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Pharmacy Tutorials: ClinicalTrials.gov

Clinicaltrails.gov is an important website for clinical trial search. Some of the important terms used in the website are:


Accepts healthy volunteers:

This is one of the eligibility criteria where the study recruits the patients who are not diagnosed with the disease/condition which is under study


Active comparator arm:

The patient arm for which treatment which is considered to active by physicians is indicate


Age groups in clinicaltrials.gov:

Child: 0-17 years

Adult: 18-65 years

Older adults: >65 years


All-cause mortality:

This is the total number of deaths that occur during the trial


Allocation types:

Randomized and nonrandomized


Arm:

A group of participants for which some intervention is indicated


Arm types:

Experimental Arm

Active comparator arm

Placebo comparator arm

Sham comparator arm: Arm in which device/procedure id indicated which appears as device/procedure under study however the device/procedure lacks the active process/components

No intervention arms


Baseline characteristics:

Data collected at the beginning of the trial


Canceled submission:

The submission for which the investigator recalled the submission before the quality check.


Certain agreement:

This is the agreement between the principal investigator (PI) and sponsor. By this agreement, the principal investigator cannot publish the data after the study is completed.


Certification:

A sponsor or investigator can delay the publishing of the results for 2 years once he submits the certification.


Clinical study:

A research study involving human volunteers. They can be either interventional studies or observational studies. Interventional studies are also known as a clinical trial.


Collaborator:

The organization that provides support to the study other than the sponsor.


Cross-over assignment:

Intervention model in which patients receive two or more drugs. For eg two-by-two cross over is where one group takes drug A and then takes drug B, whereas the other group takes the drug B first followed by drug A.


Exclusion criteria:

The criteria considering which the patients are excluded from the trial.


Human subjects protein review board:

The group that monitors the clinical trial. The board is responsible for the rights and welfare of the patients


Observation study:

The study in which the sponsor do no intervene, rather he just observes the outcomes


Source:

Clinicaltrials.gov glossary available from https://clinicaltrials.gov/ct2/about-studies/glossary

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