By Theis Jensen and Kieran Reals, PA Consulting
It is well evidenced that the clinical trials industry is experiencing unprecedented change. Patients are increasingly seeking trials relevant to their specific needs and lifestyles, patient advocacy groups are driving for more representative and inclusive trial processes, and regulators have begun actively advocating for clinical trials that place the research patient at the center of the study.
Decentralized clinical trials (DCTs) offer a way to improve the patient experience, with a growing body of evidence showing that they can offer increases in patient recruitment and retention and faster time to market. The road to mainstream implementation of DCTs has been long but it is increasingly becoming standard practice within clinical trial design; for example, the Heads of Medicines Agencies, European Commission, and European Medicines Agency’s newly published “Recommendation Paper on Decentralized Elements in Clinical Trials” has the stated aim of “facilitat[ing] the use of decentralized elements in clinical trials in the EU/EEA.” The challenge that sponsors are facing is how to deliver the innovative organizational transformation that this requires, while also meeting the often-competing needs of stakeholders such as the site, ethics committees, CRO partners, and other parts of their organizations. What is clear is that differing approaches to solving this problem have led to an industry landscape that varies in its ability to have a human-centric response to decisions.
For industry leaders, it can be difficult to know how to address this challenge. A framework approach will enable you to assess your organization’s current clinical trial innovation maturity and build a plan from there.
Below is a summary of what to consider, while providing a deeper dive into practical and actionable steps to become more human-centric in your approach to clinical trial design and delivery:
Stage 1: You Are Beginning Your Clinical Trial Transformation Journey
This group includes life science leaders looking to embark on a transformation journey, implement DCTs, and start realizing their time, cost, and organizational benefits. Some areas of their organization may have experience with select DCT elements or tools (either with current DCT technologies or similar technologies in other development stages) but they haven’t led to wider use. How can you move forward?
- Set a vision and define your success criteria. Define your benefits and metrics for the transformation and rally stakeholders to support it. This should be ambitious, while ensuring that you have a suitable timeframe for your goals. The emphasis should be on outcome realization (such as patient experience or a reduction in in-field study time), rather than realizing short-term cash-releasing benefits. This gives your organization room to experiment and embed the changes, opening the path to bigger, longer-term impacts.
- Understand your stakeholders. Conduct a review of your patient pain points and make these your primary focus for improvement. Create multiple patient personas to simulate a wide range of experiences in your future clinical trial. This will allow you to identify additional pain points, as well as those unique to certain patient populations. This will enable you to specifically target protocol and study requirements. It can also be valuable to initiate targeted stakeholder surveys and working groups to provide direct and immediate feedback on your work, which will allow you to stay focused on the changes that deliver the greatest value for your patients, caregivers, and staff.
- Communicate your ideas for a foundation for change. In the early stages your focus should be on clear communication of your vision and working to ensure that people are able to engage with the upcoming changes. Use techniques that help cement this as a core initiative and generate excitement within your organization. For example, set up central innovation teams, knowledge sharing forums, and positive behavioral initiatives to build an engaged community that can quickly develop and scale ideas. It will be tempting to start many pilots at once, but this may lead to a fragmented approach. Focus on quickly testing your ideas and then scale the successes throughout your organization.
Your immediate focus should be on realizing benefits across a variety of use cases, such as study phases, indications or therapeutic areas, or countries; with an eye on cost neutrality while increasing participant satisfaction. Your focus will likely be on delivering the best elements of human-centric approaches that have been successfully used elsewhere, and this is a great first step. Internally, you will start to build momentum behind your initiatives and start to feel a pull for DCT implementation, which will set you up well for the next stage of maturity.
Stage 2: You Are Forging Forward With Innovation
This group includes life science leaders who are looking to establish DCTs as business as usual within their organization, scale their initial investments in DCTs more widely across their enterprise, and capitalize on successes. They are considering forming stable preferred vendor relationships, standardizing the funding, deployment, and evaluation of initiatives, or looking to see what sits over the current innovation horizon. How can you move forward?
- Examine what has gone well (and what hasn’t). Understand where you have been successful previously and where there are further opportunities to realize value by conducting an inventory of your DCT initiatives, assessing their impact, and drawing insights that can be used in other trials. You should conduct a product or portfolio level audit and design testable hypotheses on how to maximize your return on investment and help align your future vision with your product development pipeline.
- Expand your understanding of your stakeholders’ wishes and needs. To create ongoing, meaningful change it’s important to understand the needs and motivations of your current and future patient populations. There are a wide range of tools available to gain insights into stakeholder groups, and we find that combining quantitative and qualitative methods creates powerful and usable insights to attract and retain the necessary diversity of patients. Using targeted sessions to understand the challenges and joys that your sites, patients, and staff face will help you build more complete stakeholder maps. Conducting a physical walkthrough of the trial process with your patients and their families will help you to understand real-world challenges, while organizational network analysis can show the informal communication channels that exist between individuals and highlight where you can target interventions to reach previously unengaged members of your organization. These interventions aren’t exclusive to this group of organizations and can deliver great benefit when conducted in any industry.
