Breakfast Briefing Takeaways: Beyond the Numbers… Strategic Partnering with your Statistical Colleagues 3 Jul 2022
For our latest virtual breakfast briefing, PharmaMedic Managing Director Dr Malcolm Barratt-Johnson discussed with guest speakers Dr Nelson Kinnersley and Dr Alexander Schacht – both seasoned statistical leaders- how partnering with your statistician can add value throughout the product life cycle.
We opened the event with an informal poll, asking our audience of primarily medical and clinical colleagues about their impression of the attributes of statisticians –from ‘nerdy’ to ‘strategic’ then returned to this question at the close of the presentations.
Our speakers were delighted to find that over the course of the session, the percentage of respondents describing statisticians as ‘strategic’ had increased from 50% to 79%- testifying to the quality of the insights that Nelson and Alexander had shared.
For his presentation, Dr Nelson Kinnersley focused on how drug developers can get ‘more bang for their buck’ through early phase trial design innovations that deliver improvements in evaluating novel medicines. First, Nelson highlighted how frequently new trial designs are coming forward, and how simulations can be extremely beneficial in helping to evaluate what the best approach might be. Statisticians play an invaluable role – not only in conducting the simulations, but in communicating the trade-offs to clinical stakeholders. He then recapped the classical 3+3 design used within oncology studies to identify the Maximum Tolerated Dose and explored this method’s limitations before going on to outline alternatives including the Continual Reassessment Method, and ‘BOIN’ (Bayesian Optimal Interval Design). Stressing that no single design is suitable for every context, Nelson encouraged our audience to discuss options with statistical colleagues to find the best approach for any given scenario.
Dr Alexander Schacht then discussed his principles for delivering the right evidence, at the right time, and in the right format to make decisions for payers, physicians, and patients. He reviewed different common scenarios -from Phase 2 to regulatory approval, competitor entry, payer re-evaluation and onwards- where a statistician helps to effectively answer payer, physicians, and patients’ questions. For example, if working in a rare disease area, statisticians help to characterise the disease burden at early stages for physicians and payers. In submitting HTA dossiers, statisticians create compelling data visualisations that communicate evidence in understandable ways. On competitor entry, indirect comparisons and network meta-analysis can deliver valid evidence in comparing different treatments. It was abundantly clear that at multiple points in a medicine’s lifecycle, statisticians can play a highly strategic role in supporting its success.
In fact, our second poll of the morning asked, ‘when is the right time to involve statisticians?’. 78% of our audience answered that the best time was when discussing the challenge that the study should address.
We would agree. As Sir Ronald Fisher once famously said, “To consult the statistician after an experiment is finished is often merely to ask him to conduct a post-mortem examination. He can perhaps say what the experiment died of.”
If delegates didn’t get the chance to ask questions at the breakfast briefing or you wished to contact the speakers directly. For Alexander- alexander.schacht@
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