Date: 01/25/2021

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anuary 25, 2021

The clinical research community has been disrupted in a number of ways due to COVID-19 and sparked a spirit of collaboration and innovation. Worldwide Clinical Trial’s Aman Khera gives five predictions of how clinical research could change in 2021.

The pandemic has propelled the life science industry toward higher expectations for faster, more responsive and more inclusive drug development. It has also shown the impact timely data can have when used in conjunction with transparency and education initiatives.

Still, some formidable challenges remain before the industry will fully harness the potential benefits uncovered by COVID-19. I believe 2021 promises to be a year of industry-wide introspection, assessment and analysis.

The five areas I predict will undergo special scrutiny and improvements throughout the coming year include:

transparency and accountability

public education

clinical trial diversity

real-world evidence (RWE)

digitalisation

Prediction 1: Increased transparency and accountability

It has been thrilling to watch how COVID-19 has catapulted the pace of collaboration among regulatory agencies. The immense amount of sharing — of data and expertise — among regulators around the world is expected to be the first step toward greater collaboration to help accelerate the launch of products globally.

That said, while industry is already scrutinised from within, increased public pressure for transparency will require all clinical trial experts (including regulators) to communicate proactively with the public.

“Proactive public engagement efforts need to replace age-old recruitment and retention processes”

It is likely we will begin to see the public ask more questions, which in turn may require more regular and ongoing communication efforts by industry stakeholders. The rationales behind processes and decisions will need to be explained in layman’s terms.

Hopefully, this increased transparency and accountability will translate into more collaboration among sponsors, regulators and other stakeholders — including patients — earlier in the drug development process. Sponsors may start to appreciate the benefits of allowing industry regulators to pull up a seat at the development table, for example. Yet the most important stakeholder to engage is the patient.

Increased accountability involves putting the patient voice front-and-centre in drug development. In fact, the patient voice should be heard and understood even before finalising a study’s protocol. Although including patients in the entire drug development journey (rather than as an afterthought) puts more onus on sponsors, it can ensure stronger engagement and more successful outcomes.

Prediction 2: Better public education

Conflicting headlines about COVID-19 trials further damaged the public’s already shaky trust in clinical trials. Nevertheless, at least the public is now showing a strong interest in clinical studies. That means the industry has a terrific opportunity to proactively engage the public in future R&D activities.

Sponsors will want to capitalise on the heightened public interest during 2021 and beyond by building trust. They can do so by providing education, training and sound communication — not only about their own company and products but also about the clinical indications with which targeted patient populations must live. Sponsors can tell the patient stories that go deeper than any one study, while accurately educating the public on the significance of clinical trials and how they work.

In short: Proactive public engagement efforts need to replace age-old recruitment and retention processes. Fortunately, many of the issues in this space are due to very fixable communication deficiencies.

First and foremost, we must recognise that communication — like other aspects of clinical R&D — is not one-size-fits-all. Sponsors must respect all the different dimensions involved, including the integrity of social platforms as well as various cultural competencies. In addition, sponsors should anticipate questions and be armed with answers that reiterate their commitment to education and transparency.

Prediction 3: Renewed focus on diversity

Disparities in the impact of COVID-19 within specific patient populations has spotlighted the value of diversity within clinical trial recruitment. Coupled with recent movements toward greater cultural awareness and inclusion, there is little doubt that the industry will work hard in 2021 to improve diversity in trial participation — and as a result develop more globally effective therapies.

What this means, however, is that sponsors can no longer rely on providers to recommend trial participants. Instead, sponsors, contract research organisations (CROs) and others must seek to understand all the cultural, religious and geographic differences that could impact successful recruitment within various patient pools.

Proactive outreach to patient advocacy and community organisations can help start these conversations, as well as elevate the multitude of patient voices within trial development. When done properly, participants can benefit from a clear understanding of clinical trials’ importance, and sponsors can gain a deeper appreciation of a trial’s potential impact on the lives of patients from all walks of life.

Prediction 4: More emphasis on real-world evidence (RWE)

Last year, the FDA granted its first approval based on RWE alone. To date, we have seen significant cross-industry collaborations to develop standards and new regulatory guidance for acceptable RWE use cases. It is certainly not an overstatement to say RWE and real-world data (RWD) are true game-changers.

So, we should expect drug development in 2021 to evolve toward more regulatory decisions based on RWE and fewer decisions based solely on clinical trial outcomes. Efforts to evaluate real-world outcomes versus clinical trial outcomes will increase in frequency and intensity. For sponsors, there are notable benefits to this approach, including:

RWE can help bring drugs to market expeditiously

RWE can enable trials to explore novel endpoints that are more realistic to the ever-changing landscape of patient-centred outcomes.

However, this sea change won’t be without its challenges and even some inherent dangers. If the data involved is not of suitable rigor, then we could end up amplifying the very problems we are trying to fix.

Therefore, sponsors will need access to more data sources to monitor and study safety and efficacy. They must think about innovative and resourceful approaches for sourcing RWD, including how to collect and connect datasets across multiple data providers. Furthermore, they will need data partners who can create data models that match the stringent criteria of trials that use RWE.

A careful approach will need to be considered — drug to drug, country to country, region to region, and population to population. The patients must always be top of mind. Who are they? Are we truly getting access to them? While RWE and RWD undoubtedly are steps in the right direction, they do not solve all of our challenges or negate the work that remains to be done.

Prediction 5: Disruption through digitalisation

It goes without saying, but paper-based patient data collection is archaic.

The clinical research community has realised this for years, but COVID-19 finally challenged us to further adopt digitalisation. Now, few can imagine that the industry will ever go back to the way clinical research used to occur.

Sponsors and CROs undoubtedly will continue to push the digitalisation envelope further by using new technology to monitor participant results. In tandem, the concept of decentralised trials should gain greater traction. Sponsors and agencies will want to carefully consider opportunities where it makes sense to use digitalisation to drive a decentralised approach.

However, just as with RWE, digitalisation will present some unique challenges. The regulation of digitised patient data will be an ongoing concern, of course, as will issues with standardisation, privacy and ethics. The industry will also have to catch up with the amount of patient data it stores and how it stores it. Chain-of-custody data maps, for example, may become a more prevalent way to keep tabs on data flow and integrity.

Regardless how the challenges of digitalisation evolve, sponsors cannot afford to sit back and wait for regulators to set the tone. The time to join the conversations is now, while there is still a chance to help guide the digital frameworks within which we must operate going forward.

On the path to better product development

I predict that the historic events of 2020 will prove to be the impetus needed to bring more innovation, responsiveness and inclusiveness into clinical research. It will be essential, therefore, to use the lessons learned from COVID-19 to continue improving clinical research in 2021 and beyond.

The entire industry is primed to expand the adoption of digitalisation and RWE, create diversified and patient-centric trials and enhance transparency and accountability. None of these objectives are simple to accomplish, of course. But with combined dedication and effort, achieving these goals will surely result in better, faster and more successful product development.

About the author

Aman Khera, global head of regulatory strategy at Worldwide Clinical Trials, has been providing global strategic direction in regulatory affairs for more than two decades. She has built her career on maintaining fastidious patient care with the pragmatism needed to help clients achieve effective regulatory strategies.