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Applied Clinical Trials December 2022

Ukraine invasion tests the resiliency and quick action of CROs and sponsors

Mobilizing and Maintaining Clinical Trials in Midst of War

ACT's biennial Salary Survey takes a look at the future of industry following increased adaptation of decentralized technology 

Salary Survey: The Age of COVID

Emmes announced the creation of a dedicated center to enhance its depth in cell and gene therapy research.

The new center will focus on supporting the clinical trials of clients who are developing cell and gene therapies across multiple therapeutic areas, including hematology, oncology, cardiology and ophthalmology, as well as rare diseases. The center will combine a team of 100 researchers.

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New center will focus on the clinical trials of clients who are developing cell and gene therapies across multiple therapeutic areas.

Emmes Launches Cell and Gene Therapy Center

Suvoda announced that as part of its single platform rollout, its eCOA solution is moving to the second phase of the Early Adopter program. This solution, designed to work with Suvoda IRT and eConsent, focuses on addressing eCOA challeneges such as gaps in overall delivery and execution quality, time consuming translations and localization processes, and logistics related to device management.

Functionality seeks to alleviate eCOA burdens, reduce time-to-launch, and improve site, clinician, and patient experience.

Suvoda Launches eCOA-Specific Language and Design Toolkit

As part of the Decentralized Trials and Research Alliance's (DTRA) TGIF-DCT podcast series, mdgroup will join forces with Q2 Solutions to explain how tearing down barriers between the various vendors and service providers involved in such studies is a simple yet effective starting point. 

Hosted by DTRA founder Craig Lipset, mdgroup's Director of Decentralized Clinical Solutions, Tom Brazier, will present with Q2 Solutions' Decentralized Trial Solutions Director, John Corcoran, and Manager, Stephanie Larimer.

This event will take place on Dec. 9, 12-1pm, EST. This podcast discussion forms part of a series of Clubhouse events, organized by the DTRA, of which mdgroup is a founding member, aimed at providing all stakeholders with an informal space to share DCT experiences and best practice.

How streamlining relations between central labs and mobile health providers can get the most from hybrid and DCTs.

mdgroup and Q2 Solutions to Join DTRA Podcast for Discussion on Barriers Between Vendors and Service Providers

Medidata launched a new patient-centric native myMedidata app, designed to provide trial participants with a single login for their remote trial activities. The app will feature all of the myMedidata patient-centric solutions, with an initial focus on eCOA. The app is available on iOS and Android and can be used both on the patients’ own devices or via a provisioned device.

Designed with customer and patient feedback to expand options for eCOA and other DCT activities.

Medidata Launches New myMedidata Native App

Clinical eCOA/ePRO platform technology provider uMotif has released topline study results demonstrating its proprietary data capture interface incorporated into its eCOA/ePRO app offers a validated alternative to current text-based smartphone-based instruments for clinical, post-marketing and real-world research.

The independent quantitative equivalence study was conducted by SAFIRA Clinical Research at Dublin City University. Fifty-five participants completed testing in two randomized groups using the Motif visual interface and a traditional 5-point Verbal Response Scale (VRS-5). The study results showed equivalence between the Motif interface and standard VRS (high ICC) for capturing VRS data. Study results are expected to be published in 2023.

Bruce Hellman, Co-Founder and Chief Patient Officer expanded on the history of eCOA/ePRO to the significance of this study to 

. “Traditionally, PROs were paper, with a question at the top of the sheet, and patients would check one of the boxes [answers].” This same format migrated onto PDAs, then smartphones, but in the paper/text/content format. “We knew that patients found our app more engaging…it’s quicker to use, and it’s easier to use for different populations and age groups,” said Hellman. However, eCOA scientists have always asked that PROs could be validated from paper to PDAs, then PDAs to smartphones, now the equivalence of text-form smartphones to graphical user interfaces--the uMotif interface uses a flower-petal visual, with a finger-swipe indicator for responses.

Study shows eCOA/ePRO interface is equivalent to responses from text-based smartphone formats.

uMotif Announces Validated eCOA/ePRO Interface

Senior Director, LifeSphere Clinical at ArisGlobal

Imagine a patient who is taking an experimental drug as part of a clinical trial. The patient experiences an adverse reaction requiring hospitalization. They’re admitted to intensive care, which triggers a regulatory event requiring information to be transmitted to sites, ethics committees, and institutional review boards associated with the study.

