Clinical Trial Inclusion and Exclusion Criteria: How to Know if You May Qualify

Introduction

If you are exploring clinical trials, one of the first questions you may have is: could I qualify?  

At first glance, clinical trial eligibility criteria can seem technical or overwhelming. They often include details about diagnosis, disease stage, previous treatments, lab values, and sometimes genetic markers. Understanding what these criteria mean can help you identify which clinical trials may be worth exploring and what to discuss next with your doctor or care team. 

It is also completely normal to feel uncertain when reading about clinical trials. Many patients are interested in exploring options but may not know whether a trial could be a good fit, what participation may involve or whether it is the right step for them.  

In this guide, we explain what clinical trial inclusion and exclusion criteria are, why they matter, and how to know if you may qualify for a clinical trial. This guide is intended as a starting point and does not replace a conversation with your doctor or healthcare team about whether a specific trial may be right for you. 

What are clinical trial eligibility criteria?

Clinical trial eligibility criteria are the rules that help determine whether a clinical trial may be a good fit for you based on your diagnosis, medical history, and other factors. While these criteria can seem complex, you do not need to interpret them on your own. They are typically reviewed through a pre-screening and screening process to confirm whether a trial may be suitable. 

Eligibility criteria include: 

• Inclusion criteria: characteristics participants need to have. 

• Exclusion criteria: characteristics that may prevent participation.  

These criteria may include factors such as: 

• Type of diagnosis  

• Disease stage or severity 

• Age range 

• Certain medical conditions 

• Previous treatments 

• Biomarkers or genetic mutations 

For example, a cancer trial might only include patients with a specific tumor type or genetic mutation. 

Why do clinical trials have eligibility criteria?

Eligibility criteria are an essential part of clinical trial design. They serve several important purposes, including: 

• Patient safety: Eligibility criteria help reduce potential risks for people taking part. Some treatments may carry risks for certain patients, depending on their health conditions or medications.

For example, some treatments that affect the immune system may carry additional risks for patients with certain autoimmune diseases. By carefully selecting participants, researchers can reduce potential risks. 

• Clear scientific results: Eligibility criteria also help ensure that researchers can accurately evaluate whether a treatment works. Trials include individuals with similar medical characteristics – such as the same stage of disease – so that researchers can better determine whether a treatment really works. 

For instance, if a trial is studying a therapy designed to target a specific genetic mutation, it may only include patients who have that mutation. This helps researchers determine whether the treatment is effective for that group. 

• Regulatory and ethical standards: Clinical trials must follow strict scientific and ethical guidelines set by regulatory authorities and research institutions. Clearly defined eligibility criteria help ensure that clinical trials meet these standards and are conducted responsibly.

What eligibility criteria often include

When you read a clinical trial listing, you will often see criteria about: 

• Diagnosis and disease characteristics: Many trials require participants to have a specific diagnosis or subtype of disease. This may also include how advanced the disease is or having a certain genetic mutation. 

• Age and other personal characteristics: Some clinical trials focus on specific age groups, such as adults or children. A trial may also be limited to a specific sex or to people in a particular stage of life (e.g., postmenopausal women or those who are pregnant). 

• Previous treatments: Trials may limit the number or types of treatments participants have previously received. For example, some trials require that individuals have already tried certain therapies, while others may exclude people who have received specific drugs. 

• Lab values and other test results: Clinical trials may use lab results to understand whether a treatment may be safe for you and whether the trial is a good match. Depending on the clinical trial, this can include results related to blood cell counts, inflammation, hormone levels, infection status, or how well certain organs are working. 

• Other medical conditions: Certain health conditions may affect eligibility. They may increase the risk of side effects, interfere with the treatment or trial procedures, or make it harder for researchers to interpret the results clearly. 

• Other requirements: Some clinical trials may also include additional criteria, for example, related to recent surgery, current medications, or whether you are able to travel to the trial site.  

What eligibility criteria mean for you as a patient

Reading and understanding clinical trial eligibility criteria can feel overwhelming, especially when the information is detailed or uses medical terminology. 

It is important to know that you do not need to fully understand or interpret every criterion on your own. In some cases, patient navigators and/or healthcare professionals can help review your situation and explain whether a clinical trial may be worth exploring. 

In most cases, your role is simply to identify whether a clinical trial may be broadly relevant based on factors such as your diagnosis, general health situation, or treatment history. The full assessment is typically carried out through medical review by the clinical trial team at the clinical trial location. 

Final eligibility decisions are not made by patients themselves, but by investigators and healthcare professionals who review your complete medical information in detail. 

Understanding whether to explore a clinical trial is not always a straightforward decision. It often involves balancing potential benefits, practical considerations, and personal circumstances. Taking part in a clinical trial can require more time and coordination than expected, including visits, follow-ups, and communication with the trial team.  

How to read eligibility criteria in a clinical trial listing

If you want to get a general sense of whether a trial may be worth exploring, you can start by asking yourself a few simple questions. 

• Do I have the condition the clinical trial is looking for? Check the diagnosis, subtype, or stage of disease listed in the criteria. 

• Am I within the age range? Some clinical trials are only open to adults or only to children, or people within a specific age range. 

• Does my treatment history match what the trial requires? Some clinical trials require people to have tried certain treatments before, while others exclude people who have had specific medicines. 

• Are there any factors that may affect whether I can join? This could include other health conditions, recent procedures, or certain medications. 

