Medical Device Development Clinical Studies Part 2

Medical Device Development: Clinical Studies, Part 2

In Clinical, Regulatory by Nancy Drake

There are several steps involved in the clinical phase of the medical device development continuum. Knowing what factors should be carefully considered during these steps can help reduce the number of errors and oversights, which can ultimately lead to saving time in the development process.

In part 1, we covered the importance of protocol development and clinical site selection when performing a clinical study on a medical device. Next, we will discuss some of the best practices for clinical monitoring, actively enrolling sites, data maintenance and constructing the clinical study report.

Monitoring

  • Reserve on-site monitoring for monitoring activities that can only be done on-site.
  • Complete the first monitoring visit soon after first enrollment to identify and correct issues, blind spots with regard to study procedures and execution, errors in EDC and monitoring challenges.
  • Clean data and look for data trends prior to on-site monitoring visits. Both tasks will help make your time at the site more effective.
  • Maximize your electronic data capture (EDC) capabilities.
    • Utilize the database’s ability to create electronic reports for reviewing, trending data and monitoring activities.
    • Monitoring reports using EDC can have several advantages over paper or electronic documents created with word processing software.
    • Device accountability and storage—can device tracking be done using EDC or done electronically?
  • Allow enough time at the site to do quality monitoring.
  • Provide reasonable time between monitoring visits to lessen the time on-site. Your study is likely not the only study; however, infrequent monitoring may also add additional burden to the site.
  • Utilize escalation procedures to obtain compliance for difficult clinical sites. Communicate intentions to sponsor for approval and send to site.
  • Plan final monitoring trip soon after last subject visit to be able to lock database as soon as possible.
  • Creating a positive, professional partnership with a common goal will help your trial be successful.

Actively Enrolling Sites

  • Newsletters and site staff calls to keep sites apprised of study progress—encourage high-enrolling sites to talk about what they are doing to be successful, as well as other tips and tricks.
  • Provide Annual Investigator Meetings.
  • Evaluate enrollment rates against projections and determine if a protocol revision is required.
    • Do inclusion/exclusion criteria need to be modified?
  • For ongoing study requirements, provide an electronic option (e.g., protocol addendum self-training, online EDC training).
  • Document questions asked by sites and protocol clarifications; create a list of Frequently Asked Questions (FAQs). This will help with data quality and protocol compliance. FAQs can be communicated through newsletters or as a stand-alone communication.

Data

  • Maintain Data Management Plan
  • Continuous review and cleaning of data will help shorten time to complete final report.
  • Assess the health of the database. Are sites responding to queries? Do queries make sense? Are data edit checks working correctly?
  • Provide hands-on EDC training for investigators and coordinators, if possible.
  • Timely sign-off of eCRFs/CRFs will expedite end of study activities (e.g., final report completion).
  • If using study worksheets to supplement source data, are they being completed correctly?
  • Obtain metrics to look for data trends.
  • Lock database soon after last monitoring trip.

Final Steps – The Clinical Study Report

The statistical programming and validation of the programming can begin before the final monitoring visit. At this time, there is agreement with the Sponsor on the content of the Tables, Listings and Figures. The “shell” of these is created as the beginning of the Clinical Study Report draft. This draft can also include all the sections that are to be included in the report; many of these can be written in advance of the database being locked. Many of the appendices can also be completed at this time. Once the database has been locked and the data is analyzed, the final Tables, Listings and Figures are added to the report. The CRO and Sponsor will do a final review for accuracy and the conclusion section can be written. This document becomes part of the submission for clearance or approval of the product. Working in parallel with other study aspects allows this report to be finalized within a few weeks after the database is locked.

Having a good project plan allows many tasks to be completed in parallel to shorten time to completion of the study which can result in a shorter time to clearance or approval!

Be sure to keep an eye out for the next post in this series, Medical Device Development: Market Approval.

In case you missed it, you can check out Medical Device Development: Clinical Studies, Part 1, here.

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This post was written accompanied by Mike Grillo, former Senior MRM at NAMSA.

Authors:

Nancy Drake is Manager, Clinical Research Services with NAMSA, focusing on MRO projects with a clinical requirement. She holds a master’s degree in biochemistry from Rice University and has been in the medical device space for 40 years. She has worked in a number of medical disciplines in Clinical, Regulatory, Manufacturing and R&D.