While most business sectors accept change as an unavoidable constant, the medical device sector embraces radical, whirlwind change as a core feature of its industry. Ingenious technological advancements, regulatory and legislative modernization, and optimized data management and analytics applications are just a few of the continually evolving developments that make the medical device industry so exciting and that spur such a wide array of innovative breakthroughs. A new white paper entitled “Top 5 Clinical Trends in the Medical Device Industry in 2018” delves into the current clinical developments causing pronounced reverberations throughout the medical device sphere. The white paper also provides valuable insight into how device companies can adapt and thrive in a burgeoning industry that perpetually reinvents itself on a seemingly daily basis.
Author Patricia Santos-Serrao, RAC, MasterControl’s director of clinical and regulatory solutions, elaborates on five key clinical trends that are anticipated to have considerable ramifications for medical device companies this year. Santos-Serrao draws from her expertise as a member of the Regulatory Affairs Professional Society (RAPS) and the Drug Information Association (DIA), as well as more than two decades of experience in clinical and regulatory endeavors.
The following is a brief synopsis of three of the foremost clinical trends highlighted in the white paper. For a comprehensive analysis of each of the top five medical device clinical trends to keep an eye on this year, download the complimentary white paper.
The U.S. Food and Drug Administration (FDA) is encouraging all companies seeking clinical approvals from the agency to adhere to good clinical practice (GCP) guidelines. And, in the latest step toward a global standardization of clinical data, the agency will require GCP compliance for all data gathered from device trials conducted outside the United States as of Feb. 21, 2019.[i] This change is intended to provide congruency across different submission or application types, no matter where in the world a clinical study is conducted. Similarly, recent developments with the China Food and Drug Administration (CFDA) and the European Union’s (EU) revamped Medical Devices Regulation (MDR) are poised to establish more stringent demands for clinical evaluation and postmarket clinical follow-up as well. By moving toward common global standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical investigation data, the FDA and other regulatory agencies believe device companies will be able to provide greater assurances that “data and results are credible and accurate” while also demonstrating that “the rights, safety, and well-being of subjects are protected.”[ii]
Santos-Serrao takes the position that modern innovations in data management technologies are making it possible for companies conducting medical device clinical trials to keep up with these trends by streamlining the access to and tracking of clinical trial information and by strengthening data security and integrity. And while these technologies can streamline access to accurate and real-time clinical data, she says that it’s logical to conclude that “regulatory agencies will in turn increase their demands for centralized statistical monitoring and robust data analytics.” To these ends, the white paper outlines the benefits of implementing an integrated electronic system that allows clinical data to be managed from within a central, secure and highly transparent platform.
The term “certified copy” is rife with ambiguity in the world of clinical research because the precise meaning of certified varies somewhat between different regulatory agencies and regions. Perhaps the most widely recognized definition is found in Section 1.63 of the ICH E6(R2) Addendum, which states that a certified copy is a “copy (irrespective of the type of media used) of the original record that has been verified (i.e., by a dated signature or by generation through a validated process) to have the same information, including data that describe the context, content, and structure, as the original.”[iii]
While this definition might seem to provide a great deal of latitude in how clinical research organizations maintain copies that can be considered certified, Santos-Serrao says that it provides an ideal opportunity for these organizations to draw their own conclusions according to their individual risk assessments. She recommends that a clinical organization should first define its own internal interpretation of what constitutes a certified copy and apply it throughout the clinical enterprise. Then, that self-administered guideline can be used to substantiate all subsequent practices, processes and decision-making. Best practices can be based upon an internal benchmark once a company has satisfactorily decided upon a definition of a certified copy and documented all clinical activities accordingly. Santos-Serrao’s white paper also goes into great detail about assessment tools like internal risk evaluations and validation processes that can be indispensable mechanisms for making decisions about which documents should be classified as certified copies and which lower-risk data should be exempted.
Due primarily to the recent ICH GCP E6(R2) guideline updates pertaining to essential documents in clinical trials, regulatory inspectors are increasing their requests to access trial master file (TMF) documentation during inspections and clinical study audits. The amended guidance requires documents that are deemed essential to a clinical trial to be available for audit by the sponsor’s auditor and for inspection by regulatory authorities. As such, TMF inspection readiness has vaulted to the top of the priority list of clinical enterprises that strive to maintain regulatory compliance.
Santos-Serrao explains how most impediments to TMF inspection readiness are caused when clinical documentation is maintained in paper-based or other inefficient systems that silo information, hinder access and visibility, and prohibit the accurate measurement of the status and performance of clinical activities. She points out that electronic systems designed for TMF management can:
Achieving a state of continual TMF inspection readiness is best achieved through regular checkups on the quality of TMF content and the completeness of the data set, according to Santos-Serrao. Defining goals and objectives for TMF completeness and documenting the quality of information at target indicators helps keep studies on track while also ensuring that data integrity is kept in check and continually monitored for quality.
For a deeper dive into these and more of the most prominent clinical issues and trends shaping the medical device industry, download the full white paper.
References [i] FDA Guidance for Industry “Acceptance of Clinical Data to Support Medical Device Applications and Submissions – Frequently Asked Questions,” February 21, 2018. Viewed on March 19, 2018 at: https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm597273.pdf
[ii] Federal Register “Human Subject Protection; Acceptance of Data from Clinical Investigations for Medical Devices,” February 21, 2018. Viewed on March 19, 2018 at: https://www.federalregister.gov/documents/2018/02/21/2018-03244/human-subject-protection-acceptance-of-data-from-clinical-investigations-for-medical-devices
[iii] FDA Guidance for Industry “E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1),” March 2018. Viewed on May 31, 2018, at https://www.fda.gov/downloads/Drugs/Guidances/UCM464506.pdf
James Jardine is a marketing communications specialist at MasterControl Inc. and has covered life sciences and regulatory issues for more than a decade. He has a bachelor’s degree in journalism from the University of Utah.