The Effect of Biomarker Use on the Speed and Duration of Clinical Trials for Cancer Drugs

Luqmaan Mohamed, Siddhi Manjrekar, Derek P Ng, Alec Walsh, Gilberto Lopes, Jayson L Parker
Program News, Research
L Mohamed
S Manjrekar
Siddhi Manjrekar,
Class of 2021
L Mohamed
Luqmaan Mohamed,
Class of 2021

 

‘Having taken courses on pharmaceutical industry innovation – providing life-saving medication to patients as fast and equitably as possible, as well as the importance of having a competitive advantage, this sparked our interest in researching whether biomarkers have an impact on the speed and/or duration of clinical trials. This project was a large undertaking, screening over 8630 clinical trials across 4 indications to develop a novel visualization method to assess and compare the length and duration of trials by phases. This research provided us with many learnings to apply within our industry work and gain a deeper understanding of the complexities of the industry from research & development all the way to commercialization. Learnings from the MBiotech program and continuous support by the program and faculty (in particular Dr. Parker) allowed us to succeed in this research.’

The Oncologist, 2022, 27(10), 849-856
› 10.1093/oncolo/oyac130

Impact Factor: 5·8

Application relevance: The study showcased a novel visualization method to assess and compare whether biomarkers have an impact on the speed and duration of oncology clinical trials (across 4 indications). The novel visualization method revealed longer gaps between trial phases, later clinical trial start times, and shorter periods of concurrently run trials for drugs that used biomarkers. The study, therefore, highlights that biomarker-driven trials may impact drug approval timelines, and so these and other findings allow clinical researchers to carefully consider biomarker inclusion in their clinical development plans in oncology.

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