Can Statisticians Contribute to Enhance the Position of Patients in Clinical Trials?

Posted by Cytel

Nov 12, 2018 8:04:00 AM

 

In this blog, we talk with Robert Greene, Founder and President of the HungerNDThirst Foundation, about his upcoming presentation at Cytel’s East User Group Meeting on 14th and 15th November at Merck in Darmstadt, Germany. Robert will bring a fresh perspective to the discussion of the role statisticians can play in enhancing the position of patients in clinical trials. Patient-centricity is a...

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Topics: Adaptive Clinical Trials, Trial Design, phase 2, Program and Portfolio Optimization, Simulations, East, adaptive designs, Bayesian Methods, Phase I, biostatistics, Statistical Innovations in Clinical Development, randomization, patientricity


Webinar: Basket Trial Design and Implementation Considerations

Posted by Cytel

Nov 9, 2018 11:33:00 AM

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...

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Topics: Oncology, basket trials, webinar


Data Management Fundamentals for Your Next Clinical Trial

Posted by Cytel

Nov 8, 2018 9:55:00 AM

 

 Data is the most crucial asset in any clinical trial and is used to ultimately drive the decision-making process related to the development candidate. Therefore, for any sponsor, paying close attention to the data management aspects of clinical operations should be paramount. The principles of data management are simple and well-founded. However, the application of these principles needs...

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Topics: Data Management


New publication addresses critical issues in ultra-orphan indications

Posted by Cytel

Nov 5, 2018 7:01:00 AM

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...

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


The Good Data Submission Doctor: 5 Top SDTM Frequently Asked Questions

Posted by Angelo Tinazzi

Nov 1, 2018 7:35:00 AM

 

In this second post of the “Good Data Submission Doctor” ( read my first post The Master Recipe: Quality and Attention to Detail Matter here) I would like to go through some of my favorite SDTM Frequently Asked Questions. These are questions I regularly receive in my capacity as a CDISC Subject Matter Expert, either from my colleagues or from the sponsor. Let’s start by taking a look at five...

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Topics: clinical research, clinical trials, SDTM, ADaM, CDISC


Incorporating patient preferences and values into risk-benefit calculations opens new horizons

Posted by Cytel

Oct 26, 2018 8:59:00 AM

 

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Topics: clinical research, clinical trials, clinical development, biostatistics, patientricity


Career Perspectives: Interview with Munshi Imran Hossain, Senior Data Scientist

Posted by Cytel

Oct 23, 2018 11:00:00 AM

Cytel data scientists apply advanced statistical techniques including predictive modeling of biological processes and drug interactions to unlock the potential of big data.

In this blog we talk to Munshi Imran, who is based in Pune, India to find out more about his career path, current role at Cytel and his interests outside of work.

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Topics: Statistical Analysis, careers, clinical research, Statistical Programming, CRO, Recruitment, Cytel Strategic Consulting, adaptive designs, Adaptive Clinical Trials, clinical trials, Regulation, big data, Trial Design Software, Software Simulations, genetic algorithm


Selection Bias for Treatments with Positive Phase 2 Results with Simon Kirby

Posted by Cytel

Oct 18, 2018 11:09:00 AM

 

In this blog, we talk with Simon Kirby, former Senior Director at Pfizer, about his upcoming presentation at Cytel’s East User Group Meeting on 14th and 15th November at Merck Darmstadt, in Germany. Simon will address the topic of Selection Bias for Treatments with Positive Phase 2 Results and in this blog he explains why this is a key topic of particular relevance for pharmaceutical companies...

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Topics: Adaptive Clinical Trials, Trial Design, phase 2, Program and Portfolio Optimization, Simulations, East, adaptive designs, Bayesian Methods, Phase I, go-no-go, biostatistics, Statistical Innovations in Clinical Development, randomization


Highlights from the SCDM 2018 Conference

Posted by Cytel

Oct 16, 2018 11:00:00 AM

The Society for Clinical Data Management (SCDM) conference brought clinical data managers from around the world to Seattle-Bellevue, WA on September 23-26. The conference offered an unmatched opportunity to discover innovative solutions in the clinical data management industry. In this blog, we will share our data management colleagues' experiences, observed trends and contributions to the...

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Topics: clinical data management, data manager, Clinical Data, clinical research, clinical trials, clinical development, CDM


When Knowledge Drives Results: The Impact of a Winning Data Strategy

Posted by Cytel

Oct 10, 2018 12:31:00 PM

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Topics: CDISC, SDTM, Data Management, clinical data management


Interview with Stephen Senn: 70 Years and Still Here: The Randomized Clinical Trial and its Critics

Posted by Cytel

Oct 5, 2018 7:00:00 AM

 

We are delighted that Stephen Senn will be joining us at the EUGM on November 14th and 15th in Darmstadt, Germany. In this blog, we sit down for a discussion with Stephen about his career in statistics, his advice for early career statisticians, his upcoming research, and the topic of his presentation at the East User Group Meeting “70 Years Old and Still Here: the Randomized Clinical Trial...

