The quality of the scientific and operational design and conduct of clinical trials is crucial for the safety of participants, the success of the study, and the credibility of results. We need to pursue a quality approach to clinical trials to avoid errors, collect data that is fit-for-purpose, and reduce patient burden. Engaging all stakeholders early in trial development is also key to designing high quality studies. Actively engaging stakeholders outside of sponsoring organizations, including patients and site staff, can help identify barriers to participation and ensure study outcomes are meaningful to patients, improving the quality of research. In CTTI’s 2030 vision for clinical trials:
- Clinical trials address clear and meaningful scientific questions that are determined with the input and consideration of those who will use the results, including care providers, regulators and payers.
- Clinical trials are fit for purpose—designed with study activities that are essential to ensure the safety of trial participants and the credibility of key study results and with nonessential activities eliminated in order to simplify conduct, improve trial efficiency, and target resources to most critical areas.
- A broad range of relevant parties, internal and external to the sponsor organization (e.g. patients and study coordinators), are involved in protocol development and discussions around study quality of individual trials.
- Consideration is given to the validity and efficiency of clinical trials prior to their conduct, including the clarity and conciseness of the protocols and informed consent materials, the ease of adequate data collection that is not excessive, and the validity of analysis plans matched for the purposes of the trials.
- Innovative trial designs (e.g. statistical approaches) will continue to be developed and used to more efficiently and effectively conduct clinical trials.
- Where possible clinical trial infrastructure is reused.
Resources
Ensuring Quality | Expert Meetings
Developing Effective Quality Systems in Clinical Trials: An Enlightened Approach
The Clinical Trials Transformation Initiative (CTTI) has been conducting a project to identify effective and efficient methods to monitor clinical trials. In seeking to identify how best to ensure the...
Ensuring Quality | Webinars
Designing High-Quality COVID-19 Treatment Trials
CTTI Project: Quality by Design Webinar Presenters: Pamela Tenaerts (Clinical Trials Transformation Initiative) Janet Woodcock (FDA, CDER) Ed Cox (Regeneron Pharmaceuticals, Inc.) Martin Landray (University of Oxford) John Marshall...
Ensuring Quality | Webinars
Accelerating Evidence Generation – Resources for Implementing a QbD Approach to Clinical Trials
CTTI Project: Quality by Design Webinar Presenters: Greg Pennock, EMD Serono David Rodin, Amici Clinical Research Ansalan Stewart, FDA Karlin Schroeder, Parkinson's Foundation Steve Young, CluePoints Webinar Resources: Download Powerpoint...
Ensuring Quality | Case Studies
Bristol Myers Squibb (BMS) Co-Hosts Quality by Design Workshop with CTTI to Achieve Quality Culture Aligned with ICH E8(R1)
Bristol Myers Squibb (BMS) Co-Hosts Quality by Design Workshop with CTTI to Achieve Quality Culture Aligned with ICH E8(R1)
Clinical Trials Landscape | CTTI News
New CTTI Project to Develop Common Framework to Assess Progress Towards TT2030 Vision
Clinical trials are critical components of the evidence generating system in research. Launched in 2021, CTTI’s Transforming Trials 2030 vision outlines five pillars for how clinical trials should be performed...
Ensuring Quality | Resources
Critical to Quality (CTQ) Factors Principles Document
Critical to Quality (CTQ) Factors Principles Document
Ensuring Quality | Recommendations
Recommendations for Quality by Design
Recommendations for Quality by Design
Ensuring Quality | Recommendations
Recommendations for Effective and Efficient Monitoring as a Component of Quality Assurance in the Conduct of Clinical Trials
Recommendations for Effective and Efficient Monitoring as a Component of Quality Assurance in the Conduct of Clinical Trials
Ensuring Quality | Resources
QbD Maturity Model Walkthrough and Scoring Examples
QbD Maturity Model Walkthrough and Scoring Examples