Not the gold medal winning Sally

1. Not the gold medal winning Sally

2. Preparation • Four months out – scratching on whiteboard • Research question/hypothesis • Compelling argument • Gaps • where does the project fit • global perspective and Australian context • Methodological approaches – strengths/limitations • Feasibility • Three months out • Talk it through – in and outside field • Collaborators – never underestimate the importance of this • Literature searches – make sure you are on top of the evidence • Ethics applications (aims and methods pinned down) • Two months out – at the starting blocks • Guidelines - read thoroughly

3. The event • First draft – be prepared to let it go!!!! • Importance of first page • Clarity of purpose (aims and big picture issues) • Logical thread • Direct links between aims and methods • Emphasise key points • Tell the reader what you would like to hear back about your work • Feasibility • Cautionary notes • Keep it simple • Walking the fine line between innovation and low risk • Market the project without overselling

4. Up front Our overall objective is to evaluate the use of four targeted cancer therapies available via publicly funded access programs in Australia. The project will serve the dual purpose of advancing the field of cancer pharmaceoepidemiology internationally and also generate much needed ‘real world’ data to enhance the evidence base upon which pharmaceutical policy decisions are made. We will bridge the current evidence gaps by: Describing the treatment populatiosnincluding socio-demographic characteristics, previous treatment history and co-morbidities; Examining use of the agents and chemotherapeutic partners including duration and order of use; To achieve these aims we will make best use of linked secondary health data collected across State and Commonwealth jurisdictions. Our project proposal dovetails directly with one of the Special Research Areas nominated by the NHMRC in their Strategic Plan 2007-2009, Effective Health Care: Comparative Effectiveness Research.

5. Emphasise key points Our current proposal will generate new evidence, by way of a series of observational studies,about the use of targeted cancer therapies outside clinical trial conditions in the largest cohorts of patients using these agents internationally. The modern drug development and approval process has created a situation whereby real-world observational studies provide the only opportunity to answer important questions about cancer medicines use. However, after medicines have been subsidised for use in Australia we know little about the way in which they are used in clinical practice, their impact on resource utilisation and whether the people who will derive the most benefit from their use are gaining access to them. This situation persists despite the existence of good quality, routinely collected administrative health data which is a by-product of our universal health care system.

6. Feasibility of proposal • Reviewers? • oncologists/epidemiologists/health services researchers/ pharmacoepidemiologists?? • What do they understand about the field? • What are their likely biases/preconceived notions • Have you done this before – demonstrate you have proven the concept? What happened? • Data access and availability

7. Limitations One page of the proposal As in any epidemiologic study we must consider the potential biases and limitations of our research proposal. Some of the concerns raised in relation to administrative database research and the conduct of pharmacoepidemiological research include: • Medicine exposure • Diagnosis and outcome misclassification • External validity of research findings • Reliability and feasibility of data linkage methods • Availability of data sets in specified timeframes

8. The end game • Circulate, circulate, circulate • Take note of ALL feedback • Less is more – let go of your words • The finish line • Proof-reading – typos not conceptual issues