• Do I seem to meet the main criteria  or is it still worth exploring further? Not all criteria can be assessed without medical review. 

• Is there anything in the trial listing that feels unclear or confusing to me? If so, you can write down your questions and doubts and ask your doctor, the trial team, or a patient navigator to help explain them. You can also consult our clinical trial glossary to understand common terms you may see while reviewing this information. 

Other factors to consider

Alongside the medical eligibility criteria, you may also want to think about a few practical considerations.  

Practical considerations can also include how often visits are required, and whether participation fits with your daily life, work, or caregiving responsibilities. These factors are not always part of the formal eligibility criteria, but they can still influence whether a clinical trial is a realistic option to explore. 

In some clinical trials, travel and participation support may be available. Depending on the trial and sponsor, this may include help arranging travel, lodging, meals, or local transportation. Some trials may use a travel concierge service or provide support in advance, such as a prepaid card or per diem for eligible expenses. In other cases, participants may need to submit expenses for reimbursement after travel. 

For international clinical trials, additional considerations may include cross-border travel, temporary relocation, and immigration requirements, such as obtaining a visa. Some related costs may be covered by the sponsor, while others may need to be paid out of pocket. 

Because support varies by clinical trial and location, it is important to ask what is covered, whether a caregiver or family member is included, and whether expenses are paid upfront or reimbursed later. 

If a clinical trial does not appear to be a fit or is not available, other pathways such as Expanded Access programs may sometimes be considered, depending on your situation and availability. 

Expanded Access, sometimes called compassionate use, is a way for patients with serious or life-threatening conditions to receive an investigational drug or treatment outside of a clinical trial when no other satisfactory treatment options are available and after the assessment by their doctor. 

What happens after you find a potentially relevant trial?

If a clinical trial appears to be a potential match, researchers need to confirm whether you meet the trial’s eligibility criteria. The next steps usually involve an initial review of your information (pre-screening), followed by a referral to a clinical trial location and a more detailed evaluation process (screening) to confirm eligibility.  

Confirming eligibility usually includes three steps: 

It is also important to keep your treating physician informed. They know your medical history, can help you understand whether a clinical trial may be worth discussing, and may support you as you consider your options. In some cases, they may also need to provide a referral, share relevant medical records, or confirm details about your diagnosis and treatment history. 

How myTomorrows can help you understand eligibility

Understanding clinical trial eligibility criteria can feel overwhelming, especially when they include complex medical terms, test requirements, and details about prior treatments.  

Support may be available to help you better understand what these criteria mean and whether a clinical trial may be worth exploring. At myTomorrows, patient navigators help review your situation, organize relevant medical information and identify clinical trials that may be aligned with your profile.  

The process typically follows a structured pathway 

• Identify relevant clinical trials based on your condition and medical history. 

• Pre-screening, where key eligibility criteria are reviewed at a high level. 

• Connection to a clinical trial location, where your information may be shared for further evaluation. 

• Screening at the trial location, where final eligibility is confirmed through medical assessment. 

This approach helps reduce uncertainty and ensures that both patients and clinical trial locations can focus on options that may be the most relevant. 

It is important to understand that myTomorrows does not decide whether a patient is eligible for a clinical trial and does not influence enrollment decisions. Final eligibility decisions are determined by the clinical trial investigators and doctors at the trial site. myTomorrows also does not provide medical advice or replace the role of your healthcare team. 

Key takeaways

Eligibility criteria can feel overwhelming at first, particularly if you are already dealing with a diagnosis or trying to compare different options. The good news is that you do not need to figure everything out on your own or understand every detail straight away. These are the main points to keep in mind as you review whether a clinical trial may be worth exploring. 

• Inclusion and exclusion criteria are the rules that help determine who may be able to join a clinical trial. 

• These criteria are designed to protect participants’ safety and help researchers understand whether a treatment works. 

• Common criteria may relate to diagnosis, age, previous treatments, lab results, other medical conditions, and practical requirements. 

• Reading the criteria can help you get a general sense ofwhether a clinical trial may be worth exploring, but it cannot confirm eligibility on its own. 

• Final eligibility is usually confirmed through medical review, pre-screening, and screening by the clinical trial team. 

• Practical factors such as travel, time commitment and possible reimbursement may influence participation. 

• If anything in the listing is unclear, your doctor, the trial team, or a patient navigator may be able to help you understand the next steps. 

• Even if you are unsure or do not meet all criteria at first glance, it may still be worth exploring further 

Frequently Asked Questions

Helpful resources

Getting started with clinical trials:   

• What is a Clinical Trial? How Clinical Trials Work  

• Clinical Trial Glossary: Key Terms and Definitions for Patients  

• Introducing clinical trials: phase 1–4 explained   

• Introducing clinical trials: How to find clinical trials for cancer   

• Introducing Clinical Trials: Safety Information to Consider   

• 10 Questions to Ask About Clinical Trials   

• Accessing Investigational New Drugs   

Clinical trials by disease   

• Glioblastoma Clinical Trial Eligibility: What Patients and Caregivers Should Know 
• Lung Cancer Treatment Options including Clinical Trials   

• Clinical Trials for Pancreatic Cancer   

Understanding expanded access and compassionate use   

• Understanding Expanded Access, Compassionate Use and Similar Terms   
• A Brief History of Expanded Access (Pt. 1) 1960 – 2009