Tag: Virtual trials

The Future of Decentralized Clinical Trials Starts with a Patient-first Design Approach | Blog

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.

Major patient-facing challenges

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.

How can vendors overcome patient-facing challenges?

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

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Six aspects of a patient-first design approach

  • Empathetic: DCT solutions should portray a deep understanding of the needs, well-being, and interests of patients, fostering trust and emotional connection. Vendors need to map the entire trial journey and look at it more holistically rather than logistically. Incorporating patient feedback into designing solutions will reduce a lot of stress and burden on patients
  • Secured: Concerns with data security, compliance, and privacy have increased with the rise in DCT adoption. Patients fear the consequences of device and network hacking, data leaks, and unauthorized access to data. DCT vendors must incorporate stringent security and compliance measures, secure the networks, and prevent all types of unauthorized access. With precise security measures in place, patients will feel safer with their data and will be more willing to share data for clinical research
  • Adaptable: DCT solutions must be able to incorporate the changing patient context, needs, and preferences to build fluid experiences. The same solutions should be adaptable and scalable as per the study requirement, ensuring a consistent patient experience and providing long-term sustainability
  • Engaging: Delivering engaging content is the best way to keep patients motivated in this digital world. Interactive educational materials, timely communication of trial progress (lay summaries), and patient reports go a long way in increasing patient engagement and retention. Patients can be motivated by increasing their trial literacy, setting up patient advocacy boards, and rewarding them for their contributions to the trial
  • Personalized: A one-size-fits-all solution will not work as patient experience varies at each stage and with each individual. Individualized care and personalized solutions help in building trust, loyalty, and retention rates among patients. Giving patients the liberty to choose their treatment plans (wherever possible), creating patient-specific digital ads, and supporting patients via artificial intelligence (AI) assistants are some of the ways to incorporate personalization into clinical trials
  • Reciprocity: Patients, vendors, and enterprises should be encouraged to communicate and share relevant experiences. Beyond trial periods, vendors and enterprises can engage patients with information on lifestyle, new developments on drugs or medical devices, upcoming trials, diet plans, etc. This type of communication will increase the willingness among patients to share personal data with AI systems as well as the scope with vendors, leading to more customized solutions that promote relevant and progressive experiences

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 | Blog

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

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Five factors to enhance patient experience with DCTs

Patient experience can be broken down into the following aspects:

  • User-friendly interface – The User Interface (UI) of DCT applications and devices must be simple, yet effective. They must provide clear instructions and display only relevant and concise content. It should be well organized, making all options easily accessible and ensuring that the application can be used with minimal explanation
  • Easy to set up platform/app – Patients should have an easy time setting up a wearable, sensor, or application. It should be intuitive even to an average user with limited exposure to digital devices. The device should be as close as possible to a ready-to-use mode
  • Smooth operation – The applications or devices should not pester patients with unnecessary notifications, malfunctions, or failures that would cause unwanted frustrations, resulting in reduced patient engagement. A smooth operation with minimal or zero disruption is the best-case scenario
  • Robust education and training – Patients come with different levels of digital literacy, and they need to be supported during the trials. They must be aware of how to enroll themselves for the trial, schedule appointments, feed in data, and get important information about their health and the trial. Sponsors can create the knowledge pool, conduct training sessions, and build artificial intelligence (AI) bots to provide education and training to patients
  • Multilingual app and support – To reach a global audience, multilingual offering and support must be available. The devices or applications used should provide instructions and information in the commonly used languages across the world. If a trial is geographically focused, the regional language should be configured in the device

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.

The Changing Face of the CRO: Becoming the Everything Store for Decentralized Trials | Blog

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.

Pushing the gas on decentralized trials

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.

Becoming the everything store for decentralized trials

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

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.

