Cancer Drug Intervention Study

A Cancer Drug Intervention Study is a clinical drug intervention study for a cancer drug.

• Context:
  • It can range from being a Small-Scale Cancer Drug Clinical Research Intervention Study to being a Large-Scale Cancer Drug Clinical Research Intervention Study.
  • It can range from being a Regional Cancer Drug Clinical Intervention Study (such as an India Cancer Drug Clinical Trial) to being a Global Cancer Drug Clinical Intervention Study.
  • It can range from being a Government-lead Cancer Drug Clinical Trial to being an Organizational-led Cancer Drug Clinical Trial, such as a Merck-led cancer drug clinical trial.
  • It can range from being a Centralized Cancer Drug Clinical Trial (with clinical research intervention site) to being a Decentralized Cancer Drug Clinical Trial (with direct to patient assessments).
  • It can range from being a Phase 1 Cancer Drug Clinical Study, to being a Phase 2 Cancer Drug Clinical Study to being a Phase 3 Cancer Drug Clinical Study to being a Phase 4 Cancer Drug Clinical Study.
  • …
• Example(s):
  • a Lung Cancer Clinical Trial.
  • a Keytruda Clinical Trial.
  • an Avastin Clinical Trial.
  • …
• See: Overall Survival (OS).

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References

2021

• https://www.frontiersin.org/articles/10.3389/fonc.2021.672916/full
  • QUOTE: ... In clinical trials that assess novel therapeutic agents in patients with non-small-cell lung cancer (NSCLC), overall survival (OS) is considered the gold-standard endpoint for establishing clinical benefit (1–3). ‘Early’ endpoints, such as progression-free survival (PFS) and objective response rate (ORR), ...

    ... Furthermore, high-quality real-world evidence (RWE) could be leveraged to enable drug approvals in oncology, linking it to the value proposition of drugs. Regulatory bodies, such as the US Food and Drug Administration, have recently shown a willingness to expedite access to new cancer medicines by using RWE ...

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