[Survival Battleground] The Mystery of Clinical Trials

After graduation, most people will face the major life event of "finding a job". Then, at the time of the New Year and the festival, there will always be one or two relatives who are thirsty and not very familiar , trying to find a way to inquire about your current situation, trying to ask questions or sneer.

"Is Aanris graduating this year? Did she find a job? What's the salary? Shouldn't it be 22K?"

"Oh, I only know that he works in a company. He seems to be doing clinical experiments . To be honest, I don't know exactly what my daughter is doing."

Yes, most of the people don't know what we are doing in this business, even my parents don't know, so I can't explain it to my relatives. In this way, my work has always been a mystery. Anyway, it is not illegal things such as drug trafficking, fraud, robbery, etc., and probably no one cares. (Or all they care about is salary XDD)

After graduation, most medical students will take the national examination and become clinical practitioners . For example, the doctors, nurses, pharmacists, physical therapists, and medical examiners who are most in contact with everyone in general (no reason, because I graduated from the Department of Medical Technology). Furthermore, another part of the people will invest in biotechnology , most of them are start-up companies, and most of their positions are related to R&D. There are also some powerful classmates who will enter the pharmaceutical factory and become a group of Propa shuttles in the hospital. Finally, there is an option called a clinical trial company .

What is a clinical trial?

Definitely not an experiment!!!! This is a point that must be clarified, we are definitely not experimenting with patients. Please don't misunderstand that we are a group of inhumans, and the health of our subjects is our top priority.

Clinical trials are a very long journey that must go through before a new drug/new medical technology/new medical material is launched. For the cancer-targeted drugs that I am mainly responsible for, it takes about ten years to complete a complete clinical trial, and the amount of investment required is astronomical. There's no way to earn that much.

During the ten years of the experiment, the people who will meet can be roughly divided into several roles, namely:

1. Medical behavior execution: including physicians, research nurses, pharmacists, etc.
2. Regulatory review: Taiwan Food and Drug Administration (TFDA), Hospital Ethics Research Board (IRB)
3. Test client: pharmaceutical factory/biotechnology factory
4. Clinical Trial Monitoring: Clinical Research Corporation (CRO)

For example, when a pharmaceutical company successfully develops a drug, completes animal experiments and wants to advance to human trials, they will decide which team of physicians to cooperate with, and must provide subject consent and a trial plan before the trial begins. TFDA and IRB review (of course not only these two, there are many documents to prepare QQ). During this rigorous review process, the committee has a comprehensive understanding of the entire trial process and asks questions where there are concerns. After successfully passing the test, the physician can begin to accept the case (patient admission), and explain the entire trial process clearly to the patients who meet the acceptance criteria. Only after the patient fully understands and agrees and signs the subject's consent form can the course of treatment begin. During this process, as long as the patient does not want to continue the course of treatment, he can withdraw from the trial without any reason.

For my CRO, we will be responsible for the quality monitoring of the entire trial process. Through the clinical trial specialist (CRA), we will visit the hospital regularly to confirm that everything is fine. Because it is a human study, all the data must be well and correctly retained, ensuring the patient's medication safety and confirming that all medical behaviors are carried out in accordance with the trial plan, which is one of the main tasks of the CRAs (I talk about it). , but it's actually quite a great job).

After the trial is completed, that is, after the patient's course of treatment and follow-up are all over, the data obtained will be analyzed and the analysis results will be awaited (that is, the "unification of blinding success" event that was very popular a while ago). If it is successful here, the next new drug listing review can be conducted, and the road to making a fortune will begin. '

Just a simple fur explanation has made my article. It's really just the fur in the fur, I'm new to the industry and I still have a lot to learn. So, I simply did not explain to my relatives what I was doing.

In fact, I think that all medical practitioners will have a heart that wants to help mankind. Even after years of devastation, we may have shed so many tears in the dead of night when we were faced with those rude patients, the absurdity of hospital evaluations, the indescribable health care system, and the inexhaustible pressure and grievances. What supports us in going forward is the smile of patients after recovery and the excitement of new drugs on the market. Maybe we can never return to the kind of enthusiasm we had when we graduated, but everyone still has a pure land in their hearts, filled with the desire to do something for the society.

 May we all continue to contribute ourselves in our own positions. Of course, we don’t need to burn our lives to the point of forgetting to eat and sleep. We still need to remember to eat and drink water and toilets.

All the best.