Has this ever happened to you: you read about a clinical trial and feel as if you need to have a medical degree to be able to understand it? You’re not alone! Having worked in the biopharma industry for more than 20 years, I’ve seen how bewildering medical jargon is for patients. Letting you in on a little secret, when I starting in th industry I relied on google to explain to me hat had been said in meetings and I still do it today, fortunately (for those I work with and come to me for guidance) less frequently.
A Guide to Clinical Trial Terms
Eligibility Criteria
Consider these to be the guest list for an extremely invitation-only party. Inclusion criteria are the criteria that get you in the door, and exclusion criteria are the criteria that keep you out. For example:
- Inclusion: Age 18 or older
- Exclusion: History of heart disease
Adverse Events
This is physician-speak for side effects. It can range from a mild headache to more severe reactions. Just remember, researchers monitor these closely to protect you.
Placebo and Control Groups
Ever heard of a sugar pill? That’s a placebo. Some subjects receive the real treatment, while others receive a lookalike with no active ingredients. This allows researchers to find out if the new treatment is indeed better than no treatment whatsoever.
Informed Consent
This is your ticket to know what you’re signing up for. It is a document that details all the nitty-gritty of the study. Please don’t hesitate to ask questions if something is unclear!
Clinical Trial Phases
Clinical trials are organised in stages:
- Phase 1: Is it safe?
- Phase 2: Does it work?
- Phase 3: Is it better than what we have now?
- Phase 4: Ho well are the wider patient population responding to the drug?
Navigating the Tricky Bits
It can be hard, though, to understand clinical trials, which can feel like trying to read a map in a foreign language. Here are some common hurdles:
- Complex Protocols: The rulebooks for the studies. They can be lengthy and detail-heavy; don’t panic – you’re not required to memorise them or even read them. You will be given a patient friendly documents, i.e. the patient information sheet.
- Descriptions of Side Effects: These can sometimes sound scarier than they are. Always ask your doctor what they mean in real-life terms.
- Eligibility Requirements: This can seem like an endless list of dos and don’ts. Just remember, it is not personal — it is a matter of matching the study with the right person.
What You Need to Know
You don’t have to do this by yourself. Some resources to help you become a pro at clinical trials:
- Glossaries: Often found on clinical trial websites. They’re kind of like mini-dictionaries for medical terms.
- Patient Advocacy Groups: These organisations often have excellent resources at their disposal and can put you in touch with others who have gone through trials.
- Educational Videos: In some cases, seeing is believing. Search for visual descriptions of trial processes or look for any form of media that helps you in your decision about taking part.
- Interactive Websites: Some websites allow you to explore clinical trial concepts at your own pace.
Speaking the Same Language
Remember — your research team supports you. Here are some strategies for communicating clearly:
- Ask questions, do not hesitate to ask. There are no silly questions when it comes to your health.
- Request explanations in plain English. If something is not clear, say that.
- If English is not your first language, ask that information be in your native tongue.
Wrapping Up
Understanding the terminology of clinical trials may feel intimidating, but with these tools and tips, you are on your way to ‘clinical trial-ese’ fluency. Knowledge is power, and this is especially true with respect to your health and possible treatment options.
Simply familiarising yourself with these terms and concepts is a significant step in your health journey. Whether you’re thinking about joining a clinical trial or simply want to understand the research better, this knowledge helps you make informed choices about your health. So the next time you see an abstract (summary) of a clinical trial, you will be able to interpret it like a champ!