Denied Potentially Life Saving Treatment, A 71-Year-Old Man Fought His Way Into A Clinical Trial Despite His Age. Now, He’s Back To Biking Around 3,000 Miles A Year

Establishing inclusion and exclusion criteria for study participants is standard for any high-quality research. Inclusion criteria can be defined as “the key features of the target population that the investigators will use to answer their research question.” Exclusion criteria can be defined as “features of the potential participants who meet the inclusion criteria but present with additional characteristics that could interfere with the success of the study or increase their risk for an unfavorable outcome.”

RELATED: Check Out The SurvivorNet Clinical Trial Finder

Thankfully, Rubin’s son-in-law happened to be a founder of Orca Bio the biotech company that engineered the cells for the stem cell transplants performed as the clinical trial. After asking the trial's principal investigator to treat his father-in-law and to consider lifting the trial's age limit so Rubin could enroll, Rubin got a way in. Very few people are this lucky, but the story is important because it demonstrates the limits of research and the frustrations many people encounter.

What Is a Blood Cancer How Is It Different?

It also helped that Rubin was extremely active. He played tennis regularly and often rode his mountain bike to work for a 12-mile round trip around the hills of San Francisco.

RELATED: Are You Looking For A Breakthrough Cancer Treatment Like The One Making Headlines Now? We Can Help You Find A Clinical Trial

Dr. Everett Meyer, Rubin’s transplant doctor at Stanford University, said Rubin’s age still made him think twice despite his overall health.

"You always worry about the unexplainable things," Dr. Meyer said. "You see elderly patients who after a transplant fail to thrive and you don't know exactly what is wrong."

Rubin’s family was worried, but they thought the trial was Rubin’s best hope.

"It was frightening to think that my dad might not make it out alive from the treatment alone, but that the harsh treatment was likely his only chance at long-term survival," Rubin’s daughter said.

Rubin underwent the transplant in April 2021 with his son-in-law by his side.

"I wanted to be there. He expected me to be there," the son-in-law said. "It is family."

Thankfully, Rubin’s transplant went well and he was able to start biking again just three months after the procedure. Looking back on 2022, he estimates he road around 3,000 miles with no plans to stop in the new year.

What Is A Clinical Trial?

Mikhail Rubin’s story is one of clinical trial success. But it begs the question for all cancer patients how do you know you're getting the best treatment option for your specific cancer? And when are clinical trials such as the one above the right move to make?

Well, for starters, let's taker a deeper look at what clinical trials actually are. Generally speaking, clinical trials are research studies that compare the most effective known treatment for a specific type or stage of cancer with a new approach.

Why I'd Choose A Clinical Trial For Myself

Clinical trials can be an option for people with cancer at many stages of their treatment journey. If you have an advanced disease or there's a drug that currently considered investigational but may work better than the current standard of care, your doctor may have spoken with you about possibly enrolling in a trial. Even still, you should always feel free to ask a medical professional about clinical trial options if you're curious.

Pros and Cons of Clinical Trials

All new drugs have to go through clinical trials before the The United States Food and Drug Administration will approve them, and these trials do give people special access to potentially life-saving treatments, though this is not always the case.

Clinical Trials Can Be Life-Saving For Some

Dr. Beth Karlan, a gynecologic oncologist with UCLA Health, previously told SurvivorNet that clinical trials can play an important role for some patients' treatment, but they also serve a larger purpose.

"Clinical trials hopefully can benefit you, but it's also providing very, very vital information to the whole scientific community about the effectiveness of these treatments," Dr. Karlan said. "We need everyone to be partners with us if we're ever going to truly cure cancer or prevent people from having to die from cancer."

That being said, there is no guarantee you'll receive more effective treatment than the standard of care, and clinical trials certainly aren't right for everyone. You should always talk with your doctor(s) before getting involved in one. Some risks to consider are:

• The risk of harm and/or side effects due to experimental treatments
• Researchers may be unaware of some potential side effects for experimental treatments
• The treatment may not work for you, even if it has worked for others

What Is Informed Consent?

Informed consent process for a clinical trial is when the research team presents you with both standard consent forms as well as any other relevant information you might need regarding treatments so you can properly decide whether you wish to take part in the trial or stay in one if you're already enrolled.

Before you enroll in a trial, you must be given the opportunity to read the consent documents fully and ask any questions you may have. The documents will likely contain the following:

• The purpose of the research
• Any risks and benefits expected from the research
• Information about procedures that may cause discomfort (like frequent blood tests)
• Any alternative procedures the patient might consider instead
• How the patient's information will be kept private
• How long the study is expected to take
• A form confirming you are participating in research voluntarily
• Whether any compensation or additional medical care is available if some sort of injury occurs
• The patient's rights (like the right to stop research in the middle of the trial)
• Contacts for any patient questions

Why Do People Get Excluded From Clinical Trials?

It's important to remember that participants are allowed to walk away from a trial at any given time. If researchers make new discoveries while you're participating, they may ask you to sign a new consent form or you may decide to no longer take part in the trial.

Overall, it's crucial you understand your rights as a voluntary patient and remember that the the treatment may not work before you sign on.

What If You're Not Eligible?

Trials have specific criteria that patients need to meet in order to take part, so there will always be certain factors for inclusion and exclusion.

But even if you're ineligible for a clinical trial you wish to partake in, you might still have options. The U.S. passed something called "Right to Try" legislation a few years ago which gives terminally ill people access to highly experimental drugs that are in "phase one" of the clinical trial process.

The 'Right to Try' Controversy: When Should People Be Given Experimental Drugs?

Your doctor may also request access to a single patient IND (investigational new drug) on your behalf, which can also give access to treatments the FDA has not yet approved.

SurvivorNet’s Clinical Trial Finder

Whether you've already decided that a clinical trial is right for you or you're just beginning to explore your treatment options, you should know that SurvivorNet has a new tool for you. Introducing the SurvivorNet Clinical Trial Finder: an A.I. driven tool for patients to find clinical trial options for treatment.

The tool, which launched earlier this month, is built on top of clinicaltrials.gov  a database maintained by the U.S. government that compiles privately and publicly funded clinical trials conducted around the world and gives access to more than 100,000+ individual clinical trials, updated daily.

To use the SurvivorNet Clinical Trial Finder, simply answer some basic questions using our custom-designed chat feature and we'll send customized clinical trial options within your region right to your email. In simplifying the search, we hope to offer multiple opportunities for clinical trial sponsors and clinical research organizations to engage with patients.

"Clinical trials are critical to the development of new therapies, and as we live through this extraordinary revolution in genomics, immunotherapy and targeted therapy, it's clear that one of the most pressing needs for patients, clinical trials sponsors, and researchers is simply a better way to find patients," SurvivorNet CEO Steve Alperin said. "Even one percent more people successfully enrolled in clinical trials can change the world."

Contributing: Laura Gesualdi-Gilmore

Learn more about SurvivorNet's rigorous medical review process.