Cancer Clinical Trials: Basics, Timeline, Safety, Risks/Benefits & Myths (Part 1)

Why It Matters

Understanding trial phases, risks, and ethical safeguards empowers patients to make informed decisions and accelerates the development of life‑saving therapies.

Key Takeaways

• Clinical trials span prevention, screening, diagnostics, treatment, and quality‑of‑life.
• Phase 1 focuses on safety; Phase 2 on efficacy; Phase 3 on comparison.
• Only 10‑14% of Phase 1 drugs achieve FDA approval.
• IRBs and Belmont Report ensure ethical oversight and patient protection.
• Participation offers early access to therapies and contributes to medical advancement.

Summary

In this introductory session, Gabrielle Gargano and Cassel Mangalinden walk viewers through the fundamentals of clinical research, emphasizing its relevance across oncology and broader therapeutic areas. They outline the spectrum of trial categories—prevention, screening, diagnostic, treatment, and quality‑of‑life—highlighting that many studies blend multiple goals to assess both efficacy and patient well‑being. The presenters break down the FDA‑mandated development pipeline: a six‑year preclinical stage followed by Phase 1 (20‑80 participants, safety focus), Phase 2 (100‑300 participants, efficacy focus), and Phase 3 (500‑3,000+ participants, comparative effectiveness). Notably, roughly 70% of candidates clear Phase 1, only about 30% survive Phase 2, and a mere 10‑14% of all Phase 1 entrants ultimately receive market approval, underscoring the rigor of the process. Throughout, they debunk myths—clinical trials are not last‑ditch options and participants are not “guinea pigs”—and cite historical abuses that shaped today’s ethical safeguards. The Belmont Report’s principles of respect, beneficence, and justice, together with Institutional Review Boards, now govern trial design, ensuring patient safety and informed consent. For patients and communities, the talk stresses that trial enrollment can provide early access to cutting‑edge therapies, superior monitoring, and the chance to advance science. Expanding trial sites, such as the new Brooklyn satellite, aims to broaden participation, improve health equity, and accelerate the pipeline of innovative treatments.

Original Description

Clinical trials offer access to cutting-edge cancer treatments, but understanding how they work, eligibility criteria, and their potential benefits and risks can feel overwhelming. Join Perlmutter Cancer Center (PCC) experts for a two-part webinar series designed to help you understand the clinical trial process, separate myths from facts, discover it's impact, and hear answers to real questions from patients and caregivers.

In part 1, you'll learn about trial phases, safety and ethics, potential risks and benefits, common myths, and why participation matters.

Outline:

00:00 Opening Remarks

02:03 What is a Clinical Trial?

06:01 Phases of a Clinical Trial

14:18 Safety & Ethics

17:37 Risks vs. Benefits

21:44 Patient Enrollment to Trial Timeline

26:53 Why Clinical Trial Participation is Important

28:31 Clinical Trial Participant - Denise

32:10 Audience Questions & Answers

View slides: https://image.e.nyulangone.org/lib/fe3611717164067e731573/m/1/6f1acda5-415b-46c7-b084-6da9897d1986.pdf

Watch the entire Cancer Clinical Trials Series:

Part 1: https://youtu.be/PR342rdBa9E

Part 2: https://youtu.be/Bt3CIgmbSpE

Learn more about PCC’s Clinical Trials and Research Studies: https://clinicaltrials.med.nyu.edu/cancer/

Learn more about Perlmutter Cancer Center’s Clinical Trials Office: https://med.nyu.edu/departments-institutes/perlmutter-cancer-center/cancer-research/cancer-clinical-trials-office

Learn more about NYU Langone’s Clinical Research Studies: https://clinicaltrials.med.nyu.edu/

*** If you need assistance finding a study at PCC or if you have any questions, email:

[e-mail]

Other Resources:

Office of Science & Research

https://med.nyu.edu/research/office-science-research/

Human Research Protections

https://med.nyu.edu/research/office-science-research/clinical-research/resources-researchers-study-teams/human-research-protections

Clinical Research Studies- NYU

https://clinicaltrials.med.nyu.edu/

Belmont Report

https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html

CISCRP

https://www.ciscrp.org/education-center

NIH Clinical Trials: https://clinicaltrials.gov/

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