Clinical Researcher—February 2022 (Volume 36, Issue 1)

TRIALS & TECHNOLOGY

Ricky Lakhani

 

With accelerations in medical science and the advent of personalized medicine and patient centricity, drug and device developers have the chance to tackle unmet needs and grow their businesses like never before, but only if they make wholesale changes to the way “do” clinical trials.

Spiralling operational costs, strict compliance procedures, and difficulties in recruiting and retaining participants are age-old barriers to efficient development. Trends such as more complex trial designs, ever tightening regulations, and targeted therapies reducing the pool of potential study subjects are only serving to compound these problems.{1} In addition, there is a growing supply and demand issue—since the arrival of COVID-19, the overall volume of clinical trials and the number of procedures and endpoints they include has skyrocketed, yet sites are facing increasing financial and staffing pressures.{2}

The time is right to shake off these shackles and realize the potential of innovation. How the industry responded to COVID-19 has proved that it is possible, and now it must elevate the conversation and realize that cutting-edge science needs cutting-edge technologies.

Pandemic Change

Digital solutions are nothing new, but COVID-19, which demonstrated the need for agile, adaptable trials and for better risk management, also highlighted just how far clinical trial technology has come in recent years.

According to an article published in The Lancet in August 2020,{3} thousands of trials were suspended at the start of the pandemic to comply with social distancing and lockdown rules. As these studies came back online, sponsors and contract research organizations (CROs) turned to clinical trial technology to get back up and running quickly, safely, and cost effectively. What they found was that today’s digital platforms are faster, easier, and cheaper to implement than their traditional counterparts, and that they were more suited to modern trial conduct than ever before.

These digital platforms can, for example, generate the high-quality, clean data needed to support the focus on data-driven decision making. In addition, thanks to their greater usability, they can support trial continuation in rapidly evolving work environments, where some study team members are still working remotely and many companies are opting for hybrid home-/office-based models.

In essence, we have witnessed a monumental, and possibly unprecedented, change in clinical trial conduct. It was born of necessity but would not have been possible without agility—the hallmark of any sustainable business. The last 18 months have shown that the typically slow-moving industry can adapt to changes in the marketplace and seize new opportunities.

Further, while it may have taken a pandemic for the industry to wake up to the advantages of advanced clinical trial technologies, the benefits will extend much further than simply addressing the challenges of COVID-19.

Unified Trial Management

From supermarkets to the automobile industry, insurance to hospitality, most sectors understand the key to business growth is digital transformation. The integration of digital technology into all areas of a business fundamentally changes how it operates and delivers value to its customers. However, it is about more than just technology—it is a cultural change that requires businesses to continually challenge the status quo, experiment, and become comfortable with failure.{4}

To date, pharmaceutical, biotech, and medical device companies have been slow to rise to the digital transformation challenge. In the main part, they have taken an operational, one-dimensional approach to clinical trial technology. Individual solutions to individual problems have been employed on a piecemeal basis with little effort to “connect the dots,” but next-generation clinical trial technology has the potential to offer so much more. It can provide strategic, enterprise-wide oversight that leaders can use to identify unmet needs, ensure risk management, build in agility, and, ultimately, direct company growth.

A crucial missing part of the jigsaw is represented by clinical trial management systems (CTMSs), which are often considered discretionary. In many cases, more precedence is given to operational technologies like electronic data capture (EDC), interactive response technology (IRT), and electronic trial master files (eTMFs). However, intelligent CTMSs can be central to some of the master data required to drive the operational systems, and can be a place to unify data.

A standalone eTMF, for example, requires the duplication of master and operational data, much of which are sourced from, and reside within, the CTMS. Intelligent CTMSs can unify these disparate technologies, reducing unnecessary duplication. In turn, this increases quality and proactivity, drives process optimization, and boosts collaboration between clinical teams.

CTMSs do this in a number of ways; for example, through the eradication of spreadsheets and other manual tools, they reduce the risk of human error, thus protecting safety, easing compliance, and leading to valuable gains in clarity and efficiency in a fast-paced environment. By being at the center of an ecosystem of inbound and outbound data, intelligent CTMSs also increase transparency, aiding data reporting and informed decision making.

