Month: October 2019

Building a Quality Assurance Program for Investigator-initiated Trials

Abby Statler, MPH, MA, CCRP
Research Regulatory Quality Assurance Coordinator
Cleveland Clinic Cancer Institute

Two clinical researchers analyzing information on a computer

Abstract: In 2008, The Cleveland Clinic Cancer Institute established a quality assurance (QA) program for investigator-initiated trials (IITs). Over the past nine years, the program has become an integral part of the Institute’s research department, supporting the growth of IITs while improving the proficiency of regulatory operations. This article describes the program’s objectives and discusses the operational strategies employed to achieve these goals. Other clinical research sites are encouraged to consider how components of the Cleveland Clinic Cancer Institute’s QA program may be adapted to meet the needs of their organizations.

Introduction

The research sponsored by Cleveland Clinic investigators supports the Foundation’s innovation initiatives, making it a top priority for the Institute’s leadership team. Thus, the development and implementation of the Cleveland Clinic Taussig Cancer Institute’s QA program was motivated by the organization’s commitment to effectively oversee the conduct of IITs. Launched in 2008, the Cancer Institute’s QA program was the first of its kind, specifically focusing on providing operational support for investigator-initiated trials.

Before the department was implemented, investigator-initiated trials had few operational resources, protocols required multiple revisions, Investigational New Drug Applications were submitted inconsistently to the U.S. Food and Drug Administration (FDA), and processes for effective essential regulatory documentation management had not been established. To date, the QA program has grown from one to five members, which has enabled the department to cohesively support the IIT profile while also improve the operations of industry-sponsored and cooperative group trials. In this article, I will outline the essential components of a QA program, discuss the challenges that our department faced during the program’s development, and highlight how the Institute’s commitment to quality has enhanced the Cancer Center’s conduct and initiation of clinical trials.

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Reducing Over-reporting to INDs and Increasing Efficiencies at Clinical Research Sites

Sarah Attwood, BSc
Director of Client Services
IntegReview IRB

Abstract: Institutional review boards (IRBs) continue to be overburdened with reports not required by federal regulations. It is important to understand the difference between what the regulations require and what has become an industry standard. Additionally, clinical research sites are often confused about reporting requirements and err on the side of conservatism by over-reporting. By clearly identifying regulatory requirements, the clinical research industry may become more efficient and eliminate unnecessary work for sites as well as IRBs.

Clinical researcher at computer

Introduction

Study sites are over-reporting adverse events (AEs) and serious adverse events (SAEs) for studies conducted under Investigational New Drug (IND) applications. IRBs are required by the U.S. Food and Drug Administration (FDA) and the Office of Human Research Protections (OHRP) within the Department of Health and Human Services to review “unanticipated problems involving risks to participants or others.”  

IntegReview IRB is a central IRB that reviews many protocols each year, just as institutional IRBs do. In 2016, IntegReview IRB saw an increase in the number of IND safety reports and a slight decrease in SAE reports. The reason for these changes is unknown. IntegReview IRB is seeing about a four-fold increase in IND safety reports, which is far above the increase in business.

IRBs receive many IND safety reports that are not related to the current protocol at the clinical researchsite. The reports could be about something that is happening in Asia or Europe, a different use of the drug, or a different research project. These reports must be processed, even though they are not under the jurisdiction of the IRB for the current study, creating information overload.

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