ICH E6 Good Clinical Practice Principles

The ICH E6 Good Clinical Practice (GCP) Guideline is widely used by clinical trial researchers beyond the membership and regional representation of ICH itself and has a significant impact on trial participants and patients. Acknowledging the wide and substantial impact of ICH E6, the ICH Management Committee is making available a draft, work-in-progress version of the updated principles that are currently under development by the ICH E6(R3) Expert Working Group (EWG). The principles are interdependent and should be considered in their totality to assure ethical trial conduct, participant safety, and reliable results of clinical trials.

Clinical trials are a fundamental part of clinical research that support the development of new medicines or uses of existing medicines. Well designed and conducted clinical trials help answer key questions in health care and drug development. Their results are essential for evidence-based healthcare decisions. Trials with inadequate design and/or poorly conducted trials may place participant safety at risk and yield inadequate or unreliable evidence. They waste resources and the efforts and time of investigators and participants. The principles of GCP are designed to be flexible and applicable to a broad range of clinical trials. This guideline, along with ICH E8, encourages thoughtful consideration and planning to address specific and potentially unique aspects of an individual clinical trial. This includes evaluation of trial characteristics, such as the design elements, the investigational product being evaluated, the medical condition being addressed, characteristics of the participants, the setting in which the clinical trial is being conducted, and the type of data being collected. Careful consideration of factors relevant to ensuring trial quality is needed for each clinical trial. The principles are intended to support improved and more efficient approaches to trial design and conduct. For example, innovative digital health technologies may expand the possible approaches to trial conduct. Such technologies can be incorporated in existing healthcare infrastructures and enable the use of a variety of relevant data sources in clinical trials. This will aid in keeping clinical trial conduct in line with advancing science and technological developments. The use of technology in the conduct of clinical trials should be adapted to fit the participant characteristics and the particular trial design. The use of innovative technologies may help enable those designing and conducting a trial to include relevant patient populations. This guideline is intended to be media neutral to enable the use of different technologies for the purposes of documentation.

Clinical trial designs that bring the trial to participants and their communities may improve the representativeness of the participant population and enable wider participation. The process of building quality into the design of the trial may be supported by participation of those directly involved. These may include a broad range of stakeholders, including patients and treating physicians. Their input can increase the likelihood of meaningful trial outcomes, which are relevant to both trial participants and future patients. This input will also guide decisions on the feasibility of data collection and assure that participation in the trial does not become unduly burdensome for those involved. Clinical trials should be designed to protect the rights, safety and well-being of participants and assure the reliability of results. Clinical trial designs and processes should be proportionate to the risks inherent in the trial and the importance of the data being collected. Trial designs and processes should be evaluated to minimize unnecessary complexity and burden. The following overarching principles provide a flexible framework for clinical trial conduct. They are structured to provide guidance throughout the lifecycle of the clinical trial. These principles are applicable to trials involving human participants, i.e., healthy volunteers or patients. The principles are interdependent and should be considered in their totality to assure ethical trial conduct and reliable results

1. Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with good clinical practice (GCP) and applicable regulatory requirement(s).
2. 2- Clinical trials should be designed and conducted in ways that ensure the rights, safety, and well-being of participants.
3. Informed consent is an integral feature of the ethical conduct of a trial. Clinical trial participation should be voluntary and based on a consent process that ensures participants are well-informed.
4. Clinical trials should be subject to objective review by an institutional review board (IRB)/independent ethics committee (IEC).
5. Clinical trials should be scientifically sound for their intended purpose, and based on robust and current scientific knowledge and approaches.
6. Clinical trials should be designed and conducted by qualified individuals.
7. Quality should be built into the scientific and operational design and conduct of clinical trials.
8. Clinical trial processes, measures, and approaches should be proportionate to the risks to participants and to the reliability of trial results.
9. Clinical trials should be described in a clear, concise, and operationally feasible protocol
10. Clinical trials should generate reliable results
11. – Roles, tasks and responsibilities in clinical trials should be clear and documented appropriately.
12. Investigational products used in a clinical trial should be manufactured in accordance with applicable Good Manufacturing Practice (GMP) standards and be stored, shipped, and handled in accordance with the product specifications and the trial protocol.