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The future face of clinical trials?
WILMINGTON, N.C.—In April, PPD extended its digital clinical trial solutions to support biopharma companies’ research continuity initiatives and to help ensure patient safety during the COVID-19 pandemic.
PPD says it has an extensive, flexible suite of digital trial solutions that includes electronic patient consent, telehealth and both hybrid and fully decentralized/virtual trials—thus enabling biopharmaceutical customers to advance their current and planned clinical research programs.
The coronavirus pandemic continues to pose challenges to how clinical trials are set up and conducted, including the inability of some patients to visit impacted research sites when subject to government stay-at-home orders, or to avoid exposure risk.
In response, PPD has been collaborating with customers, regulatory authorities and business partners to deploy innovative digital and virtual solutions as a part of the company’s long-term digital strategy.
PPD has remained invested in developing new clinical study models designed to improve the patient experience by reducing the number of in-person visits in favor of remote and digitally enabled study participation. These products combine operational solutions like direct-to-patient and direct-from-patient models incorporating home healthcare nursing, study drug administration, sample collection, pickup and return of study materials, and digital solutions like eConsent, telemedicine, devices/wearables electronic clinical outcome assessments (eCOA) and electronic patient reported outcomes (ePRO).
“The pandemic’s impact is driving a new consensus that the need is now for expanded use of digitally enabled trials,” said Niklas Morton, PPD’s senior vice president, digital services. “Our flexible customer solutions across the digital spectrum are designed to increase trial-participation access for patients and enhance their experience, resulting in time-efficiency and data-quality improvements for our customers. In today’s challenging environment, our digital solutions can contribute to minimizing trial disruptions and helping our customers keep their drug development programs on track.”
In response to the impact of COVID-19 on existing studies—and acknowledging that traditional providers in the space were not innovating in the direction and speed to meet the needs of the company’s digital strategy—PPD has invested in and collaborated with Medable and Science 37, two of the industry’s leaders in virtual trials, thus supporting the modernization of the industry as a whole.
Recently, Science 37 pioneered an innovative new study model which is helping make virtual trials the new reality. As a market leader, Science 37 has conducted numerous decentralized, interventional trials. Together, PPD is leveraging Science 37’s Metasite model or hybrid clinical trial methodology, which combines traditional sites with an expansive in-house network of telemedicine investigators and home-health nurses supported by a comprehensive, fully integrated clinical trials platform. With the Metasite model, PPD is gaining more proof points on the potential of fuller decentralized trails.
PPD has recognized Medable as one of the most progressive decentralized trial platforms for such purposes, so PPD initiated a strategic alignment on how to develop a solution that uniquely combines their technology platform and PPD’s operational services. Medable’s digital trial platform helps with implementing these trials and helps PPD to combine eConsent, eCOA, telemedicine, and device/wearable integrations in one technology platform with one patient and site interface. Additionally, these collaborations have enabled PPD to rapidly deliver continuity solutions for clinical trials affected by the COVID-19 pandemic, including the use of telehealth to remotely screen patients and conduct study visits.
PPD is rapidly deploying innovative solutions to mitigate study challenges. This includes new mobile applications that enable patients to connect visually with their clinical study sites, allowing investigators to better complete safety assessments, and collect eConsent, eCOA or data from devices/wearables on the same digital trial platform. Additionally, PPD is deploying trial models that enable or augment, respectively, the use of traditional brick-and-mortar sites with full digital support and decentralized, or virtual, site alternatives to allow the recruitment and retention of patients remotely.
Currently, PPD’s Accelerated Enrollment Solutions business (AES) is also leveraging similar capabilities to increase customer access to patients by reaching beyond AES’ physical site infrastructure of more than 180 research sites, including rapidly delivering continuity solutions for clinical trials affected by the COVID-19 pandemic, such as telehealth to remotely screen patients and conduct study visits.
Digital trial solutions can benefit pharma by reducing the burden on patients participating in clinical trials, increasing the access of patients to clinical trials and improving the data quality through direct data acquisition. PPD believes this results in improved patient recruitment and retention, thus decreasing drug development cycle times. Digital enablement allows companies to capture key patient interactions such as informed consent or eCOA directly from the sites, patients or caregivers using smartphones or tablets. Digital trial solutions also may promote higher quality data through better patient engagement and more rigorously defined standards.
“COVID-19 has sparked a paradigm shift, not only for PPD, but for the industry as a whole,” Morton tells DDN. “We anticipate that digital and decentralized trials are advantageous in mitigating the risks associated with a pandemic or other crises that impact the healthcare setting and its ability to prioritize clinical research. What’s next is consistently designing studies that integrate digital and decentralized components and shift the focus to proactive strategic operationalization to mitigate risk, rather than reactive, rescue implementation to attempt to address challenges on negatively impacted trials.”
“We are leveraging the full power of our enterprise organization and our digital business unit to maintain the continuity of critical clinical trials and development programs to the greatest extent possible,” Morton added. “ With COVID-19, more than ever, it’s imperative for PPD to proactively focus on digitally enabling study conduct and providing innovative services for customers. The need for digitally enabled and decentralized trials—and by that, I mean fully virtual or hybrid studies—is now more relevant than ever.”