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Navigating the Clinical Research Paradigm for Cost Savings and Efficiencies

Clinical Trial Issues
So, what are the clinical trial challenges for a sponsor? Investigator recruitment is pivotal to success. However, while it’s
often easy to recruit PIs—everyone gets excited about the latest, greatest and newest device—there is often a slight misstep to actually quantifying how those investigators are going to be able to contribute to the trial. With the need to screen everyone carefully, it can be difficult to quantify the actual numbers and volumes of patients a PI will be able to enroll at a site. Patient recruitment and eligibility screening are essential to the success of the trial.

A second challenge is developing appropriate infrastructure and support. The clinical research coordinator is a vital part of any successful clinical research trial. If the PI does not have a coordinator, it will prove very difficult for the site not only to maintain enrollment, but also to ensure the collection of quality data.

Data reporting represents one of the largest challenges, particularly in terms of tracking adverse events, adhering to the protocol requirements, maintaining monitoring schedules and using electronic data capture technology to streamline enrollment. Further, most new products require a variety of specialists and silos to manage the demands of a clinical trial. Coordination of key vendors and their services is critical. For example, how does one coordinate the regulatory requirements with study operations and data management? Another consideration is reimbursement and when to phase this in. How does it impact protocol design or patient recruitment?

Value of Vertical Integration
A vertical integration model, incorporating all the services required for a study, can make trial management much more efficient. Looking at all of the necessary components and proactively planning their inclusion is critical. Industry must put reimbursement at the top of the list (in addition to thinking through regulatory, economic and market issues). It is essential to identify any potential reimbursement obstacles or issues likely to arise as part of the protocol process, as opposed to finishing a trial and then finding out that there are little or no reimbursement options available.

Since a host of issues must be covered, vertical integration of services is optimal. It allows the sponsor to address not only the issues of reimbursement strategies, clinical trial management and regulatory compliance, but also utilization and outcomes measurement, monitoring, patient recruitment, site initiation and site closeout in a seamless fashion.

Vertical integration also lends itself to cost savings and relationship building. It creates an element of communication that allows you to “fast-track” many essential functions of commercialization. Getting to market much sooner, reducing enrollment time for patients, avoiding the need to redo data collection because of corruption and mitigating the scope of post-market studies due to weak data are all essential to the value proposition and are achievable via a vertical integration model.

Protocol Development
Protocol development is not an event, but a process. Several companies, when attempting to launch new products, met with obstacles that shut them down and inhibited their ability to bring the revolutionary transformation they set out to accomplish. Those products are listed here as food for thought:

The intradiscal electrothermal annulopasty (IDET) minimally invasive outpatient procedure was devastated by a Blue Cross and Blue Shield technology assessment that produced a denial of coverage.

The CHARITÉ lumbar disc may be the first device inmedical history that was cleared by FDA as safe but denied reimbursement by Medicare due to study nuances. Today, many carriers continue to consider lumbar disc arthroplasty as investigational and deny coverage despite a significant amount of data to the contrary. As a result, its utilization has suffered.

Kyphoplasty and Coblation have fought long and hard to overcome investigational claims and denials of coverage in the marketplace.

It’s very important from the outset to think about reimbursement as a pre-planning event.

There are other issues you must think about from the pre-IDE/pre-outcomes study planning perspective. You must look at functional, biomaterial and procedure analyses to define where the technology fits with today’s procedures, particularly those that represent the gold standard and state of the art. You want to investigate the fee structures of professional and facility services, as well as the cost of disposables and product requirements, against the backdrop of usual and customary reimbursement. It may be necessary to explore any opportunity to include payments on the inpatient and/or outpatient side in order to mitigate potential lost revenue from utilization of the product.

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