PhUSE 2017 took place in Scotland’s capital city Edinburgh, 8th - 11th October, and brought together a range of experts to tackle the most pressing issues facing statistical programmers today. We found this year's event informative and well attended. In this blog we share some highlights from the sessions and posters the Cytel team attended. We will share Cytel's own contributions in a...
Nov 17, 2017 5:00:00 AM
Oct 4, 2017 7:34:36 AM
The Society for Clinical Data Management (SCDM) conference landed in Orlando last week providing insights and key trends for clinical data managers from around the world. In this blog we share an infographic of some of the agenda highlights along with a more detailed overview of our Alla Muchnik's contribution to the session Study Medication Compliance: Data Collection Challenges.
Aug 15, 2017 7:16:00 AM
Last month, Cytel statisticians headed to Baltimore for the Joint Statistical Meetings and shared some of their latest research and insights. In this blog we will summarize our highlights -both from Cytel contributions and the sessions Cytel delegates attended. We also provide access to the valuable slide decks from the Cytel authored presentations.
Jul 19, 2017 9:00:13 AM
With adaptive and innovative trial designs on the rise, operational implementation of interim analyses, including management of Independent Data Monitoring Committees is increasingly important. In this blog, we will share a case study of how Cytel provided a client with seamless Independent Data Monitoring Committee support encompassing committee selection and management, independent...
Jun 8, 2017 9:50:07 AM
Cytel's Madhusmita Panda presented at this year’s PSI Conference in the Innovative Methodology session on the topic of ‘Measuring Intergroup Agreement and Disagreement’.
In this blog, we share the context, abstract and slides from Panda’s presentation.
May 22, 2017 9:00:00 AM
James (Jim) Bolognese, Senior Director, Strategic Consulting, Clinical Services at Cytel Inc. was named a 2017 fellow of the American Statistical Association (ASA). Jim will be officially honored by the ASA at the Joint Statistical Meetings in Baltimore, Maryland this summer.
May 10, 2017 5:48:04 AM
PSI is a global member organization dedicated to leading and promoting best practice and industry initiatives for statisticians in the biopharmaceutical industry. 2017 marks a significant milestone for the organization's PSI conference as it hits its 40th year of promoting statistical insight. This is reflected in its status as the key event on the calendar for statisticians in the...
May 4, 2017 9:07:00 AM
As a recognized expert in adaptive trials, Cytel has extensive experience designing and managing trials with interim analyses. To ensure success in what are often complex studies, data management as well as statistical expertise is required. Cytel data managers are well versed in the various nuances and demands of managing the successful delivery of an interim analysis from a data...
Apr 25, 2017 6:24:00 AM
At a recent conference Adam Hamm, Director Biostatistics at Cytel, presented his thoughts on Best Practices and Operational Considerations for Adaptive Designs and Interim Analyses. In this blog, we share some highlights from his presentation, drawing out some of the key operational priorities from the biostatistician's point of view.
Feb 9, 2017 7:34:58 AM
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...
Nov 21, 2016 11:42:00 AM
While adaptive designs can deliver significant benefits to clinical development- including ethical benefits for patients, reduced costs, and improved likelihood of trial success- they are not suitable for every clinical trial. In making the assessment of whether or not to choose an adaptive design, trial planners need to weigh the strategic benefits against the practical implications.
Jun 16, 2016 10:23:00 AM
Predicting the course of a clinical trial is something which people will always want to do-whether for statistical reasons, planning reasons or business reasons. In this blog we look at examples of where prediction goes off course, and how we can resolve these issues. We also share valuable video and slidedeck resources from our VP Consulting and Software, Yannis Jemiai.
Jun 14, 2016 8:00:00 AM
At Cytel, we are very often asked to get involved in DMCs ( Data Monitoring Committees) in a variety of capacities. Our statistical experts are recognized for their work in many of the areas related to DMCs including-group sequential and adaptive designs, multiplicity, missing data, and decision sciences. One key operational management issue when producing analysis for DMCs is that rules...
Mar 19, 2015 5:26:00 PM
A well-timed interim analysis can generally supply added benefits to the operational and administrative aspects of a clinical trial. Particularly when clean data and safety adjudications provide information that is instrumental for stopping a trial early or informing sensitive interim decisions, the timing of an interim look may play a crucial role in leveraging all of the flexibility that a...
Feb 10, 2015 5:28:00 PM
Cardiovascular outcome trials (CVOTs) have earned the reputation of being the untamable behemoths of the clinical world. Needless to say these trials are long and require extremely large sample-sizes. The Contrave LIGHT study required 8900 patients. The SAVOR TIMI trial enrolled 16,492 patients. Even the EXAMINE trial, which benefited from a promising zone design, required 650 patients.
Dec 9, 2014 12:17:28 PM
When planning a conventional trial, one can anticipate the drug supply necessary for the trial by determining how the number of patients reflected in the sample size will distribute across the trial sites. Implementing an adaptive trial, by contrast, raises many challenges for predicting the necessary drug supply. It can require planning for different sample sizes depending on the outcome of...
Sep 18, 2014 10:44:00 AM
When designing clinical trials, many trial designers are advised to keep the trial simple. Prima facie, the keep it simple principle seems like sound advice. There are various logistical uncertainties that arise when implementing a clinical trial, and the more simple a trial – so conventional wisdom says – the easier it is to respond to these uncertainties.
According to Zoran Antonijevic, a...
Topics: Oncology, Promising Zone, sample size re-estimation, Enrichment, Cytel Consulting, Efficacy, Interim Analyses, forecasting, optimization, Program and Portfolio Optimization, R&D, Adaptive Clinical Trials
FDA-Industry Session on Cardiovascular Outcome Trials: Mehta on EXAMINE Trial’s Promising Zone Design
Sep 9, 2014 10:41:00 AM
The FDA requires sponsors of new antidiabetic drugs to conduct cardiovascular outcome trials (CVOTs). CVOTs demonstrate that new therapies do not place unacceptable cardiovascular risk on patients suffering from Type 2 diabetes. The average CVOT requires about 5000 patients and takes an average of 5 years to complete. However, a recent white paper by the Cardiac Safety Research Consortium...
Jun 10, 2014 7:01:00 AM
The FDA’s Tatiana Prowell (Breast Cancer Scientific Lead in the Office of Hematology & Oncology Products) recently gave an interview to the Nature Review Drug Discovery, in which she discusses the top three pitfalls faced by drug developers in oncology. Issues which Prowell cite include: selection of appropriate dosage, trial designs without...