NYU Langone Health

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

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.