The Cytel blog keeps you up to speed with the latest developments in biostatistics and clinical biometrics.

Webinar: Basket Trial Design and Implementation Considerations

November 9, 2018


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 trial design consultant to biopharma companies in addition to his role as Professor of Oncology and Biostatistics, Bioinformatics, and Biomathematics at Lombardi Comprehensive Cancer Center and the Innovation Center for Biomedical Informatics, Georgetown University Medical Center.

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New publication addresses critical issues in ultra-orphan indications

November 5, 2018


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 population enrichment, adaptive sample size re-estimation trial and how it overcomes some fundamental challenges of clinical development in ultra-orphan oncology indications. The publication is timely, in the context of the August 2018 news that the FDA has launched a complex and innovative designs pilot program to facilitate and advance the use of complex adaptive, Bayesian, and other novel clinical trial designs in late-stage drug development. The initiative seeks to further innovation by allowing the FDA to publicly discuss those trial designs that are being considered through the pilot program. Indeed, the TAPPAS trial incorporated regulatory input from both the FDA and EMA and received a Special Protocol Assessment from the FDA. As of the date of publication, the authors were not aware of any other pivotal population enrichment trial that has been implemented in oncology, and therefore the paper’s deconstruction of the design’s key elements will be invaluable to researchers considering similar innovative approaches.

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Novel immunotherapies lean on old methods (or how to teach your dragon old tricks)

September 17, 2018

 

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 T-cell–stimulating antibodies, with the field continuously expanding.

While medical science behind immune-oncology (IO) treatments is fascinating and expanding at a rapid pace, so too are the statistical challenges posed by the development of these agents.

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Opportunities of FDA’s Complex Innovative Trial Design Pilot Meeting Program

September 7, 2018

 

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.

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Addressing Critical Unmet Oncology Needs in the Era of Precision Medicine

May 23, 2018

 

 

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 discuss
his work, his views on the key advancements in oncology development, the unmet needs yet to be overcome, and the importance of efficient trial design in rare cancers. Click here to download a .pdf of the article, or read on. 

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Rewriting the oncology textbook with cell-based immunotherapies

May 16, 2018

 

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 yet to be overcome, and the importance of strategic biostatistics input to his organization. Read on, or click here to download a copy of the article to read offline.

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Innovative Oncology Trial Designs in Practice

May 9, 2018

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.

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Infographic: Overcoming Data Management Challenges in Immuno-Oncology Trials

April 25, 2018

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 needed to overcome them. 

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Cytel Congratulates Lipopharma and CLINGLIO Consortium on Recent Grant Award

February 27, 2018

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.

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