Author: Dan Beaudry, Senior Vice President, Customer Success
As the shift towards decentralized clinical trials accelerates, powered by the COVID-19 pandemic as well as the more patient-centric approach it provides, there is a significant role to be played by risk-based quality management (RBQM) technology.
Designed to support the remote collection and monitoring of clinical trial data, it offers a framework for study teams to focus on the most critical data and to visualize and analyze data in the dimensions typical in full or hybrid DCT studies.
Following on from our blog about considerations for small biotech’s looking to implement RBQM, here’s a closer look at how mid-sized biopharma has successfully implemented the approach – and some valuable lessons that have been learned along the journey.
1. Desired outcomes to be defined at the start
Identifying the criteria for success from the outset is vital. As we stated in our earlier blog, as you set out on this journey you need to define why you are undertaking the transition to a risk-based approach. Clearly defining what you want to get out of the technology will help develop a proper foundation to achieve those aims.
Setting both short-term and long-term goals will ensure the quality and integrity is there from the outset.
2. Understanding people and how to work with partners
This point has three strands: Firstly, particularly for both small and medium-sized companies, understanding the people you have within your business is critical. Fewer people, though likely of a higher caliber, means a tighter approach is needed as it will entail a different position on methodology and outsourcing.
Secondly, make sure you understand the institutional knowledge your people may already have about RBQM – and identify the flagbearers for its implementation early on. RBQM champions have an important role to play in working across the organization to communicate, motivate and educate.
Thirdly, consider how you will utilize partners – both CROs and eClinical providers – to facilitate the implementation. Every person on the cross-functional team needs to know who is doing what and, as well as a clear understanding of roles, it is necessary to define each person’s expectations. Defining the participation of various roles according to the RACI (responsible, accountable, consulted, and informed) matrix can be invaluable to delineate the activities being undertaken, both in-house and with partners.
Understanding the people you have, and their view of these approaches is going to be critical as we move forward. For example, if the head of clinical at a pharma company who is extremely well-versed in risk-based approaches is working with a CRO who is relatively unsure of risk-based approaches, each needs to understand the perceptions of the other and how it will influence the direction of travel.
3. Understand who they are as a business and how to operate
With outsourcing strategies, it is important to be clear when you want other organizations to stay involved, and when to empower others to do the day-to-day activities, to avoid conflict. Sponsor companies providing oversight may want to dig deeper into the data, for example, which is why it is vital to consider how you want the process to operate and ensure that view is shared.
There are two models which have worked well for mid-sized biopharma: the sponsor owns the study and the sponsor’s resources do the heavy lifting, or the CRO is empowered to do the job with clearly defined oversight from the sponsor. The third model, which can be a little more problematic, is that the sponsor outsources the study but wants to remain heavily involved. It is important that what happens in practice doesn’t conflict with the intention – which requires working out what you want as an organization, and how the people within the organization support that, to ensure the reality matches the strategy for all parties.
4. All terminology being defined from the outset
To avoid any confusion, it is critical that every party understands what is being discussed in order. Every term, from data surveillance to supervised risk review and root cause analysis, should be defined upfront to guarantee uniformity and universal comprehension.
5. Agreeing standard operating procedures and processes early on
The more clearly and articulately teams operate, the better chance of achieving the desired outcomes. With RBQM, the more the process can be defined – as well as people’s roles, using the RACI matrix – the easier it is going to be working together along the journey and to make that journey a success.
This is something we see organizations asking for more and more, but it is important to stress that it doesn’t need to be onerous. You can implement RBQM without standard operating procedures or process diagrams, but it is a useful approach to create clear reference points for everyone involved and save time and effort in the long term.
6. Define the journey and implement RBQM gradually
Mid-sized biopharma companies that successfully implemented RBQM did so pragmatically, revealing the value incrementally. Risk-based approaches offer the opportunity to increase quality and resource efficiency and reduce the timeline for clinical trials – and there are quick wins available as you work through the journey.
By ranking priorities in order of value, then beginning with the most important tasks, the approach can rapidly add value; less-pressing priorities can then be tackled further down the line. Again, this is not burdensome – there is no need for additional resources or time. We have worked with organizations to implement key risk indicators initially on a monthly basis, providing information to pass to CROs to action. Then, once the trial was well underway, we augmented the process with data surveillance to add further value once the building blocks were in place.
7. Identifying what can be standardized and what is study-specific
Using a statistically based approach means that it is worth investing a little time upfront to learn the methodology. As mentioned in our earlier blog data literacy is vital: you don’t need to be a statistician but investing a little time early on will pay dividends further down the line.
Similarly, define at the outset what can be used as a standard for each trial and then identify the elements that need to be study specific. Develop a methodology to allow you to quickly identify the study-specific data and deal with it, for example how to manage protocol deviation oversight across the board.
8. Assessing the risk profile of the types of trials and therapeutic focus
Who are you as a business? What is the disease state you are in? This can help to supply a significant amount of historical data that you can get a head start with.
9. Working out the requirements that could impact implementation
For organizations keen to plug in CluePoints, it is helpful to first research what the quality and IT parameters will be for its implementation. What tech restraints could hamper the introduction of RBQM? What is your Software Development Life Cycle and how will this affect the implementation of RBQM? Will it take a matter of weeks or months? It is always something we raise early with clients to help them focus on preparing for implementation.
10. Identifying ways to prove value from the start
Mid-sized biopharma are initiating the adoption of RBQM technology for a reason – and early proof points can help to convince executive management that it is a useful addition. If we can identify the plans and generate early success stories, it will help accelerate the pace of development.
Successful companies added stage gates to the project management to offer evidence of value: for example, a proof-of-concept phase followed by a proof-of-value phase before full implementation. This ensures every level of the organization is on board with the value the approach offers so those involved can get to business as usual as quickly as possible.