19/01/2022
You’ve not been feeling yourself, lately. It happens to all of us, from time to time. You can’t shake it, whatever it is, so you bite the bullet and go to see your GP. You do that thing where you try and sit as far away from everyone else in the waiting room (this place is full of sick people, after all), and you might get a bit annoyed at anyone who thinks it’s okay to have a conversation in such a place without using their quiet voice. I know I do.
After far too long (sometimes I think the notion of a specified time for an appointment is so detached from reality that I wonder why they bother), you get the call, put down the three-year-old dog-eared copy of Heat and hope you can remember which door your doctor is behind.
Your doctor will ask you why you have come to see them, you’ll try your best to remember every symptom, forget at least one, and if you’re really lucky, maybe you’ll get to lie on a huge piece of tissue paper and get a physical examination. The doctor will make a diagnosis, tap on the keyboard, and a printer that must be at least thirty years old prints off a prescription, really loudly. The doctor will sign it – sort of – and you will thank them (at least, I hope you do), and on the way out, the receptionist may mug you very politely. I mean, how many muggers give you a receipt?
You’ll go to the nearest pharmacy, ask them how long it will take (please don’t say we’re really busy and it will be at least an hour) and finally get your medication after being mugged once more.
Do you ever read the neatly folded medicine instructions? I usually have a quick peek at the potential side effects, but if I know how many tablets I am supposed to take and when, I trust the system.
And every time you pop a pill that you have never popped before, you are trusting the system with your life. And that’s fine, because the system works.
No drug is 100% safe for absolutely everyone – there is just too much diversity in human life for that to ever be a reality – but the risk you take when you take a new drug is absolutely minimal from a statistical perspective.
And that’s because of drug research and the efficacy of clinical trials.
There are four stages of testing drugs on humans.
1. Phase 1. This is possibly the stage that people automatically think of when they think of drug trials. Phase 1 is where drugs are tested on human subjects for the first time. Often, the participants will be healthy and will be paid to take part. This is the riskiest part of drug testing, and is done by specialist companies that monitor the subjects very, very carefully. Adverse effects are still relatively rare but are most likely to happen in Phase 1.
2. Phase 2. The rules in the process change here. This time, the participants will have the medical condition that they medication was designed to treat. People taking part are not paid (although out of pocket expenses will be refunded). Patients will be monitored carefully (they always are, throughout the process), and the function in this phase is to get a better understanding of how the drug reacts to different people, and how it effects the condition it was designed to treat.
3. Phase 3. This is where the substance is truly tested. Clinical researchers will use a variety of techniques that are far too convoluted to discuss here, but the idea is that the drugs are “blind tested”, so that neither the clinician or the patient knows what drug they are taking (placebos can be used here), or what dose they are receiving. More participants will be involved across multiple sites globally, and this phase can take a long time. The “blind” element ensures that the drug is truly tested in an entirely objective manner. For the first time in the testing process, Doctors (specialised in the condition) will be heavily involved.
4. Phase 4. By now, following Phase 3, the drug will be authorised for use by the public. It can be prescribed by GPs and other doctors. Side-effects will be reported, and this is a work in progress for all medication.
It’s entirely possible that any given research trial won’t get to phase 4. The scientific processes undertaken are unwavering and unaffected by optimism, hope and profit. A drug either works safely, or it doesn’t.
That’s basically it for the process of approving a new medicine. There are a lot of layers here, though. Because of the potential for danger to human subjects (and mistakes learned the hardest of ways), drug testing is staggeringly strictly regulated. The scientific process means that small improvements and changes will always be made – that’s how science works.
In Ireland, all clinical trials must be approved by the HPRA (link), and this process can take a long time. It’s unheard of for a proposed trial to pass immediately. The recruiting of patients is also a complicated process. Strict criteria always apply, and patients are “screened” very, very carefully. It’s not enough to be willing to take part – patients will qualify, or they won’t. There are no grey areas here.
Independent monitors constantly keep an eye on proceedings, making sure that absolutely everything is exactly how it is supposed to be. Everything is recorded, and the records must be kept perfectly.
A company like the CRP (LINK) build their reputations in the sector by employing talented, experienced professionals who are dedicated to ensuring that clinical trials are conducted without error or fault. It can be a very pressurised environment. Patients are often vulnerable and suffering, and sometimes the nature of the trials means that they won’t get what they wanted to get out of the experience.
However, there are no surprises. All participants are afforded huge amounts of time to ensure that they understand exactly what they are signing up for. Research nurses care deeply about their patients, and become very invested in making sure that they are treated respectfully and ethically.
Clinical trials are an integral, vital weapon in the arsenal that science uses to fight illness and disease, to improve longevity and quality of life. Without them, there are no new drug treatments. The advantages to those taking part are obvious: in the best-case scenarios, they will be some of the first people to get a new treatment that will improve their lives. Even in the worst case, they will have participated in a process that will help other people like them.
We’re the Clinical Research Platform, and we are proud to be Ireland’s leading company in the clinical trials sector.
