CASE STUDY – Clinical trials are known for their rigorous analysis and approval process. The experience of Roche Brasil teaches us what lean and agile thinking can do to speed it up.
Words: Augusto Elias da Fonseca, Ludmila Lara Matai Xavier, and Robson Gouveia
Historically, Brazil has been one of the countries that take longer to obtain the approval necessary to initiate clinical trials. This means we often miss out on the opportunity to participate in such studies and we are left with a smaller number of research participants compared to other countries that carry out the approval process more quickly.
In this context, Roche – one of the major pharmaceutical companies in the world – took on the difficult task of reducing the lead-time of the process to ensure Brazil doesn’t lag behind and miss any more opportunities resulting from these studies. Participation in trials is critical to develop new, innovative treatments against different conditions. The corporation managed to reduce the approval time in Brazil by nearly 50% using Lean Thinking, thus achieving times that are similar to those we see in other countries (like certain European nations).
Roche currently has a new management system that relies on daily management and visual management to support their decision-making and accelerate the overall process. By changing their siloed structure, which made them work together but in a disjointed way, they achieved greater levels of experience and solution sharing.
The result of all this is a cultural and behavioral change of the people involved in the process, who started to implement improvements beyond the discussions of the individual silos. This way, they reduced times and increased the productivity of problematic tasks, leveraging the discussions resulting from the daily management to establish more systemic thinking.
HOW DID THEY DO IT?
Brazil is a core country when it comes to conducting clinical trials, whose number nearly doubled between 2019 and 2020. However, with the country’s highly complex and unpredictable regulatory system, this perception of heavy workload combined with the company’s restriction to continue with new hires at the same pace of recent years made Roche’s current way of working unsustainable.
That’s why the pharma company has been on a transformation journey since July 2020, with the aim to increase the investment in trials and development and to double the number of projects within five years. As a response to the need to help Brazil reach the same pace as the rest of the world, Roche needed to design a new management system with the vision of providing three to five times more benefits to patients and half the cost for the business.
So, the work began. The analysis of the company’s current state highlighted the main causes behind the long lead-time – working as a starting point to define cross-functional issues and objectives – and allowed them to understand how to bridge the gap between current and future states (the latter being where they wanted to be, based on the chosen objectives). This way, they were able to identify the actions and countermeasures they would need to implement to stabilize or improve the current state, implementing several kaizen along the way. The results didn’t take long to appear…
THE “KATE 3” STUDY
One of the Roche clinical trials that showed excellent results thanks to implementation of Lean Thinking was the “Kate 3”. They managed to reach an activation time of 133 days, well below the target they had set at the beginning of the project, which was 155. These results surprised the global Roche team because they were similar to the numbers observed in countries with much more solid processes in place for clinical trial approval, such as US. This was something unthinkable in Brazil, which was traditionally seen as a country whose clinical trials are marred with complexity and slowness. More than that, Roche managed to make Brazil the first country to file a submission for this trial and one of the first countries to recruit trial participants and begin the research – a truly impressive result.
Brazil started to be looked at more favorably by the Roche global team, which in turn gave a big push to the lean transformation of the organization. In recognition of these results, Brazil was given priority in receiving trial documentation – which means that new medication (the subject of the study) reached country much faster than it normally would have.
The planning and collaboration among all the teams involved in this study had a clear, positive impact on the results, leading the trial to a level success that had never been seen before at Roche Brazil. The trial became a reference for Roche’s clinical trials, in Brazil and beyond.
Six months into the project, Roche managed to increase the number of trials from 65 to 81, with the expectation to reach 100 within the next six months – all of this with no extra resources. The company recently ranked first in the world for corporate reputation according to patients’ association around the globe – as can be seen in the Corporate Reputation of Pharma report published by PatientView, an independent organization in the UK. In 2018, Roche had come in fourth.
To continue growing and follow the right path, the company will have to take in the lessons learned so far and use them to inform their plans. The impressive results they achieved were a result of their efforts to connect the lean philosophy with agile thinking, to carry out problem analysis, and to engage in short implementation cycles. The engagement of the team and the speed at which they improved the process were essential elements in the success of this initiative, and certainly made continuous improvement a part of the company’s narrative.
Armed with all this experience, the team is now looking to bring kaizen to the ethics, regulatory and feasibility levels, connecting cross-functional issues to daily management. Expanding the transformation across the company and going deeper and deeper into Lean Thinking will provide a great contribution to Brazilian society: the more agile the process, the more access to medications (and benefit from them) people will get. Such is the power of Lean Thinking!
The transformation at Roche was facilitated by a team of lean coaches from Lean Institute Brasil.
Augusto Elias R. da Fonseca is a Project Manager at Lean Institute Brasil.
Ludmila Lara Matai Xavier is Compliance, Processes, Training and Systems Manager at Roche Brasil.
Robson Gouveia is Director at Lean Institute Brasil.