Clinical Trial Foundations

Explore the purpose, stakeholders, five phases, ethics committees and regulators like IRBs and FDA, and informed consent in India and the United States.

Learn the foundational steps to design a clinical trial, from defining objectives and eligibility to creating a study protocol, recruiting participants, collecting data, and applying statistical methods.

navigate site selection and patient recruitment, obtain informed consent, and manage data collection under approved protocols. monitor safety, report adverse events, and conduct study closeout with interim analyses.

Analyze clinical trial data through a ten-step process, selecting appropriate statistical methods, performing analyses, linking significance to outcomes, and preparing reports for regulatory authorities.

Analyze clinical trial data through statistical methods for two case studies: a hypertension drug trial using paired measurements and a vaccine trial using chi-square analysis, targeting efficacy and safety outcomes.

Explore the key challenges in clinical trials, including patient enrollment and retention, site selection, data privacy and integrity, endpoints and surrogate measures, ethical consent, and multi-center coordination.

Explore a phase three Crohn's disease trial evaluating Fexinidazole, an investigational antibiotic, using two-sided intention-to-treat analysis with 576 participants, showing 47% clinical remission at week 12 and p<0.001.

Examine a phase three AstraZeneca trial of tezepelumab, a monoclonal antibody targeting TSLP, for severe asthma, showing reduced exacerbations and FDA approval in March 2023.

Explore Eli Lilly’s phase 3 trial of baricitinib for moderate to severe plaque psoriasis, assessing efficacy and safety in 2119 participants with a PASI 75 at week 12.