Clinical Research
Screening, Enrolment & Randomisation: From Recruitment to Allocation
The participant journey through the CONSORT funnel — screening, eligibility, enrolment, the methods of randomisation, and allocation concealment vs blinding.
The participant journey through the CONSORT funnel — screening, eligibility, enrolment, the methods of randomisation, and allocation concealment vs blinding.
The trial’s blueprint — protocol contents, amendments, and the crucial difference between a protocol deviation and a violation.
Consent is a process, not a signature — its three components, the elements to disclose, documentation, and special situations (illiterate, vulnerable, children).
The foundation of the Clinical Research paper — trial phases (0–IV), the ethical milestones (Nuremberg, Helsinki, Belmont) and the ICH-GCP framework.
Trial designs by structure (parallel, crossover, factorial, cluster, adaptive) and by hypothesis (superiority, non-inferiority, equivalence).
Hit vs lead, methods of lead identification, what makes a good lead, lead validation and SAR-driven optimisation into a drug candidate.
The full pipeline — target ID, validation, hit, lead, optimisation, candidate, preclinical and the clinical phases — plus Lipinski’s Rule of Five.