How to read clinical trial listings
Whether you’re searching for a clinical trial through ClinicalTrials.gov or using a tool like Antidote Match, it can be really challenging to understand what a clinical trial listing means. Language used in clinical trials listings is often confusing and complex. Our Clinical Informatics Manager, Richard Towne, shares some of the key terms to look out for when reading a listing or study page. Use this advice to find trials that are the best fit for your needs.
Key phrases in a clinical trial listing or study page
Clinical trial listings offer everything you need to know about a given trial, but are usually bogged down in a lot of medical jargon. Here are a few important terms that you’ll want to know to get the most out of your clinical trial search:
Sponsor: A sponsor is whoever is funding the study. This can be a pharmaceutical company, a university, a government organization, and/or an individual researcher.
Disease/condition: The disease (or the condition) under study is whatever the clinical trial is aiming to research. This can be a broad disease state (something like heart disease) or something very specific (cancer with a certain mutation).
Treatment: The treatment (also known as an intervention) is what researchers are evaluating for safety and effectiveness. This can be a drug, a procedure, a medical device, or some other type of intervention.
Phase: The phase of the trial determines how far along a certain intervention is in research. The higher phase a study is, the closer the intervention under study is to FDA approval. In a phase 1 study, the safety and dosing of a drug are being looked at in a small group of healthy volunteers. In a phase 2 study, the effectiveness of the drug is looked at in a small group of people with the disease. In a phase 3 study, the drug’s effectiveness is compared to whatever the standard of care treatment is. Usually, after this stage a drug can receive FDA approval if it’s proven to be safe and effective. A phase 4 trial looks at the long-term safety of a drug after it has been approved by the FDA.
Study design: The study design is the details for how the study is going to be conducted. A study can be:
- Interventional: there is a study treatment
- Observational: patients are studied without receiving any treatment
- A registry: patients that meet certain criteria are added to a list
- Blinded: participants/researchers do not know who has been given what drug
- Open label: the participants are aware what they are taking
The study design also lists how many patients are estimated to be enrolled in the trial.
Eligibility criteria: The eligibility criteria show the requirements that must be met for a patient to join a clinical trial. The inclusion criteria is a set of criteria that a patient must meet ALL of in order to join the clinical trial, whereas the exclusion criteria is a list of criteria that a patient cannot meet ANY of if they want to join. Also important here is to note what ages and sexes of patients are being considered for the clinical trial — some trials might only be for children or for one sex of patient.
Contacts and locations: The contacts and the locations show the individual study sites and researchers that are helping to conduct the clinical trial – it is where participants are screened for eligibility into the study and where they will usually receive the study treatment. If someone is interested in a clinical trial, this section helps them to figure out who to contact if they are interested.
With an understanding of the key clinical trial listings definitions above, you should be equipped to find the right trial for you.