Clinical Trials 101

Happy Spring and welcome back to this month’s Clinical Trial Conversations series featuring Maia Walker, Lead Curator of the Fight Colorectal Cancer Trial Finder, and Manju George, Scientific Director of COLONTOWN!

If you missed our first blog introducing Maia and Manju, be sure to check it out here.

This month, we’re going to spend a bit of time unpacking the basics of clinical trials. In the colon and rectal cancer universe, we hear lots about clinical trials and terms like eligibility, overall response rate and informed consent forms - but these terms -and the logistics of finding, and getting on a clinical trial - can be super confusing. 

Before we dive in - be sure to check out Fight CRC’s clinical trials mini magazine to get up to speed on some of the basics of clinical trials, including facts and myths!

Maia and Manju, you both have been championing clinical trials for the community for some time now. Can you describe what a clinical trial is, and why we conduct them?

Maia

Talking from a patient’s perspective, a clinical trial is a carefully designed research study in which people participate voluntarily, to help doctors find better treatments for colorectal cancer, for example.

There are many types of clinical trials! Some trials may investigate how well a new medicine (drug) or a new procedure works, while other trials aim to compare known treatments: whether one works better than another does. Some trials test a medicine for the first time, and many others use already-approved drugs in a new way. Some trials are for patients who have been recently diagnosed, while others are for those who have already received several lines of treatments.

For the patient, a clinical trial is the possibility of benefiting from cutting-edge treatments that are available only in research.

Manju

There are some great videos on YouTube that break down clinical trials. This is a video from Canada and the content is equally applicable to us.The NCI has this website which explains what a clinical trial is. In very simple terms, a cancer clinical trial is a research study involving people through which doctors find new ways to improve treatments and make life easier for patients with cancer.

Check out Fight CRC’s Clinical Trial magazine for more info on understanding clinical trials!

What are the most confusing terms that come to mind when patients are searching for clinical trials?

Maia

Reading a clinical trial record at clinicaltrials.gov requires a bit of training but even those of us without a medical background can do it!

From a practical point of view, one first could look at “Recruitment Status.” Often, only the records marked with “Recruiting” and “Not yet recruiting” will be of interest - those are the trials taking new patients or which are about to open to take new patients. Trials labelled “Active” or “Completed” are not taking new patients.

Eligibility” aims to answer the question “who can participate in this study?” “Inclusion criteria” lists the characteristics required for a person to have to participate in the study (“must have”), while “Exclusion criteria” mentions factors which prevent a person from participating (“canNOT have”).

Another term that deserves reflection is “Randomized.” A “randomized allocation” means that participants are assigned to the arms of a clinical trial by chance, but that never means that only one arm receives treatment: there are trials with two, or more, arms, and all of them may receive the experimental treatments (sometimes, they involve different medicines, or the same medicines at diverse doses, for example). Even in the possible case of a placebo, the participant would be receiving at least the standard of care treatment.

What are common misconceptions you hear from the patient community about enrolling in a clinical trial?

Maia

"Clinical trials are a last resort.”

“Proven treatments are better than unproven ones.” While the statement is true, clinical trials do not offer access to “unproven treatments” but to “treatments being proved.”

“You need to exhaust standard of care to be admitted in a clinical trial.”

Manju

“If standard of care treatments are working for you, you don’t need to think of trials yet.”

“You are treated as guinea pigs in trials.”

“You may get randomized to a placebo arm.”

“If you are on a trial it means you have no more options.”

Oftentimes, when clinical trial research is published - we hear terms like Overall Survival, Overall response rate, survival rate, and partial response. Can you describe what these terms mean, why they’re important for patients, and other words patients may hear?

Maia

All of these terms are “endpoints” in clinical trials, that is: outcomes, results of the clinical trial that can be measured, and that are/were goals or objectives since the design and start of the trial. Those goals might be survival, improvements in quality of life, relief of symptoms, disappearance/reduction of the tumor.

  • Overall Survival (OS) is the length of time from the start of treatment that patients diagnosed with the disease are still alive. It is the universally accepted measure of direct benefit.
  • Progression-Free Survival (PFS) is the length of time from the start of treatment until there are signs of new disease progression.
  • Objective response rate (ORR) refers to the percentage of patients whose disease decreased (Partial response –PR) and/or disappeared (Complete response –CR) after treatment.
  • Other important terms often included in the endpoints are:
  • Stable disease (SD) or No change (NC), used to indicate between a 30% reduction or <25% increase in the size of all detectable disease.
  • Progressive disease (PD) refers to patients or proportion of patients with a 25% or greater increase in size of disease since previous measurement.
  • Partial response (PR) is used when there is at least 30% reduction in size of all measurable disease.
  • Complete response (CR) means the disappearance of all clinical evidence of disease.

If a patient is interested in learning more about clinical trials, what resources do COLONTOWN  and Fight CRC provide?

Maia

The Fight CRC Clinical Trial Finder, Powered by Patients, serves patients and their caregivers with a curated list of potential clinical trials for “MSS” colorectal cancer, for them to subsequently discuss with their medical team. The tool is “version 2” of a spreadsheet begun by stage IV patient and scientist Dr. Tom Marsilje. Dr. Tom took his personal spreadsheet and made it public for all patients battling CRC.The database is curated to include only immunotherapy trials that accept MSS-CRC patients as well as Phase 2 or 3 trials (of any type of novel therapy) directed towards treating CRC.

Manju

The Tom’s Trials Clinical Trials neighborhoods in COLONTOWN are an excellent place to learn about clinical trials. All new members are added to our CRC101 group, where they learn some basic information about their cancer. All stage 4 patients are strongly recommended to join the main clinical trials groups, focused on MMR (MisMatch Repair) status or mutations.

In these groups, information about promising clinical trials is posted on a regular basis. Members routinely post questions about trials of interest to them, which admins, staff and other members answer. Trial participants (former and current) answer specific questions about logistics, their responses, key things to consider etc. 

We have recently started the Clinical Trials Learning center, that provides some basic information about clinical trials, in COLONTOWN University, which is the newest offering from Paltown Development Foundation, the non-profit that runs COLONTOWN.

You can learn more by going to: https://colontown.org/university.

The process of finding a clinical trial, and enrolling can be daunting. Fight CRC and COLONTOWN are committed to providing the resources and tools to help the patient community identify the best option to improve quality of life, and improve access to care. 

Stay Tuned for More!

Once a month, Maia and Manju will spend time unpacking important research trials, tips, and advice for our community. Be sure to subscribe to sign up with Fight CRC and join COLONTOWN’s online community to continue receiving the most relevant updates in the CRC world!

You can also follow Maia (@sassycell) and Manju (@manjuggm) to stay updated on research and trials and visit ClinicalTrials.gov for more information on trials.

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