ICH GCP changes are happening so fast that even seasoned clinical trial professionals find it hard to keep up.
The International Council for Harmonisation released a draft of ICH E6(R3) in April 2021, with two annexes to follow in 2022. Clinical research organizations should familiarize themselves with the basic R3 guidelines before the updates are released.
ICH GCP (R3) frequently asked questions are answered here.
What is the purpose of revising ICH GCP?
Dr Crissy MacDonald of The Avoca Group attributes the quick release of ICH E6(R3) to the rapid changes in clinical trial design approaches. The ICH wanted to ensure that the Good Clinical Practice principles in ICH E6 apply to many types of trials. Also, they wanted the ICH E6 standard(R3) to be flexible so companies could use it in their sites.
What will change in ICH GCP (R3)?
ICH GCP (R3) will require clinical trials to follow several new principles, including protecting participants' rights, safety, and well-being, and receiving approval from an independent Institutional Review Board or Independent Ethics Committee.
In addition to this, ICH GCP (R3) introduces several new principles for clinical trial teams to comply with.
How will ICH GCP (R3) affect sites and sponsors?
The new version of ICH E6(R3) introduces four new principles, which are: quality should be built into the scientific and operational design and conduct of clinical trials. Roles, tasks, and responsibilities should be clear and documented appropriately.
Each new principle has been broken down to show what it means for sponsors, contract research organisations (CROs), and clinical trial sites.
1. The scientific, practical, and conduct of clinical trial should all be done with quality in mind.
ICH GCP (R3) asks trial professionals to be proactive rather than reactive, and to build quality into the design of clinical trials from the very beginning. This means training operational staff members on ICH regulations and implementing quality checks early in the process.
2. Clinical trial procedures, standards, and methods ought to be proportionate to participant risks and the accuracy of trial findings.
Risk-based monitoring allows clinical trial sites, CROs, and sponsors to embrace Risk-Based Monitoring and Risk-Based Quality Management. This helps trials move faster without compromising participant safety or the validity of the trials' results.
3. Clinical trials should generate reliable results.
A subprinciple of this new principle explains what reliable results mean:
“The quality and amount of the information generated in a clinical trial should be sufficient to provide confidence in the trial`s results and support good decision-making.”
This fits together with the other principles that have changed. Instead, researchers need to collect and monitor the data that regulatory agency will use to make good, scientifically sound decisions.
4. Clinical trial roles, duties, and tasks should be clearly defined and properly recorded.
ICH GCP (R2) and ICH GCP (R3) both require that the people running the trial are fully qualified to perform the tasks they`re in charge of. As new physicians` offices and pharmacies get involved in clinical trials, the people who work there will need to know which responsibilities lie with them and which lie with the research site staff.
ICH GCP (R3) requires that tasks and responsibilities be documented and assigned to qualified individuals.
Getting ready for ICH E6 (R3)
Clinical trials can welcome a wide array of experts, from technology-minded clinical research staff to physicians to statisticians. Clinical research professionals can use a variety of trial designs, including platform trials or decentralized trials, as long as those designs protect participant safety and data integrity. All these experts can contribute their ideas to produce effective and efficient clinical trials.
We will update our GCP training courses to include R3 as soon as it is finalised to provide the most recent information to our trainees.
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