The collection and utilization of clinical trial data have evolved rapidly in recent years—and the COVID-19 pandemic served to step up the pace. Teresa Montes, clinical practice lead with Daelight Solutions, spoke with Outsourcing-Pharma about the ways the industry has shifted and shares words of wisdom on how trial teams can stay on top of the changes.
OSP: How has data collection evolved in clinical trials over the past several years?
TM: Clinical trials, by their very nature, are challenging. The purpose of a clinical trial is to ask and answer a new question, often about a novel compound with limited historical research. Exploring recently identified genes, working in rare disease states, engaging new vendor partners, leveraging emerging technologies, and relying upon humans and all their associated inconsistencies – these do not make a clinical trial easy to run. Even after years of clinical trial experience, so much continues to be uncharted.
Limiting human interaction to stem rapid disease transmission during the COVID-19 pandemic has hit clinical trial operations hard, as well. Although clinical trials methods and endpoints continue to morph and resist standardization, technology has been continuing to find solutions to manage the administrative burden.
Spurred by limitations from the pandemic, sponsors and CROs are taking the leap to more fully employ opportunities to interact electronically. Integrated clinical toolsets, capable of more seamlessly sharing information, have improved the landscape of data sharing platforms. These available improvements are impacting key players: sponsors, CROs, and sites, as well as those sharing across critical clinical functions.
Within clinical, platform integrations that tie electronic data collection, data management, and site payment management with other functional tools, such as trial master file and site communication systems, make the administration easier. Connected platforms eliminate redundant administrative activities for the sites, reduce the number of disconnected toolsets and provide alternatives to the often-fragile point-to-point system integrations.
Even document reuse opportunities have matured enough to move to center stage. Traditional document sharing between regulatory and clinical and across clinical studies has seen major improvements, making the process easy while keeping the quality of the data high.
OSP: You mention that COVID-19 has impacted data collection and management—could you please talk about some of the ways the pandemic has altered the landscape and caused an accelerated adoption of automated tech?
TM: The most obvious impact from COVID-19 is the forced move from in-person to virtual visits. Previous efforts focused on reducing the number of in-person visits, rather than replacing them with virtual visits. Remote monitoring efforts used metrics and quality criteria to justify an in-person visit, in order to reduce the frequency of on-premises, site-monitoring visits.
With COVID-19, visits were recreated as virtual contacts, using video conferencing and telephone contacts. Fully embracing these technologies for visits became the rule, no longer an option that could be delayed or ignored because of preference or lack of skills and tools.
The tougher problem has been to manage time constraints created by COVID restrictions, spotlighting the burden of administrative tasks for site teams. Extra hours were no longer available for redundant tasks, in particular the sharing of data and documents on a clinical study. The need to optimize site time accelerated the adoption of available tools for the seamless sharing of data and documents between the site and sponsor.
A new generation of tools is allowing the industry to move beyond the typical painful situation where one clinical trial will have its own set of systems for site use. Each data system has its own set of credentials and training. If the site is conducting more than one study, the impact of multiple systems is amplified -- e.g., one set of credentials and training per system and per study. Lots of lost time resetting passwords, submitting the same documents to multiple systems, and sitting in repetitive training is wasted time, particularly when there is no time to spare in a day.
The “free to sites” tools such as the Veeva Site Vault have become more attractive. These tools provide a way to manage the site’s internal site file (ISF), required for clinical site documents, and eliminate the overhead involved with multiple credential sets needed for sponsor systems. This one interface allows for connection directly to a participating sponsor with a Site Connect capability.
The sharing of site staff documents and data is a fairly standard and repeatable process, so the set-up of Site Vault and the establishment of a connection to a sponsor study is a one-time, quick process.
Credentials for the site personnel can be input once and the same tool utilized for clinical studies from multiple vendors. Posting of a CV, medical license, or training documentation is immediately visible to both the sponsor and the site, reducing administrative overhead and improving the completeness reporting available to both the sites and sponsors.
OSP: What kinds of challenges do trial teams face when looking to take on automated data collection technologies?
TM: It depends. Technologies vary, and the processes they support may be standard across the industry or very specialized.
Using the site system in the previous example, the processes are very well understood and repeatable, lowering the barrier to implementing a system. Site Vault implementations typically require only a couple of weeks.
For larger systems, providing support to multiple groups and processes, the complexity is greater than the single site experience. Planning for the update of existing processes, engaging people involved with the change, and providing structural support, from leadership to operations, will greatly simplify the effort and improve outcomes. Below are some points to consider in the pre-planning for a system change.
Process
- Prospective systems need to be evaluated for usefulness and alignment with business requirements and process. Time needs to be allocated for the evaluation and update of process before configuring the system.
