What to Know Before Enrolling in a Clinical Trial

“We believe the best care for patients [with advanced or otherwise difficult-to-treat disease] is within the confines of a clinical trial. And the reason for that is that the quality of care is very good in clinical trials, and also, it allows patients access to and to be able to be part of the future of understanding how to help patients with interesting new compounds and new drugs that are out there,” Dr. Michael Jain, a medical oncologist at the Moffitt Cancer Center, previously told SurvivorNet.

“I think the best thing to do is speak to your oncologist about what clinical trials that they may have or what options may be there,” he explained.

The ABCs of Trial Design

There are many different types of cancer trials, yet they share common DNA: a structured plan (the protocol) reviewed by ethicists and enforced by law. Four phases mark a therapy’s evolution from first-in-human dosing to real-world use. The early phases test safety, the middle phases test whether the approach works, and the final phases compare it to the standard treatment currently in use.

Knowing a trial’s phase helps you set realistic expectations.

• Phase I trials primarily focus on determining the safety and dosage of a new treatment. While there’s a possibility of early benefit, the main goal is to understand how the drug affects the body and identify potential side effects.
• Phase III trials pits an almost-ready treatment against best current care

“Ideally, your doctor should be able to give you information about what he or she thinks is a good potential clinical trial option,” Dr. Leena Ghandi, a thoracic oncologist, previously told SurvivorNet. “But also could help you navigate options that you come in with.”

Weighing Potential Benefits Against Risks

While clinical trials can provide a lot of hope, there are many questions to consider before enrolling in one. There are important questions to discuss with your healthcare team — like how much time you’ll have to spend in a trial, what the potential benefits are, how you will be monitored, and more.

Zoom out and ask about the following beforehand:

• Potential benefits: Does preliminary data suggest longer survival, better response rates, or fewer side effects than what’s already on the market? Be sure to ask about the specific side effects observed in the trial so far, as they might differ from those of standard treatments.
• Care Expectations: How many extra appointments will you juggle? Will you need to travel to and from distant care centers — and how will this disrupt your life?
• The cost: While the experimental drug is almost always free, routine labs and scans may still hit your insurance deductible. Many centers have financial counselors who can estimate out-of-pocket costs before you commit.
• Other options: If the trial drug doesn’t work, can you quickly pivot to another therapy? A good oncologist always holds fallback options in reserve.

Putting those answers side by side on paper can help clarify whether the trial aligns with your life goals and tolerance for uncertainty.

Reading the Fine Print of Eligibility

Every trial uses inclusion and exclusion criteria, not to discriminate but to protect safety and ensure scientifically valid results. Common deal-breakers include impaired kidney function, specific heart conditions, or previous exposure to similar experimental drugs.

If you’re ruled out:

• Ask if criteria may loosen in a future protocol amendment; researchers sometimes broaden rules once early safety data look promising.
• Seek second opinions at different institutions. Another study may suit your exact medical profile.
• Revisit timing. A short course of standard therapy might correct a lab value that currently blocks enrollment.

Logistics: Turning ‘Yes’ into a Practicable Plan

Imagine agreeing to a trial in another city with twice-weekly visits—then discovering parking costs $40 a day and the hotel is always full. Real-life hurdles can derail good intentions, so it’s important to map them out before enrolling in a clinical trial.

Consider the following so you don’t run into logistical issues:

• Confirm ride-share vouchers, gas cards, or lodging stipends if travel exceeds 50 miles
• Arrange childcare or adult-caregiver backup for appointment days
• Ask your employer about intermittent FMLA or remote-work flexibility
• Store electronic copies of consent forms and medical records on a password-protected device for easy sharing between doctors

The Emotional Impact

You may feel entirely emotionally ready to take part in a clinical trial in the early stages, but that excitement can fade after friends and loved ones express concert about the treatment or after you have a particularly rough week of side-effects.

Feeling uncertainty is normal throughout the cancer treatment process, even for those not enrolled in clinical trials. If uncertainty lingers, consider a session with a psycho-oncologist, a specialist trained to help cancer patients weigh complex decisions.

They won’t push you toward or away from enrollment; their role is to help you find the choice that keeps you at peace when your head hits the pillow.

The Support Web You Didn’t Know Existed

For clinical trials, most major cancer centers offer an array of additional services to patients.

These might include:

• Navigation nurses who coordinate scans, lab draws, and insurance paperwork
• Social workers who locate grants covering travel, co-pays, or utility bills
• Dietitians to adjust meal plans if side effects affect your appetite
• Peer mentors, or survivors trained to share first-hand wisdom without sugar-coating reality

If your hospital doesn’t offer these outright, ask. Sometimes a service exists but the brochure never made it into your folder.

Your Legal Rights

Federal regulations require that every U.S. trial undergo continuous oversight.

You also have personal rights, including:

• Voluntary participation: You can leave whenever you wish
• Access to medical records: You may review lab values, imaging, and physician notes
• Care continuity: The study sponsor must arrange ongoing treatment for any significant harm directly caused by your participation in the trial
• Privacy protection: Data sent to external researchers is coded so your identity remains confidential

Understanding these safeguards converts vague trust into measurable confidence.

Making the Decision

After absorbing facts, logistics, and emotions, many patients experience a clarifying moment — sometimes in the shower, sometimes during a midnight doom-scroll — that reveals the answer they’d give if no one else were listening. Honor that instinct. Science thrives when volunteers enroll freely, not under pressure.

Whether you sign the consent form or decline, remember why trials exist: to turn today’s maybe into tomorrow’s standard of care. If you join, you stand on the frontier where possibility becomes proof.

Questions to Ask Your Doctor

• What are the potential benefits of this trial?
• Am I likely to be eligible?
• What sort of logistical planning should I do?
• What if I want to drop out?

Remember: whatever choice you make about enrolling, you remain an active, empowered participant in your own cancer journey.

Learn more about SurvivorNet's rigorous medical review process.

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