ICH-GCP E6 R2 Current Updates

In a Publication Report from the Institute of Medicine (IOM) was based on a workshop held with the focus on the importance of “Public Engagement and Clinical Trials.”

As we all know that many clinical trials are slow to enroll patients, and some studies never reach their recruitment number goal. Patient recruitment challenges for a range of medical conditions, illustrate the role of stakeholders’ perspectives in shaping their engagement with the clinical trials enterprise. In this report, IOM points out the fact that lack of engagement of the stakeholders and experts in a discussion about possible solutions to improve public engagement in clinical trials. Advances in the field of medicine are dependent on the quality of research that is conducted.

As the report points out, “Clinical Trials are the linking step that enables basic research findings to emerge at the patient’s bedside and the physicians’ examining rooms. The questions clinical trials seek to answer change over time, depending on advances in basic research and the population health problems they are intended to address. Potential new treatments must be tested in humans in order to find out whether they succeed and whether they cause harm.”

Unfortunately, some of the public’s opinion of clinical trials, or “human research,” has been influenced by a haunting past. From the Tuskegee Syphilis study to the clinical Trial Disaster In France Last year, these are examples of serious research misconduct. No person wants to be seen as a “means to an end.” Could these trials have an effect on the general public’s trust of the research industry?

This is why Good Clinical Practice is so important. Yes, most investigational treatments must go through clinical trials, but each study team should have a mindset that is absolutely essential to protect patients’ rights and assure data integrity. Take the time to download and read from Guideline for Good Clinical Practice – ICH to better understand the process of Good Clinical Practice.

The new ICH GCP E6 R2 regulations

To address the concerns from GCP regulatory inspections in June 2015, the ICH released an amended version of the international guidelines for GCP: ICH GCP E6 (R2). The new GCP draft represents the biggest revision of the international ICH GCP guidelines for over 20 years and has the potential to fundamentally alter the way in which clinical research is managed (2). The EMA welcomed the R2 changes, stating that these new guidelines “will provide increased clarity and encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording, and reporting” (3). The new ICH GCP E6 (R2) Addendum introduced 26 new items covering three main areas of clinical research: data management, and sponsor and investigator responsibilities
Please share your thoughts on steps our industry can take to engage the public in clinical trials.