Our Industry Voices series showcases our clients’ innovative work and breakthrough therapeutics in oncologic indications and other critical areas of medical unmet need.

In this article, we sit down with Charles Theuer, M.D., CEO of TRACON Pharmaceuticals to discusshis work, his views on the key advancements in oncology development, the unmet needs yet to be overcome, and the importance of...

Topics: biostatistics, Oncology, Phase 1, Phase 3, Clinical Development Strategy, Adaptive Clinical Trials

 

Our Industry Voices series showcases our clients’ innovative work and breakthrough therapeutics in oncologic indications and other critical areas of medical unmet need.

In this article, we are delighted to share an interview with Kurt Gunter, M.D., Chief Medical Officer of Cell Medica in which he discusses his work, his views on the key advancements in oncology development, the unmet needs...

Topics: biostatistics, Oncology, Phase 1, Phase 3, Clinical Development Strategy, Adaptive Clinical Trials

As we prepare to head to ASCO in under a month's time, we are pleased to share a new ebook that showcases some key applications of innovative trial designs in the oncology development space.

Topics: biostatistics, Oncology, Phase 1, Phase 3, Clinical Development Strategy, Adaptive Clinical Trials

 

Last month was the eighth American Conference on Pharmacometrics (ACoP8) in Florida, a key event on the calendar for Cytel’s Quantitative Pharmacology and Pharmacometrics subject matter experts.

Cytel was delighted to contribute to the event this year and present two posters. This was excellent opportunity to share our knowledge and innovative research, alongside networking with likeminded...

Topics: Clinical Data, pharmacometrics, pharmacology, Clinical Research Services, model-informed-drug-development, clinical development, Phase 1

As a  biometrics -focused CRO, Cytel regularly works across a program of studies, providing data consistency, and helping to minimize the oversight burden for the sponsor. In this case study, we describe our work with a client on two Phase 1 studies, and how we were able to carry a number of important efficiencies from the first study to the second.  

Topics: biostatistics, Phase 1, outsourcing, Clinical Research Services, Statistical Programming, medical writing, clinical data management, Clinical Data

Sadly, clinical development of anti-cancer therapeutics faces particularly high rates of failure, even in the context of low success in drug development as a whole. Operating costs for oncology trials are also higher than those observed across the spectrum of clinical development.  In a recent article produced for the Pink Sheet ( a leading provider of  insights and analysis for biopharma...

Topics: biostatistics, Oncology, Phase 1, Phase 3, Clinical Development Strategy, Adaptive Clinical Trials

 At ASCO 2017, Cytel trial design experts joined our medical and academic colleagues to share the most recent innovations in cancer research.In this blog we will share the abstract and pdf of the poster presentation: TAPPAS: Adaptive enrichment phase 3 trial of TRC105 and pazopanib versus pazopanib alone in patients with advanced angiosarcoma (AAS), co-authored by Cytel's Cyrus Mehta and...

Topics: biostatistics, Oncology, Phase 1, Phase 3, Clinical Research Services, Clinical Development Strategy, Adaptive Clinical Trials

 

 

 In this blog, Adam Hamm, PhD, Director Biostatistics at Cytel shares some of the most important knowledge he uses in  his day to day work as a biostatistician working extensively in oncology research. Adam has broad experience with statistical analysis and methodology over all phases (I-IV) of development, in particular working in the oncology arena. 

 As a Director of Biostatistics at...

Topics: Oncology, Dose-Escalation, Dose-Finding, biostatistics, adaptive trials, Interim Analyses, Phase 1, phase 2, Phase 3, Early Phase Trials

Single ascending dose (SAD) and multiple ascending dose (MAD) studies are typically the first in human studies.  They seek to gain information on safety and tolerability, general pharmacokinetic (PK) and pharmacodynamic ( PD)  characteristics, and of course identify the maximum tolerated dose (MTD).

Conventionally, SAD  and MAD studies were conducted separately, but increasingly are combined...

Topics: biostatistics, adaptive trials, adaptive designs, Cytel Strategic Consulting, Cytel Consulting, Statistical Programming, Compass, Dose-Finding, Phase 1, Phase I

In this blog we’ll highlight some unique challenges that are encountered from a Data Management perspective when working on early phase Oncology trials. We’ll also discuss approaches which can be employed to mitigate these issues.  

Topics: Oncology, Data Management, Clinical Research Services, Phase 1, Clinical Data, phase 2, EDC, database build, data manager, CDM, Biometrics

FDA draft guidance on “Co development of two or more unmarketed investigational drugs for use in combination”  notes that:

“Combination therapy is an important treatment modality in many disease settings, including cancer, cardio-vascular disease, and infectious diseases. Recent scientific advances have increased our understanding of the pathophysiological processes that underlie these and...

Topics: Oncology, Phase 1, Early Phase Trials, Adaptive Clinical Trials, BLRM, Bayesian, PIPE

 

 Francois Beckers, Global Head of Biostatistics & Epidemiology at Merck KGaA joined us at the East User Group Meeting in March and presented case studies of Merck KGaA’s experiences with Blinded Sample Size Re-estimation in early phase studies, more specifically in the context of biosimilar studies.

 

Topics: sample size re-estimation, Cytel Consulting, Cytel Videos, Phase 1, Early Phase Trials

 

 

Cost of pharmaceutical development and R&D productivity is an ongoing industry concern, consistently discussed in the mainstream and specialist press.  The issue is held in delicate balance against the increasing pressure on pharmaceutical pricing and cost containment measures.

A study by Tufts Center for the Study of Drug Development published earlier this year in the Journal of Health...

Topics: Phase 1, Program and Portfolio Optimization, Phase 3, phase 2, go-no-go, clinical development

On March 16th and 17th the 5th East User Group Meeting took place in London.  This very successful 2 days saw a variety of talks on aspects of clinical trial design innovation.  Over the next couple of weeks, we will be reviewing some of the key topics which were addressed during the meeting.

In this post, we'll take a look at Paul Frewer of Astrazeneca's presentation on Decision Making in...

Topics: Bayesian Methods, Cytel Consulting, Cytel Videos, Phase 1, Early Phase Trials, phase 2

Topics: Data Management, Clinical Research Services, Regulation, Phase 1

Seamless adaptive clinical trials have gained popularity for reducing the projected time it takes to complete the process of drug development.  However, a study by Cuffe et al., shows that despite a tremendous amount of statistical knowledge about seamless trials, sponsors remain unsure about how to calculate the financial and operational costs of a seamless clinical development program [1]....

Topics: Phase 1, Early Phase Trials, Clinical Development Strategy, Phase 3, Adaptive Clinical Trials, phase 2

Topics: Dose-Escalation, Bayesian Methods, Phase 1, Early Phase Trials

 

 

Use of the continual reassessment method (CRM) is safe, efficient, and flexible, according to a comprehensive review of 53 published Phase I trials from 2003-2013. The review, just published in the Journal of Clinical Oncology by leading researchers Iasonas and O'Quigley, challenges common misconceptions about model-based dose escalation designs.

Topics: Dose-Escalation, CRM, Phase 1