http://www.appliedclinicaltrialsonline.com/where-quality-gcp Where is the “Quality” in GCP? Mar 16, 2015 By Suzanne Tran Applied Clinical Trials Over the years, clinical study management has become more fragmented. There are more organizations participating in a study, each bringing their own experiences, interpretations of requirements including how quality is defined. How is it possible that requirements and quality be interpreted so differently? To start, the Code of Federal Regulations (CFR) items pertaining to Good Clinical Practices (GCP) do not mention the term “quality” directly. Any reference to the use of “quality” is typically associated with an attribute. For example, in 21 CFR 312, it refers to quality in terms of “scientific quality” and “quality” of the drug substance, whereas the term “quality” on its own is used in numerous parts of 21 CFR 58 ( Good Laboratory Practice for Nonclinical Laboratory Studies ): Part 38 alone addresses the requirement for a quality assurance unit (QAU) to monitor nonclinical studies. Quality practices as they relate to GCP are more visible in the Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance (1996) . The introduction states, “This guidance should be followed when generating clinical trial data that are intended to be submitted to regulatory authorities.” Since quality control and quality assurance are not mentioned directly in the CFRs but in guidances such as ICH E6, does this mean that quality is not important in GCP? No. Essentially, quality involves a set of principles/practices an organization uses to verify that requirements are being fulfilled. Applicable standards, regulations, and customer requirements as well as guidance and industry-wide practices comprise “requirements” to be fulfilled. Despite the role an organization has in GCP, there is need for the requirements to be clearly established and controlled systematically throughout the clinical study. Why? A study is only as strong as the weakest participating group. Essentially, a process is an activity or group of activities that takes an input, adds value through the use of resources, and provides an output to internal and/or external customers. The value added by a process comes in exchange for the resources it uses, including people, equipment, material, money, and time. For example, if site monitoring is not a well-defined activity and is performed without proper oversight, the weakest organization has the potential to introduce more variation in the execution of the study protocol and thus potentially compromise the study results. It should be noted that relying on one area of quality, such as quality control activities, is not enough. At a minimum, there is a need for both quality control and quality assurance activities. As defined in ICH E6: Quality Control (QC): The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial-related activities have been fulfilled. Quality Assurance (QA): All of those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with GCP and applicable regulatory requirement(s). In other words, QC includes many activities (operational techniques) to ensure that a protocol is being followed, such as with clinical site monitoring and the establishment of an Institutional Review Board (IRB). QA includes the actions taken to ensure that the activity is conducted effectively and efficiently. It encompasses the use of established practices that include, but are not limited to: management commitment, written standard operating procedures (SOPs), audit reports, computer system validations, and training records. To aid in controlling process variation, a well-established process approach should be used throughout the study and understood as well as practiced by all participating organizations. This practice breaks down the life cycle activities in terms of smaller interrelated processes. It also maintains focus on how the quality of one process affects the quality of the next. As with the difference between QC and QA, there is a difference between what demonstrates a quality system and a quality management system. A quality system typically focuses on a few areas of quality practices (techniques), such as written SOPs. While a quality management system is more comprehensive. Quality management is focused not only on product and service quality, but also on the means to achieve it. Quality management therefore uses QA and control of processes to achieve more consistent quality. A good model for establishing a quality management system is the ISO 9001 standard. Developed and published by the International Organization for Standardization ( www.iso.org ), an international standards writing body, ISO 9001 standard is a set of requirements. The ISO 9001 requirements reflect time-proven, universally accepted business practices. This standard is probably the best known international standard for quality management. What does ISO 9001 demonstrate? By implementing the requirements, the organization is capable of demonstrating that: (1) it has the ability to consistently provide products or services that meet customer and applicable statutory and regulatory requirements; and (2) the organization aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. In general, the ISO 9001 requirements address the following: · Implementing structure by establishing a quality management system · Establishing responsibilities by involving top management · Providing resources to achieve goals through resource management · Designing and performing to requirements (such as customer, statutory, regulatory) · Raising the bar by measurement, analysis, and improvement activities The quality, not just compliance, in GCP therefore comes from organizations that collaborate in conducting a clinical trial that protects human subjects and meets the applicable statutory and regulatory requirements, as well as proactively improve the use of resources to gain regulatory approval in a timely manner so that others may reap the benefits of the new therapy. Suzanne Tran is a QA Compliance Specialist for TRI. She has over 20 years of experience in the quality field. She is an ASQ Senior Member and an ASQ-Certified Manager of Quality/Organizational Excellence, Quality Auditor, and Software Quality Engineer.
