trends & perspectives in clinical research

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Dangers lurk in an eClinical Monopoly

by Jae Chung

Clinical Research Organizations (CROs) are often portrayed as the bastions of innovation in the pharmaceutical industry when it comes to running clinical trials, which is not surprising given that outsourcing of trials is estimated to exceed 70% by 2020, and process optimization is key to both their differentiation strategy and increased margins.

Dangers lurk in an eClinical Monopoly

The lowest hanging fruit is the automation of manual processes, which entails the deployment of eClinical tools. Electronic data capture (EDC), eTMF (electronic Trial Master File), CTMS (Clinical Trial Management System), and SSU (Study Startup) cloud-based tools play a distinct role in optimizing the full clinical trials process.

In this environment opportunities abound but none of these systems is a panacea. These tools perform separate functions but serve overlapping user groups and need to be assessed as part of the overall picture of clinical study management, rather than just looking at one piece of the clinical trial jigsaw.

Life science vendors hoping to expand their customer base and revenues have also embarked on a standard business process of vertical integration, a strategy where a company expands its business operations into different steps on the same production path, resulting in bloated eClinical tools that report to do everything but with caveats and gotcha's—a diluted offering, lacking focus with an incomplete feature set.

Indeed, dangers lurk in an eClinical monopoly. Monopolies are best characterized by poor levels of service, and consumer exploitation. Neither of which should be appealing to CROs who would essentially be fixing a problem by implementing another one. A monopoly leads to customer exploitation as competition is lacking resulting in the customer getting a raw deal in terms of needed features and enhancements, quality in terms of bug fixes, and pricing. Lack of competition may also lead to low quality in terms of dated services resulting in a lack of innovation and a diminished ability for a CRO to differentiate its services.

While a 'one-stop-shop' sounds appealing, it simply is not possible today. What works best is using and integrating a small number of tools that are purpose-build for specific clinical operational objectives—a focus on combining "best of breed" applications verses relying on a "one size fits all" approach. It is imperative that CROs look at the overall process, identify where specific tools can help, determine how those tools interrelate, and implement good information governance across the system.

Kathie Clark
Vice President, Product Management
Wingspan Technology
"What we often hear is that organizations who buy the vision of a single platform often find that they never implement a second module of the platform. This may be due to high cost, lack of a business case in abandoning other systems that are working reasonably well, or lack of key features in other modules. This result may be "buyer's remorse" that their decision making process focused on an elusive future version rather than on choosing the best solution for their business needs."

One of the key findings from the recent Tufts CSDD research report, Study Accessing Practices and Inefficiencies Associated with Site Selection, Study Start Up and Site Activation, is a renewed interest by the pharmaceutical industry in study startup with the assignment of dedicated teams and budget.

Cloud-based eClinical systems represent a quantum leap in speeding clinical trials, but their adoption rates vary. And significantly, they do not address one of the most inefficient and costly bottlenecks of clinical trial conduct—study startup.

The life sciences industry has recognized study startup as one of the worst performing areas in clinical trials. Many organizations struggle to control costs and resources associated with ramping up clinical trials. It is generally a manually intensive and highly inefficient process. The multistep process of collecting, reviewing and approving regulatory documentation is cumbersome, resulting in millions of dollars of waste per client, and can lead to delays in findings and ultimately, approvals.

Jeff Kasher
Patient's Can't Wait
"Patients across the globe are waiting for new therapies, but complicated study protocols, globalization, and paper-based methods of conducting trials continue to delay market entry. Current thinking looks to an improved study startup process as holding great promise for accelerating clinical trials."

Jeff was formerly VP Clinical Innovation and Implementation at Eli Lilly and Company

The processes involved in study startup are complex and rarely performed via a single function with the CRO organization typically requiring the interaction of multiple people at the individual sites such as contracts, regulatory and finance, in addition to the coordinator and Principal Investigator.

Study startup—the fastest road to first patient in—is a bottleneck at the outset of clinical trials that slows drug development. The process leading to site activation is complex. It requires sponsors to select sites, negotiate contracts, fund and staff the trial, gain institutional review board (IRB) approval, obtain supplies of the drug to be tested, and comply with pre-enrollment regulations. Most pharmaceutical companies still track these site activation tasks and documents using email, clunky spreadsheets, shared file drives, or cumbersome homegrown applications. With multiple parties making updates, materials get out of sync rapidly—this makes it difficult to track the overall status of the project.

Integrating and automating the exchange of information between study startup, CTMS, and eTMF can provide efficiency gains and cost savings, but companies need to be pragmatic about the integration that is needed between systems. Careful analysis is needed to determine which data should be owned by each system. The system that owns the data (the system of record) should be integrated with other systems that use it so that users don’t have to re-enter data, which can lead to inefficiencies and the potential for entry errors. For example, when a site is selected to participate in a study, that site data should be shared with the CTMS, study startup tool, and eTMF instead of being re-entered. As users are working in the downstream systems, any changes to site data need to be updated in the system of record as well.

According to Clark, "The choice of 'best-in breed' solutions helps organizations to achieve these benefits. As an analogy, think of your banking needs. Do most people have their checking accounts, mortgages, car loans, and safety deposit boxes with a single bank? Of course not. The bank that gives you great services and low fees for your checking account may be uncompetitive with regards to mortgages, and may not have a location convenient to you for your safety deposit box. You are best served by selecting the solutions most closely meeting your needs for each element."

To keep costs low, maximize competitive advantage, and to deliver life-saving therapies to patients as quickly as possible the pharmaceutical industry must leverage technology to accelerate clinical trials. The industry needs to be skeptical and warily of vendors reporting to provide replacement options for key components in the eClinical stack, which would ultimately, at best, lead to a monopoly but at its heart would be counter intuitive to the goals of deploying the software in the first place. These vertical integrators are nothing more than 'wolves in SSU clothing'.

Learn more about study startup, CTMS and eTMF, and the roles of these technologies in the eClinical stack in our latest whitepaper: Using eClinical systems to speed up clinical trials.

See how you can accelerate your clinical trials—request a FREE demonstration today.

Jae Chung
President and Founder
goBalto, Inc
Jae Chung is the president and founding visionary of goBalto. A startup evangelist, Chung wants to change the way pharma and CRO companies initiate clinical trials. goBalto's purpose-built study startup SaaS solution allows stakeholders to better adhere to established timelines and budgets, with customers reporting reduction in cycle times by 30-plus percentage, thereby getting medicines to those in need faster.

Chung works with Rock Health to mentor healthcare technology startups, and previously co-founded Celltrion (068270:KOSDAQ), a leading biopharmaceutical manufacturing company. Prior to Celltrion, he worked as a strategy consultant with McKinsey & Company.

In 2013 Jae was recognized as a FierceBiotechIT Top-10 Techie list and in 2010 was awarded the Bio-IT World Judges Prize for Technology Innovation. Jae has experience in drug development, commercialization, and business development. He has an MBA from New York University and holds a CPA.

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