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Let's Talk Clinical Trials!

Julia Corbin
2022-07-06 13:00:00

At the most basic level- Clinical trials are any research study that involves people, which is exactly why we are so interested in this field here at PRSONAS™. Something involving people, for the betterment of all people, count us in!!

Clinical trials are the reason for pretty much all medical advancements. Without them, the medical field wouldn’t be nearly as advanced as it currently is!

There are two types of clinical trials - 

 

Interventional

Interventional study icon

Observational

Observational study icon

An interventional study is scheduled and tends to be outside of the usual therapeutic treatment when a drug or treatment is used in a closely monitored environment to more closely see the efficacy and safety of a treatment. 

An observational study or "non-international study" is less closely controlled. It's taking a drug or treatment, and adding it to someone's therapeutic plan. to see how the treatment works in a more "real-world" environment. 

 

So now that we know the basics, let’s dive a little deeper.

 

Arguably, the most important part of any clinical trial is consent. Informed consent to be more specific. The people involved need to know exactly what they are signing themselves up for, in a way that they can comprehend and understand. This ensures that participants know the risks, benefits, and activities of the study. Each patient must sign that they are participating having been given informed consent. But this isn’t some binding contract- they can withdraw and revoke consent at any point!

So finding ways to communicate the steps and purpose of the trial effectively is one of the most important steps in starting a clinical trial.

 

That’s just one of the steps that our friends at RTI international have to take to get a trial up and running. In 2021 alone, RTI completed all this:

Projects icon

3,977 Projects

Clients icon

1,217 Clients

Revenue in hand icon

$1.078B in Revenue

And with every project comes its own challenges!

.The challenges with getting started:

  • Approvals - All federally supported or conducted clinical trials that involve a drug, product, or device regulated by the FDA must be reviewed, approved, and monitored by an institutional review board, aka IRB
  • Patient Recruitment - 80% of studies are halted or closed due to low enrollment! 

And that's now even including the costs, selecting the site, or patient access!

What about the actual trial? What are some challenges that come with that? Glad you asked!!

Clinical trial management is a massive world of its own. Often, a trial will be run in multiple different sites/locations to ensure that there is a diverse group of people involved. So, managing multiple sites alone can be a challenge. Along with tight timelines, tons of regulations, and oversight - It's a miracle that so many trials are still able to happen!

But like we said earlier, clinical trials are the reason for the medical advancements of today. Their importance can't be understated. So how are we going to tackle these challenges?

{PRSONAS™ is already out there taking on these challenges to (hopefully) help simplify this complex industry so that these incredible advancements can keep coming. 

 


 

Take a look at how Dr. Bell assists with clinical consent for RTI!

 

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