Evolving Decentralized Trials: Insights from Sponsors & Vendors

Since the pandemic began, numerous elements of trials have shifted to accommodate decentralized practices. In our webinar Hindsight 2020: Evaluating Decentralization and Supply Chain Trends, panelists from Biogen, GSK, PCI, and Suvoda reflected on over a year’s experience navigating the effects of the pandemic. They described lessons learned since the beginning of the pandemic, what trends they see advancing to become more permanent, and what’s next in the technological pipeline.

Panelists:

  • Imran Shakur, Associate Director of Clinical Supply Capabilities at Biogen
  • Abigail Stephens, Manager of Services Delivery, Suvoda
  • Joe Bangert, Head of RAMOS IRT at GlaxoSmithKline
  • Tris Evans, VP, Global Quality, PCI Clinical Services
  • Andrés Escallon, VP of eClinical Innovation at Suvoda

Below are the event’s highlights. 

How do you define decentralization or decentralized trials?

Imran Shakur: From my perspective, it’s about creating convenience for the patient. It’s offering patients the flexibility of coming into the clinic and leveraging technology for when visits can be done at home. Ultimately, the significance is in expanding access to patients who may not be able to fully participate in trials currently. 

Abigail Stephens: Decentralization isn’t an all-or-nothing approach. Trials can have components for flexibility for patients who may live further away from sites.

Joe Bangert: A trial can be decentralized on a number of aspects. Some examples are that it could use eConsent or eCOA,  patients may not come in for visits, or drug may be shipped to the subjects’ homes. Any of these aspects can be applied in a number of ways, whether to some of the subjects, some of the sites, or some of the visits.

 

How have trial designs or other elements of trials shifted to incorporate elements of decentralized trials?

Abigail Stephens: My team and I at Suvoda saw a marked increase in decentralized elements of trials. The pandemic definitely highlighted a need for more direct-to-patient shipment in trials. We had to help companies shift to a direct-to-patient solution mid-study or to equip them up front before the trial commenced to give them that flexibility.

Tris Evans: We’ve seen less of an uptick in true direct-to-patient from depots. We’ve had to support sponsors to send drug from site to patient with the help of the global courier base that we work with and our direct services. While supply chain restrictions have relaxed, it’s still a challenge to maintain fluidity and plan ahead for contingencies for various complications that didn’t previously exist.

Andrés Escallon: Decentralization brought about a shift in mindset to the biopharmaceutical industry. The level of flexibility with which sponsors have had to respond is bringing a level of inclusion in trials and greater partnership across companies to adapt. And it’s also seen as an opportunity for companies to contain costs more efficiently across studies.

Imran Shakur: Wearables are increasingly being considered up front in protocol development to track real-time information. More generally, though, we’re seeing companies’ 5 or 10 year technology roadmaps compressed into the next 2 to 3 years. The rate of adoption is accelerating.

 

What are the challenges of decentralized trials that are inhibiting progress?

Joe Bangert: Direct-to-patient shipment from depots to patients is still a grey area. The infrastructure isn’t exactly in place and it’s still hard to discern what regulatory agencies will allow. This is due to things like HIPAA laws, questions around storage of patient data such as which system stores it and how secure is that data, tracking shipments to subject homes, managing temperature excursions during shipments, and choosing the right couriers.

Tris Evans: Licensing requirements can vary across states and in countries to create restrictions on direct-to-patient shipments. It would be fantastic to see harmonization across geographies. And given audits are mostly remote now, when audits go back to in-person, time will tell whether regulators will trust us more than they do currently to uphold quality and patient safety with regard to supply. 

Andrés Escallon: Speaking to the history of eCOA, it wasn’t until regulators began to see the value of the technology that the industry began to adopt it. I see direct-to-patient and decentralization have forced us to adopt this ‘new normal’ and regulators have responded accordingly. We as an industry have to push adoption to engage regulators and actively demonstrate the value that decentralization can bring to broaden the scope of clinical research.

 

Which evolutions in decentralized trials are on track to becoming more permanent?

Joe Bangert: It seems the burden of proof for decentralized trials has all but disappeared. Before the pandemic, sponsors used to ask ‘why do you need this flexibility?’ It seems now that the expectation is that patients will have access to a number of decentralized elements in a trial for convenience and for safety.

Abigail Stephens: Due to the pandemic, even people who aren’t in clinical trials have heavily adopted telehealth to speak with their doctors. With that kind of shift in demand, patients who participate in trials will likely ask sponsors if they have telehealth and other elements of trials that they’ve seen out in the mainstream such as drug shipments. Even before the pandemic, I have seen a push from industry to make trials more inclusive in order to recruit a greater diversity of patients, and I fully expect this trend toward inclusion to continue.

Imran Shakur: We will see more permanent adoption of flexibility in the supply chain. In IRT, for instance, you may need the flexibility to change shipping lanes more easily. Having the ability to make decisions like this quicker means partnering up front with an IRT vendor who can help create that flexibility.

 

What have you learned in the last year in your efforts to decentralize trials?

Imran Shakur: From a technology standpoint, I have come to value more and more the interoperability of systems in managing trials across multiple software platforms. If systems are not able to integrate to manage data more easily, then the question becomes, ‘which system is the source of truth?’ Being able to act on disparate data can create a lot of doubt as a result. Being able to get together as vendors and sponsors as task forces to quickly make key decisions is key to making sure systems work efficiently and we can take steps together to spur innovation and adoption of decentralized processes.

Joe Bangert: The pandemic really strengthened the conversation around making sure that systems work holistically so that, say, designing an IRT system takes into account the challenges inherent within labelling and packaging logistics. To facilitate large-scale change that decentralization requires, there’s a lot of communication that needs to be done in order to get buy-in from key stakeholders.

Tris Evans: I’ve learned to be more appreciative of the workforce during the pandemic. Whether it’s shop floor personnel or remote workers doing project management, it’s important to work together to get drug to patients.


Want to learn more about where these experts expect decentralized trials to advance?

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