June 1, 2021 – Life Science Leader – For decades, operational progress within the clinical research industry has been profoundly shaped by the relationships between sponsor companies and their CRO partners. Among other advances, these relationships have contributed to sponsors’ abilities to globalize clinical trial operations, expand therapeutically, manage risk effectively, and optimize processes, impacts that have been studied for nearly 20 years in the annual Avoca Industry Survey.
In the May 2021 issue of International Clinical Trials, ICT interviews Steve Whittaker at WCG Avoca, who describes how the evolving regulatory landscape of the clinical trial industry stands to spur change in the way we manage data.
A consortium model of pharmaceutical players helps The Avoca Group change the clinical trial execution process
March 23, 2021 – Inc.com – The clinical trial process is a key component of the $2.6 billion it costs, on average, to roll out a new medicine. Clinical trials are highly regulated medical research studies designed to evaluate the impact potential new medications have on patients. There are currently more than 365,000 clinical trials underway in 219 countries worldwide.
July 7, 2020 – Clinical Leader – In clinical research, we learn to act instinctively and quickly when it comes to making decisions about subject protection, data validity, and ethical conduct. That skillset inherently comes with the ability for problem-solving with a focused determination on the patient. The challenges of COVID-19 shine the light on how we use this skill to carry on the mission of bringing needed medicines to those who need it.
June 15, 2020 – CenterWatch – With the International Council on Harmonization (ICH) poised to begin work on another revision to its good clinical practice (GCP) guideline, ICH E6, sites and sponsors have questions about what they can expect from upcoming changes while they still are struggling to interpret requirements placed on them by the previous 2016 revision. Speakers at two recent CenterWatch webinars provided some insight. Marina Malikova is executive director of surgical translational research, operations and compliance at Boston University School of Medicine, and Steve Whittaker is a senior consultant at The Avoca Group.
Leveraging approaches in RBQM to enable effective corrective and preventive action processes.
May 2020 – When it comes to implementing corrective and preventive action (CAPA) plans in clinical tri-als, we consistently hear similar frustrations from members of the research community year after year. They typically identify and implement corrective actions, but identifying and implementing preventive actions, which aim to minimize risks to other studies, is still somehow getting lost in the shuffle.
With recent reports indicating that organizations do not have a way of tracking and managing the timeliness of data entry or of site payments, The Metrics Champion Consortium wanted to see if there were opportunities to align incentives in the industry so that both sites and sponsors can achieve their goals with positive impact on clinical trials and patients.
September 2017 – The Metrics Champion Consortium (MCC) recently issued two reports based on industry surveys of data entry timeliness by sites1 and on site payments.2 The reports indicate that, in general, organizations do not have an effective way of tracking and managing the timeliness of data entry or the timeliness of site payments. MCC wanted to see if there were opportunities to align incentives in the industry so that both sites and sponsors can achieve their goals with positive impact on clinical trials and patients.
Most firms are now using a standard set of key performance indicators
October / November 2016 – During the past 15 years, my teams at the Tufts Center for the Study of Drug Development (Tufts CSDD) have frequently encountered organizations struggling with the collection and application of meaningful and relevant management metrics. These struggles have largely been specific to each given company’s culture and operating structure: In the past, it was not unusual to find companies participating in Tufts CSDD working group studies who are not actively collecting certain management-level metrics. On the opposite end of the spectrum, some participating companies have appeared to be collecting too much performance and quality data, often without a clear sense for its purpose. In many cases select financial and quality metrics have been too difficult for many organizations to collect, as this data resides in separate functions and cannot be accessed easily.
April 7, 2017 – During the past 15 years, my teams at the Tufts Center for the Study of Drug Development (Tufts CSDD) have frequently encountered organizations struggling with the collection and application of meaningful and relevant management metrics. These struggles have largely been specific to each given company’s culture and operating
The pharma industry agrees that the importance of entering data into an EDC as soon as possible following a subject is paramount. Slow site data entry can impact the credibility and usefulness of centralized monitoring data analytic reports.
But MCC survey indicates poor oversight undermines ability to monitor study quality
With the adoption of the addendum to GCP, ICH E6 (R2), there are some significant developments that are needed by the industry in relation to identification and management of risk and defining critical data points. As stated in section 5.0 Quality Management, “The sponsor should implement a system to manage quality throughout all stages of the trial process. Sponsors should focus on trial activities essential to ensuring human subject protection and the reliability of trial results.” Section 5.0.1 Critical Process and Data Identification starts “During protocol development, the sponsor should identify those processes and data that are critical to ensure human subject protection and the reliability of trial results.”1
Just because information can be gathered and shared more quickly among stakeholders does not mean that it can identify risk. This article describes the need for pharma to adopt fully-vetted, standardized operational-level time, cost and quality performance metrics as tools for tracking and predicting performance.
August 2016 – The proliferation of cloud-based technologies has made it easier for stakeholders to collect and share performance data that flow into data analytic tools. To access these data, sponsors and contract research organizations (CROs) have invested heavily in electronic data capture (EDC), eSource, and other solutions since data from these systems can be aggregated into a single database to run data analytic reports. Metrics found in these reports provide the foundation upon which emerging clinical trial strategies, namely risk-based management (RBM) and quality by design, can be implemented, with an eye toward better performance. In keeping with this effort, organizations such as TransCelerate1 and Metrics Champion Consortium (MCC)2 have been developing proactive methods and tools around risk assessment and management to improve clinical trial quality while increasing patient safety.
How Quality Performance Metrics Enable Successful Change