Resilience to external events

Date: 05. 16. 2023

The clinical development sector is highly sensitive to external events for two main reasons. One, because of the many moving parts involved – from patients, clinicians, sponsors, regulators and supply chain partners. And two, the fact that it is global in nature – often involving people and materials from many different countries and regions. In the end, we want our innovative medicines to benefit all patients, regardless of where they reside.

Because of this, the outbreak of a pandemic or war, the sudden impact of a natural disaster, or an unexpected supply chain hiccup can wreak havoc on clinical trials.

The good news for the clinical development industry is that the data and technology now exist to minimise the impact of these disruptions.

Digital technologies are transforming the industry and in particular the processes involved in traditional “wet” trials – making decentralized studies and remote patient monitoring possible.

But perhaps more important is that thanks to advances in data science and predictive analytics, real-world data can be used to simulate and model outcomes before patient enrollment even begins. The analysis of historical and real time trial and patient data across all disease areas will optimize trial design and ensure that:

  1.   Chances of clinical and commercial success for drug candidates are high.
  2.   The right patient cohorts are recruited– i.e. where they are available and they have relevant characteristics for the indication of study.
  3.   Allow robust identification of risk factors and risk mitigation to avoid disruption.
  4.   ‘What if…?’ scenario modelling and prediction capabilities are incorporated to foresee issues and minimize amendments or cancellations.
  5.   Costs are reduced and innovative new treatments get to patients faster.

Given the current economic crisis, the short-term future is looking increasingly challenging. A data-driven approach can accelerate the clinical development process keeping patient experience front-and-centre.

Phesi’s AI-driven Trial Accelerator Platform provides sponsors with the world’s most comprehensive integrated clinical trial analytics database. With real-time and real-world data insights, sponsors can reduce the risk of avoidable protocol amendments and save up to $1,500,000 per Phase 3 trial in amendments alone. The industry needs to accelerate trial execution and tightly manage costs, while keeping the patient as the priority. With AI and analytics, Phesi can help you achieve this goal.

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