Patient perspective key to any redesign of clinical trial protocols to suit decentralized approach

Dawn Anderson, managing director of life sciences, Deloitte, was speaking about developments in decentralized trials leading up to and post-pandemic at last month’s virtual DIA annual meeting.

We caught up with her to hear more.

“As an industry we have made a lot of strides in digital clinical trial capabilities around decentralized and virtual clinical trials.​

“During the pandemic we reached a peak – around 50 to 65% of all clinical trials had decentralized clinical capabilities and that was obviously because of the lockdowns. ​

"But post COVID-19, we are actually seeing a resurgence of interest from sponsors and patients [in terms of the decentralized model]. The patients like the convenience, the fact that they can do some monitoring from home instead of having to go into the clinic, and investigators have even started to notice some improvements in retention and overall patient compliance [via decentralized trials]."​

Furthermore, she told us, Deloitte sees a lot of sponsors starting to design clinical trials with endpoints based on electronic patient-reported outcomes (ePROs) and clinical outcome assessments (eCOAs).

Data collection 

Are there any therapeutic areas that are not adapted to the decentralized clinical trial approach?

“Most people assume that certain indications like oncology are not well suited to the decentralized [model] but what we see is that while there are those indications that are most suited to this approach – dermatology, metabolic and respiratory – follow on visits in oncology are leveraging ePRO or eCOA or connected devices. ​

"I wouldn’t say there are certain indications that won’t be amenable to decentralized clinical trials, I think it is more of a question of how much decentralized data collection will happen in certain therapeutic areas, but we are seeing more of an interest in collecting quality of life data, and daily living data, with connected devices, ePROs and eCOAs supporting that.”​

The term ‘decentralized trial’ actually encapsulates a hybrid model, where some visits will be done in the clinic and some will be done remotely, she emphasized. That remote visit could see the patient completing a survey or using a connected device such as a glucometer at home or potentially having a home health nurse come to them to conduct a test, added Anderson.

“We are seeing a host of areas where we could have not only the patients collect the data themselves or have a health nurse do so but where even some local laboratories and pharmacies can start to take part, meaning patients don't have to travel the whole distance to the clinical trial site, but use local resources instead.”​

Amending clinical trial protocols 

Deloitte has been working with sponsors to help them redesign their clinical trial protocols to suit this model, and also supporting them as they go about training and selecting their investigator sites in relation to telemedicine capabilities, the ability for physicians to monitor patients on a more real-time basis.

“Sponsors have to think differently about how they design and conduct the virtual components within a decentralized trial. They need to provide better helpdesk support for patients. They need to think about new technology."​

Pre-COVID-19, Anderson said a lot of clients would have had a two-five year strategy in place as regards a timeline for implementing decentralized clinical trials. “And then the pandemic hit and, within a few months, everyone was scrambling to do some form of decentralized or virtual visits within their studies. First and foremost for many, in terms of priorities, was being able to run a telemedicine visit between the physician and the patient.”​

Later on, the hunt was on for additional digital tools and devices to support the model. 

“The ability to walk a patient through the clinical trial using a schedule of activities, a daily to do list, with reminders and notifications - all of a sudden, it became incredibly important to have that kind of technology, and you had a wealth of providers offering eConsent and eCOA services coming into the market very quickly.”​

The current trend, she said, is to ensure the remote patient experience is not disjointed, so suppliers are beginning to innovative along those lines, bringing all capabilities such as onboarding modules, participant authentication, eConsent, eCOA and full data capture into the one platform.

Recruitment, retention 

While devices alerts and notifications help with patient compliance, Anderson noted that sponsors are also now working with behavioral and motivational science experts to ensure participants are encouraged but not overwhelmed by new technology:

“Decentralized trials typically have a few main goals. The first is of course is to reduce the burden on patients. And if companies can do so by having fewer visits to the doctor’s office, focus groups tell us that increases patient motivation to join a clinical trial. ​

"Once the participant is in a clinical trial, those focus groups suggest that the number one engagement tool is positive feedback, with patient education vital in that respect; they really want to learn more about their disease, about the testing that is happening. We have to be careful not to overwhelm the patient, but there is a wealth of information that can be shared with them to make them feel more like they are a partner in the study instead of being a research subject."​

Boosting diversity 

The reduced burden, along with alerts and notifications and patient education tools aided by the decentralized model can help ensure better recruitment, retention and compliance in clinical studies, said the Deloitte representative. 

Digitalization of clinical trial matching capabilities can also help with trial enrollment, she noted.  ​

“Ultimately, we hope that all of those factors will allow us to also improve trial diversity because, traditionally, certain ethnic minorities have been underrepresented in clinical studies. We really want to change that."​

When sponsors are redesigning clinical trials for a decentralized process, Anderson stressed it is important to think about the journey of the patient and the investigator as they are both very different. “Companies really need to get involved with focus groups and [get feedback from] patient communities to understand what motivates a patient to join and then stay in a clinical trial."​

It is all about engagement, and the decentralized model is evidently supportive of that, she added.