Drug Induced Liver Injury (DILI) presents a critical challenge to the pharmaceutical industry and patient care.
Hepatotoxicity has been the most frequent single cause of drug marketing safety withdrawals for the past 50 years and is the most common cause of aborted drug development.
Monitoring and diagnosing DILI is challenging, and notable gaps exist in current regulatory guidance on detecting and monitoring DILI in clinical trials of new drugs.
There has been no industry-led effort focusing on clinical aspects of DILI, which are not sufficiently covered by existing guidance.
In June 2016, the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) endorsed the establishment of an initiative on the clinical aspects of DILI.
The IQ-DILI Initiative is focused on defining best practices for the detection, monitoring, management and prevention of DILI in clinical trials and post-marketing pharmacovigilance programs.
The goals of the IQ-DILI Initiative, pursued by all of the working groups, include conducting literature searches to gather publicly available information on DILI, conducting surveys to gather companies’ current practices, and developing white papers summarizing current data in the literature, current industry practices, and proposed best practices for monitoring, diagnosing, managing, and preventing DILI in clinical trials and in post-marketing pharmacovigilance activities. The IQ-DILI Initiative is also continually scanning the landscape and developing strategies to collaborate with organizations addressing similar topics to avoid redundant efforts and build synergies with others in the field. Longer term goals include data sharing to substantiate best practices recommendations.
The Steering Committee provides strategic oversight of the initiative's portfolio. The Steering Committee has representation from all member companies and is the primary decision-making body for the IQ-DILI Initiative. Acting on the recommendations of working groups and on its own initiative, it establishes objectives, policies, and plans of action. Whenever possible, the Steering Committee operates on a consensus basis.
The Planning Committee provides leadership and guidance in the management of the business and affairs of the consortium between meetings of the Steering Committee, implements strategic plans recommended by the Steering Committee, and provides general counsel and tactical advice on significant challenges faced by the Initiative's Working Groups.
Working Groups are standing venues that allow experts in clinical DILI to discuss key topics that present challenges to preventing, diagnosing, monitoring, and managing DILI in patients.