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Voice of Industry

Overcoming Barriers to Data Collection

Orthopaedic and spinal device manufacturers must provide product data showing clear clinical benefits to experience success in the marketplace. Purchasers, payors and policymakers seek, at a minimum, details on product effectiveness, patient outcomes and cost effectiveness. The in-depth process of collecting data can be time-consuming and costly, thus demanding a great need for accuracy.
ORTHOKNOW sought insights from device companies on measurement and communication of their products’ comparative advantages, as well as best practice guidance from companies that help OEMs perform data collection. In the constant conversation on data collection, we invite others to respond, as well. Please send your input to Carolyn LaWell at carolyn@orthoworld.com.
Thoughts from Device Companies: SANUWAVE and Ortho Kinematics
Question #1: What do you consider to be the key(s) to hurdling the data collection challenge?
Joel Batts, Vice President of Clinical Affairs, SANUWAVE Health
Confidence in your collection activities. What I’ve learned regarding data collection can be summed up in four points.
1. Define the need for the data. In the same way you would clearly define the market demand for a device before you build it, know the reason you need the data before you commit resources.  
2. Spend time on the ground. Don’t let monitoring be the only reason to visit investigators: tell and then re-tell them face-to-face why their contribution is vital to the protocol’s deliverables.
3. Know the competition. The efficiency by which you get the data is largely dependent upon the rate at which enrollment occurs. Choose sites that are not in the enrollment phase of trials that compete for the same patient population as required by your trial.
4. Don’t assume that checked boxes are indicative of a well-done trial. Nobody questions the necessity of building compliance into data collection processes. However, a trial can be compliant, yet miss key metrics by running too slowly or having high site turnover. A firm’s clinical affairs leadership should continually assess whether its staff are executing on processes that are both compliant and deliverables-driven.
Ken Walker, R.N., Vice President of Clinical Operations, Ortho Kinematics
Time and complexity. Almost all of the orthopaedic and spinal societies, at one time or another, have attempted some type of patient outcome registry. Due to the number of healthcare providers (HCPs) wanting to participate in the registry and each participant’s own take as to what should be included, the enrollment process was perceived to be too complicated and time-consuming—such that either patients refused to participate, or the HCP’s staff failed to collect a complete data set. Orthopaedic and spine companies have also attempted to collect data, but the outcomes were limited to each company’s products, and the data collected was used purely for marketing purposes. I believe that a true registry should be simple enough for enrollment compliance, yet be able to focus on all outcomes of the procedure, primarily patient satisfaction and return to daily activities. I also believe that payors and unbiased entities should play a role in the design, implementation and funding of these studies.
In most cases, orthopaedics and primarily spine lack the more definitive diagnostic tools that other medical disciplines have readily available to them, such as cardiology and gastroenterology. Those disciplines have a much higher patient satisfaction rate and lower denial rates. I believe that can be attributed to the proven outcomes those disciplines have shown. A diagnostic decision tree that better pinpoints pathologies will lead to a more informed treatment plan, which produces better outcomes. Better diagnostics will prove to be the path to better outcomes.
Question #2: What else have you learned from your data collection journey thus far? 
Walker: As long as we use the current payor system, reimbursement decisions will always lag behind innovation and technology. Educating payors about the “clinical effectiveness” of new product is a major part of the equation. Just as quality, compliance and marketing go into the product development plan for a new product, so should the education of the payor’s state and national medical directors. Including them in the “development” plan may prove to be one of the most valuable avenues to product adoption. Having a product that can represent a lower overall cost to the payor as represented by better outcomes and fewer revisions will be advantageous to all concerned parties. 
Joel Batts joined SANUWAVE in October 2011. He previously served as Senior Director of Clinical Affairs at Wright Medical Technology with a focus orthopaedic recon, foot and ankle products and wound therapy. 
Ken Walker has more than 18 years of experience in the orthopaedic industry, with over eight years specifically dedicated to spine. Prior to joining Ortho Kinematics in 2010, he served as Director of Clinical Education and Support for Vidacare’s Bone Access Division. From 2006 to 2009, he was responsible for the surgeon and sales rep training programs at Zimmer Spine/Abbott Spine. 
Thoughts from Clinical Research Providers: Remedy Informatics and Huron Life Sciences
Question #1: What is the first step orthopaedic device companies should take when collecting data?
