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 type 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 knowledge of that topic – for help and advice. Phoning the right friend when it mattered most had the power to boost the contestant’s success on the show significantly. At Veramed, our consultancy team acts very much as a statistical ‘phone a friend’ – and 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.In this blog, 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.

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.

2. When you need help with CRO oversight

Biopharma companies who have decided to outsource all their clinical project management activity, but don’t have an in-house statistical group, will still need to perform oversight of the statistical and programming deliverables such as Statistical Analysis Plans, dataset specifications and outputs to meet their obligations as sponsors. Having a Statistician on hand to perform the review ensures not only the statistical robustness of study documentation but also that the quality is high and often gives a different perspective than what might be available from in-house, non-statistical personnel.

3. When you need support for regulatory interactions

At various points during the drug development journey, the sponsor needs to meet with regulators and answer questions about the trial. Whether reviewing a proposed trial design, attending an end of Phase 2 meeting or preparing for submission, no CMO would walk into any such make-or-break discussions without the support of a knowledgeable Statistician, either in the room or working behind the scenes, preparing regulatory responses and briefings. 

Having an established, ongoing relationship with a statistical consultant with experience of regulatory interactions is invaluable in such cases to ensure that they have the background knowledge and understanding of the trial programme and established relationships with the sponsor team as well as providing flexibility and the ability to respond quickly should questions arise. 

For example, we worked recently with a client who needed to discuss various aspects of their study design with the FDA. One of our statistical consultants produced simulations for a range of scenarios that were included in the briefing document provided to the regulatory agency. They were also able to attend the meeting alongside the sponsor to answer questions about the design and influence a successful outcome. 

4. When you’re not sure what support you’ll need!

As we mentioned at the outset, many smaller or virtually structured companies don’t need a full-time Statistician; what they do need is to get a statistical point of view as and when they need it. From delivering sample size calculations, giving input for poster presentation, or streamlining a design, working with a statistical consultant brings you the peace of mind that comes with expertise at the end of the phone, as and when you need it.  And, when the time comes in your development programme that you do require operational statistical support, as well as advice from your consultant Statistician, Veramed has the breadth and depth of capabilities to tailor a service to meet your project’s needs.Did you catch us at the PSI Conference this week? We had posters and presentations from the team on:

• Statisticians in Phase IV
• Real World Data
• Real World Evidence
• Unconscious Bias
• Data Visualization
• Recruitment Modelling
• Interim Analyses

Stay tuned for more information about how you can access our content from PSI!

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