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Experts Offer Strategies for Clinical Trial Execution and Outsourcing

Orthopaedic device manufacturers continue to outsource clinical research projects, as the importance of data collection grows and the complexity and cost of studies increases. BONEZONE® asked three experts to share their insights on best practices and strategies for conducting clinical trials inside and outside of the U.S., as well as ways to manage outsourcing of the process to a partner.

Participants included:

Marcy Rogers, President and CEO, SpineMark
John Lehmann, Director of Business Development, IMARC Research
Hallett Mathews, M.D., Executive Vice President and Chief Medical Officer at Paradigm Spine and Former President, Musculoskeletal Clinical Regulatory Advisers (MCRA)

BONEZONE: What challenges do OEMs report with clinical trials?

Marcy-Rogers WEB
Marcy Rogers:
Traditionally, the biggest challenges have always been patient recruitment, managing the budgets (whether they are choosing an insurance model for payment for clinical services versus cash) and meeting the enrollment criteria of FDA without incurring a long list of post-market studies.

John-Lehmann 140_WEB
John Lehmann
: The biggest challenges that we see lie in the areas of trial recruitment and protocol compliance.

Hallett-Mathews WEBHallett Mathews
: First of all, the barrier for clinical trial approval has changed so much with regard to whether it’s a 510(k) approval or a Premarket Approval (PMA). The trial itself is under challenge, specifically, not necessarily if it’s a 510(k) of just being substantially equivalent, but could it show equivalence with clinical data to support outcomes? Outcomes are being injected into 510(k) approval status, so a lot of 510(k)s actually have to produce clinical evidence as well as substantial equivalence to get their 510(k) approval. For the PMA, it’s a whole different game. It’s usually a level one perspective randomized control study that really challenges methodology and challenges the highest level of evidence, because it’s difficult to have blindedness in medical device insertion or device trials. It’s difficult to have sham procedures, so we are always challenged to get the highest level of evidence in order to get the best labeling or approval for a PMA study.

BONEZONE: What clinical trial strategies or best practices do you recommend, presently? Do these recommendations differ greatly from those of five years ago? Ten? How so?

Rogers: There are a number of trials going on right now. Some are smaller registry type trials, looking at collection of data on patients; others are new technologies. Orthopaedics currently has more innovation than spine in terms of trials. Spine is not very active in conducting the large number of studies that they had in the past. In 2008, there were ten, 12 or 15 clinical trials going on at the same time. Orthopaedics seems to be more active in that area and the trends are addressing biologics, new devices from our generation one, two or three, innovative ways for access and various bone substitute materials.

Lehmann: There has been an increased emphasis on risk-based monitoring (RBM) and increasing awareness on value of auditing. RBM has been a hot topic of late. Many see this as a way to control monitoring costs, which isn’t always the case. IMARC sees this as “intelligent” monitoring, making decisions based on site performance. As to auditing, more sponsors are making this investment earlier in studies as a way to prepare and take corrective action in case of an FDA audit.

Mathews: Obviously, evidence rules, and the better the level of evidence, the better your marketing claims and your ability to receive approvals for new technologies. I really think that it’s important that people understand the game that they’re in, whether they’re in the 510(k) world and want to be substantially equivalent and get quick to market, or if they want to be able to make marketing substantiations through evidence. With evidence, then comes the ability to look at clinical outcomes and performance, safety and efficacy of a device. Then, that can be translated into marketing claims and differentiation for their products.

  Continue reading about clinical trials: 

Rethinking the Role of Clinical Affairs

Post-Market Studies in Lieu of Clinical Trials

Understanding Requirements for Post-Market Clinical Follow-up 


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