Clinical Corner: A brief breakdown of clinical research terms in the THIS vs THAT format
Ana Sofia Correia
?? Medical Translator and Writer ?? Clinical Trial Ambassador ?? Helping you make treatments and information available to patients ?? Medical Translation Mentoring ?? Women in Localization PT Chapter Marketing Manager
Every Friday, I spotlight clinical research terms that came up during my work week in the THIS vs THAT format. If you've been following along, you'll recognize some of these. For those who haven't, this article serves as a comprehensive guide, compiling all of these breakdowns in one place.
An endpoint is a pre-defined event or measurement used to assess the effect of an intervention. Outcome refers to the health status resulting from healthcare or an intervention.
?? Think of endpoint as a specific goal or target in a study, like measuring blood pressure. Outcome is the broader result, like overall heart health.
Efficacy refers to the maximum ability of a medication to produce a result; it's about the medications's power to do what it's supposed to do, regardless of dosage. It's usually measured in clinical trials under controlled and ideal conditions. Effectiveness on the other hand, refers to how well the medication works in real-world scenarios. This includes everything from the medication's actual performance outside of a clinical trial to patient adherence to the medication regimen, its cost, and the way it is administered. Efficiency refers to the cost-effectiveness of the medication, that is, the ratio of the cost of the medication to the health benefits it provides. It's a broader measure that takes into account not just the medication's ability to produce the desired effect, but also the resources used to achieve this effect.
??Efficacy is like testing a car's speed on a smooth racetrack. Effectiveness is seeing how that car performs on regular roads with traffic and potholes. Efficiency is assessing not just the car's speed and performance, but also its fuel efficiency, maintenance costs, and overall cost-effectiveness.
Inclusion criteria are the characteristics that participants must have to be included in a study. Exclusion criteria are those that disqualify potential participants.
?? Inclusion criteria are like the "must-haves" on a job application, while exclusion criteria are the "deal-breakers."
Safety involves assessing the risks and adverse effects of an intervention. Tolerability refers to the degree to which these adverse effects can be tolerated by patients.
?? Safety asks "Can this harm you?", while tolerability asks "Even if there are side effects, can you handle them?"
In an observational study, researchers observe participants without providing any treatment. In an interventional study, participants receive specific interventions or treatments.
?? Observational is like watching animals in the wild. Interventional is like training animals to do specific tasks and seeing what happens.
Baseline is the starting point or initial set of measurements. Benchmark is a standard or point of reference against which things may be compared.
?? Baseline is your starting line in a race. Benchmark is the record time you're trying to beat.
Pharmacokinetics studies how the body interacts with a drug, including absorption and elimination. Pharmacodynamics studies how a drug affects the body, like its therapeutic effect.
?? Pharmacokinetics is the journey of a drug through the body. Pharmacodynamics is the impact the drug has once it's there.
Contraindication is a specific situation where a procedure or medication should not be used. Precaution indicates a condition or factor that may increase risks.
?? Contraindication is a red light, signaling "stop". Precaution is a yellow light, signaling "proceed with caution."
Preclinical research involves studies before testing on humans, often in labs or on animals. Clinical research involves studies on humans to test safety and effectiveness.
?? Preclinical is the behind-the-scenes lab work and animal tests. Clinical is when we test on humans to see if it's safe and works as intended.
A placebo is an inactive treatment, often used in trials for comparison. A control group may receive a standard treatment, no treatment, or a placebo.
?? A placebo is like a "sugar pill" with no real medicine. A control group helps researchers compare results by not getting the new treatment.
In open-label studies, both researchers and participants know the treatment being given. In blinded studies, one or both parties are unaware of the treatment.
?? Open-label is like knowing the ingredients of a mystery dish. Blinded is tasting the dish without any clues.
Compliance is the extent to which a patient's behavior matches prescribed medical advice. Adherence is the consistency and accuracy with which a patient follows the regimen.
?? Compliance is like following a recipe exactly once. Adherence is consistently making the dish the same way every time.
Prognosis is a prediction of the likely progression of a disease. Diagnosis is the identification and naming of a disease.
?? Prognosis is forecasting the weather for the week. Diagnosis is stating today's weather.
领英推荐
An orphan medicine is developed specifically for rare conditions. Off-label use is using a medicine for a purpose not officially approved by regulatory agencies.
?? Orphan medicines are like specialized tools for rare tasks. Off-label use is like using a butter knife to turn a screw—it's not its main purpose, but it can work.
In a single-arm study, all participants receive the same intervention. In a multi-arm study, participants are divided into groups receiving different interventions.
?? Single-arm is like everyone tasting the same dish. Multi-arm is like different groups trying different dishes to compare.
Bioavailability is the extent and rate a drug enters the bloodstream. Bioequivalence compares the bioavailability between two drugs to ensure similar effects.
?? Bioavailability is how much of a drug gets into your blood and how fast. Bioequivalence ensures two drugs act the same way in your body.
Relative risk compares the risk of a certain event in one group to another. Absolute risk is the chance of an event happening without comparison.
?? Relative risk is like saying a car is twice as fast as a bike. Absolute risk is saying a car can go 100 kmh.
Treatment-na?ve patients have never received treatment for a condition. Treatment-experienced patients have received treatment for a condition.
?? Treatment-na?ve is like never having tried sushi. Treatment-experienced is having sushi before and knowing your reaction to it.
Crossover is a type of study where participants receive multiple treatments in a specific order. Washout is the period in a study where participants receive no treatment to clear previous treatments from their system.
?? Crossover is like trying both chocolate and vanilla ice cream on separate days. Washout is like taking a break between flavors to cleanse your palate.
A prospective study follows participants over time to observe outcomes. A retrospective study analyzes past data to draw conclusions.
?? Prospective is like planting a tree and watching it grow. Retrospective is like studying the rings of a cut-down tree to learn its history.
In vitro experiments are done outside a living organism, often in a test tube. In vivo Experiments are done within a living organism.
?? In vitro is like testing a new recipe on a small dough sample. In vivo is like baking the whole bread and tasting it.
Sensitivity is the ability of a test to correctly identify those with a disease. Specificity is the ability to correctly identify those without the disease.
?? Sensitivity ensures we don't miss anyone with the disease. Specificity ensures we don't wrongly label healthy people as sick.
Primary endpoints are the main results used to evaluate a study's success. Secondary endpoints are additional results that provide more information but aren't the main focus.
?? Primary endpoint is the main goal in a game. Secondary endpoints are bonus achievements.
Brand-name products are marketed under a specific trademark. Generic products are equivalent to a brand-name but without the brand label.
?? Brand-name is like buying "Kellogg's." Generic is like buying store-brand cereal. Both taste similar, but one has a known brand.
An infectious disease is caused by pathogens, such as bacteria, viruses, parasites or fungi. A contagious disease is spread (communicated) by transmission of a pathogen through direct or indirect contact.
?? All contagious diseases are infectious, but not all infectious diseases are contagious. Think of it as squares and rectangles.
Symptom is a subjective evidence of disease perceived by the patient. Sign is an objective evidence of disease observable by others.
?? Feeling tired is a symptom. Having a fever is a sign. You feel the first, but others can measure the second.
????
Whether you've been following this series from the start or are just joining in now, I hope you find these breakdowns useful.
As always, I welcome feedback, insights, and the sharing of experiences from fellow professionals in the field.
Although I spotlight terms I have dealt with during my work, please don't hesitate to suggest terms where a THIS vs THAT might be useful!