You’ve heard of clinical trials before, and maybe you’ve even seen billboards and other advertisements asking for volunteers – but what exactly is a clinical trial? Why do we need them? How do they work?
In this post, we’re going to do our best to answer all of those questions for you from the viewpoint of a company with an incredibly experienced team of professionals who have been conducted over 1,000 clinical trials combined. In other words, they know their stuff.
Let’s dive in.
How an RCA Clinical Trial Is Born
Medical research never stops. Scientists are constantly looking for new ways to detect, treat, and prevent debilitating diseases and conditions.
Mixing together chemicals in a lab will only get you so far, though. Researcher need to know if the new treatments they create actually work. They need to know if they are safe.
That’s where clinical trials come in. These are specific types of studies that are used to determine whether or not a particular treatment, device, or strategy is safe and effective for people to use.
How is this determined? By testing that treatment, device, or strategy on people.
They may sound a bit scary, but stay with us.
Before anyone is ever tested, researchers come up with a protocol. In the protocol, the researchers lay out the requirements someone needs to meet to be an eligible participant, the procedures and medications involved in the trial, how long it should take, any associated risks, and the goal they hope to achieve.
They also break the trial up into phases, which we’re going to talk about next.
The Phases of an RCA Clinical Trial
There are five possible phases for every clinical trial, from Phase 0 to Phase IV – though sometimes Phase 0 is also seen as merely the earliest part of Phase I, and it’s not required, so often it is not even done. In fact, at RCA our team only handles Phase I-IV, but it’s worth spending a few moments detailing Phase 0 just so you understand how the process works.
Essentially, the first phase – Phase 0 – is about asking that most basic of questions: does this even work? Because of this, human exposure during this phase is incredibly minimal. There are typically no more than 15 volunteers, and they don’t last long.
In terms of how this impacts volunteers, it’s both good and bad. The low exposure means that your risk of harm is almost nonexistent. However, it also means that you are unlikely to experience any major benefits either. Generally speaking, Phase 0 volunteers aren’t there to help themselves, but to further the science so that others may benefit later.
If results are positive in Phase 0, it’s time for Phase I.
Phase I – Is It Safe?
Starting with Phase I, the clinical trial guidelines become much more specific. This phase involves:
- 20-80 healthy volunteers
- Learning about safety
- Determining any side effects
- There are no placebos in Phase I
If the level of safety concerns during Phase I are too high, the trial will end. Otherwise, it will move on to Phase II.
Phase II – Learning More about Effectiveness
- 100-300 volunteers
- Continue watching for safety concerns
- Study short-term side effects
- Use placebos to compare effectiveness with those in a controlled environment getting no real treatment
- Begin collecting data on how those with a certain condition or disease are impacted
Phase III – Large-scale Studies to Make Sure Everything Really Is Okay
- 1,000-3,000 volunteers
- Studying different populations
- Confirming effectiveness
- Further evaluating safety
- Monitoring side effect
- Comparing to currently used treatments
- For drugs, determining dosage for those with a specific condition and seeing how it works in combination with other drugs
After Phase III is completed, information about the new drug or treatment will be sent to the appropriate health authorities. If the FDA approves product and says that it can be marketed to the public, we move on to Phase IV.
Phase IV – Ongoing Monitoring of the Approved Medical Product
- Studies include thousands of people
- Examining risks, benefits, and optimal use
- Watching for rare side effects
- Safety over time
- May look at quality of life and cost effectiveness
Phase IV trials can continue for years, since the point is to see how medical products pan out once they are in wider use amongst the general public.
Ready to Start Your Clinical Trial Journey at RCA?
Interested in volunteering for a Phase I-IV clinical trial with us? Which Phase is right for you will depend on what you want to get out of the process.
Phase IV volunteers don’t gain access to any kind of treatment or procedure early – they’re basically just helping researchers by providing them with more data which could positively impact future treatments. Earlier phase volunteers are like beta testers – they get to try something most people can’t yet – but they are also participating in a more experimental part of the process.
Not quite sure what’s right for you? Reach out to our office.