Cancer and Drug Development Terms

Some terms in this glossary are defined according to FDA and NIH standards, ensuring accuracy and alignment with these trusted sources.

A

Accelerated Approval

Advisory Committees

B

Biologics License Applications (BLAs)

Breakthrough Therapy

C

Cell & Gene Therapies

Center for Biologics Evaluation and Research (CBER)

Center for Devices and Radiological Health (CDRH)

Center for Drugs Evaluation and Research (CDER)

Circulating Tumor DNA (ctDNA)

Clinical Benefit

Clinical Trials

Clinical Trials Diversity

Clinical Trial Endpoints

Comparative Effectiveness

Computational Pathology

D

Diagnostic Assays

Digital Pathology

Disease Free Survival – Defined under Clinical Trial Endpoints

Drug Approval Process

E

Expedited Programs

Eligibility Criteria

F

Food and Drug Administration (FDA)

First-line Therapy

Five-year Survival Rate

G

Genetic Medicine

H

Hybrid Pragmatic Trials – Defined Under Pragmatic Trials

I

Intended Use Population

Investigational New Drug Application (IND)

L

M

Market Exclusivity

Master Protocol

N

National Cancer Institute (NCI)

National Institutes of Health (NIH)

New Drug Applications (NDAs)

Next Generation Sequencing (NGS)

O

Oncology Center of Excellence (OCE)

Oncologic Drugs Advisory Committee (ODAC) – Defined under Advisory Committees

Overall Survival

P

Patient Advocacy

Patient Reported Outcomes (PRO)

Patient Focused Drug Development

Pragmatic Trials

Prescription Drug User Fee Amendments (PDUFA) & User Fees

Personalized Medicine

Post-Market Clinical Trials

Priority Review

Q

Quality of Life (QoL)

R

Randomized Clinical Trials

Real-World Data (RWD) & Real-world Evidence (RWE)

RECIST Criteria

Regenerative Medicine Advanced Therapy Designation (RMAT)

S

Single-Arm Clinical Trials

Standard of Care

Surrogate Endpoints

T

Targeted Therapies

Toxicity (Tolerability & Dosing)

U

Unmet Medical Need