Quality in clinical trials is of utmost importance to the pharmaceutical industry, with the need for quality management systems estimated to grow to $4.5 billion by 2032 according to Global Market Insights.
The best pharmaceutical pipelines are driven by good quality data. And, to meet regulatory requirements, stakeholders need to improve on quality in clinical trials by developing systems with specific standards for each clinical trial process.
The quality systems include:
- personnel roles and responsibilities,
- training and competency,
- policies and procedures,
- quality assurance and auditing,
- document management,
- risk management,
- change management,
- record retention,
- results reporting, and
- corrective and preventive action.
What is quality in clinical trials?
In clinical trials, the wellbeing of trial participants and the integrity of generated data is at the center of all decision making; therefore, quality is essential in ensuring that error-free clinical data is generated, and accurate, effective decisions are taken.
The four types of errors likely to occur in clinical trials may pertain to:
- study design,
- recording (both random and fraudulent), and
- analytical measurements.
With this in mind, it is imperative that quality be built into the scientific and operational design and conduct of clinical trials. This is referred to as “quality by design” and was amongst the recent changes implemented with the revision of the International Council for Harmonization (ICH) E6(R3) Good Clinical Practice (GCP) Principle 7, currently under public consultation.
According to Quality by Design Principles and Philosophies by the Society of Clinical Research Associates, “an organization should have an independent entity to measure/review quality standards, along with an integrated system to continuously verify, analyze, correct and prevent issues from arising.”
Therefore, it is necessary to build quality into clinical trials, but equally important to learn how to measure quality through metrics in order to continuously improve on past performance.
Why is quality in clinical trials important?
GCP is the universal ethical and scientific quality standard for conducting clinical trials and it applies to all aspects of the clinical trial process.
During the clinical trial process, conformance to GCP quality standards provides the surety that the generated results and clinical data:
- protect the integrity, safety, rights, and confidentiality of the clinical trial participants;
- maintain consistency of procedures and processes;
- are accurate, complete, and original.
Whether it is a clinical research site, a contract research organization (CRO) or a sponsor, quality should never be summarized into a department within an organization. It can be argued that the management of quality should function as an independent entity in order to prevent potential bias and provide objectivity; it can be equally valid to argue that quality should be an integral part of all operations in order to be a constant reminder to set high standards.
By implementing quality in operations, an organization is better protected against risks, increases efficiency, reduces waste, and improved profitability.
Within MMS, this collaborative approach is demonstrated by the Service Line Quality Champion (SLQC) Initiative. The initiative’s objective is to establish a strong collaboration between service lines and, quality and compliance department, in order to optimize quality value and support service line maturity across the organization.
Implementing quality in clinical trials
The Clinical Trials Transformation Initiative (CTTI) is a program created by the US FDA for building quality into scientific and operational design, as well as the conduct of clinical trials. The CTTI’s recommendations are quality in clinical trials is summarized below.
- Instill a culture that values and rewards critical thinking about quality, and that goes beyond reliance on tools and checklists. Encourage the development of innovative methodologies for ensuring quality by proactive engagement about what is important to quality in a particular development program or clinical trial. “One size fit all” approaches that hinder the creation of specific strategies and actions intended to support quality should be discouraged.
- Prioritize activities that are essential to the credibility of study outcomes by evaluating and streamlining the clinical study design to ensure that planned activities and data collection are essential. Non-essential activities may be eliminated to simplify study conduct, improve clinical trial efficiency, and prioritize resources to critical areas.
- Allocate resources, where possible, to identify and prevent or control errors that may significantly impact the safety of clinical trial participants and the credibility of key study results.
- Engage a broad range of stakeholders in clinical study protocol development and discussions around study quality; this is an important feature of quality by design. Significant insights pertaining to the feasibility of enrolling participants that meet the prescribed criteria, whether the set procedures or scheduled study visits are in alignment with the targets and would not lead to early dropouts may be provided by sponsors, trial participants, investigators, and other study personnel.
- Identify and periodically review aspects that are critical to maintain quality in clinical trials, such as the generation of accurate, reliable data and provisioning appropriate protections for research subjects.
To ensure an ethically and scientifically valid clinical trial, it is essential that full compliance to quality principles is maintained. The crucial objective of maintaining data integrity and subject confidentiality can be achieved by a systematic approach to the whole process of trial conduct.
The ability to generate reliable data, essential for making appropriate decisions concerning clinical interventions, is under constant threat by the ever-increasing complexity of clinical trials and associated costs. To overcome this inefficiency, it is essential for key stakeholders to adopt policies for improving protocol design, trial planning, risk-based inspections/audits, and quality oversight. And, as the need for quality management continues to grow, so should a team’s approach to ensure that everyone plays a role in improving and maintaining quality in clinical trials.
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Authored by: Jackson Mutua; Senior Specialist, Quality and Compliance.