Reach Us +44-1522-440391
Biomarker-Based Clinical Trial Designs in Oncology | OMICS International
ISSN: 2155-6180
Journal of Biometrics & Biostatistics

Like us on:

Make the best use of Scientific Research and information from our 700+ peer reviewed, Open Access Journals that operates with the help of 50,000+ Editorial Board Members and esteemed reviewers and 1000+ Scientific associations in Medical, Clinical, Pharmaceutical, Engineering, Technology and Management Fields.
Meet Inspiring Speakers and Experts at our 3000+ Global Conferenceseries Events with over 600+ Conferences, 1200+ Symposiums and 1200+ Workshops on Medical, Pharma, Engineering, Science, Technology and Business
All submissions of the EM system will be redirected to Online Manuscript Submission System. Authors are requested to submit articles directly to Online Manuscript Submission System of respective journal.

Biomarker-Based Clinical Trial Designs in Oncology

Jianchang Lin*

Takeda Pharmaceutical Company Limited, Cambridge, MA, USA

*Corresponding Author:
Jianchang Lin
Takeda Pharmaceutical Company Limited
Cambridge, MA, USA
Tel: +1-617-679-7000
E-mail: [email protected]

Received Date: April 7, 2016; Accepted Date: April 8, 2016; Published Date: April 15, 2016

Citation:Lin J (2016) Biomarker-Based Clinical Trial Designs in Oncology. J Biom Biostat 7: 296. doi:10.4172/2155-6180.1000296

Copyright: © 2016 Lin J. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Visit for more related articles at Journal of Biometrics & Biostatistics


In the precision medicine era, especially in the oncology area, there have been explosions in knowledge of the molecular profile of disease. With cost for the genomic sequencing are also decreasing and becoming more affordable, a large number of tumors are now be able to be classified from molecular biology perspective, with different treatment options and tailored strategies for patients based on their tumor biomarker status. Under the drug development setting, there are new generation trials emerged and targeted to patients selection within any given tumor type based on specific underlying molecular and biologic characteristics. In the early phase drug development of targeted therapies, ‘Basket trials’ usually are focused only on specific molecular aberrations, in several tumor types (Figure 1). On the other hand, ‘Umbrella trials’ focus on drug development targeting several molecular subtypes in one tumor type (Figure 2). These innovative approaches to clinical drug development have resulted in rapidly revolutionized methodologies, including adaptive randomization [1], to conduct clinical trials in the setting of biomarkers and targeted therapies, where the traditional paradigm of treating very large number of unselected patients is increasingly less efficient, lack of cost effectiveness and ethically challenging.


Figure 1: Basket trial and example [2].


Figure 2: Umbrella trial and example [2].

In the past few years, there have been a variety of thoughtprovoking next generation biomarker-based clinical trials conducted multi-institutionally in oncology: specific recognized examples include I-SPY2, BATTLE, NCI MATCH, LUNG-MAP, ALCHEMIST and FOCUS4. Changing the traditional clinical trial design paradigms, biostatisticians are fully integrated in these clinical trials partnering with clinicians, and make critical contribution for advancing therapeutic development in this era of molecular medicine. Meanwhile, the new development of immunotherapeutic agents and implementation of next-generation sequencing (NGS) also brings many new and exciting opportunities in the biomarker driven trials design. From clinical trial operational perspective, they are some logistical challenges to implementing these innovative designs, e.g. central assay testing, drug supply, multiple institutional collaboration, real time data collection and integrations. However, these additional efforts are all worthwhile given the substantial improvement of efficient medicine development, and most importantly, the benefit of the patients.


Select your language of interest to view the total content in your interested language
Post your comment

Share This Article

Relevant Topics

Article Usage

  • Total views: 8687
  • [From(publication date):
    April-2016 - Aug 17, 2019]
  • Breakdown by view type
  • HTML page views : 8588
  • PDF downloads : 99