Rob Ludlow, Vice President of Product Management and Product Manager for RemedyJoint, Remedy Informatics
The first step in data collection begins when a device manufacturer selects a platform for capturing and storing data. For long-term success, choose a modern, browser-based (cloud-hosted) platform that enables multi-site collaboration and offers a flexible yet structured data model to support your evolving data collection requirements. 
Orthopaedic device manufacturers must choose data capture solutions that enable global collaboration and that can be easily configured to support evolving research needs.
Marci Juneau, Director, Huron Life Sciences
To begin collecting clinical trial data for state and Federal aggregate spend reporting, device companies should first analyze and document all touch-points for transfers of value (ToV) with HCPs and healthcare organizations (HCOs) related to clinical trials. Companies need to identify all processes and systems through which clinical trial site payments may be made; this may include accounts payable, a clinical trial management system or manual processes. Once these processes and systems are identified, companies must determine which data points required for disclosure (e.g. principal investigator, detailed site information, etc.) are currently being captured and which are missing within each system or process. Additionally, companies need to establish a list of all Clinical Research Organizations (CROs) or other vendors who are providing ToV on their behalf to HCPs/HCOs and identify what detailed payment and investigator data points are currently being received from each CRO or other vendor.
After companies evaluate this information, they should write a roadmap to address the clinical trial requirements of disclosure laws; this strategy should include improvements to systems and processes to enhance clinical trial transparency efforts. Companies that are already collecting commercial data should consider how they can leverage these processes and systems to capture their clinical trial data.  
Question #2: What mistakes do companies often make when it comes to data collection? What can they do to avoid them?
Ludlow: Device manufacturers often invest in hard-coded solutions that can’t support a dynamic global organization’s changing research needs. These brittle applications are costly to change, and prevent organizations from quickly adding needed outcome measures. The solution: select a flexible informatics platform that is user-friendly and allows authorized users to configure their own Electronic Data Capture forms, capture Patient Reported Outcome Measures (PROMS), analyze data using “SQL-free” queries and visualize population data to accelerate pattern recognition without specialized IT-support.
Another common mistake occurs when implant manufacturers are too narrowly-focused on a single study and underestimate the value of reusing research data for cross-study trials. Developing a unified informatics foundation across all studies from the outset allows manufacturers to collect data once and then reuse it multiple times in retrospective meta-studies that are uniquely positioned to answer novel questions.
By anticipating the need for flexibility, orthopaedic device manufacturers can capture rich longitudinal data in a dynamic, collaborative research environment and then reuse it to answer complex questions in retrospective clinical trials.
Juneau: One of the largest mistakes that companies often make related to aggregate spend data collection for clinical trials is failing to establish clear and meaningful data collection standards related to CROs or other outside vendors. Initially, companies may not properly identify all of their CROs, since some of these may be global or non-U.S. based CROs running global trials with payments to U.S. sites. Even when all CROs are identified, manufacturers may fail to establish clear guidelines for what data they expect CROs to send. For example, CROs may not be providing enough information to uniquely identify each principal investigator, may not properly update their payment records when investigators change, or may have different understandings of a manufacturer’s reporting standards related to dates or amounts. To address these issues, companies should consider creating a centralized mechanism for collecting data from CROs and other vendors. Providing CROs with clear guidelines, training and communications of requirements for reporting and holding them accountable will also provide more accurate reporting.  
An additional mistake that companies often make is not ensuring proper leadership buy-in or alignment to changes put in place for clinical trial data collection. Since requirements to collect clinical trial data are more recent than those related to commercial spend, companies need to build awareness in their clinical groups or divisions with key employees to ensure that the leadership team is aligned to the same program objectives and has a consistent understanding of the end goals. Manufacturers must drive this vision throughout the clinical organization to ensure the core team, functional area partners, employees, and third-party affiliates are all working toward the same end state.  
Rob Ludlow has more than 15 years of product management, business development, operations and management consulting experience. Before joining Remedy Informatics, Ludlow led business development for Microvision’s consumer project display business and started GE Healthcare’s Preclinical PET imaging business. 
Marci Juneau is a Director at Huron Life Sciences, focusing on pharmaceutical, biotechnology and medical device companies with compliance, reporting and regulatory risks related to state and federal aggregate spend reporting, sales and marketing activities, medical affairs and clinical and research and development activities.