We are excited to announce an upcoming webinar in our Trial Innovations Series. “Basket Trials: Design and Implementation Considerations” on 4th December 2018 at 11am EST. Noted basket trial expert, Robert (Bob) Beckman will share his most recent experiences with Cytel Strategic Consulting Statistician Sam Hsiao on expanding the application of this innovative breed of trials. Bob acts as a...

Topics: Oncology, basket trials, webinar

Cytel biostatisticians Cyrus Mehta and Lingyun Liu, together with Charles Theuer, CEO of TRACON Pharmaceuticals have recently co-authored a publication in the journal Annals of Oncology: “ An Adaptive Population Enrichment Phase 3 Trial of TRC105 and Pazopanib Versus Pazopanib Alone in Patients with Advanced Angiosarcoma (TAPPAS Trial)”. The paper explores the features of this innovative...

Topics: clinical research, clinical trials, Oncology, Precision Medicine, adaptive trials, adaptive designs, adaptive sample size re-estimation, population enrichment

 

Immunotherapy has brought us many promises, most notably, of a future where humans are able to harness their body’s own ability to protect them from illness. Immuno-oncology (IO) may be the ultimate frontier of that future reality, with a promise of being able to help our bodies deflect or cure us of any malignancies. Today, these therapies include cell therapies, cancer vaccine, and...

Topics: Oncology, immunotherapy, biostatistics

 

On August 29th 2018, the FDA announced (1) that it would be establishing a Complex Innovative Trial Design (CID) Pilot Meeting Program. This follows the release earlier in August of a draft guidance (2) to help advance effective and innovative clinical trial designs early in drug development that can expedite new cancer therapies.

Topics: biostatistics, adaptive trials, adaptive sample size re-estimation, Seamless designs, FDA, Oncology

 

 

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

Data management is an essential building block for successful Immuno-Oncology (I-O) trials. At the Immuno-Oncology Clinical Trials operations meeting in New York in earlier this year,  Patti Arsenault, VP Quality Assurance at Cytel discussed with Christopher Lamplugh, AVP, Clinical Data Management, Global Data Operations at Merck, the key challenges for data management in the space, and what’s...

Topics: big data, EDC, data manager, Clinical Data, database build, Clinical Research Services, Data Management, Oncology, clinical trials

We extend our congratulations to Lipopharma and the CLINGLIO project consortium on their recent 6,15M€ grant award by the European Union’s Horizon 2020 program. Led by Lipopharma, the multinational consortium brings together 12 academic and industry organizations from Europe, Israel, and the USA.

Topics: adaptive trials, Oncology, Trial Design, personalized medicine

As we prepare to close the door on 2017, we thought we would take a look back at the  topics which have been most popular on the Cytel blog this year.  It's an interesting insight on what pain points and opportunities feature highly on our global biopharma audience's radar.  Read on to learn which of our 2017 blogs have received the most interest from our audience so far.

Topics: Statistical Analysis, R language, data science, Trial Design Software, Cytel Strategic Consulting, Data Management, pharmacometrics, NONMEM, estimands, Oncology

In this blog, we share the second part of our interview with Bob Beckman, about a design concept for a confirmatory basket trial. Beckman is Professor of Oncology and of Biostatistics, Bioinformatics, and Biomathematics at Lombardi Comprehensive Cancer Center and the Innovation Center of Biomedical Informatics, Georgetown University Medical Center. The first part of the interview, which...

Topics: Clinical Data, adaptive designs, FDA, basket trials, Oncology

At the East User Group meeting (EUGM) on 25th and 26th October, we will welcome a number of renowned industry speakers to discuss some of the most promising approaches in innovative trial design. Over the next few weeks, we will profile a number of the speakers and their talks. In this blog, we talk with Bob Beckman M.D in advance of his presentation ‘Design Concept for a Confirmatory Basket...

Topics: biostatistics, Clinical Research Services, Clinical Development Strategy, Statistical Innovations in Clinical Development, East, Oncology, basket trials

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

The Joint Statistical Meetings (JSM) is the largest and arguably most highly respected gathering of statisticians in the world.  It will bring together over 6000 statisticians and runs from Saturday, July 29, to Thursday, August 3, 2017. With over 600 sessions,  it can be a challenge to identify the most crucial ones to attend. To help out, we've asked some of the Cytel team for their top...

Topics: biostatistics, Oncology, Clinical Research Services, Clinical Development Strategy, Adaptive Clinical Trials, Statistical Innovations in Clinical Development, Statistical Analysis, Statistical Programming

 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 we share a case study in which our statistical consulting team helped a client redesign an oncology pragmatic trial to address regulatory agency questions.

Topics: biostatistics, real world evidence, Oncology, Regulation

 At the recent Biosimilars Summit in Philadelphia, Cytel's Pantelis Vlachos presented on statistical challenges and flexible approaches in biosimilar development.  In this blog we summarize some of the challenges and share the slides from talk.

Topics: biostatistics, Phase 3, Oncology, Biosimilars, adaptive sample size re-estimation

We continue our case study series with this example of a Phase 3 design that uses Bayesian decision making combined with frequentist final analysis.

Clinical Development Background

Our biopharmaceutical client’s lead drug candidate is a late clinical-stage cancer immunotherapy for treatment of a rare oncology indication.  Clinical development of therapies in this indication faces inherent...

Topics: biostatistics, adaptive trials, adaptive sample size re-estimation, Bayesian Methods, Bayesian, Oncology, Phase 3

 

 

 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

At a recent Pfizer/ Cytel seminar on rare disease and oncology development, Cytel’s Lingyun Liu presented innovative work on a patient enrichment design. In this blog, we share some design and operational considerations. This approach can help mitigate against underpowering of a clinical trial where there is uncertainty and heterogeneity of treatment effect among subpopulations.

Topics: biostatistics, Cytel Strategic Consulting, Enrichment, patient enrollment, adaptive trials, Oncology, Phase 3, personalized medicine