Implications for CROs

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:

  • Innovate or perish: CROs would be competing directly with product vendors – an industry notorious for innovation. Investments aimed at improving the product quality, product enhancements, and fixing issues would be critical to win client trust
  • Incorporate success stories: Showcasing client success stories and case studies will reduce client hesitation to adopt the one-stop DCT solution and drive increased product uptake
  • Offer innovative commercial constructs: Traditional ways of contracting (for example, per study or volume-based constructs) may not work with DCTs. While offering clients a BPaaS construct, check for risk-sharing agreements as clients appreciate vendors who showcase skin in the game

Looking into the crystal ball

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]

BioClinica and ERT to Merge: Perspectives on Potential Synergies | Blog

On December 10, 2020, ERT, a clinical end-point data solutions company, announced its merger with BioClinica, a clinical trial management and imaging solutions company. The goal of the resulting enterprise will be to integrate the best of both worlds – ERT’s expertise in electronic Clinical Outcomes Assessment (eCOA), therapeutic expertise in cardiac safety and respiratory, and clinical endpoint measurement through wearables, with BioClinica’s expertise in imaging and clinical trial management solutions. The merger will equip the combined company to deliver data analytics, insights, business intelligence, virtual patient visits, and technology solutions to its clients.

In analyzing this development, we’ve taken a look at the hottest topics in the life sciences industry right now – decentralized and virtual clinical trials.

Virtual clinical trials – a revolution catalyzed by the pandemic

A virtual clinical trial is one in which certain parts of the clinical trial are conducted outside a clinical site, such as patient consent capture, trial data capture, or patient monitoring through sensors or wearables. The benefits to the pharmaceutical company include cost savings, better patient recruitment and retention, and improved data quality.

Earlier this year, we published a blog predicting that the 2020s would be the decade of virtual trials. It seems we were way off the mark – by about nine years. The year 2020 has already seen its fair share of virtual trials, as clinical trials that were put on pause due to lockdown restrictions were rescued by being converted to fully virtual or hybrid trials, such as cases in which clinical experts visited patients at their residences to collect vitals or samples, reducing delays.

#NoGoingBack

The virtual trial momentum isn’t temporary, and there’s increasing focus on virtual trials, even among investors. Not only this, many in the industry have pledged to preserve the progress they’ve made in clinical research due to the pandemic, including virtual trials.

On the same day the news of the merger was announced, the Decentralized Trials & Research Alliance (DTRA) was formed to unite stakeholders with a mission to make clinical trial participation widely accessible by advancing policies, research practices, and new technologies in decentralized patient-focused clinical research. Companies that are part of this alliance include technology vendors such as Medidata Solutions and Oracle Health Sciences, pharma companies such as Pfizer and Roche, CROs such as Parexel and Syneos Health, and others such as Amazon and the US Food and Drug Administration.

M&A and investment activity has increased, too. For example, Medable and Science 37 each received funding during the pandemic to advance their virtual trial offerings. And in November 2020, VirTrial, a telehealth platform for managing decentralized and virtual clinical trials, was acquired by Signant Health, a Clinical Trial Management System (CTMS) vendor, thus augmenting its virtual trial capabilities.

Clearly, virtual trials are a ripe area for M&A and investment activity given their disruptive capabilities and benefits. And we continue to expect more acquisitions, funding, and collaboration in this space in the near future.

What this all means for the merger

Our recently concluded PEAK Matrix assessment on clinical development platforms pointed out that BioClinica’s Cloud platform for clinical development does not have the capability to support virtual trials; we said it needed to invest in remote monitoring and eCOA capabilities to deliver on virtual trials. However, the solution does have a broad set of capabilities in the clinical, regulatory, and safety value chains.

As a result of the merger, however, BioClinica will be able to offer virtual trial capabilities to clients. ERT is one of the leading eCOA providers and through its wearable and sensor data capture capabilities, it is well positioned to conduct virtual trials in certain therapy areas. And it will be able to use the BioClinica Cloud offering to give clients a holistic clinical development experience, a win-win-win for ERT, BioClinica, and their clients.

