Cancer and Drug Development Terms

A

Accelerated Approval

Advisory Committees

Appropriations

B

Biologics

Biologics License Applications (BLAs)

Biomarkers

Breakthrough Therapy

C

Cancer

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

Control Arm

 

D

Diagnostic Assays

Digital Pathology

Disease Free Survival – Defined under Clinical Trial Endpoints

Drug Approval Process

Drug Safety – Defined under Clinical Benefit

E

Expedited Programs

• Accelerated Approval
• Breakthrough Therapy
• Fast Track
• Priority Review
• Regenerative Medicine Advanced Therapy (RMAT) Designation

Eligibility Criteria

F

Fast Track

Food and Drug Administration (FDA)

First-line Therapy

Five-year Survival Rate

G

Generic Drugs

Genetic Medicine – Defined under Biomarkers

H

Hybrid Pragmatic Trials – Defined under Pragmatic Trials

I

Immunotherapy

Intended Use Population

Investigational New Drug Application (IND)

L

Label

M

Market Exclusivity – Defined under Generic Drugs

Master Protocol – Defined under Clinical Trials

Metastases

N

National Cancer Institute (NCI) – Defined under National Institutes of Health (NIH)

National Institutes of Health (NIH)

New Drug Applications (NDAs) – Defined under Biologics License Applications (BLAs)

Next Generation Sequencing (NGS)

O

Oncology Center of Excellence (OCE)

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

Orphan Drugs

Overall Survival – Defined under Clinical Trial Endpoints

P

Patient Advocacy

Patient Reported Outcomes (PRO)

Patient Focused Drug Development

Pragmatic Trials

Prescription Drug User Fee Amendments (PDUFA) & User Fees

Personalized Medicine – Defined under Biomarkers

Pivotal Trial

Post-Market Clinical Trials

Priority Review

Q

Quality of Life (QoL) – Defined under Clinical Trial Endpoints

R

Randomized Clinical Trials – Defined under Control Arm

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

RECIST Criteria

Response Rate – Defined under Clinical Trial Endpoints

Regenerative Medicine Advanced Therapy Designation (RMAT)

S

Single-Arm Clinical Trials – Defined under Control Arm

Standard of Care – Defined under First-line Therapy

Surrogate Endpoints – Defined under Clinical Trial Endpoints

T

Targeted Therapies – Defined under Biomarkers

Toxicity (Tolerability & Dosing)

U

Unmet Medical Need