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Topics: Adaptive Clinical Trials, Trial Design, phase 2, Program and Portfolio Optimization, Simulations, East, adaptive designs, Bayesian Methods, Phase I, go-no-go, biostatistics, Statistical Innovations in Clinical Development, randomization


The "Master Recipe": Quality and Attention to Details Matter When Submitting CDISC Packages to Authorities

Posted by Angelo Tinazzi

Oct 1, 2018 6:01:00 AM

One of my wife’s favorite TV shows is ‘Quattro Ristoranti’ (Four Restaurants). In each episode of the show, 4 restaurants of the same style are assessed and the one getting the best evaluation wins the prize. One of the first things the TV presenter Alessandro Borghese, a famous Italian chef, does while visiting the restaurant is to assess (of course!) the kitchen and how much the kitchen and...

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Topics: CDISC, SDTM, ADaM, PhUSE, Statistical Programming, FDA


Decision Making in Development Programs with Targeted Therapies: with Heiko Götte

Posted by Cytel

Sep 27, 2018 9:00:00 AM

 

In this blog, we talk with Heiko Götte, Senior Expert Biostatistician at Merck about his upcoming presentation at Cytel’s East User Group Meeting on 14th and 15th November at Merck Darmstadt, in Germany. The topic Heiko will address is Decision Making in Development Programs with Targeted Therapies and he explains to us why this is a key topic for pharmaceutical companies today as they...

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Topics: Adaptive Clinical Trials, Trial Design, phase 2, Program and Portfolio Optimization, Simulations, East, adaptive designs, Bayesian Methods, Phase I, Biomarkers, go-no-go


Career Perspectives: Interview with Adam Hamm, Director of Biostatistics

Posted by Cytel

Sep 20, 2018 1:04:00 PM

At Cytel we believe that expert statistical input has the power to shape the future of clinical development: de-risking portfolios, accelerating timelines, and increasing the probability of success.

In this blog we talk to Adam who lives in North Carolina United States to find out more about his career path, achievements, current role at Cytel and his interests outside of work.

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Topics: Statistical Analysis, careers, clinical research, Statistical Programming, CRO, Recruitment, Cytel Strategic Consulting, biostatistics, adaptive designs, Adaptive Clinical Trials, clinical trials, Regulation


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

Posted by Natasa Rajicic

Sep 17, 2018 5:25:00 AM

 

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...

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Topics: Oncology, immunotherapy, biostatistics


Could data science be about to revolutionize the regulatory approval of new drugs?

Posted by Cytel

Sep 10, 2018 6:52:00 AM

 

The biopharmaceutical and healthcare industries now collect more data than ever before due to advances in the variety of information sources combined with the ability to store vast quantities of diverse data. Sophisticated machine learning (ML) and artificial intelligence (AI) techniques allow us to accessand analyze any combination of a multitude of data sources. The way that traditional...

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Topics: biostatistics, data science, real world evidence


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

Posted by Cytel

Sep 7, 2018 9:55:00 AM

 

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


Podcast: Enhancing Patient Enrollment Forecasting with EnForeSys 2.0

Posted by Cytel

Sep 5, 2018 8:50:00 AM

 

EnForeSys is Cytel’s tool for patient recruitment planning. We have discussed on the blog recently with Tufts University's Center for the Study of Drug Development, Ken Getz, the problem the industry continues to face with patient recruitment, and the fact that most trials significantly exceed their original planned duration. In the face of this problem there's a pressing need to create more...

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Topics: patient enrollment, enforesys, clinical trials


Highlights from the JSM 2018 Conference

Posted by Cytel

Aug 31, 2018 11:32:00 AM

 

JSM 2018, ASA’s annual gathering of over 6500 attendees attracted statisticians and data scientists to the beautiful city of Vancouver on July 28 – August 2. The conference offers a one of a kind opportunity for statisticians to exchange ideas and explore opportunities for collaboration. In this blog, we will provide access to our team's slide decks from the event, as well as some of their...

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Topics: biostatistics, adaptive designs, data science, Bayesian, careers


Career Perspectives: Interview with Meredith Alm, Manager, QA Compliance

Posted by Cytel

Aug 23, 2018 9:11:00 AM

Cytel has grown significantly over the last 30 years, with operations across North America, Europe, and India. All of our processes, talent, and expertise are applied to maximizing the value of clinical data. At Cytel, quality comes first, and our QA team are committed to ensuring processes are in place to support our services.

In this blog we talk to Meredith who lives in Somerville,...

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Topics: Statistical Analysis, careers, clinical research, Statistical Programming, CRO, Recruitment, Cytel Strategic Consulting, biostatistics, adaptive designs, Adaptive Clinical Trials, clinical trials, Regulation, Trial Quality


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