Here is an overview of the conference programme. You can browse by category to see full details of the sessions you are most interested in or click on the tabs on the interactive calendar to see what's on each day. Clicking on any of the speakers or sponsors will show you more information about them and why they are supporting this event.
• Looking back at diabetes as a major health concern in the developed world: What were the trends influencing this development?
• Highlighting the major challenges of running trials in developed countries and determining factors that may deter investigators such as slow study start-up or limited patient pools
• Uncovering the rise of diabetes within developing countries and understanding the associated factors to gain an improved global outlook that will help strategic planning of trials
• Assessing the potential of running trials within developing countries that will benefit drug approval procedures
• Establishing the challenges that are faced when running trials within developing countries and considering ways the difficulties can be overcome
• Evaluating the benefits and drawbacks of running trials in developing countries over developed countries
• Optimising the clinical trial process in developed and developing countries to successfully obtain drug approval
• Overview of the body of evidence that has provided the rationale for additional cardiovascular measures
• Evaluating the potential to design a trial protocol that will satisfy the FDA and EMEA regulations whilst maintaining a controlled trial budget
• Determining the amount of data that will be necessary to justify your drug as being ‘safe’ for use to prevent delays in product launch
• Assessing the current diabetes trial protocol set up in order to determine how it can be improved
• Considering the additional biomarkers that have to be tested in cardiovascular trials for drug approval
• Forecasting the EMEA cardiovascular outlines that might deviate from the FDA guidelines and preparing for cater for these deviations
• Highlighting the nature of T2DM as a life-threatening disease
• Assessing the current pharmacological interventions for lowering T2DM and their potentially serious side-effects
• Determining the side-effects of glucose-lowering treatments on the cardiovascular system
• Considering the best methods to re-evaluate T2DM treatments to minimise the risk profile of patients
• Identifying future endpoints to be considered during clinical trials in diabetes to ensure successful drug approval
• Assessing the current diabetes trial protocol set up in order to determine how it can be improved
• Considering the additional biomarkers that have to be tested in cardiovascular trials for drug approval
• Analysing the stages at which the cardiovascular tests should be implemented during the clinical trials that will provide a realistic reflection of the cardiovascular endpoints
• Determining the optimal study design that is tailored for different drug profiles to maximise trial efficiency
• Integrating the cardiovascular trials into diabetes trials in a cost-effective manner
Case study on a large cardiovascular outcome trial for diabetes from site selection through to patient retention that has been quite successful. Details to follow.
• Background and benchmark on recruitment within diabetes
• Running clinical trials globally towards a shared goal that will enable success
• Communicating and focussing on stakeholder management to ensure successful clinical trials
• Determining the challenges of patient recruitment and retention and determining the optimal strategies
• Learning to cope with patient drop-outs and minimising the effects on the trial outcome
• Tracking and follow-up activities to ensure successful data collection
• Reflecting on the lessons learned from patient recruitment and retention at Novo Nordisk
• Highlighting the significance of the genetic profile and lifestyle that has induced diabetes or pre-diabetes on the potential outcome of clinical trials
• Outlining the key challenges of identifying the correct patients for clinical trials that will provide realistic trial results
• Evaluating the effectiveness of the current strategies employed to determine the desired patient pool
• Assessing the effects of selecting the wrong patient pool on the fate of the trial drug
• Considering the optimal methodologies for determining the correct patient profile with particular focus on cardiovascular risk profiles and obtaining these patients
• Determining the feasibility of employing the optimal methods of patient profiling that will allow for successful clinical trials in diabetes and other illnesses
• Explaining the rationale for the development of a diabetes trial dating agency to improve patient recruitment
• Determining the goals for the project and the database infrastructure
• Defining the protocol for patient assessment once interest has been registered
• Showcasing the successes of the diabetes trial matchmaking programme and highlighting the future challenges and goals for the project
• Generating guaranteed patient pools for clinical trials that will speed up study start-up
• Assessing the potential for the matchmaking service to be implemented outside the United Kingdom
• Overview of the FARSITE software by looking at its abilities and limitations
• Audience participation through the submission of data parameters to demonstrate the software potential
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