Read Part 1 of this article right here.  
 

What are the Phases of a Clinical Trial? 

Before any treatment is tested in people, it goes through preclinical research in a laboratory where scientists gather information about safety and dosing. 

Then comes the human testing, broken into phases: 

  • Phase 1: Fewer than 100 patient volunteers help researchers study safety and find the right dosage. This phase typically lasts several months. 
  • Phase 2: Up to several hundred patient volunteers help researchers look at how effective the treatment may be and whether side effects appear. This phase can run up to two years. 
  • Phase 3: Up to a few thousand patient volunteers help test and monitor both effectiveness and side effects for a period up to four years (though most are shorter). 
  • FDA Review: After Phase 3, the FDA reviews all the data collected. If the treatment is approved, it becomes available by prescription. 
  • Phase 4: Sometimes research continues after approval to study long-term safety and benefits, or to compare the drug with other available, similar treatments. 

Treatments earn their way forward through real-world evidence, gathered carefully at every phase of the clinical trial process. 

What Are the Benefits of Joining a Clinical Trial? 

People join clinical trials for different reasons, and all of them are important. Benefits include: 

  • Possible access to an investigational medication not yet available by prescription 
  • Consistent, attentive care from an expert medical team 
  • A chance to contribute to what is known about a condition that may be affecting your family 
  • An opportunity to help people in the future who are diagnosed with the same condition 
  • A whole network of education and community resources available to you throughout the process 

Research is about science, but it’s also about support. Most families want both. 

Charter Research patient volunteers have already helped change the course of Alzheimer’s care. Two investigational treatments they helped test, donanemab and lecanemab, have since received FDA approval and are now available to patients across the country as Kisunla and Leqembi. People just like you, who simply accepted an invitation to be part of the research, made these treatments possible. 

What About Risks or Side Effects? 

There are risks to everything, and you should know them going in. 

As a patient volunteer, you might receive a placebo rather than the investigational medication. Or the drug being studied may not help you personally. Side effects are possible, and occasionally they can be serious. 

Knowing the risks is exactly why asking questions is so important. The more you understand going in, the more confident you’ll feel in your decision. 

What Questions Should You Ask Before Joining a Clinical Trial? 

Every family comes to the idea of a clinical trial with different concerns.  

These are some of the questions that tend to come up, and that are always worth asking:  

  • What is this study trying to learn?  
  • Who’s sponsoring it, and who has reviewed it?  
  • What are the chances I’ll receive a placebo?  
  • What phase is this trial in?  
  • How often would I need to come in, and would it affect my daily routine?  
  • If the treatment works, can I keep receiving it after the trial ends?  
  • Will I find out how the trial ultimately turned out? 

Does It Cost Anything to Participate in a Clinical Trial? 

No. Participating in Charter Research’s clinical trials is completely free. You don’t need medical insurance, and we never request payment from you or your insurance company.  

Patient volunteers are also often compensated for their time and participation. For many families, that answers one of the first concerns that comes up when they start looking into research. 

Can You Stop Participating Once You Join? 

Yes, you can always decide to stop taking part in a clinical trial. Participation in a clinical trial is completely voluntary. You can stop at any time and for any reason. If that becomes the right choice for you, just let your care team know. 

Joining a clinical trial is your decision. So is staying in one.  

Why Join a Clinical Trial Through Charter Research? 

Families looking into clinical trials come with a lot on their minds. They want to feel cared for, guided, and heard. 

Our approach is built around personalized care, education, and community support. As a patient volunteer, you may have the opportunity to receive medications not currently available by prescription, which may help ease symptoms or slow their progression. 

What you contribute as a patient volunteer reaches further than you might expect. Every medical breakthrough depends on patient volunteers who decide to take part in research.  

This decision to participate in a clinical trial rarely happens alone, and it shouldn’t have to. If you’re a family member or caregiver trying to understand what a clinical trial might mean for someone you love, our team is glad to speak with you, too.  

Your Next Steps 

Somewhere down the road, someone will take medication that helps them.  

They won’t know your name. They won’t know you said “yes” to research, showed up for your visits, and played a part in something bigger than any one person.  

But your decision will have touched their life anyway. That’s meaningful.  

Give us a call when you’re ready. We’ll walk you through what comes next. 

Orlando: 407-337-3000 
The Villages: 352-441-2000 
Chicago: 773-300-1000