The drug development lifecycle is facing an interesting data dilemma. On one hand, the rise of automation/AI, Real World Data, and industry globalization has streamlined processes, allowing sponsor’s to gain actionable insights faster. On the other hand, increasing costs, complexities in new forms of data, market competition, and regulatory changes are stretching timelines and inflating budgets. As a result, today’s quickly evolving industry has brought challenges that, amongst other things, can require a specific type of statistical support at a moment’s notice. This is especially true for companies that don’t need the scale of support seen in a larger scale, long term FSP agreement or don’t have any in-house statistical team.
Here are 4 reasons why an on-demand stats team could boost your clinical trial.
1. Trial Design: Align your trial endpoints with data collection right from trial initiation
Efficient and robust trial design is an essential cornerstone of clinical development, and it’s one that ensures that the study generates the right evidence to answer the research question of interest. However, when should these conversations start? What added support can a Statistician provide?
The increasing use of complex trials such as Pragmatic Trials, Synthetic Control Arms, and Adaptive Designs have changed the game, which means obtaining the expertise of a Statistician early is vital. The complexity in new forms of data can also lead to urgent re-design or tweaks. Bringing a Statistician on-board from the outset, before protocol development, to advise on trial design, can save time and money down the line. A Statistician can advise on sample size estimates or simulations to assess the impact of different scenarios on the size and length of the trial.
2. Study Oversight: Ensure Data Quality and Integrity
Your study is in motion but stakeholders have become increasingly concerned about the efficiency of the trial, the quality of the outputs or the analysis – how can you alleviate your concerns at short notice? What additional support can you get to maximize efficiency? Procuring the right type of oversight for your trial can be tricky, especially for companies that have already outsourced to a full service CRO to manage the trial end to end. Understanding the issues and quality checking is often not possible within the constraints of in-house statistical experience or bandwidth. Getting on-demand access to a reliable statistics team for oversight can be crucial.
Whether it’s study planning, data management, quality control, or regulatory compliance, a Statistician’s review ensures not only the statistical robustness of study documentation, it also reinforces a high standard of work. Having an experienced, high quality Statistician to provide CRO oversight provides a different perspective than what might be available from in-house or non-statistical personnel. This can be a major factor when it comes to ensuring on-time, accurate deliverables.
3. Regulatory Support: Navigate the Regulatory Landscape
Rapid advancements are being seen across the drug development lifecycle, and regulatory submissions are no exception. The rise of RWE and patient-centric reporting has brought changes to regulatory requirements and process. One such example is the HTA regulatory updates coming in 2025. This is where the knowledge and insight from a Statistician can help – click here to learn more about our approach to the upcoming HTA regulatory changes.
Even without any drastic changes to the regulatory landscape, the benefits of a high quality Statistician in the room during the submission phase cannot be underestimated. An on-demand Statistician can provide the necessary flexibility and expertise to respond quickly to any questions that arise during the submission phase. They can support the sponsor in various ways, depending on the situation – either directly, playing a key role within the room, or behind the scenes, preparing regulatory responses and briefings. Unfortunately, Market Access and regulatory approval can often become fragmented, with key stakeholders undermining the importance of a Statistician’s input. Taking a flexible approach to your Statistical needs and reaching out to the experts when it’s needed is the best way to ensure trial success.
4. The Unexpected: Why Staying Flexible is Vital
There are certain stages over the course of the clinical trial journey where a Statistician’s expertise may be required at a moment’s notice. However, pre-empting every decision and possible hurdle throughout the clinical trial journey to include a Statistician’s viewpoint can be tricky and expensive. Tightening timelines, rising costs, and pressure from senior stakeholders can sometimes mean certain decisions get rushed without the right expert to interpret and communicate insight first.
Having even a single Statistical expert on-call can be a great way to reduce costs, make more accurate decisions and maintain the integrity of your trial. Whether it’s delivering sample size calculations, streamlining/tweaking trial designs, providing input for poster presentations, or simply needing some meaningful advice, a Statistician’s role should never be pigeonholed to just one phase or scenario of the drug development lifecycle, especially in today’s fast-paced industry.