As scores of trial teams have learned in the past two years, making the change from onsite studies to decentralized clinical trials (DCTs) or hybrid is not a simple matter. To learn more about what it takes to shift, Outsourcing-Pharma spoke with two representatives from the PPD Clinical Research Services business of Thermo Fisher Scientific:
- Jennifer Crager, executive director of digital and decentralized solutions
- Tim Rich, vice president of digital and decentralized solutions
OSP: What are some of the key questions that need to be answered before a trial team considers making the jump to DCTs?
TR: Regardless of the trial model, it’s important to think about the trial from the perspective of the key stakeholders: patients/caregivers, sites, clients, and regulators. When designing the strategy, imagine yourself in the role of each stakeholder, starting with the patient. The patient should be central to all decisions:
- Does adding eClinical technology such as eCOA, eConsent or other decentralized strategies such as home nursing make it easier for the patient to participate?
- Can an entire site visit be eliminated by using a patient app or other remote data collection method or would the patient still be required to go on-site to participate in activities that aren’t yet able to be decentralized?
This will help you determine which digital and DCT strategies makes sense for your protocol.
Next, think about the site: Will digital technologies cause increased work for the site? If so, proactively seek out solutions to mitigate that possibility.
For the client, consider their approach to innovation and design:
- Are they innovation leaders or followers? Conservative or leading edge?
- What key evidence/experience could you share to convince them of the value proposition?
And, lastly, from a regulatory design perspective we need to be thinking about country regulations, patient profiles, patient recruitment pathways, endpoint collection, IMP safety profiles, and any prior study knowledge. Once these factors have been fully considered, one can start thinking about changing the protocol and ICF to ensure flexibility for the DCT approaches. Needless to say, the earlier these design strategy/stakeholder analysis discussions can take place, the better.
OSP: Could you offer some advice on how they can operationalize their DCT strategy?
JC: In the last couple of years we have seen amazing progress in the area of decentralization of clinical research to make it easier for patients to participate. As a company, we have been at the forefront of incorporating innovation and digital tech into our study strategies. With all of the new digital and DCT technologies available, we have to be very mindful of choosing the right strategy that is fit for purpose for our stakeholders.
We need to ask ourselves how this technology will be used and where the technology will interconnect with existing processes and technologies already part of the study design. This is the case especially if there are multiple tech vendors used where integration of data is key. We do not want to add a digital technology simply because we can; we want the technology or app to provide value.
One key to the success of operationalizing an eClinical solution is to create an operational plan and workflow showing how the approach will be developed, deployed, and integrated with other systems. The workflow can be reviewed and discussed to evaluate any risks or gaps in utilizing the solution(s).
Another key to a DCT methodology is to ensure the quality of the software development stays intact. In the past two years, the industry has looked at ways to implement studies at a quicker pace. Many eClinical solutions need to follow a proper software development lifecycle process to ensure they are being built and tested appropriately before being released. We need to ensure this process is protected so key quality steps are not skipped.
When incorporating DCT strategies it is also key to understand the regulatory landscape in the countries supported in the study. Some countries are slow to adopt decentralized approaches and may not approve them to be used in a study.
OSP: Can you share an example of a recent DCT strategy you were able to help a client design and put into place?
JC: We designed and implemented a study strategy that incorporated several different vendors with integrated workflows. This allowed a patient to have consented, complete screening questionnaires, and complete all assessments for the study in a seamless way, despite interacting with multiple eClinical technologies. On the surface, it sounds like a simple design, but there was significant complexity in integrating the eClinical technologies in a way that would allow for a smooth patient user experience.
OSP: Then, what are some specific considerations to keep in mind when working in the DCT space?
JC: Because the DCT space is evolving so rapidly, it is very important to track the progress and success of the current solutions being deployed. The best way to do that is to either find subject matter experts within your organization who have experience in this space or partner with an organization that has been implementing DCTs and is using the experience gained to adapt and improve its processes. The lessons learned from past decentralized deployments can be applied to new solutions, even if they are very different.
OSP: How do you keep track of the evolving regulatory landscape?
JC: With PPD clinical research services, we rely on the staff in our regulatory affairs team to stay on top of the changes across the regulatory landscape. They monitor and track regulatory updates in real time and maintain that information in a database so the project teams operationalizing the DCT strategies have a comprehensive analysis of the landscape that can be easily mined when evaluating how best to operationalize a study.
OSP: Can you give us an idea of how many onsite trials can be made fully decentralized, and how many are hybrid?
TR: All studies and all indications have an opportunity to be decentralized to some level. In terms of a fully decentralized trial, industry metrics indicate that around 5-10% of studies will fall into this category. However, significant growth has occurred in the hybrid category where we apply a mix of on-site and remote options.
The industry is innovating quickly, so there has been a lot of growth in varying DCT offerings from technology to operational with growth in community solutions. These DCT solutions in combination enable us to bring research to a patient while decreasing the burden to participate and opening the door to more possibilities for decentralization in the future. We expect DCT to become a key component of the clinical trial spectrum.