Clinical research in oncology: in memory of Professor Gordon McVie

Area of Science:

• Oncology
• Clinical Pharmacology
• Drug Development

Background:

• Gordon McVie advocated for integrating scientific and clinical expertise in cancer research.
• Modern cancer clinical trials often target specific molecular pathways but retain outdated drug development paradigms.
• Anticancer drug development has seen minimal change from traditional chemotherapy models, characterized by a 'more is better' approach and inevitable toxicity.

Purpose of the Study:

• To highlight the persistent need for merging scientific and clinical expertise in cancer drug development.
• To identify common challenges that impede current anticancer drug development processes.
• To discuss issues in interpreting results from phase 3 randomized trials and personalized medicine trials.

Main Methods:

• Review of historical perspectives on cancer drug development.
• Analysis of current practices in molecularly targeted therapy trials.
• Examination of challenges in interpreting clinical trial outcomes.

Main Results:

• The fundamental approach to anticancer drug development has not significantly evolved from traditional chemotherapy.
• Current clinical trials face difficulties in interpreting results, particularly in phase 3 randomized and personalized medicine settings.
• There is a disconnect between targeting molecular pathways and optimizing drug development strategies.

Conclusions:

• Merging scientific and clinical expertise, including pharmacokinetic and pharmacodynamic studies, remains essential for effective cancer drug development.
• Current drug development paradigms require re-evaluation to address limitations in interpreting trial results and improving patient outcomes.
• Addressing these challenges is critical for advancing personalized medicine and optimizing cancer therapies.