“Are you locked in a padded room?”

This was an actual question I was asked as a clinical trial recruitment manager by one of the patients I talked to. The recruitment department for a clinical trial site is vital in working with patients that are interested in participating in clinical trials. The recruitment department for a clinical trial site is vital in working with patients that are interested in participating in clinical trials. But I may be partial (wink wink).

How it works: You could see an ad for a clinical trial on Facebook, or other social media for example. You click on the link, and if you want, you apply. The recruitment team calls those that apply and gives them a brief overview of the study (purpose, duration, visit count, compensation, etc.). If the person is interested in the study, they would gather their medical history, demographics, and then ask the study related questions that determine who may be a good fit for the study and vice versa.

In this 2-part blog, we are going to look at what may prevent a person from participating in a clinical trial by busting myths and answering the most common questions I have been asked. Hopefully, removing any remaining reservations for those that are not completely sure about participating.

Busting the Myths

I spoke with thousands of patients just like you. I say just like you because whether you have made your mind up or not about participating in a clinical trial, you at least have some interest. If not, you wouldn’t be reading right now.

In my personal experience, most of the wonderful folks I talked to had questions, but there was not an exact fear for the most part. There were misconceptions, myths, and just downright wrong information, but most people did not have fear. Here are some of my favorite misconceptions that I’ve heard over the phone:

  • Myth- The doctors are fresh out of college, or still “training”.
    • Fact- Clinical trials are regulated by the FDA. The Investigator, or Doctor for the clinical trial must meet criteria put forth not only by the FDA but also by the pharmaceutical company that hires them. The investigator must also have the resources (staff, facility, etc.) to support a clinical trial.
  • Myth- Patients are locked in a padded room with no outside contact.
    • Fact- There are no padded rooms (do they even have those now?) but, if you are participating in a trial that has a surgical aspect, typically there is limited family contact. This is to make sure correct rating scale information is gathered, and that no one is slipped anything they should not be.
  • Myth- You will be forced to participate, even if you no longer want to.
    • Fact- The process is 100% voluntary, through 100% of the timeline. You can stop at any time, even if the study is not over.
  • Myth- You have zero protection if something goes wrong.
    • Fact- You are taken care of 100% if you have a side effect directly related to a medication or device in the clinical trial.

Honestly, I could go on and on. When I did come across someone who is uneasy, once I explain to them the process is 100% voluntary, that goes away. Our job is to give you the information so you can make an informed decision. From there, you can decide what your next steps are.

Remember, you can have all the interest in the world to participate in a clinical trial, but there are requirements that must be met for you to continue through the process. These requirements are there to keep you safe. The pharmaceutical, or medical device development company wants their product on the market. The only way to do that is to keep everyone safe during the clinical trial process.

Stay tuned for the second part of this blog in early August. We’ll end this series with the most common questions I have been asked.

MyLocalStudy.com is dedicated to matching you with a study in your area. To check out the studies we have enrolling near you, click HERE.

References:

https://www.amgen.com/science/clinical-trials/information-for-healthcare-professionals/investigator-resources/

https://www.clinicaltrials.gov/ct2/about-studies/learn