Befiore we dive into new research, we wanted to give you a quick primer on clinical research. I think most of us have probably lots of different “breakthroughs” on the news at some point. You know the type, “New drug CURES everything in Phase 1 trial.” Cue excitement – but hold your horses, it’s important to understand what’s promising research and what’s a click-bait headline. So, let’s break down what clinical trials actually involve.

What’s the deal with clinical trials?

Clinical trials are research studies that test how well new treatments (drugs, therapies or lifestyle changes) actually work. They’re also there to check if these treatments are safe. But, and it’s a big but, the road from lab research to you actually taking that drug is long and full of challeneges.

There are four main phases of clinical trials, and they each serve different purposes. Let’s go through them one at at time.

Phase 1: The safety check

This is the first time the drug leaves the lab and is tested on people – usually a small group of volunteers. These people may be healthy or they could have MS. But the thing is, Phase 1 is usually just making sure the drug doesn’t come with any serious side effects. It’s all about safety, not effectiveness. About 70% of drugs pass this stage.

Phase 2: Does it actually work?

With safety established, we can move on to Phase 2. Now the drug is tested on a larger group to see if it actually works. This is the phase where we start seeing if it has any positive effect on MS symptoms. But keep in mind, this is still early days. About 67% of drugs fail to make it out of Phase 2.

Phase 3: The big one

By this point, a new treatment starts to look really promising. Hundreds, maybe thousands, of people are involved at this stage. The goal here is to figure out if this new drug is better than what’s already out there. It’s also where any side effects that have remained hidden so far can be picked up. You might think, “Surely if it’s got this far, we’re good to go!” But that’s not always true. In fact, up to 50% of drugs fail here, too. Drug development is a costly and risky process.

Phase 4: Post-launch surveillance

Phase 4 is after a drug has passed all its previous trial and it’s finally approved. But the research doesn’t stop there. Phase 4 kicks in to keep an eye on the long-term safety and effectiveness now that it’s out in the public domain (i.e., you and thousands of others are using it). Rare side effects? Unforeseen problems? That’s what they’re watching for here. It’s very rare for anything to go wrong at this point, but it’s not impossible. Around 4% of drugs that get through Phase 3 trials and enter the market are later recalled or heavily restricted. This is why ongoing surveillance even after a drug is approved is so important.

In vitro, in vivo – what does it mean?

You’ll often see the terms in vitro and in vivo when looking at any reseach. Simply put, in vitro means testing stuff in a lab dish (outside a living body), and in vivo means testing it in animals or humans (inside a living body). Just because something works in vitro doesn’t mean it’ll work in vivo, and that’s why you shouldn’t get too excited about in vitro results. They’re just the first baby steps of a long journey. Similarly, if a study is in vivo but it’s in mice or something else, that doesn’t mean it’ll have the same effect in humans.

Why does all this matter?

Well, next time you see a headline about a miracle MS drug, you’ll have a better idea of how far it’s got to go. Clinical trials take years – sometimes decades – and most drugs fail at some point along the way. Only about 1 in 5,000 compounds tested in a lab will actually end up available on prescription. So those Phase 1 results might be exciting, but they’re really just the earliest steps.

We’re not saying don’t get hopeful. But we are saying keep your expectations in check. Understanding clinical trials means you’ll know when to take those “breakthrough” headlines with a big pinch of salt. And, more importantly, you won’t be left disappointed when the latest wonder drug doesn’t pan out after all.