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The biggest benefit of Decentralized Clinical Trials (DCT) is the opportunity to enhance the patient experience, but the process is rife with challenges that create disengagement. The problem is not that patients are unengaged, but rather the vendor products are not always very engaging. The solution lies in undertaking a patient-first approach. Discover the tenets of a patient-first design approach in this second blog in our continuing coverage of this timely topic.
The pandemic has propelled decentralized clinical trials (DCT) into the mainstream, and multiple enterprises have transitioned into the virtual model for conducting clinical trials. Both enterprises and DCT vendors have stated that improved patient experience is the biggest benefit of the decentralized model. What do enterprises mean when they talk about patient experience? Read our blog, How Decentralized Clinical Trials Put the Patient Experience at the Forefront, to find out.
To deliver a superior patient experience and derive maximum benefit from this model of conducting trials, enterprises and vendors must be aware of the patient-facing challenges that might pose major hindrances. A closer look at the top challenges will help businesses develop effective measures to improve patient engagement and retention.
The entire remote model has reduced in-person interactions. Insufficient communication from sites and sponsors often leads to disengagement among patients. The human touch, an important psychological aspect in healthcare, goes missing in this model. Added to this is the burden of learning about new products and technologies.
Patients have very limited digital literacy and may find it extremely difficult to operate a new sensor, a smartphone, or an application. Vendors are struggling to develop robust training and support programs while enterprise buyers are more concerned about patient education capabilities and post-implementation support in their sourcing criteria.
All these factors create a general sense of discomfort and disengagement among patients, thereby defeating the principal benefit that vendors and enterprises expect from a DCT solution.
Designing a patient-centric solution is the best way to address these challenges. Having a deeper understanding of patients’ journeys and their pain points, while involving them in solution design will lead to greater compliance and engagement. The following exhibit highlights the various tenets of a patient-first solution.
Exhibit 1: Tenets of a patient-first design approach
Patients do not want to be treated as mere statistics. They want the touch of empathy and personalization, pushing DCT vendors to think more ‘humanly’ and add ‘emotional’ content while designing DCT solutions.
When all the above elements are incorporated in building DCT solutions, it will not only increase participation and adherence but also improve the brand value and bottom line for DCT vendors.
Over and above the empathy-backed approach toward creating a patient-centric solution, DCT vendors and enterprise buyers can look further at certain initiatives aimed at improving patient experience.
A sheer lack of awareness among patients regarding ongoing or planned trials exists. Enterprise buyers and vendors should spread information about upcoming clinical trials and steps to participate in them while promoting the ease of using digital technologies (via social media, newsroom, public releases, etc.). Home-care nurses or physicians still must make monthly calls or visits to motivate patients and add some scope for face-to-face interactions between patients and healthcare professionals.
Though the pivot or the integral enabler for DCT solutions is technology and connected systems, the focus should be on improving the patient experience and building the future towards a patient-intuitive smart DCT solution suite.
What are your views on how businesses can improve the patient experience? Reach out to [email protected] and [email protected] to discuss further.
How Decentralized Clinical Trials Put the Patient Experience at the Forefront
With the COVID-19 pandemic accelerating the adoption of Decentralized Clinical Trials (DCT), the opportunity to deliver a patient-centric experience is viewed as a top benefit of this alternative mode of clinical trials that uses digital and remote technologies. What factors are enterprise buyers looking for DCT vendors to provide in their platforms to increase satisfaction and ultimately drive patient enrollments? Learn about the five factors that go into a “patient centered” experience in this blog.
When COVID-19 brought traditional clinical trials to an abrupt halt, Decentralized Clinical Trials (DCT) proved to be a savior for sponsors looking to safely restart their paused research activities. While DCTs have been around for a decade and are slowly gaining traction, the pandemic accelerated the use of these alternative methods to collect clinical trial data through sensors or remote monitoring devices carried by a patient.
The top reason for moving toward this model has been its patient-centered focus that makes it easier for more people from a broader geographic area to participate in trials without the need to visit a site.
The growing mainstream acceptance for DCTs has increased the appetite among clinical research organizations (CROs) and sponsors to adopt the latest technologies and virtual models for clinical trials. This has resulted in an uptick in innovation and DCT product adoption recently. We see DCT vendors increasingly focus on co-innovation, continuous product improvement, and market education to help clients get started on their DCT journey.
Top benefits of DCT adoption
Our Decentralized Clinical Trial Products PEAK Matrix® Assessment 2021 found the most promising benefit for enterprises to consider decentralizing their trials is the opportunity to enhance the patient experience – a benefit that two out of three DCT product buyers also agree with based on Everest Group interviews. Other advantages of DCTs include reducing trial costs and timelines, attracting a more diverse patient population, and capturing real-time data for trials.
With DCTs, patients can now take part in a study from the comfort of their homes, spend more time with their family members, and focus on work and other responsibilities. This mode of clinical trial also opens the door to the patients who suffer from mobility issues and allows sponsors to reach a global audience, increasing inclusivity and diversion.