- Build a positive culture of innovation and change across your whole organization. You will likely have various levels of experience across your organization, and some areas will be more open to change than others. At the core of driving a successful transformation is ensuring that all staff have the appropriate awareness, training, and support structures to allow them to consider human-centric approaches. You can use this opportunity to take a fresh look at how you reward innovation, recruit for roles, and provide recognition structures that encourage your new way of working.
Consider adjusting existing scorecards and evaluation mechanisms to value innovation more highly. This can be linked to return on investment (ROI) measures that contain both quantitative and qualitative success measures. Consider using a triple-bottom line approach: financial benefits, increased stakeholder experience, and environmental sustainability.
Through continual refinement you will start to demonstrate increased speed to market and create a network of stakeholder supporters for your initiative. Importantly, you will also be able to draw lessons from every opportunity and translate these insights into successful future projects. This helps establish a culture that values innovations that provide meaningful impact across the stakeholder landscape.
Stage 3: You Are Trailblazing Into The Future
This group includes life science leaders who have a strong corporate vision when it comes to DCT strategy and are looking to continue to develop their approach to create an enterprise advantage. Their activities are underpinned by a solid business design that fosters collaboration across therapeutic areas and internal departments. They include a wide variety of stakeholders in their work, often reaching across preclinical, regulatory, procurement, evidence, and market access to ensure a well-rounded approach that minimizes risks. How can you move forward?
- Make innovation central to your strategy. Review your strategic approach to see how you can refine it based on the lessons you’ve learned. If you have a therapeutic area or an affiliate that hasn’t yet been able to implement DCT at the same success level as elsewhere in the organization, then it might be time to rework how you are approaching change. Step back and take an all-encompassing look at what you are doing and where you want to go.
Consolidate your expertise, continue to invest in organizational capacity, and focus on making innovation central to the organization. This may require you to take a critical view of your processes and existing tools. To truly stretch the boundaries, you also need to focus on how you test new ideas and whether your internal structures support experimentation.
Take stock of your relationships, too. Consider engaging directly with regulators through industry consortia to positively drive the direction of clinical trial innovation. This will also help you understand how changes in global healthcare systems might impact your long-term vision. Investigate how you can align more closely with academic research groups.
- Continually improve your feedback channels to ensure no voice goes unheard. You have an opportunity to grow the horizons of your insights. Review your current channels and challenge whether these include everyone who could provide insight. Trial-naïve healthcare professionals experience additional challenges when engaging with clinical trials, requiring additional support to ensure an optimal experience for their patients. The methods that you use to obtain insights may prevent underrepresented groups from having their voices heard. Patient advocacy groups can provide additional support if they are engaged with consistently and considerately. Asking yourself tough questions about the ways you are currently operating allows for the continual improvement of feedback channels, transforming them into a two-way conversation.
- Go beyond current paradigms and ensure future scalability. Study your past successes to see what has gone well in other change activities, reflect on any changes that didn’t last, and identify if there are any pockets of change that you have difficulty scaling. Future horizon planning and wargaming tools are an excellent way to think beyond current paradigms and assess whether your current models will keep you ahead of the curve.
Your organization’s structure and culture need to reflect your ambition to move a larger number of successful pilots into business as usual. Although support from the C-suite is essential to drive transformation, you need to establish channels to gather ideas “bottom-up,” ensuring that those who are closest to the challenges can easily engage with your innovation team to drive meaningful improvements in the stakeholder experience.
This approach to continual learning and adoption will help you to stay at the forefront of innovation while keeping a clear focus on increasing speed to market and reducing development costs. You will allow your staff to focus on human-centric measures, such as increased participant diversity, patient treatment adherence, care access, real-world data generation, and close collaboration with healthcare systems to support population health data gathering. As the clinical trial market continues to develop, your participant-first position will help you stand out as the top company for clinical trial sites, patients, patient advocacy groups, and systems to work with – improving your clinical operations and brand equity in equal measures.
With the level of adoption of decentralized trial methodologies continuing to grow despite the predicted pullback following the lessening of pandemic restrictions, all organizations should be asking how they can do more, and move faster, toward more human-centric trial designs.
The approach outlined in the above framework is based around agile principles. This allows companies to quickly gather insights, create an idea, and test it with the impacted community. You will start to see how programs of work move beyond testing phases and embed as standard practice throughout your organization.
Life science leaders can use the framework to identify the actions that will deliver more human-centric clinical trials and capitalize on the opportunity to improve patient recruitment, retention, and time to market.
About The Authors:
Kieran Reals is a life sciences expert at PA Consulting. He helps healthcare and life sciences organizations design and deliver digital and operational transformation initiatives. A specialist in human-centric clinical trials, he specializes in radically transforming clinical trial portfolios. Contact him on LinkedIn.
Theis Jensen is a life sciences expert at PA Consulting. He works with pharmaceutical companies on the decentralization of clinical trials and helped a consortium of pharmaceutical companies set a long-term vision for more patient-friendly clinical trials. Contact him on LinkedIn.