Abstract: a short summary of the study's purpose, methods, results, and conclusions

Accelerated Approval: an FDA program that allows a faster approval process for drugs that treat serious conditions and fill an unmet medical need; drug companies are still required to meet the same requirements as the non-accelerated approvals 2

Clinical Trial: a research study that is done to discover answer regarding specific health conditions or treatment options 1

Control: a group that serves as a comparison to the experimental group that is being investigated 1

Data: information that is collected during a study

Hypothesis: an idea that can be tested

Literature Review: an overview of published findings related to the topic of study; provides a background for the direction of future studies 4

Informed Consent: researchers are required to explain the experiment/clinical trial process and expectations clearly to the study participants; a patient understands that they have the ability to withdraw from the study at anytime 1

Institutional Review Board (IRB): a group of individuals, often doctors, scientists, community members etc., that review and monitor research that involves humans to ensure it is meeting ethical standards 1

Orphan Drug: a medication that is used to treat a rare disease

Patient Registry: an organized collection of data to collect information and track the prevalence of a specific disease to measure patient outcomes

Placebo: inactive substances such as medicine that is used to compare the experimental treatment to the control group 1

Prescription Drug User Fee Act (PDUFA):

Principal Investigator: the person responsible for overseeing the clinical trial, typically a physician or researcher 1

Randomization: participants are randomly assigned to their group to ensure the test results are unbiased 1

Reliability: a measure of if the results can be replicated when the experiment is repeated under similar conditions 3

Validity: a measure of if the results measure what the purposed measure was 3