A Behind-The-Scenes Look At Clinical Trials

By Aileen Lee

Beginning a clinical trial is a lot like preparing for a wedding or another large celebratory event with many details and different people working together. In the case of starting a clinical trial, the “big day” is your first day of treatment.  Planning a wedding entails coordination with multiple vendors – venues, florists, catering – all within a set period of time. Similarly, there is a set timeline for determining eligibility and enrolling on a clinical trial. We call this process “screening” and everyone who is interested in starting a clinical trial must go through screening prior to enrolling on the trial. The screening process requires collaboration with:

  • Physicians and nurses who work directly with you to perform specific procedures and tests necessary for eligibility
  • Lab technicians who process your blood or other samples according to study specific protocols
  • Sponsors (such as pharmaceutical companies) to verify your eligibility for the trial
  • Pharmacists to ensure you are dispensed the proper drug and dose
  • Federal oversight (such as the FDA) to ensure proper safety reporting for you as well as past and future patients exposed to the treatment

Coordination can be difficult. That’s where I come in.

Just as a wedding planner assists brides, as a study coordinator, I assist patients. I work diligently behind the scenes with a range of health care providers and clinical research colleagues to ensure that each step of the screening process is feasible for patients to complete, and to help ensure that there are no delays in starting treatment.

IT’S LIKE A CLOCK COUNTING DOWN

So what exactly is screening? Here are three things to know:

  1. Screening begins the moment you enroll (most often by signing a consent document)
    It’s a checklist of items that must be completed within certain windows of time to verify your eligibility for a trial. The timeline varies depending on the study protocol, but on average, scans and labs must be completed within 28 days of receiving the first treatment. Sometimes, labs must be completed within 14 days prior to starting a clinical trial.
  2. Screening does not guarantee eligibility
    It’s not enough to complete a test. Sometimes, your test results must fall within a certain range. Often, this is for safety reasons, but it can also be because the drug is only thought to work in certain populations or with certain pre-established disease parameters.
  3. The biggest challenges are coordination and accommodation
    In reality, completing this checklist is not always simple, but we do our best to simplify it and accommodate you.

Screening consists of standard-of-care procedures – tests you’ve likely completed from previous visits with your provider, like blood tests to determine white blood cell count, hemoglobin levels, etc. – and study specific procedures – tests that are normally not conducted, but that the trial would like to test, such as magnesium, phosphorous or amylase.

If you have had standard of care procedures prior to consenting that we can use to verify your eligibility, we will use them, but depending on when they happened, this may decrease the amount of time we have to complete the other required tests, since all testing must occur within a certain window of time.

IT REQUIRES SUPPORT

Beginning a clinical trial can be a daunting task, but rest assured that in addition to the support of your family and your healthcare team, you also have a network of clinical trial personnel cheering you on during each step of the way.

To find a clinical trial that may be right for you, check out our new A-Z search feature.

WMC_GU_Team

Aileen Lee_Headshot
Aileen Lee is a genitourinary (GU) cancer clinical trial coordinator. Through the Weill Cornell Medicine and NewYork-Presbyterian Joint Clinical Trial Office (JCTO), Aileen screens patients interested in participating in a clinical trial for kidney, bladder, prostate or testicular cancer. She also contributes to Dr. Molina’s Kidney Cancer Support Group. She is an Oregon native, violinist and aspiring physician.