Labor Day Gaps Posted on September 5, 2011 by Michael Morrison On this Labor Day weekend it’s appropriate to examine economic trends that influence all Americans and our collective quality of life. A number of interwoven trends follow. Everything is connected! Employment issues are at the forefront of this Labor Day weekend so let’s begin with that topic. Unemployment claims, per the following figure, remain high and GDP growth is not sufficiently robust to accommodate population growth for those desiring to enter the workforce. In addition, the percent of job losses relative to peak employment in the most recent recession have never been as large or persisted for so long, when compared with other post WWII recessions. Intermixed with reluctant job recovery are record corporate profits . Corporations are making profits (good) but they are not hiring (bad). Here’s a graph I created using the FRED online application at the St. Louis Federal Reserve, demonstrating the gap between after tax corporate profits and civilian employment. Note that prior to and during the recession civilian employment and corporate profits tracked fairly well. After the official recession (gray bar) there’s a huge disjunction between the two. Corporations are not hiring, despite record profits. Corporations have become leaner and American worker productivity has steadily increased over several years. Robert Reich’s opinion piece summarizes the concerns. Here’s a graph he produced from many sources: From 1947 to approximately 1980 increases in productivity, average hourly compensation and average hourly wage tracked steadily upward. Contrast those 33 years with the trend lines from 1980 to 2009. Productivity steadily accelerates with an 80% change from 1980 to 2009. On the other hand, average hourly wages and average hourly compensation remained relatively flat with 7 and 8 percent increases, respectively over the same time period. Despite rising worker productivity the following graph depicts a widening gap between real GDP and real disposable income, occurring over five decades. The above graphs depict averages so they don’t demonstrate how income is distributed in the economy. When the distribution of income is taken into account the gaps are even more staggering. Anthony B. Atkinson, Thomas Piketty, and Emmanuel Saez found the bottom 99 percent of incomes grew only 1.3 percent per year from 2002 to 2007 while the top 1 percent captured over two-thirds (65 percent) of income growth. Looking at the issue over a longer period of time economist Robert Reich produced the following graph using data from Piketty and Saez classic study: Income has become more concentrated in the hands of the top 1%, matching similar levels of inequality just before the beginning of the Great Depression. (Reich’s “wealth” labeling of the above graph is actually an error as the graph depicts income, not wealth. Wealth is even more highly concentrated .) A recent study by Northeastern University economists demonstrates that corporations have been one of the primary beneficiaries of sluggish economic growth: “Between the second quarter of 2009 and the fourth quarter of 2010, real national income in the U.S. increased by $528 billion. Pre-tax corporate profits by themselves had increased by $464 billion while aggregate real wages and salaries rose by only $7 billion or only .1%. Over this six quarter period, corporate profits captured 88% of the growth in real national income while aggregate wages and salaries accounted for only slightly more than 1% of the growth in real national income . …The absence of any positive share of national income growth due to wages and salaries received by American workers during the current economic recovery is historically unprecedented.” Don’t misunderstand — profits are good! But the current system is out of balance with a great segment of our society in financial, and probably, emotional trouble. Labor’s share of the economy has dwindled, to stay afloat the middle class workforce was given massive quantities of credit, and women joined the workforce in record numbers to help the family achieve the American Dream. The following graph clearly depicts a troubling decline in labor’s share of the economy. Equally troubling is the gap between real GDP per capita and median household income as revealed by a graph produced by Princeton economist Uwe Reinhardt from data from the Economic Report of the President to the Congress . From 1975 to 2009, the gap between real GDP per capita and real median household income is staggering. Real GDP per capita rose by an annual compound rate of 1.9 percent while real median household income rose by an annual compound rate of 1.18 percent. Conclusion This Labor Day is characterized by many economic challenges. Yet, don’t bet against the United States! We have faced more difficult challenges and come out on top. We are an adaptive, innovative society, changing when change is required. In that regard I pass along Nouriel Roubin’s recommendation for a balanced approach to the challenges we face: “To enable market-oriented economies to operate as they should and can, we need to return to the right balance between markets and provision of public goods. That means moving away from both the Anglo-Saxon model of laissez-faire and voodoo economics and the continental European model of deficit-driven welfare states. Both are broken. The right balance today requires creating jobs partly through additional fiscal stimulus aimed at productive infrastructure investment. It also requires more progressive taxation; more short-term fiscal stimulus with medium- and long-term fiscal discipline; lender-of-last-resort support by monetary authorities to prevent ruinous runs on banks; reduction of the debt burden for insolvent households and other distressed economic agents; and stricter supervision and regulation of a financial system run amok; breaking up too-big-to-fail banks and oligopolistic trusts. Over time, advanced economies will need to invest in human capital, skills and social safety nets to increase productivity and enable workers to compete, be flexible and thrive in a globalized economy. The alternative is – like in the 1930s – unending stagnation, depression, currency and trade wars, capital controls, financial crisis, sovereign insolvencies, and massive social and political instability.” The American Dream holds promise for all, not just the few. Let’s not forget the marginal propensity to consume by the top 5% cannot be the engine to drive a consumption-based economy. (Recall consumption spending accounts for 70 percent of GDP.) Our capitalist system requires a strong, viable middle class and an enlightened self-interest that recognizes the need to find a more balanced economic outcome for people who are working hard, following the rules and trying to raise good families. This entry was posted in Economy , Inequality and tagged corporate profits , disposable personal income , distribution of income , economy , inequality , median household income , productivity , real GDP per capita , unemployment . Bookmark the permalink . ← Why Didn’t Canada Have a Banking Crisis in 2008 (or in 1930, or 1907, or …)? More Evidence: The American Dream is in Trouble →
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