Every clinical development director or Chief Medical Officer needs a Statistician’s support to navigate the complex quantitative aspects of clinical trials, but smaller and virtual biopharma companies often lack dedicated internal statistical resources.  In the cases where they do have internal statistical resources, they may lack capacity to meet the volume of required work when coming up to critical milestones such as starting phase 2 development or preparing for submissions. These types of organisations also often have limited visibility over their statistical requirements, and don’t necessarily need the scale of ongoing support offered by a Functional Service Provision agreement which typically involves a large, dedicated team assigned to a client’s work. Instead, they may need access to statistical expertise on a more flexible basis, very much like you would rely on someone in your internal team – for advice, input, and support.

Some of us probably remember the ‘phone a friend’ feature on a famous TV quiz show of days gone by. When faced with a tough question, the contestant could grasp the lifeline of calling on a friend with the hope that they would be available at a moment’s notice. Timing was everything and the support of that friend was vital. At Veramed, our consultancy team acts very much as a statistical ‘phone a friend’. Of course, in the case of clinical development, with the prospects of a new medicine riding on a trial’s robust design and execution, the stakes are substantially higher than the TV game show. High quality support can be required at a moment’s notice. 

In this series of blogs, I’ll highlight four typical scenarios in which we support clients through flexible consultancy models that allow on-tap access to an expert Statistician, like a virtual arm of your own internal term. The first offering we have on “speed dial” is trial design.

1. When you need trial design support

Ronald Fisher 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.” 

Fisher was right, and his premise is perfectly applicable to clinical trials. Efficient and robust trial design is an essential cornerstone in clinical development to ensure that the study generates the right evidence to answer the research question of interest. Statisticians are instrumental in getting the design right- whether that be a traditional approach or an adaptive or Bayesian design that may stand to increase efficiency and reduce the required sample size. It’s always best practice to bring a Statistician on board to discuss trial design options at the outset, before protocol development, to consider the possible scenarios in collaboration with other stakeholders. In essence, the earlier you bring a Statistician on board for your project, the better to ensure that the route taken maximises the probability of trial success.

As well as providing input into the optimum design, our Statisticians can deliver sample size estimates or simulations to assess the impact of different scenarios on the size and length of the trial.

For example, during the pandemic, Veramed helped a client to design a Phase III COVID-19 trial. Working in a new indication like COVID-19 was particularly challenging due to the lack of precedent set by prior clinical trials. Our consultant Statisticians performed simulations and sample size calculations for a range of complex study designs. These included group sequential designs, sample size reassessments, co-primary endpoints and hierarchical testing strategies. With our statisticians support and expert advice the client was able to assess the risks associated with each potential strategy and identify the study design which was most suitable for the company.

Visit our statistical consultancy page to learn more about how we can find a flexible solution to meet your requirements.

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