This new patient-centric approach is driving increased enrollment and retention rates. With these valuable benefits, it is not surprising that having a people-orientated platform has become central to enterprise buyers in making their sourcing decisions – even more so than innovation or reviews from other buyers.
What do buyers want from DCT vendors?
What do enterprises buyers mean when they talk about patient experience? Multiple facets contribute to the notion of patient experience as presented in the exhibit below.
Exhibit 1: What enterprises buyers mean when they say patient experience
Five factors to enhance patient experience with DCTs
Patient experience can be broken down into the following aspects:
Enterprises want DCT solutions to integrate smoothly into the daily lives and operations of patients. Patients should not feel isolated when doing the trial since the significant amount of digital literacy required might deter them from participating.
Vendors also need to be aware of the top patient-related challenges that might hinder them from elevating the patient experience through their products and services. Multiple challenges might lead to an inferior experience, resulting in disengagement and dropouts. DCT vendors and enterprise buyers must identify these challenges and take discrete steps to improve the patient experience and engagement.
Keep following this space as we dive into the top patient-related challenges and present initiatives aimed at improving the patient experience.
What are your views on the patient experience in DCTs? Reach out to [email protected] and [email protected] to discuss more.
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On February 24th, 2021 we saw an announcement of one of the largest mergers/acquisitions that the CRO space has ever witnessed. ICON, the Dublin-based global CRO, announced that it has entered into a definitive agreement to acquire rival North Carolina-based PRA Health Sciences in a deal valued at US$12 billion. The deal, which makes the combined entity the second-largest CRO, next only to IQVIA (itself a merger of IMS Health and Quintiles), is one of the many instances of the rapidly consolidating CRO industry, accelerated by COVID-19.
While there are a lot of potential synergies in this acquisition, such as minimum overlap in terms of geography, deeper therapeutic capabilities, and broader service offerings, one important takeaway from this acquisition echoed by Dr. Steve Cutler, Chief Executive Officer of ICON, is the shift towards Decentralized Trials (DCTs).
With decentralized trials gaining importance, thanks to the pandemic, there has been an increasing focus from CROs to shore up their capabilities and develop an integrated solution. For instance, Bioclinca and ERT recently announced a merger that enabled the combined entity to provide holistic solutions in eCOA, imaging, and clinical trial management solutions. ICON, through this acquisition, has set out to achieve an integrated offering in DCTs as well. It seeks to combine its home health services, site network, and wearables technology with the mobile health and connected health platforms and other real-world data solutions from PRA Health Sciences.
Traditionally, a CRO was considered a business process service provider, managing trial operations in regulatory, safety, and clinical conduct. Very few offered technology solutions along with business process services as this was often considered the forte of product vendors such as Oracle Health Sciences and Medidata. However, with the pandemic halting clinical trials, stakeholders analyzed how to restart paused clinical trials by virtualizing certain components of the trials through some short-term fixes, such as use of eConsent and eCOAs solutions, resulting in an uptick in DCTs.
Initially, partnerships had been the preferred route for CROs to support DCTs, for example, the Covance partnership with Medable wherein Covance’s patient and site interface would be powered by Medable’s DCT offerings. However, the recent M&A activity suggests that CROs are now considering adding product capabilities to enable DCTs by acquiring product players (such as what Bioclinica did with ERT) or by acquiring CROs with strong technology capabilities to support such trials (such as ICON and PRA Health Sciences). The result – offering a one-stop-shop solution to support DCTs, as highlighted in the visual below.
Figure 1: A one-stop shop solution for supporting decentralized trials
The advantage of such an integrated solution is that it augments the CRO’s value proposition to conduct DCTs – integrating platforms, services, site networks, and data capabilities, all into one place. Such CROs can now provide patient recruitment, engagement, and retention services (which has traditionally been their stronghold) using the underlying DCT suite through which the patient can enroll, record clinical outcomes, and engage in video consultation with the doctors/physicians. Additionally, they can also provide auxiliary support services, such as the provisioning of devices used for remote patient health monitoring and offering home nursing services aimed at reducing or eliminating patient visits to trial sites, medical record review services to check for completeness, accuracy, and compliance of medical data, and remote CRA services to oversee the DCT.
While, at first, the advantages of an in-house DCT suite seem to improve the value proposition for the CRO, it is also pertinent to note that in this scenario, CROs are also competing directly with DCT product vendors such as Medable and Science 37. The key challenge for CROs would be in convincing clients who still hesitate, while adopting technology offerings given their business process services heritage.
CROs aiming to walk down the acquisition path should keep the following pointers in mind:
The DCT space is ripe for disruption and the string of M&A activities shows the increasing emphasis that CROs are putting on DCTs. As efforts to improve the value proposition intensity and innovation ensue, the industry can expect more tuck-in acquisitions and even some mega-mergers, such as ICON and PRA Health Sciences, to continue well into the future. What are your thoughts on this? Let us know at [email protected] and [email protected]
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