potential volunteer , either by phone or through the clinic to offer you more information about the clinical trial.
2- Consenting:
After the potential participant receives all the clinical trial details and agrees to participate in the trial, he will be asked to sign a form to document his willingness to participate, and that he received all the information he needed to make an informed decision.
3- Screening:
The potential participant will move to screening step where he will be screened for medical history, lab tests and general health status to determine whether he meets the inclusion and exclusion criteria or not.
4- Enrolling in the study:
After passing the screening, the participant will be enrolled in the study and start the study procedures according to the protocol.
5- Study Visits:
The participant will come for follow up visits, according to the follow up visits schedule and procedures in the study protocol.
6- Completing the Study Course:
In this step, the participant will finish all study related procedures and complete receiving the study drug course. However, his participation has not ended yet.
7- Follow Up:
After completing the study drug course the study team will follow up with the participant over the phone or in the clinic to check on his condition until the end of the study.