- Teams will depend on standards and processes to integrate the use of new technologies into working practices. Be sure that consideration is given to these in advance with consultation from impacted teams. Allowing for the organic growth of standards results in inconsistencies and avoidable rework. Plan and confirm the standards and process in advance.
People
- Determine if the timing is right for this type of change; concurrent organizational and system change pressures often impact timelines and increase stress on users.
- Different functional personnel will have unique needs. Include them in the discussion of the process and needed functionality and use them to test assumptions before the system is locked for delivery.
- Personnel using or managing the systems will require training at system launch and throughout the life of the project. Assure plans are in place to accommodate this ongoing need.
Structure
- Recognize that the initial price tag is not the only cost; specialized resources are required to implement and maintain a system in a controlled, operational state.
- Manage vendors, functioning as system providers, system support teams, and system users.
- Assure costs are understood for additional services and the team is available to support changes to the system.
- Vendors have both people, processes, and structure to be considered. Communicate and align on expectations for the needed actions, deliverables, and timing before launching the project.
- Collected data will need to be considered for utility throughout the organization. Be clear on who needs this data and how will it be shared. Investment in integrations may be needed.
Making changes with remote teams may be more familiar following pandemic restrictions. The ability to work as a team, even when remote, increases the flow of vital information and allows system changes to deliver cost savings and the reduction of administrative burden promised by the system benefits.
OSP: Could you please share some questions clinical trial leaders should ask when looking to take on automated collection systems (including any possible missteps common to such transitions)?
TM: Asking the right questions is difficult because the answers are not always what you want to hear. Honest consideration of some key questions will help prepare for the successful implementation and adoption of a data collection system. Below are a few.
Process
- Are there consistent and established processes?
- What process will be followed when using the system?
- Do processes need to change? Agree and document these changes in advance of project launch.
- Do I have the structures and standards to manage data cleanly?
- How do I get data before, during, and after the clinical trial?
- Is data collected well defined? Does this variable name mean the same thing in all systems?
- Do I have this data elsewhere in the organization already?
- Does data need to be shared? How quickly? With whom?
People
- How critical is the use of this system? Will use meet resistance?
- Do I have the right people on the project? Are there leaders, subject area experts, thought leaders, personnel with a willingness to change and use new systems?
- Is the team able to accept an initial version of the system with basic functionality? Building new capabilities and enhancements after initial release?
- Is this system change part of a bigger plan? How does it fit? Communicate the value to the team.
- Do I have the training team and tools to support development of team skills?
- Do I have the communications structures to build awareness of the system and provide answers to user questions when they arise?
Structure
- Do I have engaged leaders with authority within IT and the business area to clear obstacles and make decisions for the project?
- Will my systems be able to share data or is additional investment needed?
- How clean is the data? Inconsistent data will increase costs, so clean data in advance.
- Do I have the structures to support the operational management demands? Support team?
- What are the contractual relationships? Do terms need to change? What will it cost?
- How hard is it to break up with your vendor partner, if needed in the future?
- How is data made available when removing data from the system?
OSP: Could you please tell us about Daelight Solutions—who you are, key capabilities, what sets you apart, and how your company can be useful to clients concerned about building a successful data collection and management infrastructure?
TM: Daelight Solutions (based in Princeton, New Jersey) is an IT consulting company that is relentlessly focused on meeting the enterprise information challenges of the life sciences industry. Centered on delivering meaningful outcomes and value for clients, Daelight has an expert team of life sciences IT specialists with decades of experience in the space. Daelight provides clients in the pharmaceutical, biotech, and medical device industries with services that ensure IT projects begin with the real world in mind.
Daelight Solutions prides itself in working hard and doing things right. Daelight has talented, experienced people who are experts in their domain. Daelight specializes in supporting companies with the implementation of systems and handling needed data and document migrations.
The company does not make money pushing software; services are technology agnostic. As a Veeva Preferred Services Partner, Veeva Migration Certified Services Partner, and Generis Certified Partner, Daelight has earned recognition as a trusted partner for both software companies and their clients.
OSP: Anything to add?
TM: Whether spurred by COVID-19 or other unforeseen circumstances, the collection and organization of clinical data is complex. Multiple processes, activities completed by external partners using different systems, and multiple, competing functional area requirements are a reality for many projects. Introducing a system that offers real improvements to productivity, consistency, and quality is a terrific accomplishment.
Give system-responsible personnel permission to adhere to the rules: clear and relevant standard operating procedures, work instructions, data standards, and change processes. Maintaining standards, clean data, and demonstrated compliance with regulations will assure that the value of the system investment continues to reap benefits for years to come.
