From The Editor | November 17, 2021

Clinical Trials Enter A New Digital Era

Ed Miseta

By Ed Miseta, Chief Editor, Clinical Leader
Follow Me On Twitter @EdClinical

Concept of change iStock-660328504

The life sciences industry has been undergoing a transformation. Its seen advancements in how therapies are developed and improvements in how the industry works together. One development that has helped the industry evolve is the shift to digital technologies. The COVID-19 pandemic forced companies to adopt decentralized technologies to enable remote trial execution. The shift introduced more technologies into the trial ecosystem, which has created challenges for companies.

A panel of experts at the Veeva R&D and Quality Summit Connect addressed this topic in a roundtable discussion. The panel consisted of Lorena Gomez of AbbVie, Staci McDonald of Celerion, Mayank Anand of GSK, and Mark Morais of Labcorp Drug Development.

The panel notes COVID forced companies to quickly adopt digital approaches, but drug developers are now trying to be more forward thinking. Digital technologies present pharma with the opportunity to make clinical studies more accommodating of sites and patients. A strategic enterprise plan will likely be required to make protocols simpler and easier to execute while facilitating digital approaches.   

If pharma companies do not understand the challenges they face, the added complexity of clinical trials will manifest itself in terms of additional burdens to sites and patients. Drug developers must think about the impact of digital technologies on sites, patients, and protocol design, especially in terms of what companies are capturing and how they are doing so.

Moving forward, it will be important for companies to strategically collaborate to understand how the patient journey and site relationships will change. In the past, sponsor companies have always brought trials to sites. Now, they will have to find a way to bring patients to trials.

The panel believes digital technologies are going to greatly broaden the opportunities to reach new patients in a more cost-effective way. However, if not planned carefully, complexity could derail the opportunity and hurt the industry.

Gomez summed it up best, noting, “There are still many unknowns. It's the wild west in the digital space and even regulators aren't necessarily aligned on things as simple as whether devices need to be labeled or not. There are a lot of different moving parts and there's a lot of work ahead to pave the path to digital.”

From a system landscape perspective, digital presents challenges for sites. There are many systems sites are forced to deal with, and while digital tools can be great for patients and studies, they can lead investigators to have 10 logins. For sites, it can be challenging to execute trial processes through 10 different systems.

Can Digital Simplify Protocols?

Simplified protocols would be good news for the industry. Biomarkers have become more readily available, but with them has come an increase in trial complexity. Unfortunately, protocol designs have remained the same. Finding ways to simplify protocol development would be good news for the industry.

Anand notes there are two components adding to the increased complexity in trials: data and technology. Although technology will play a vital role in future trial strategies, digital technologies are not fully mature. At the same time, organizations are looking for multiple solutions, increasing risk and creating an even more complex environment.

Increased data collection is the other challenge. Companies may have plans to use sensors and other decentralized technologies to increase their data by 10x or 20x. Companies may struggle to manage that data when they are already struggling with the data they collect from trials.

“This adds another level of complexity,” says Anand. “Data is going to explode in the next couple of years. Instant data cleaning will become a bigger challenge because the expectation will be that if data ingestion is faster, the output must be faster too. With technology and data, we must address how we plug in to enable simplicity and a connected architecture. Otherwise, in the next five years we'll be doing another project or transformation to address these issues.”

Digital solutions, while having a lot of promise, have increased the potential challenges related to system fragmentation, technology maturity, and data silos. This raises the question of what organizations can do to advance better trial outcomes.  

Anand notes one solution is the clinical hub. While the concept has been around for some time, data existing in different silos has elevated the need for a better approach. The future may lie in having a single source of ingestion and aggregation. This is difficult to accomplish at present because of the inability of companies to standardize.

“If we want to simplify trials, standardization should be at the core of what we do,” says Anand. “Companies should stop customizing tools according to protocols or specific requirements. Adopt and adapt the tool the way it is. That will be a more efficient way to bring simplicity to trials. This will not only help you but will benefit investigators and patients because they face the complexity of these customized systems.”

While standardization is good, too much of it can stifle innovation. Morais cautions that we need to find a balance between the two.

What Role Will Regulators Play?

eConsent and ePRO have a lot of promise but face barriers to adoption. Those barriers can vary across country and region. Gomez believes there are two pieces to the challenge. The first is the upfront strategy around how the digital pieces fit together from a data perspective. The second is the implementation of the tools and whether you can do so in the countries where you’ll be conducting your trial.

“It took time to move from CRFs to eCRFs, and that is where we are now with digital technologies,” says Gomez. “Even regulators are still working on figuring out this space. As an industry we need to continue communicating with each other. Sharing best practices and setting standards as an industry will be critical to eliminating the obstacles that exist.”

Anand agrees, noting European data protection doesn’t allow ease in using data centers outside the EU in relation to EU data protection law. This sometimes creates a bottleneck for organizations adopting technologies that don’t have data storage within the EU. Addressing the data challenges will require the industry to change its mindset.  

This issue has many wondering what the role of regulators will be. Anand believes it will be important for all regulatory authorities to have a dialogue with pharma companies. He believes sponsors and CROs are ready to have that conversation and doing so in an incubation center will help the industry understand what needs to be unlearned. Not doing so will slow the shift to digital trials.   

“We are starting our journey toward digital, so it's very important to have those incubations and those conversations such as new ways of looking into data privacy,” says Anand. “It is usually said that if the data is outside the country or region of origin, it is in danger. But that's not the reality if you have the right validated tools in place. Regulators are still not convinced that with all this digitalization, the industry will be able to safeguard people's rights in terms of data privacy. That’s the industry-wide conversation that must happen.”

Morais agrees, noting the industry must have a forum or information sharing session where every stakeholder can speak openly about the impact of digital technologies and share what roadmaps must look like to drive towards a cohesive strategy. He believes this will be a difficult challenge.

“We all need to understand the impact that digital is going to have on protocol design, the way it will influence research in the future, and recognize that it's a changing landscape,” he says. “This is an ongoing conversation where we come back to the table and continue to look at the adoption and the evolution.”