Innovations in technology, economics, policy and scientific discovery occur with such frequency and speed in the fast-changing, hypercompetitive world of life sciences that only the most versatile and far-sighted pharmaceutical and biologics companies can thrive. In a new white paper, Patricia Santos-Serrao, RAC, MasterControl’s director of clinical and regulatory solutions for pharmaceutical, blood, and biologics, sheds light on the top five clinical trends that are sure to have a massive impact on the pharmaceutical and biologics sectors this year.
The paper is drawn from Santos-Serrao’s deep clinical knowledge as a member of the Regulatory Affairs Professional Society (RAPS) and the Drug Information Association (DIA) and more than two decades of professional experience in the regulatory affairs and clinical areas of the pharmaceutical industry. In it, she provides details about recent important clinical and regulatory developments and illustrates how companies can adapt to challenges by making fundamental adjustments to the way they manage clinical research and trials.
The following is a brief rundown of several of the major clinical trends highlighted in the white paper. For in-depth analysis of all five of the major clinical pharma/bio trends to watch in 2018, download the white paper.
Regulatory inspectors are increasingly requesting direct access to trial master file (TMF) documentation during inspections and clinical study audits. This is due in large part to the recent updates to the ICH GCP E6(R2) guideline that address essential documents in clinical trials. Since the amended guidance mandates that documents that are essential to a clinical study “may be subject to, and should be available for, audit by the sponsor’s auditor and inspection by the regulatory authority(ies),”[i] TMF inspection readiness has soared to the top of the priority lists of clinical organizations that hope to maintain regulatory compliance.
The most significant hindrances to TMF inspection readiness arise when clinical documentation is managed in siloed, predominantly paper-based systems that impede study teams’ access and lack a means of accurately measuring status and performance. To counteract these barriers to inspection readiness, Santos-Serrao recommends the implementation of an electronic system expressly designed for TMF management. Specialized eTMF systems provide a variety of benefits, such as:
If you ever want to silence a chatty clinical professional, just ask that person to define what qualifies as a “certified copy” of a clinical research document. The term has become an ambiguous buzzword in clinical circles because different regulatory bodies assert their own definitions of certified copies in the absence of a concise industrywide definition. The closest thing to an official, globally recognized definition is likely Section 1.63 of the ICH E6(R2) Addendum’s statement 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.”[ii]
Given the wide berth this would seem to permit in determining what is or is not a certified copy, Santos-Serrao recommends that organizations first define their own internal interpretations and then thoroughly document those self-administered guidelines to substantiate their subsequent decision making, processes, and standard operating procedures (SOPs). “Once a company has satisfactorily defined what it believes a certified copy to be, it can base its own best practices upon that benchmark,” she says. The white paper also explains how internal risk evaluations, validation processes and other assessment practices can be indispensable means of determining which documents should qualify as certifiable and which lower-risk data can be excluded.
When all parties involved in a clinical study collaborate effectively during each phase of a critical TMF document’s lifecycle, clinical processes and overall efficiencies are enhanced across the board. However, difficulties relating to the security, accessibility and accuracy of TMF documentation make collaborative efforts extraordinarily problematic and are often the source of major content bottlenecks.
Common sense dictates that the most effective means of maximizing TMF oversight and avoiding such hazards is the implementation a single management system that can provides signposts to indicate where all TMF documents and artifacts are located while also rendering real-time status updates. But, since TMF documents are inevitably scattered among many systems and sites throughout an organization, establishing this type of centralized, utopian TMF management system seems like a pipe dream to most organizations involved in clinical research. Connecting disparate systems that store clinical research information is not only possible but is particularly advocated by TMF experts like Santos-Serrao.
To get started on the path toward effective TMF system alignment she recommends first confronting any known data security and/or integrity issues. After thoroughly evaluating existing data concerns and planning for any consequent data management implications, there are three primary considerations that should be effectively addressed:
The white paper also makes a point of noting the dramatic recent upswing in the number of clinical research organizations making the shift toward using systems based on the TMF Reference Model in order to promote adherence to regulatory imperatives, reduce information failures, and streamline overall clinical activities.
For the full exploration of the notable clinical issues and trends currently shaping the trajectory of the constantly evolving pharmaceutical and biologics industries, download the complimentary white paper.
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.
 FDA Guidance for Industry “E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1),” March 2018. Viewed on May 21, 2018, at https://www.fda.gov/downloads/Drugs/Guidances/UCM464506.pdf