Exhibit 1 shows the combined solution landscape.

Exhibit 1: The merger synergies

bioclinica

The merged entity will be able to showcase an end-to-end clinical development platform with enabling layers for virtual trial conduct. This move is definitely the right direction, at the most opportune time, and is just another sign of increasing interest in decentralized and virtual trials.

What are your views on this merger? Let us know your thoughts at [email protected] and [email protected].

The 2020s Will be the Decade of Virtual Clinical Trials | Blog

Virtual clinical trials – wherein trial data is collected through sensors or remote monitoring devices carried by the patient – can deliver many benefits to pharmaceutical companies, including cost savings, better patient recruitment and retention, and improved data quality.

In 2011, Pfizer conducted the first-ever randomized clinical study that managed participants using mobile phones and the internet. Over the next few years, the virtual approach waned because of limited success stories and the considerable upfront capital investment required for sensors and platforms.

However, with recent technological advances, the proliferation of wearables (smartwatch shipments have doubled in the past several years), and the FDA’s urging clinical trial sponsors to keep their research ongoing via telemedicine in the wake of the COVID-19 situation, the clinical trial landscape is ripe for disruption by virtual trials.

Indeed, as a bellwether of growing viability, the first virtual trial conference was conducted in December 2019. During the two-day event, the key discussion points were understanding the decentralized model, regulatory challenges for virtual trials, and ensuring compliance for such trials.

Enter technology companies and Big Tech

To build momentum and drive synergies, pharma companies have started to partner with technology companies to test the virtual trials model. For example, in 2018, Novartis, Sanofi, and UCB individually partnered with Science37, a tech company focused on patient-centric models for clinical research, on patient-friendly clinical trials at home. Boehringer Ingelheim followed suit in 2019.

Numerous startups that address some aspect of virtual trial requirements have emerged. For example, VirTrial, a telehealth platform that allows pharmaceutical companies and Contract Research Organizations (CROs) to create patient-centric trials by replacing some in-person visits with virtual visits, was founded in 2018. Since then, it has ramped up its capabilities and expanded internationally across 31 countries. Also in 2018, IQVIA, a leading CRO, enhanced its portfolio by launching virtual research solutions aimed at patient-centric trial design and execution. And today, numerous companies, including Clinpal, Covance, Medidata, ObvioHealth, PRA Life Sciences, and Transparency Life Sciences, boast their own virtual trial platforms.

Not wanting to be left out of this highly lucrative market, the Big Tech players are also exploring additional opportunities. For example, Apple, Best Buy, and J&J recently collaborated to launch a virtual study to gauge whether the Apple Watch could help reduce a person’s risk of stroke. Apple has also been involved in this space through its ResearchKit, an opensource software tool for medical researchers, doctors, and scientists to collect data on people suffering from diseases. Similarly, Verily, a Google sister company, has teamed up with pharma majors to modernize clinical trials and improve patient engagement and recruitment, and aggregate data from wearable devices.

Technological advances

Of course, much of virtual clinical trials’ success lies in the strength, viability, and rigor of the technologies that support them. The picture below shows the technologic interventions that enable the virtualization of a clinical trial.

Technologies that enable the virtualization of clinical trials

And fortunately, the above technological interventions speed up patient recruitment, improve patient adherence and monitoring, and eliminate data siloes by having a single source of truth in the cloud – ultimately enabling a smooth and virtual experience during a trial.

The road ahead

Delivery model and technological advances and co-innovation among stakeholder organizations have set the stage for trials to transition from traditional to virtual. Technology players are more capable, risk-tolerant, and knowledgeable than before, leading to increased trust and synergies with pharma companies. While pharma companies are resorting to the motto of “fail fast, win cheap,” virtual trials hold great promise to revolutionize the trial landscape. And what better time than now, when the field is ready, and the fruit is ripe?

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