Reimagine Clinical Trials Optimization in the Digital Era

Clinical Trial Industry – the challenges

There is constant pressure on Life Sciences companies to innovate and discover new products, manage costs, increase operational efficiency, be compliant with various regulatory mandates and provide enough proof for the safety and efficacy of their products. Clinical Research Organizations (CROs) are becoming an increasingly important partner of the Life Sciences companies in this challenging atmosphere by helping them in the complex drug and device development journey.

The clinical trial industry is trying to evolve from the traditional approach of conducting trials and adopting new-age digital technologies and approaches to meet the complex cost, quality and operational requirements of pharma, biopharma and medical devices industries. Here we focus more on the cost aspect with the industry being pushed towards innovating more and more efficiently in the Covid era.

First, let us look at some data points:

• In the past decade, 17.2 percent of Phase 2 trials and 12.2 percent of Phase 3 trials have been terminated before the schedule. Globally, pharmaceutical R&D spending sits around $125-$160 billion a year, so those early terminations collectively cost around $20 billion a year.
• Out of 138 pivotal trials assessing 59 new therapies that received FDA approval between 2015 and 2016, there was a more than 100-fold difference in the costs of clinical trials, as per a study published in JAMA Internal Medicine in 2018.

Cost of Trial – going into the details

The cost of clinical trials is high. This high cost, along with the many incomplete or failed studies, only add to the financial burden of the sponsors. The cost considerations are at per-patient level (e.g. patient recruitment cost, retention costs and clinical procedure costs) or per site level (e.g., Site monitoring costs, administrative staff costs, site selection and retention costs) or per study level (e.g., protocol creation and amendment, planning and data management).

If we look at the cost distribution across phases of the trial, cost categories like Data Management Costs, Recruitment, Retention and Monitoring costs for Patients and Site add up to significantly increase the overall cost for each of the first 3 phases of the trial. There are many important factors which are driving the increase in the overall cost of trials  – increasingly complex therapeutic areas needing complex procedures/ therapies, recruitment of patients with very specific criteria and their retention, global regulatory requirements, supply chain logistics challenges,  effort consumed in managing big data and the increasing cost of manual effort of a specialized workforce.

In Search of Solutions

With the Covid enhanced focus on cost optimization, clinical organizations are looking at leveraging the latest technologies which can help them in digitizing clinical trials and optimizing their operations. The cost take-out initiatives should be automation-led and designed such that it is sustainable and supports the future industry needs.

Data aspect – Effective use of data is one of the key aspects which will help efficient and innovative execution of trials. Starting from a proper understanding of diseases and molecules to better protocol criteria creation, patient selection and understanding, and remote monitoring resulting in efficient adaptive trials and ensuring fast closure of trials in case of unfavorable outcomes are all important points to consider for today’s trials.

Process aspect – Automation in clinical trials is increasing, thus leading to reduced site visits by patients and clinical operations’ staff. Efficient usage of sites, personal and logistics (site clustering based on therapeutic area, supporting remote global sites for niche disease with supporting logistics, etc.) all supported by digitized intelligent processes will enable cost-efficient execution with a focus on the quality outcome.

It is expected that the trials industry will go through lot of innovations with the increasing importance of omics data, personalized medicine, orphan drugs, etc. It will be interesting to observe how the industry transforms itself – both the CRO industry and the digital clinical trials operations within pharma companies as it navigates through all these.

In the upcoming blog, we will discuss about the data aspect and see how it can help enable transparency and provide real-time visibility into clinical trial management. Stay tuned.