Now imagine how long it would take to distribute the necessary documentation if the process to do so were manual: paper mailing and faxes, global recipients each with their own processes for receiving and processing reports, and the need to gather recipient details from a third-party clinical trial management system (CTMS).

The primary purpose of reporting during human clinical trials is to ensure patient safety. Drug developers have just 

seven calendar days to report life-threatening reactions

—including death—and 15 calendar days to report non-life-threatening reactions to regulatory authorities. To prevent repeat serious adverse reactions during a trial, drug teams must report life- and non-life-threatening results to the regulators and investigators quickly, accurately, and efficiently.

number of adverse event reports it receives increase by nearly 200%

. Electronic SUSAR (suspected unexpected serious adverse reactions) applications streamline and improve the drug development processes, which is especially important when time is of the essence.

As more drugs go to market more quickly, patient safety remains critical to pharmacovigilance—yet another reason beyond strengthening compliance efforts with regulators and improving oversight that the industry needs more effective, accurate reporting. Electronic SUSAR reporting platforms enable pharmacovigilance and clinical operations teams to better manage safety document distribution, in compliance with pharmacovigilance and patient safety standards, requirements and regulations.

The challenges of managing safety document distribution

Study sponsors and contract research organizations (CROs) face multiple challenges in managing safety document distribution—for example, hitting deadlines on time and with complete information—when relying on costly, labor-intensive manual processes with a higher potential to create compliance risks.

Manual processes carry many inherent risks for both pharmacovigilance and clinical operation teams, namely introducing inaccurate information throughout the entire reporting process because it involves multiple steps.

Determining whether a serious adverse event (SAE) qualifies for expedited reporting.

Collecting reports from the pharmacovigilance teams.

Selecting relevant studies, investigators, institutional review boards, and ethics committees.

Preparing and collating reports for distribution packages sent to organizations, including MedWatch and the Council for International Organizations and Medical Sciences.

Distributing the reports via email, mail, fax, and web portals.

Generating distribution reports and other documentation.

The nature of the distribution is quite costly because organizations require a significant amount of staff and manual, inefficient steps. The staff, too, become less efficient because they must conduct every part of the process by hand.Inefficiencies create longer timeframes for task completion. The more teams rely on manual steps to complete each process, the higher the opportunity for error—and the greater the cost.

If these challenges aren’t enough to convince sponsors and CROs to automate their safety document distribution, here are other reasons. Automation:

Increases efficiency and accuracy by reducing the number of manual processes associated with the distribution process.

Improves compliance and oversight, enabling clinical operations teams to distribute reports on time, trace the distribution and acknowledgment, generate compliance documentation and do so in a central, non-siloed location—a single source of truth.

Facilitates the immediate distribution of expedited reports, shortening latency between a safety event’s identification and subsequent report distribution. Automation instantly transmits these safety event reports through a secure web portal to ethics committees and investigators.

Supports organizations in meeting their good clinical practice (GCP) guidelines and improves process oversight.

Generates cost savings by reducing both deployment and labor costs.

A large CRO identified multiple pain points. It lacked global process harmonization for safety reporting and relied on outdated, inefficient distribution methods including faxes and USPS for notifying investigators. The organization’s rapidly increasing book of business for safety reporting services meant its staff faced increased pressure.

Implementing a new safety document distribution system to streamline distribution and acknowledgment process tracking. The team inputs global distribution rules from the World Health Organization (WHO) into a single system to manage variances. The organization also implemented global safety reporting processes overseen by its pharmacovigilance department, integrating five existing regional processes into one and migrating ongoing projects into the new model. The CRO also launched a web-based secure document delivery platform specifically for investigator notification and, in doing so, saw improvements in cost, reliability, scalability, security, and traceability.

After executing this project, the CRO saw multiple benefits. Its relationship with sponsor customers improved as it received positive customer feedback. Compliance rates rose, as did acceptance levels from investigators and authorities. It saw faster and more reliable solution offerings and gained more cost-effective business opportunities.

