2022-09-26 | Shrinivas Anikhindi
Where is the greatest hotbed of innovation within the pharmaceutical industry? At first glance the answer to that question seems obvious – drug discovery and clinical trials are the furnaces of innovation without which the remainder of our industry would surely collapse.
And yet our approaches to the delivery of clinical trials have struggled to adapt to the needs of modern times, struggling in areas of patient recruitment, retention, and diversity.
These challenges are of no insignificant threat to our ability to rapidly develop, test, and launch efficacious medicines to the populations that need them. An important question must therefore be asked: What is the key to delivering effective and lasting change in clinical trials?
In this issue of Second Opinion, we will delve into the challenges faced by those seeking to bring transformation in the clinical trials space, and explore why the importance of change in clinical trial approaches has soared recently, ultimately unlocking the key to delivering effective and lasting change.
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PROOF OF CONCEPT: HOW COVID-19 PAINTED THE ART OF THE POSSIBLE
For years now there has been a rise in the search for solutions that address key barriers to clinical trial effectiveness. Issues with the recruitment of broad patient groups and retention of patients through long trials have put both cost and speed pressures on trial delivery. Meanwhile, limited diversity of trial groups has in turn impacted the efficacy of drugs in minority patient populations and raised concerns about the equity of the clinical trial process.
Being able to deliver faster, cheaper trials that are relevant to a greater proportion of patients is of value to pharma and patients alike, which makes this an important evolution that we must undertake.
Challenges to transformation in clinical trial approaches
Across the sector, intensive analysis and study continue to inform a search for root cause barriers to innovation in clinical trials, and overcoming these is no small feat. We have identified three important cultural challenges which may act as brakes to change that we feel need greater attention from change-makers.
- Firstly, the strict regulatory environment is a significant contributor to more conservative mindsets. It can be difficult to embark on significant change at the best of times, especially when the success / fail decision is down to an external entity.
- Secondly, we have noticed in our experience a hesitation by clinical teams (and the governance structures which manage them) to break what isn’t broken. The clinical trial process, though slow and costly at times, has proved to be a reliable and regular driver of innovation and value, and no-one wants to be the one to kill the goose which has laid a thousand golden eggs.
- Finally, as a result of the previous two, we have observed what I like to refer to as the ‘moving scenery’ effect. The nature of R&D is that change is omnipresent, from the molecular entities being tested to the diseases being treated. As a result, the idea of leveraging further change upon the same process is unappealing to key decision makers as it offers greater risk to what has already been successfully managed.
Change in the time of COVID-19
Despite all of this, we have all lived to see a period of extreme change within the field of clinical trials. During the COVID-19 pandemic, trial providers rapidly evolved and updated their processes to be able to deliver remote and decentralised trials.
Was it easy? No, and we were involved on the ground in establishing new processes for companies seeking to manage this new reality. That said, did it happen, and did it happen quickly? Absolutely.
What were the drivers of this? A greater value opportunity due to a high level of need from patients/physicians alike, funding & alignment with governments to provide support, and reduced reliance on ‘the old normal’ for solutions to new challenges.
So, when all is said and done, if we’re capable and there is the chance to offer greater value, how can we pursue this opportunity with open arms?
THE KEYS TO CHANGE
Based on our assessment of the principal challenges standing in the way of effective delivery of clinical trial transformation, and our experience in iterating change at that level, we have produced a summary of the primary keys to unlock your transformation efforts.
- 🔊💎 Clearly communicate the value of change
- Immediately pivoting to begin positioning change as a matter of WHY, rather than WHAT is incredibly important. In a part of the value chain where there is so much going on and people have so many balls to keep in the air, being able to reduce a complicated transformation down to: “What will be different, and how will you benefit” can be of great value. Be sure to link all change communication back to that benefit statement to build consistency.
- Further Reading: Ask us about our Change Impact Analysis Tool – it is a simple but effective asset to keep a birds-eye perspective of changes being made to inform their positioning with different stakeholder groups.
- 🌊♻ Say good-bye to ‘step changes’, embrace wave-based iteration
- The old era of change was fixated on ‘step changes’ – big weighty programmes that delivered brand new ways of working and, optimistically, big improvements in performance as a result. Our stance, however, is that this approach is cumbersome, inflexible, and not suitable for fast-paced and complex environments found in R&D. Iterating smaller changes in successive waves allows for cheaper change that can be tested and improved with feedback to reduce resistance from employees and users.
- Insider Tip: To make sure iterations are effectively assessed, organise them around measurable outcomes – combining operational metrics with employee feedback is crucial to demonstrate success and preserve momentum.
- ⚒👷🏽♀️ Build the right capabilities to facilitate the embedding of change
- Finally, change is meaningless if it isn’t tactile and long-lasting. The most dangerous mistake an organisation can make is not building the right operational and human capabilities to be able to take advantage of a specific transformation. Pre-empting the capabilities required through an analysis of short- and medium-term needs is vital to begin closing gaps before and in lockstep with transformations, rather than after, which will impact belief.
- Insider Tip: Similarly, understand what motivates and empowers your people to begin building the right behaviours in affected teams, relying on behaviours over SOPs to facilitate sustainable change.
WHAT CHANGES ARE WE OPENING THE DOOR FOR?
Digitalisation of clinical trials
Looking back at the threats facing the clinical trials space of cost, patient numbers, and patient accessibility, one of the biggest opportunities to bring trials into the next generation hinges on decentralisation.
The reasons this has taken time to become a mainstream school of thought are understandable – clinical trials are built on the holy principle of being delivered in controlled environments to guarantee reliable results. Previously, any attempt at taking trials out of the clinic and into homes would risk ruining that reliability. Recent innovations in the ability to remotely measure and monitor key health data, however, offer a chance to use digital innovation to run trials remotely.
During COVID-19 this concept was rapidly experimented with, successfully for many, and exposed the potential for this transformation to be more widely adopted by the industry.
We have written about this at length before, which you can find here, but the headlines are simple: being able to pivot to effective and reliable digitally delivered trials allows for them to be run much cheaper and be more accessible, therefore increasing the attractiveness for the recruitment and retention of patients.
Improving diversity of trial populations by understanding diverse experiences
Shifting the lens from the most important inputs to trials to instead looking at the outputs, what determines the success of a clinical trial? We’ve covered the reliability of data, but what about its relevance?
Recent exposure regarding the, at times glaring, imbalances in the diversity of trial populations has been tied to subsequent failings in healthcare’s ability to treat patients from minority backgrounds. Solving this is therefore an incredibly important component of ensuring greater quality treatment for patients of all backgrounds, whether that’s looking at gender, race, or even socioeconomic background.
Structural change is required to address issues in the diversity of patient populations. Often the reason for these imbalances isn’t down to objective malice or forethought, but rather more invisible issues in recruitment, retention and even trial design processes.
By considering experience first, especially from a range of diverse perspectives, you are able to identify gaps and challenges that predominantly impact specific groups of patients but not others. In doing so you begin the transformation towards more representative and efficacious trials that meet the needs of all patients, not just a select majority.
If you want to read more about gender imbalances in clinical trials, and in healthcare overall, have a read of our Second Opinion issue focused on Women’s Health here.
Change is necessary in the clinical trials space to make room for a host of transformations that will reduce costs for organisations, improve experiences for patients, and altogether supercharge a far greater level of innovation within the Life Sciences industry; resulting in greater outcomes for patients, physicians, and pharma.
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