August 29, 2023 PAO-07-23-CL-02
Being an innovation leader requires effort and forethought. The most successful CROs adopt a three-pronged approach to ensuring that innovation remains at the forefront of novel technology development and applications in support of successful, efficient and patient-centered decentralized clinical trials (DCTs).
The first component of this strategy includes working closely with technology and services providers to bring strong in-house subject matter expertise to:
The second involves:
The third element is grounded in truly understanding the pain points sponsors face when running clinical trials and proactively seeking new solutions that can provide improvements.
PPD’s commitment to innovation is reflected in this three-pronged approach comprising operations, product and strategy. Our clinical research teams work together, along with solution and technology provider partners, to identify and address customer needs, keeping them informed about emerging technologies and their potential to increase study efficiency and productivity.
The pharmaceutical industry is complex, and clinical trials remain a particularly intricate and evolving critical component.
A CRO must be innovative as well as committed to finding the optimal solutions for each individual study to provide the most agile support to their clients and the best experience for patients. Startups often bring unique solutions that sometimes introduce additional risk to help support their deployment. While there is a lot of work involved in supporting new technologies or services from a new company, it is often the best way to tap into the most novel and disruptive ideas. Similarly, established companies with experience outside the clinical trial arena also need extra support, largely to educate themselves on the stricter regulatory standards and requirements in this space, but there can be a lot to gain from outside industry innovation as well.
It is advantageous to work with a strategic mix of different technology providers focused on different types of tools, applications and services. It is important to work with technology providers by establishing strategic and collaborative partnerships that involve two-way sharing of information and ideas.
This approach helps maximize time and resources and ensures that the most promising new solutions are brought to fruition and made available to trial sponsors. For instance, that means sharing with solution providers many of the potential variations that can occur within studies, such as those related to protocol designs, patient populations, country-specific regulations, study scopes and data types.
The pharmaceutical industry is constantly evolving. There is consequently a need for CROs to investigate new technologies or services while developing new solutions. That carries a level of risk that must be mitigated by closely collaborating with vendors and having contingencies in place. Risk management goes hand-in-hand with thinking outside the box. Both are essential, as is always remaining solution-minded.
For CROs, the best approach to managing risks associated with true innovation is to employ well-established operating models and processes built on a foundation of experience. Doing so provides a strong set of best practices that can be applied when implementing new technologies and services, thereby ensuring a fundamental level of quality and oversight for any new solution.
PPD’s operating models and processes have been in place for two decades and have evolved to incorporate lessons learned during many years of working in the clinical trials arena. With these models and processes, the business leverages a strong foundation of best practices that afford confidence in the effective implementation of new solutions and technologies.
In addition, as each new solution is introduced, we build the operating model and integrate the solution to expand on our innovation and our offerings, carrying lessons learned from one project to another. In this manner, PPD expands its knowledge base and is able to develop additional guidance and processes. In addition, we are building a level of expertise that enables PPD to continue to develop an increasingly robust approach to the implementation of DCT strategies.
Like other clinical trial protocols, DCT studies must comply with strict regulatory requirements. Different countries have different levels of acceptance of DCTs and their constituent tools and often different regulatory approaches. Two good examples are eConsent and electronic clinical outcome assessments (eCOAs), for which very different regulatory guidelines exist in different countries. Each proposed DCT strategy must be reviewed, taking into consideration the regulatory landscape for each country where the trial will potentially be conducted.
The PPD clinical research business leverages internally constructed systems that compile up-to-date information on country-specific regulations from the general to the DCT solution–specific level. This makes it easy to review and adapt the DCT strategy to meet regulatory requirements once the countries and sites have been selected.
Although eCOA has been around in some form for over 20 years, some notable advances in this technology have occurred in recent years. For many early studies that moved from paper to electronic formats, eCOAs were viewed as too expensive and time-consuming, particularly given the limited number of patient-reported outcomes to be collected.
As in-home DCTs have increased, recognition of the value of eCOAs has also grown. This approach provides quality data through tools that patients appreciate and thus are more likely to use, leading to greater patient engagement. Furthermore, eCOA continues to be an innovative space.
Patients and sponsors benefit further when eCOA technology is combined with other point solutions, including eConsent and TeleVisits. eConsent, for example, starts patient engagement at the very earliest stages and helps ensure that patients more fully understand what participating in the trial will involve. TeleVisits provide an easy means of communication with site staff so patients can get their questions answered quickly and easily.
Usage of wearables and various types of sensors is also growing rapidly with DCTs. Wearables present exciting solutions because they enable the simultaneous collection of qualitative and quantitative data. For instance, clinical investigators can compare the number of hours or quality of sleep reported by a patient to the number recorded by the wearable or sensor. Newer sensors will help monitor medication adherence, which is a potential issue with any clinical study. In fact, the opportunities for enhancing DCTs are almost limitless given the potential for innovation in sensor technologies.
In the future, the ultimate intention for DCTs is the integration of digital and non-digital tools, and the data generated by their use. Such integration is needed to truly provide a single, user-friendly experience for both patients and clinicians, for data gathering, retrieval and analysis. The maximum benefits of different point solutions cannot be realized if they are simply thrown together in a DCT trial and used independently of one another. That adds complexity for patients and clinicians and can potentially interfere with the quality of data collection. Integration connects existing solutions into a more seamless user experience and increases the collective value.