A leading global pharmaceutical company managed the distribution of safety reports via its clinical operations team but had to send reports to multiple global recipients. Again, each had different preferences and expectations on how they expected report delivery, either by portal, email or fax.

The clinical team found it difficult to manage acknowledgments centrally and remain compliant. Another roadblock was the need to manually gather recipient contact details like mailing addresses and fax numbers from third-party CTMS systems to distribute reports. The process leached time and was error-prone.

The company vetted and chose an automated system that was easy to understand and use, integrated with their existing systems, and accommodated diverse distribution methods. In addition to distributing safety documents through a web portal, the automated system provides email and efax distribution options.

This new safety document distribution system significantly streamlined processes and reduced costs by automating previously manual steps. It delivered consistency and enhanced traceability with its fully-validated system tracking the distribution and receipt of safety reports by individual investigators or sites. It also included enhanced security with a 24/7 accessible web-based system controlled via individual user accounts.

Effective, timely distribution of safety documents including SUSARs is critical for maintaining patient safety. Automating this process not only reduces the inefficiency of manual steps between pharmacovigilance and clinical operations teams but also enables sponsors to maintain compliance and reduce costs.

, senior director, LifeSphere Clinical at ArisGlobal

Automating process can reduce time and resources lost from using manual steps and allows stakeholders to maintain compliance.

The Impact of Automated Safety Document Distribution on Pharmacovigilance and Patient Safety

In this podcast, Dr. Milligan makes the case for studying drugs in pregnant and lactating women on an ongoing basis to understand long-term efficacy and safety, as well as effects of concomitant medications on these women. Sandy believes that the entire ecosystem--regulators, policymakers, governments, physicians, healthcare systems, and industry, need to have a conversation around improving the under-met and unmet needs of women, which includes understanding the unique experiences of women with conditions such as pre-term labor, menopause or endometriosis.

Podcasts

Sandy Milligan, MD, JD, Head Of Research And Development, Organon

Between June and August 2022, Tufts CSDD collected and analyzed financial, personnel, and trend data from 18 top public and private contract research organizations (CROs) to inform the industry on the current status of the CRO industry. This information is contained in the November/December 2022 issue of the Tufts CSDD Impact Report, 

Topline insights into the data include the following:

Total spending in the drug development industry on contract clinical services is approaching $50 billion in 2022.

Between 2020 and 2021, the top 10 CROs saw an unprecedented single year growth rate of 17%.

In 2022, the top 10 CROs captured nearly 70% of spending on contract clinical services.

The Impact report also summarized the problem of terms and definitions regarding sourcing strategies by sponsor companies that use a wide variety of outsourcing models to support their portfolios. A collaboration between Tufts CSDD, ICON, and a consortium of pharmaceutical companies proposed a new framework to differentiate sourcing models. A chart of which is included in the Impact report, along with a fuller discussion in this article appearing on the 

Tufts CSDD report based on data collected and analyzed financial, personnel, and trend data from 18 top public and private CROs.

Latest Tufts CSDD Impact Report Focuses on CROs

PHASTAR has announced the launch of a pro-bono service to give charities access to its volunteer statisticians, data scientists, data managers, and programmers at no cost.

PHASTAR Cares allows third-sector organizations to fulfill their charitable aims by providing biometrics support. The team of experts can advise on data collection, analysis, and dissemination.

New pro-bono offering allows charities to access PHASTAR’s biometrics experts at no cost.

PHASTAR Launches Pro-Bono Service for Charities

Two recent activities by ACRP offers insights into industry’s views on decentralized clinical trials (DCT). In a think tank convened in October, participants from a variety of clinical trial stakeholder groups, offered that lack of clarity around regulatory requirements is the leading barrier to adopting DCTs at the site level, as well as a lack of budget flexibility and the challenges of managing third-party vendors. Additionally, survey results released by ACRP revealed that on a site-level, DCT technology utilization lags behind other trial technologies, sites that use DCT elements spend more time on trial delivery activities, and personnel perceptions of DCT elements strongly influence DCT acceptance. 

Think tank and survey results inform current DCT landscape.

Featured Content

Applied Clinical Trials December 2022

Mobilizing and Maintaining Clinical Trials in Midst of War

Salary Survey: The Age of COVID