Understanding eligibility criteria for clinical research studies

When researching clinical trials for cancer, it is helpful to have an understanding of the types of information that is needed to determine whether someone is a fit or not. This information is called eligibility criteria and is typically made up of different types of data points and acceptable ranges. While some trials utilize criteria that are fairly straightforward, cancer study criteria tend to be a bit more comprehensive and complex.

Eligibility criteria for a given trial are set by the entity sponsoring the trial, which could be drug manufacturer or medical university. Criteria are based on the specifics of what the trial and its physician investigators are evaluating (called an end-point or an outcome measure). Inclusion criteria reflect attributes that a potential participant must match to; exclusion criteria are the opposite and reflect attributes a potential participant should lack in terms of medical history.

When reading a trial overview related to a cancer, eligibility criteria will likely start out with straightforward requirements such as age, gender and possible weight requirements. The primary diagnosis will also be noted. Sometimes this is very specific to specific cancer subtypes. For example, a breast cancer patient interested in clinical research may search for the condition broadly and find trials requiring a diagnosis of HER2+ or triple negative breast cancer. It will be helpful to have biomarker information when undertaking trial searches. Biomarkers include proteins or genes that can be found in tumors and may offer specific treatment options in the realm of clinical research.

Other inclusion criteria will reference additional and unique factors related to the type of cancer (i.e., any metastases, prognosis) as well as the general overall health status of the patient.

For a patient that has had previous cancer treatment or has additional medical issues, a close review of exclusion criteria is important. These are factors that prevent someone from entering a trial, most likely due to safety concerns. Since trials are essentially trying to evaluate the effectiveness of a therapy, it is important that participants fit the same profile. This helps with drawing conclusions and extrapolating to larger populations.

Exclusion criteria related to cancer trials may be a long list and will likely include items around:

- Timeframe and type of previous cancer treatment
- Presence of uncontrolled chronic illness
- History of surgeries
- Pregnancy and lactation status
- Any consistently out-of-range lab test results

It can be emotionally tiring to spend time researching trials only to find that there are no good matches based on eligibility criteria. However, cancer trials do open on a regular basis, each with their own unique criteria. Over time a patient's "fit" to criteria may evolve as well. For a person interested in clinical research as a care option, registering for access to medical records through a patient portal can make it easier to review data and latest results, trends and clinical notes.

Interested in learning more about clinical research options for different cancer types? Take a look at trials that are currently seeking participants by clicking here.