Integration will also be crucial as the use of alternative site strategies, including virtual sites and mobile health clinics, continues to increase. These DCT strategies are beneficial because they reduce the burden for patients and bring clinical studies to patients where they are comfortable, whether in their home (virtual site) or at a convenient location close to home (mobile clinics).
When implemented on the right study protocols, both virtual sites and mobile health clinics have been shown to provide measurable benefits for DCTs targeting rare diseases. They make it possible to achieve much broader geographical coverage, which is often essential to recruit a sufficient number of rare disease patients. Mobile health clinics also afford trial sponsors the ability to recruit patients in diverse, underserved and at-risk communities, which addresses a key shortcoming within the clinical trial arena that have recently become a focus of regulatory authorities.
A third option that is starting to emerge in decentralized trials is the use of retail and community pharmacies. Companies like Walgreens and Walmart are becoming actively involved in clinical trials to increase access and equity in underserved communities. This option may be preferred by patients who already use these pharmacies for prescriptions and for obtaining vaccinations.
The patient population in any study must be examined very closely to understand its unique and specific needs so the trial can be designed with these needs in mind. Not every study will benefit from a decentralized approach. The patient group may be nervous about in-home care, or the disease indication or therapeutic treatment might require regular hospital visits.
For instance, older patients should be given training and assistance with both the device and application setup that takes into account their experience level using similar technology. When this approach is used, compliance rates for older patients are often much higher than for teenagers, even though the latter are typically far more comfortable with digital technologies.
A multi-faceted approach to training ensures that patients receive education about trial participation from start to finish using various digital solutions, including hands-on demos, written guides and videos. Using different tools makes it possible to reach each patient in their preferred manner. Monitoring these efforts and gathering user feedback will help identify areas for training improvement.
The PPD clinical research business has established design sets for specific patient groups and indications, leveraging our knowledge base of previously deployed studies — which number in the hundreds across many different patient populations and indications. In addition, we consider training to be crucial to success and place significant emphasis on patient training for DCTs. This combined approach of design and training allows PPD to keep the patient at the heart of the company’s efforts.
It is equally important to consider the needs and concerns of sites when establishing a DCT strategy. Training and documentation for site personnel are very important, particularly when introducing new tools and solutions. Establishing change management — and allowing time for it — is essential. The COVID-19 pandemic did help drive greater acceptance of DCTs, but sites can become overwhelmed by the volume and variance of new technology across their study portfolio. Taking the time to introduce them to new digital and decentralized solutions helps ensure that DCTs run smoothly.
When implementing and deploying DCT strategies, it is key to have subject matter experts leading the efforts, resulting in the integration of DCT solutions into the study so there is no additional burden to the project teams, sites or patients.
While project teams are guided and coached on how to implement DCT solutions, sites are also being educated, and steps are being taken to address their concerns. In addition, it is important for digital technologies to continue to evolve to make them easier to use for both clinicians and patients.
A fit-for-purpose approach to tech strategy is required to ensure the DCT design meets the needs of the key stakeholders. Once the DCT strategy is confirmed and approved by the sponsor, the study operations teams must have the focused knowledge to provide guidance to smoothly and successfully execute those fit-for-purpose strategies.
Resistance to adopting DCTs (because of the significant upfront work required to develop and implement novel strategies involving new technologies or services) largely dissipated in the face of the tremendous advantages that DCTs provided during the COVID-19 pandemic. As the industry moves forward, additional evidence of successful DCTs and further technological innovation will continue to diminish this perceived burden.
Sponsors saw the advantages that eConsent and TeleVisits provided during the COVID-19 pandemic. Now that the urgency has lessened, they are taking a step back to consider how DCT solutions can be leveraged seamlessly and without creating additional burden. The industry realizes that there is more work to be done –– DCTs should be fit-for-purpose and not cause additional burden to sites or patients.
The assumption remains that DCTs will enable faster trial recruitment and lead to greater patient retention, while also helping overcome patient access issues associated with standard clinical trials. Now sponsors are seeking proof, and data are needed to support claims of better patient recruitment and retention and improved patient diversity, without compromising data quality. It takes time to develop those data sets, and the industry is still in the early days of DCT implementation. Across the industry, many are working toward collecting appropriate data and establishing proof points that demonstrate the value of DCTs.
Indeed, PPD is confident that clinical trials will continue to evolve in the direction of decentralization and digital technology. How long that journey will take is uncertain. Increasing automation and integration will also have a positive impact. Faster trial setup and deployment will simplify DCTs, reduce their cost and increase standardization, helping improve the user experience and data quality.
Jennifer Crager has been in a management role within the clinical research technology space for over 20 years. Jennifer oversees study strategies, design, and implementation for a wide range of digital solutions, including but not limited to eCOA, eConsent, televisits, and wearables. Prior to PPD, Jennifer worked at several solution provider companies, with oversight of software development, customer support, training, quality assurance, technical delivery, and project management.