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
This is the total number of deaths that occur during the trial
Randomized and nonrandomized
A group of participants for which some intervention is indicated
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
Data collected at the beginning of the trial
The submission for which the investigator recalled the submission before the quality check.
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.
A sponsor or investigator can delay the publishing of the results for 2 years once he submits the certification.
A research study involving human volunteers. They can be either interventional studies or observational studies. Interventional studies are also known as a clinical trial.
The organization that provides support to the study other than the sponsor.
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.
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
The study in which the sponsor do no intervene, rather he just observes the outcomes
Clinicaltrials.gov glossary available from https://clinicaltrials.gov/ct2/about-studies/glossary