Quality by Design in Clinical Research

In clinical research, “high quality” means that a study generates good, useful data, does not harm the study participants, and proceeds smoothly with few interruptions by errors or omissions. However, too many clinical research studies get mired in a time-consuming quality control (QC) process that generates numerous site monitor findings (e.g., missing data, ineligible study participants, other protocol deviations), data queries, and other after-the-fact indications that a quality problem has been found and needs to be fixed. A research site may be unable to deliver acceptable results, no matter how much the sponsor tries to help. In severe cases, the design of a study incorporates problems that make it impossible to achieve high quality results, no matter how well the study is conducted.

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Clinical Trial Management: Houston, We Have a Problem

In the management of clinical trials, whether they be local, international, multi-site, simple or complex, a variety of situations can (or should I say will) occur that will have you saying “Houston, we have a problem!” These complications may be related to an issue at the clinical site itself, within the CRO or at the Sponsor level, but could also be caused by the study protocol or the investigational drug itself. This white paper will present a methodology to optimize clinical trial management by using best practices, as well as how to avoid and resolve problematic situations that may arise throughout the trial.

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Quality by Design and Risk-Based Monitoring

Over the past decade, the clinical research industry’s standard to meet regulatory monitoring obligations has involved frequent and regular onsite monitoring visits with 100% source data verification (SDV). The belief that “more is better” continues even with new evidence that on-site monitoring practices do not necessarily guarantee patient safety and data quality. An electronic survey was conducted by the Clinical Trials Transformation Initiative (CTTI) in 2008 to assess the clinical monitoring practices utilized across different types of organizations involved in clinical research. The results published in 2011 have highlighted the heterogeneity in monitoring practices between clinical trial organizations, and the key conclusion is that traditional monitoring is inefficient and doesn’t always lead to increased patient safety and data quality in clinical trials.

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Conflicts of Interest in Conducting Clinical Research

As the pharmaceutical industry continues to grow and research activities continue to expand, especially financially, new models of “doing business” are appearing at a fast pace. Outsourcing of clinical trial functions to Contract Research Organizations (CROs) are continuing to increase in volume as more and more pharmaceutical companies decrease their internal number of resources. This trend has created some unique opportunities for CROs to grow into niche markets; however it has also created situations where concerns of conflicts of interest (COI) are beginning to arise. In addition, increasing numbers of physicians, both within and outside academic health centers, are becoming involved in partnerships with industry to perform clinical research. A definite need for protecting the integrity of the research data, and safeguarding the well-being of research participants against conflicts of interest is becoming an urgent requirement-from the perspective of both CROs and investigational sites.

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Class II – IV Medical Device Investigational Testing in Canada

The Food and Drugs Act (1) defines a “device” as any article, instrument, apparatus or contrivance, including any component, part of accessory thereof, manufactured, sold or represented for use in the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state. It includes a vast range of equipment, from a simple tongue depressor to robotically assisted surgical machines. In Canada, Medical devices are classified into Class I, II, III, and IV based on the level of invasiveness.

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Quality in Pharmaceutical Research

Organizations conducting business within the pharmaceutical industry, regardless of whether they are a sponsor or a service provider, should always hold Quality as a first priority. Unfortunately, even though a quality mindset is usually integrated as part of a company in the form of a department, system, or a series of processes, many companies lose sight of its utmost importance when conducting their day-to-day business. In other words, although a diamond may seem flawless and of high quality upon first glance, the truth is revealed when you look more closely at its facets with a microscope and discover numerous flaws within its structure.

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