Quality in Clinical Research

Quality Assurance

The Sponsor is responsible for implementing and maintaining quality assurance and quality control systems with written Standard Operating Procedures (SOPs) to ensure that trials are conducted and data are generated, documented (recorded), and reported in compliance with the protocol, GCP and the applicable regulatory requirement(s). As per the ICH – GCP Guidelines, E.6, 5.1.1.

Quality Control

Quality control should be applicable to each stage of data handling to ensure that all data are reliable and have been processed correctly. As per the ICH – GCP Guidelines, E.6, 5.1.3.

Quality

It will be helpful initially to consider why terms relating to quality, quality systems and audit are so important within the context of GCP.

1.
For Public Health and Assurance: In order to produce safe, effective and reliable medicines for use by the public, it is clearly essential to have standards that will ensure consistency in terms of their testing and manufacture. The growth in consumer power is reflected in public demand for quality systems to be in place and for compliance with those systems to be evident.
   
2.
To obtain Marketing Authorization: The assessors of marketing authorization applications for new medicines have a duty of care to the public and therefore look for evidence of quality to be provided in all submissions.
   
3.
To avoid Litigation: Increasingly, when a medicine fails, public expectation is for investigation, compensation and increased control. Litigation is costly to the pharmaceutical industry both in financial terms and in terms of corporate and individual reputations. The application of sound quality systems can reduce the likelihood of failure and mitigate the effects litigation.
   
4.
To make research efficient and cost – effective: Where quality systems are absent, there is an increased likelihood that clinical research will follow false leads and fail to recognize unproductive or even dangerous directions in drug development. Clinical Research is costly and time-consuming, and any reduction of unnecessary and unproductive activities will inevitably enhance efficiently.
   
5.
To increase pride in work: Most people spend at least one third of their days in work-related activities and would prefer to enjoy that time rather than experience feelings of frustration and failure. It appears that individuals wish, at least initially, to do a good job. However, many of the problems arising at work serve to reduce the pleasure that was originally anticipated. These problems often arise because the system in which individuals are required to perform does not adequately support their performance. Application of quality standards such as those outlined in GCP provides a safe framework within which workers can take pride in their achievements and feed back suggestions to further enhance the quality of their work.
   

When does quality become an issue?

Quality is an issue at all stages of clinical research, and the only successful approach is to build in quality from the outset.

Recruitment and training of staff

Although the old adage that “You get what you pay for” can be taken too far, it is a mistake for companies to try to conduct clinical research at the expense of their staff. Staff in all functions need to be appropriately qualified, experienced, trained and most of all, motivated. Finance, however, is just one form of motivation. The feeling of being appreciated and valued comes from many sources and is nurtured when people are involved, respected and consulted. Management must therefore take time to recruit well, invest in ongoing training, establish a system of career development and foster a feeling of involvement in order to retain loyal staff and enhance their performance.

Establishment of quality systems for all activities:

Quality is cited as Principle 13 in the ICH GCP guideline, but it could equally rank as Principle 1, because it should be inherent in every aspect of clinical research. What is required is a quality assurance system characterized by standard (high quality) procedures, quality control and audit, with appropriate feedback systems and a “no blame” environment.

Commitment to quality: a pervading culture:

Commitment is fundamental to appropriate recruitment, training and systems maintenance. Regrettably, many companies’ quality systems are led from below, with experienced and motivated staff trying to pull management into compliance with systems of which they have little awareness and in which they have had only the most rudimentary training. In the ideal corporate environment, commitment to GCP will be emphasized at recruitment and reinforced at induction. All staff in every function should understand the motivation behind the quality system, in terms of ethics, safety, data quality and ultimate job satisfaction. In a less-than-ideal environment, lip service may be the reality.

 

Information has been resourced from Principles of Clinical Research, 2001.