What makes Oncology special? Johanna MURSIC, Indication Programmer PhUSE congress Budapest, October 15 th 2012
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1 What makes Oncology special? Johanna MURSIC, Indication Programmer PhUSE congress Budapest, October 15 th 2012
2 Disclaimer The opinions expressed in this presentation and on the following slides are solely those of the presenter and not necessarily those of Novartis. Novartis does not guarantee the accuracy or reliability of the information provided herein 2 What makes Oncology special? Johanna MURSIC 15OCT2012 PhUSE congress Budapest Business Use Only
3 Introduction Whether you are a SAS programmer in pharmaceutical industry, a bank or insurance company your job is to: restructure data sets program statistical analyses create reports according to the provided requirements and specifications. With a few differences Even if still SAS is SAS and statistical reporting is still about tables, figures and listings. Wrong: Oncology is special! 3 What makes Oncology special? Johanna MURSIC 15OCT2012 PhUSE congress Budapest Business Use Only
4 Agenda Special Disease Special Data Special Analyses Special Reporting Conclusion
5 Special Disease Oncology is a very rapidly developing area in medicine, but also in science. The investigation of molecular pathways and genetic mutations involved in tumour genesis is ongoing. Oncology will be the biggest therapeutic area in 20 years! A sense of Urgency Many cancers develop very fast, and most clinical trials start as second line treatments of advanced carcinomas - Patients median survival time as short as 6 months. - In Oncology clinical trials are either accelerated, priority or on fast track. 5 What makes Oncology special? Johanna MURSIC 15OCT2012 PhUSE congress Budapest Business Use Only
6 Special Disease Trial design Ethics Placebo control arm or not - Settings: prevention, adjuvant, or early disease - Placebo-alone control usually not feasible in advanced cancer Pot practical and ethical for cancer patient use a placebo-alone treatment arm Placebo possible in combination therapy 6 What makes Oncology special? Johanna MURSIC 15OCT2012 PhUSE congress Budapest Business Use Only
7 Special Data Special Schedule: CRF organised in Cycle and not in Visit Tumor Assessment Concomitant medications: Drug/drug interaction Additional data -> identify subpopulation for targeted therapies Biomarkers Challenge for Programming: - Always difficult to plan Programming for Biomarkers: Late timelines Standard Data structure is difficult -> often done in small local laboratories 7 What makes Oncology special? Johanna MURSIC 15OCT2012 PhUSE congress Budapest Business Use Only
8 Special Data CTCAE grades In Oncology, Laboratory grades are derived following the NCI-CTCAE definition: - The NCI-CTCAE 4.2 (National Cancer Institute - Common Terminology Criteria for Adverse Events) provides definitions for AE terms and a grading (severity) scale for each AE. Eg below: Challenge for Programming: - Use of local and/or Central lab - Conversion in standard Units - Missing units is also a problem when converting - Missing Lower/Upper Normal Ranges 8 What makes Oncology special? Johanna MURSIC 15OCT2012 PhUSE congress Budapest Business Use Only
9 Special Data Dosing information Compliance: Relative Dose Intensity (RDI) - RDI is a term that refers to the amount of a particular treatment given over a specific time in relation to what was ordered Dose reduction: A reduction is defined as a decrease in dose from the protocol planned dose or a decrease from the previous non-zero dose Dose interruption: An interruption is defined as a 0mg/0tablets dose given on one or more days. Challenge for Programming: - Dealing with dosing in relation to cycles - Definitions and derivations with differents time schedule, unit... 9 What makes Oncology special? Johanna MURSIC 15OCT2012 PhUSE congress Budapest Business Use Only
10 Special Analyses Clinical Trial Endpoints Disease Free Survival (DFS) -> Recurrence, Death Progression Free Survival (PFS) -> Progression, Death Overall Survival (OS) -> Death Quality of Life (QoL) -> Side effect of the treatment, symptoms of the disease - EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30) - FACT x (Functional Assessment of Chronic Illness Therapy) What makes Oncology special? Johanna MURSIC 15OCT2012 PhUSE congress Budapest Business Use Only
11 Special Analyses Clinical Trial Endpoints (next) Overall Response Rate -> sum of partial response (PR) plus complete response (CR) - For solid tumor the gold standard is provided by RECIST (Response Evaluation Criteria In Solid Tumors) criteria published in 2000 by the European Organisation for Research and Treatment of Cancer (EORTC), NCI, and the National Cancer Institute of Canada Clinical Trials Group. - For Malignant Lymphoma CHESON (Revised Response Criteria for Malignant Lymphoma) -... Challenge for Programming: RECIST is a complex algorithm with a lot of specifications to take into account What makes Oncology special? Johanna MURSIC 15OCT2012 PhUSE congress Budapest Business Use Only
12 Special Analyses How to derive the Time point response? - Based on Tumor Assessment results - Target Lesions response - Non-Target Lesions response - Presence of New Lesions Ref: Eisenhauer EA, Therasse P, Bogaerts J. et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009;45: Challenge for programming: - RECIST is simple. Using RECIST is not 12 What makes Oncology special? Johanna MURSIC 15OCT2012 PhUSE congress Budapest Business Use Only
13 Special Analyses Interim Analyses Analysis intended to assess treatment effect with respect to efficacy or safety at any time prior to completion of the clinical trial Ethical, Economic / Efficient, Scientific, Administrative Independent Data Monitoring Committee (IDMC) Group of experts external to the study that reviews on regular basis accumulating data from an ongoing clinical trial An on-going review and evaluation of safety data and possibly efficacy data for one study or several studies within a development program. Challenge for programming: Studies can be stopped prematurely Incomplete nature of the data and not fully cleaned Event driven analyses - Deliverables/timelines accelerated 13 What makes Oncology special? Johanna MURSIC 15OCT2012 PhUSE congress Budapest Business Use Only
14 Special Reporting Planning of Programming Activities is challenging: First need finalized Statistical Analysis Plan and Tables shells Programmer must be flexible as: - Target is moving: Data Base Lock depending on Last Patient Last Visit (LPLV) Timelines and Resources estimation to be reviewed regularly - Importance of standard CRF, Data, output shells and programs to improve efficiency 14 What makes Oncology special? Johanna MURSIC 15OCT2012 PhUSE congress Budapest Business Use Only
15 Special Reporting Pooled analyses for post-approval commitments Oncologic Drugs Advisory Committee (ODAC) in USA Yearly updates of the clinical study report until study end Challenge for programming: To be ready on time even if the target is moving To standardize programming 15 What makes Oncology special? Johanna MURSIC 15OCT2012 PhUSE congress Budapest Business Use Only
16 Conclusion Oncology is very challenging and very exciting for a Statistical Programmer: ONCOLOGY IS SPECIAL To be one of the pioneers To deal with the moving timelines To understand and program algorithms such as the Lab Grading and RECIST To set-up the macros, programs and all dependencies to be ready for anything To unify derivations and naming conventions across studies for easier pooling To improve the lives of patients and caregivers 16 What makes Oncology special? Johanna MURSIC 15OCT2012 PhUSE congress Budapest Business Use Only
17 Contact Informations Novartis Oncology - Johanna Mursic Indication Programmer johanna.mursic@novartis.com Special Thanks to Kamila Duniec!! 17 What makes Oncology special? Johanna MURSIC 15OCT2012 PhUSE congress Budapest Business Use Only
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