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 picks this year.
Sunday, July 30, 2017: 9.00 AM to 10:30 AM (H-Key Ballroom 9)
214819: ASA Asian Initiative: Career Development and Leadership Skills Workshop
Representatives from IISA, ICSA, KISS, and ASA will share their thoughts in determining and nurturing the needs of Asian statisticians. Speakers representing diverse backgrounds will share their own experiences, and offer how to overcome challenges that may arise. This workshop, open to all, will be an opportunity to meet, interact, and network, with leaders passionate about this initiative for the development of Asian Statisticians.
It is important to develop the next generation of talent who eventually will have a more active role in industry over the next five years.
The session benefits from the input of some leading lights in statistics including David Morganstein, the President of the ASA and Cytel President and co-founder Cyrus Mehta. The panel will discuss development of leadership skills, communication skills and collaborative skills. Anyone developing a team or looking to progress their own career would benefit from attending.
Monday, July 31, 2017: 2.00 PM to 3:50 PM (Baltimore Convention Center Halls A&B)
243: Contributed Poster Presentations: dECiDe: Software by Cytel and AstraZeneca for Early Study Design
In Early Clinical Development at AstraZeneca we apply a consistent statistical approach to go/no-go decisions. We choose a key endpoint or two, and the sample space for the corresponding point estimate is split into three zones: red, amber and green. The amber zone represents inconclusive evidence, where our senior leaders must use their impression of the data, as well as external factors, to come to a final decision. Decision criteria are set by the team at the design stage. To simplify this task, we have worked with Cytel to develop a software tool called dECiDe, which performs the necessary calculations and produces relevant tables and figures. Outputs have a consistent format that can be presented to senior leaders at internal governance bodies. It is sometimes helpful to quantify uncertainty in frequentist terms, and we will often need to assess the impact of interim analyses on the trial's operating characteristics. At other times we naturally make Bayesian probability statements, and may wish to formally combine evidence from different sources. dECiDe gives us flexibility to do all of this.
Robust go/no-go (GNG) decision-making is essential for effectively managing risk across a clinical portfolio. In early phase development, it is particularly important to have the correct tools in place to terminate ineffective compounds quickly, while accelerating promising ones through the process. The poster presentation provides real insight into the collaborative approach od the project and what happens when a team of statisticians and software developers come together to find a solution to a problem.
Learn how the tool has positively impacted the way the statisticians and clinical stakeholders work together, and the speed at which decisions can be made.
Tuesday, August 1, 2017: 8:30 AM to 10:20 AM (Baltimore Convention Center – 327)
278: Statistical Programmers - New Brand of Leaders
Panel consists of leaders in Programming, Statistics from Industry, CRO, Academia and FDA. Statistical Programmers remain core members of delivery team that provides solutions to complex problems and create significant efficiency in overall development cycle. Programmers with their unique analytical thinking are extremely well positioned to propose and drive strategy in complex business settings. There are several successful business leaders with programming background. This panel will share their experience and thoughts on how to continue efforts and encourage programming leads to take more leadership roles and influence decision making. The challenges and headwinds that may be forthcoming and plans to address them will also be shared. Panelists: Nebiyou Bekele, Sr. Director, Gilead Sciences, Paul Schuette, Director, CDER, FDA, Pandu Kulkarni, Vice President, Eli Lilly and Company, USA, Jonathan Lisic, Mathematical Statistician USDA, Steve Kirby, Director Programming, Chiltern Inc.
Panel discussions help us see a topic from multiple viewpoints, and a debate can often add a new perspective. At Cytel we understand the importance of biostatistics and programming functions being well aligned and the vital role of statistical programmers in improving efficiency in clinical development.
Wednesday, August 2, 2017: 2:00 PM to 3:50 PM (Convention Center Room 311)
568: Current Practices in Reporting Trial Simulations for Adaptive Study Designs
This talk will provide an overview of key components in conducting and documenting simulations in the context of designing adaptive clinical trials. The talk will touch upon both the general framework of the simulation report and the ultimate goal of eliminating unnecessary barriers in communicating to different audiences the operating characteristics associated to alternative study designs. A group of statisticians from industry and the FDA came together within the DIA Adaptive Design Scientific Working Group to work on the best practices and recommendations around simulation conduct and reporting in various settings of the most frequently used adaptive clinical trial designs. When adaptive designs are an integral part of a compound development program, the simulation report is to be regarded as a regulatory document. As stated in the 2010 FDA guidance on adaptive designs, detailed documentation on the simulation report and results should accompany the study protocol. Specific references will be made to the objectives and structure of the simulation report and how they link to the different goals and types of audiences that such report needs to address.
Adaptive designs bring a number of important operational considerations, including the necessity of providing robust documentation to the regulatory agency. Simulation results under various scenarios are an integral component of this documentation, and this session will provide more detail around their conduct to help improve implementation of innovative methods.
Thursday, August 3, 2017: 10:30 AM to 12:20 PM (Baltimore Convention Center 310)
651: Perception and Use of Adaptive Designs in the Industry and Academia: Comparison of the DIA Adaptive Design Scientific Working Group Surveys with Emphasis on Improvements Over Time
The DIA Adaptive Design Scientific Working Group (ADSWG) Survey Subteam has been gathering information on the perception and use of adaptive designs (ADs) for clinical development programs across industry and academic institutions. Some key components of this survey are the number of ADs which have been designed, implemented and completed in the past four years and the perceptions of various barriers to the increased acceptance of ADs at each institution. This information has been gathered in 2008, 2012 and we have new data to present from 2016. This presentation will summarize the results of the 2016 AD usage survey and compare with previous AD surveys to highlight key areas of increased acceptance and implementation of ADs and identify areas in which significant improvements can still be made.
The work of the DIA Adaptive Design Scientific Working Group subteam is critical in measuring the industry’s use of adaptive designs. It is useful to both understand in what areas adaptive designs are increasing in use, and where the barriers to uptake are. By improving our understanding of the perceived barriers we can better address them, and further the use of adaptive designs in practice.
The Cytel team is contributing a range of sessions including multi-arm multi-stage designs, dose escalation designs, and tests of non-inferiority in a clinical trial setting. To review our full schedule of participation click the button below. See you in Baltimore!