Integrated Summaries – Tips for Meeting the Challenges Faced by Sponsors

Integrated Summaries of Safety and Efficacy are not only required for New Drug Applications, they are considered some of the most important documents for submission to the Food & Drug Administration (FDA) and the European Medicines Agency (EMA). However, Integrated Summaries can present challenging timelines, data harmonization challenges and astounding additional costs. How can Sponsors successfully face these challenges?

CROS NT’s expert webinar is designed for Sponsors who are preparing to initiate Integrated Summaries projects and are looking for advice on how to prepare successful and cost-effective projects while collaborating with vendors. This webinar looks at regulatory requirements and guidelines, project management challenges and collaboration between the statisticians, programmers and medical writers. At the end of this webinar, participants should be able to comprehend regulatory requirements, understand the steps in preparing a successful Integrated Summaries project from a timelines and cost perspective and have a better idea of the deliverables they should expect from their CRO.

The FDA requires Integrated Summaries, both ISS and ISE submissions, for NDAs which includes an overview and summary of clinical efficacy and safety within the Common Technical Document (CTD) and formal integrated analyses, meta-analyses and bridging analyses in the Clinical Study Report. Meanwhile, the EMA guidance for Integrated Summaries submissions include statistical analysis of safety data and meta-analysis of efficacy data and expert medical writing. Both the FDA and EMA support the use of CDISC standards as recommended by ICH guidelines for eCTD submissions.

Planning well in advance is fundamental for successful Integrated Summaries preparation. The biggest impact on Integrated Summaries projects costs are meeting timelines. Consistency and standardization are the keys to ensuring that integrated summary preparation goes as smoothly as possible. This includes using similar structures for datasets, such as CDISC standards, and standard formats for tables, figures and listings.

The requirements laid out by regulatory authorities for Integrated Summaries make the collaboration between statisticians, programmers and medical writers inevitable. The challenge is understanding what roles they play in the planning and preparation of Integrated Summaries and the best way of collaborating. While the biostatistician sets out an analysis plan and the programmers are pooling data, the medical writer should have a summary of analysis considerations. A dedicated Integrated Summaries team follows the project from conception to submission, deploys the same programming macros, uses the same writing style and creates an Integrated Summaries document template in line with company branding to be used for future summaries.

AGENDA

This webinar features a Senior Project Manager, Senior Statistical Programmer and Senior Medical Writer with extensive experience in preparing Integrated Summaries. They will present their tips for Sponsors on successful preparation.

I. Introduction

• FDA and EMA requirements and guidelines for Integrated Summaries
• Challenges Sponsors face in preparing Integrated Summaries

II. Project Management Considerations and Effective Planning

III. Biostatistics and Programming Considerations

• Statistical Analysis Plan
• Statistical Methodology
• Programming Processes and Timelines
• Implementing CDISC standards

IV. Collaborating with Medical Writing

V. Qualifying a CRO for your Integrated Summaries Project & Conclusion

• Checklist of what to ask your CRO for an ISS/SIE project
• Advice for Small-Medium Enterprises (SMEs)

VI. Audience Q&A

Speakers

Caroline Terrill, Director of Statistical Programming, CROS NT

Caroline Terrill is the Director of Statistical Programming at CROS NT. Caroline started her career as a statistician in University departments heavily involved in clinical trials. She then worked at SAS for 6 years, teaching people how to program and analyze data in SAS. In 2005 she joined MDSL International, a global CRO, as a Senior Statistician and Statistical Programmer and progressed up to Director of Data Services until in 2013 when MDSL International was acquired by CROS NT. Caroline worked for 1.5 years as a Senior Project Manager in CROS NT and then transitioned in to the Director of Statistical Programming role.

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Mark Paul, Senior VP North America, CROS NT

Mark has served in progressive management positions in the clinical trials industry for over 25 years. He began his clinical research career in the CRO environment as a programmer and project manager and served in project management, business development, and information technology functions. Mark was Project Director for several NDA submissions and global clinical trials, and he has served as department head of data management, clinical operations, and business development groups as well as Director, eClinical Technologies for a major CRO. In addition, Mark occupied the role of CEO of StatWorks, Inc., a data and biometrics focused CRO, for over 8 years. In his most recent role before joining CROS NT, Mark was a Managing Partner and head of sales and marketing for Veracity Logic.

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Gail Head, Senior Medical Writer, CROS NT

Gail is a Senior Medical Writer and consultant in medical writing and drug development with over 18 years’ experience in the preparation of ISS and ISE for use in the USA and worldwide. She has participated in change management programs to move from the original NDA / MAA to CTD, from CTD to eCTD, and for the implementation of CDISC compliant data standards. As a key member of NDA / BLA oversight committees she is experienced in ensuring quality, budget control and timeliness of internal and outsourced ISS and ISE activities for all functions across drug development.

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