This not only enables the effective, efficient management of individual clinical trials, it also gives organizations access to the information they need to make C suite-level decisions. In short, modern clinical trial management technologies give organizations greater strategic oversight by making the workings of disparate trial processes more visible, thus increasing the speed and agility of trial managers as they respond to changing market conditions.

If they are to embrace these new possibilities, leaders must be willing to change. If they are bold, the return on investment will be clear across a number of factors, including cost, efficiency, transparency, and, crucially, quality. For example:

• CTMSs increase access to and transparency of data, allowing for more proactive decision making based on issues and trends that are identified more quickly.
• These systems reduce duplicate data entry and errors, and aid in reconciliation through a single source of truth for data that is shared across what would otherwise be unconnected systems.
• Clinical teams are brought together, working in harmony and reducing operational overheads in training.
• Quality system overhead is reduced through the addition of vendor validation capabilities, which focus internal validation on user acceptance testing. This shrinks in-house bureaucracy, speeding up implementation and upgrades and allowing for more frequent innovation adoption.

Post-COVID-19 Action

Unifying trial management technologies will change how clinical trials are managed post-COVID-19. Staying on top of trends and accurate analysis is, now more than ever, paramount to managing uncertainty and change, and continuously adapting to new and evolving situations. CTMSs for effective trial management can be the “new normal” and ensure that trials are ready for anything.

While standalone, siloed solutions will always have a place, the advantages of unification are clear. For one, it secures data assets in the medium to long term; this helps to guide learning and inform decision making, and reduces the risks associated with moving legacy data between systems. It is also worth noting that unified systems can greatly increase adherence and compliance with industry standards and best practices.

We need to dispel the myths about who needs to adopt such technologies and clearly demonstrate that every company involved in clinical research stands to benefit. One such myth concerns CTMS as a monolith enterprise system that takes time and expertise to set up, and so is only used across multi-study programmes. The truth is that modern systems can come with built-in standards, configuration options, and validation templates, for example, meaning they can be up and running in weeks (not months) with limited in-house knowledge. This accelerates the speed of implementation, allowing it to be used for single studies. What’s more, when it is unified with eTMF, CTMS is the “brain” and eTMF the “memory” combining processes via a consolidated, single solution.

A CTMS also allows CROs to cut the number of systems they need to adopt, validate, and integrate, reducing overhead costs and increasing efficiency. By maintaining all data assets, sponsors can clearly demonstrate proactive oversight, build an evolving knowledge base of their clinical trials, and ensure they are always compliant.

For medical device companies, embracing the unified approach can help them prepare for the forthcoming electronic medical device reporting (eMDR) regulations. Traditionally, technologies such as CTMS have not catered to these companies’ needs, but things are changing. Modular, configurable systems, with built in templates and support-as-standard, offer an easy to set up, configurable, compliant solution.

Of course, a unified trial management platform will not replace every system. Rather, it will sit at the center of an ecosystem. It will collapse some siloed processes and systems and consolidate data across different sources, offering a view of the data that fall outside the boundaries of a single study, supporting business intelligence across the board, particularly at therapeutic, portfolio, and compound levels.

Challenge Convention

If the industry is to continue to make landmark breakthroughs, it must disrupt the status quo—the digital transformation of clinical trials requires a wholesale change to the established norm. Digitalization and unification have already transformed our personal lives—a phone is no longer just a phone—but what about our professional lives?

To secure successful product development for the future, clinical operations executives must be proactive and focus on the organization as a whole. Business success depends on seeing things through a strategic lens and having the ability to adapt when necessary. Advanced clinical trial technology provides that overview.

Ultimately, the time is ripe to challenge convention in clinical trials. The science required to develop life-changing interventions exists, as does the technology needed to inform decisions and drive business growth; and if COVID-19 has taught us anything, it is that the two go hand in hand.

References

1. https://apnews.com/press-release/pr-globenewswire/d942e9ac00c59d5409dfc68974d1c25e
2. https://www.centerwatch.com/articles/24969-sites-overwhelmed-by-cost-and-trial-complexity-need-sponsor-help-to-bear-the-burden
3. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31787-6/fulltext
4. https://enterprisersproject.com/what-is-digital-transformation

Ricky Lakhani is Chief Product Officer for PHARMASEAL in Nottingham, England.