A statement issued by the European Forum for GCP (EFGCP) states that provided further updates are made, the ICH guideline for Good Clinical Practice (E6) can stay relevant for another 20 years.
Provided further updates are made, the ICH guideline for Good Clinical Practice (E6) can stay relevant for another 20 years, according to a statement issued by the European Forum for GCP (EFGCP).
“The changing way we conduct research has meant that the guideline needs an update, and the E6 addendum aims to accomplish that,” EFGCP noted. “The EFGCP welcomes the update of the E6 guidance document, and the changes which will facilitate its application to electronic systems. The acknowledgement of risk-based trial activities is helpful and will keep the guideline in harmony with many recent regulatory developments.”
Discussions are ongoing, and the ICH business plan anticipates finalization in November 2016 and regulatory implementation in mid-2017. The guideline has always been tripartite, but as well as including the EU, Japan and the U.S., both Canada and Switzerland are specifically mentioned in the scope, EFGCP continued.
EFGCP has given the following feedback on the document: references to “original” and “copy” documents should be removed from section 8 (essential documents) because with electronic documents these concepts are less applicable; definitions are necessary for new terms in the addendum, especially within quality risk management; and requirements for the investigator to have control of and continuous access to the case report form (CRF) supplied to the sponsor are currently difficult to meet. The use of a third-party vendor to hold the eCRF may give the required degree of protection to the document, EFGCP suggests.
In the document, sponsors are urged to avoid unnecessary complexity, procedures, and data collection, and this is a frequent cause of clinical trial problems. “It will be interesting to see if regulators similarly push for simplification of our trials,” continued the statement.
Centralized monitoring is recognized, with the aim of identifying missing data, inconsistencies, outliers and a lack of variability, and the use of statistics is encouraged to identify trends, looking at the range and consistency of data across sites. Also, the guideline requests that monitoring plans emphasize critical data and processes, giving a rationale for their selection. It suggests that applicable policies and procedures are referred to in support of the plan.
“It is worth noting that inadequate justification of monitoring sampling plans has been the recent cause of many inspection findings. Both the sponsor and investigator should record the location of their essential documents with a view to future document identification, search and retrieval,” EFGCP stated. “The sponsor should not have exclusive control of CRF data, as has been the position in an EMA (European Medicines Agency) reflection paper. This is an ongoing challenge for clinical researchers.”
To read the full statement, click here.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
Reaching Diverse Patient Populations With Personalized Treatment Methods
January 20th 2025Daejin Abidoye, head of solid tumors, oncology development, AbbVie, discusses a number of topics around diversity in clinical research including industry’s greatest challenges in reaching diverse patient populations, personalized treatment methods, recruitment strategies, and more.
POETYK PsA-2 Trial Shows Efficacy of Sotyktu as an Oral Therapy for Psoriatic Arthritis
March 11th 2025Sotyktu (deucravacitinib) demonstrated significant efficacy in improving psoriatic arthritis symptoms compared to placebo in the Phase III POETYK PsA-2 trial, with a well-tolerated safety profile.