A summary of the new ICH GCP E6 (R3) principles comparing it to R2

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 GCP and applicable regulatory requirement(s). Clinical trials should be designed and conducted in ways that ensure the rights, safety and well-being of participants.

The safety of the participant should be evaluated periodically.

Carefully look at the goal and purpose of your study as to not generally exclude the population the IP is intended for (except in your early phase/proof of concept and bio equivalent studies)

A qualified physician or, when appropriate, a qualified dentist (or other qualified healthcare professionals in accordance with local regulatory requirements) should have the overall responsibility for the trial-related medical care given to, and medical decisions made on behalf of, participants. What does this imply? So if your country regulations allow it a Qualified Nurse can also be a PI ? )

Principle 2.2

Principe 2.3

Principle 2.7

Principle 2.11

2. 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 (or their legally acceptable representatives, where applicable) are well-informed.

Specifically states: Clear, concise and understandable. The process must take into consideration the TYPE of patient, the setting, the type of risks and benefits and the use of technology to inform.

3. Clinical trials should be subject to an independent review by an institutional review board/independent ethics committee (IRB/IEC).

4. Clinical trials should be scientifically sound for their intended purpose and based on robust and current scientific knowledge and approaches.

The trial should make sense based on available data on the disease and the IP – there must be periodic reviews to evaluate if all is still on course or if modifications are needed.

Principle 2.5

5. Clinical trials should be designed and conducted by qualified individuals.

Trials must not only be conducted by qualified individuals but also DESIGNED by qualified individuals. Individuals with different expertise and training may be needed across all phases of a clinical trial, and include a broad scope from Physician, ethicist,  CRA, CRC, Technology experts, specialist, statisticians – all qualified by education and training.

6. Quality should be built into the scientific and operational design and conduct of clinical trials.

QUALITY built in from the get go – from design through to conduct – everything must be considered and designed in such a way that it will assist you to reach the objective

Have plans in place to detect, address and prevent SERIOUS deviations to GCP, protocol, regulations.

Planning – planning – planning – design

7. Clinical trial processes, measures and approaches should be implemented in a way that is proportionate to the risks to participants and to the importance of the data collected.

BEYOND the scope of those of SOC. IP that has marketing authorization and is put back into a clinical trial may differ from routine care.

8. Clinical trials should be described in a clear, concise and operationally feasible protocol.

Not only the protocol but also the accompanying documents like the statistical analysis plan, the Data Management plan and the monitoring plan – all must be clear and concise and understandable.

9. Clinical trials should generate reliable results.

Should produce reliable results so your electronic systems and protocol must be fit for purpose – and have well controlled systems in place to manage documentation – it must be traceable, personal information must be protected and info must be verifiable.

Processes should be operationally feasible and avoid unnecessary complexity, procedures, and data collection. Trial processes should support the key trial objectives – don’t add unnecessary procedures to the protocol and database.

Records to be retained securely by sponsor and Investigator (FOR THE REQUIRED TIME) – no specified period for archiving.

Transparency: register the trial on a publicly accessible and RECOGNISED database and publicly post the trial results.

10 . Roles and responsibilities in clinical trials should be clear and documented appropriately. (NEW)

Roles and responsibilities must be clear (the sponsor is responsible for… the CRO is responsible for… the PI is responsible for …) – documented in an agreement – but resides with the sponsor (when there is a delegated CRO)/PI (when there are delegated staff).

11. Investigational products used in a clinical trial should be manufactured in accordance with applicable Good Manufacturing Practice (GMP) standards and be stored, shipped, handled and disposed of in accordance with the product specifications and the trial protocol.

Put measures in place to ensure IP is manufactured acc to GMP – take care of how it is shipped, stored, handled and dispose of as per protocol.