Adaptive Trial Design and Incorporation of Biomarkers to Maximize Achievable Objectives in Early Phase Clinical Studies

Life Sciences, Clinical Trials, Pharmaceutical, Drug Discovery & Development, Biomarkers,
  • Friday, October 13, 2017

Early phase clinical trials can be designed in such a way that multiple objectives are achieved within a single protocol, improving the overall efficiency of the drug development process and reducing the time necessary to reach late phase trials. Such early phase clinical trial designs combine food effect, PK/PD, drug-drug interaction, bioequivalence and bioavailability, age and gender studies, and ethnic populations. However, the desire to further expedite the development process has put pressure on drug developers to find ways in which to achieve even more objectives early on in the development cycle, particularly during early phase studies.  A host of strategies for increasing measurable clinical objectives were outlined in FDA’s Critical Path Initiatives (CPI, 2006); two of the most important are the employment of adaptive clinical trial designs and the use of biomarkers.

In this webinar, WCCT will discuss adaptive designs and focus on strategies for achieving additional objectives through the inclusion of biomarker evaluation in Phase 1/2 clinical trial design.  Adoption of biomarkers has been one of the most important initiatives in CPI. A validated pipeline of high quality sample preparation, and the use of cutting edge multiparameter analysis tools for simultaneous measurement of large numbers of potential biomarkers, maximizes the potential to identify populations who will experience maximum therapeutic efficacy in later study phases, and opens doors to providing personalized medicine. To demonstrate the use biomarkers in early clinical trials, WCCT will highlight the inclusion of immunological biomarkers for the development of new vaccine and oncological treatments.

While the inclusion of multiple objectives in one single trial offers clear benefits for decreasing development time, potential concerns around increasing chances of observing spurious signals frequently exist. WCCT will cover the relevant statistical issues that arise in this setting, and discuss strategies to ensure that valid statistical inferences can be drawn for each of the objectives.

In addition to discussing strategies for developing protocols which will achieve maximum objectives in early phase studies, WCCT will provide examples from recent development programs in which these strategies were implemented.


David R. McIlwain, PhD, Scientific and Medical Affairs Subject Matter Expert, WCCT Global

Dr. McIlwain serves as a scientific/medical affairs subject matter expert for WCCT Global, and has extensive experience in the design and execution of influenza challenge studies. Dr. McIlwain is also a fellow in Dr. Garry P. Nolan’s group in the Department of Microbiology and Immunology at Stanford University.

He trained for his Ph.D. at the University of Toronto, examining mouse biology using reverse genetics with renowned immunologist Dr. Tak W. Mak. His doctoral work yielded insights into alternative mRNA splicing in mammals, and an important discovery about a new factor controlling production of inflammatory mediator TNF. Dr. McIlwain later investigated host response to viral infection in the Department of Gastroenterology, Hepatology, and Infectious Disease at the University of Dusseldorf in Germany.

His current interests are to map systems-level human immune responses using an advanced single cell analysis tool called CyTOF. One focus of this work is characterizing longitudinal host immune responses during human H1N1 influenza challenge, having completed a major collaborative project between Stanford and WCCT Global. Through this work, Dr. McIlwain has established a robust CyTOF sample collection and analysis pipeline for use in current and future studies occurring at WCCT Global sites. Dr. McIlwain is currently leading a $3.7M research contract from the FDA to examine sequelae and immunopathology of Ebola virus infections in West and Central Africa applying the same tools established for influenza challenge studies at WCCT Global.

Message Presenter

Kalyan Ghosh, Vice President, Biostatistics, WCCT Global

Kalyan Ghosh, PhD, has over 20 years’ experience in biostatistics supporting clinical research, 17 of which were spent at Merck and Bristol-Myers Squibb Co., as well as 3 years in a CRO that he founded with the help of Merck Capital Ventures. He has also worked at INC Research, one of the major CROs, as Head of Statistical Consulting. Kalyan has been in charge of operational as well as strategic function of the biostatistics groups in both early and late stage trials. He has represented companies at multiple regulatory agencies – the FDA, EMA, PMDA, and the rest of the world. Kalyan has participated in a number of industry-wide groups (e.g. PhRMA) formulating opinion on statistical and drug development issues. He has served as a reviewer for multiple statistical journals, and is an expert statistical reviewer for The Lancet.

Message Presenter

Who Should Attend?

Senior executives working within:

  • Early Clinical Development
  • Clinical Operations
  • Clinical Outsourcing
  • Study Management
  • Vendor Management

The webinar will particularly benefit small to mid-size pharmaceutical and biotechnology companies, medical device manufacturers, and CROs.

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WCCT is a full-service early phase contract research organization (CRO) for the pharmaceutical, biotechnology and medical device industries. We are specialized regulatory and clinical development professionals who offer an innovative, agile and collaborative approach to every program we deliver.

Our Mission is to achieve our Sponsors’ Early Phase clinical objectives of advancing global health. This is accomplished through the development of a scientifically-informed time and budget-sensitive design; and with clinical trial research service execution that delivers high quality data, a superior client experience, and a volunteer-centric approach to care.

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