Looking at GCP in the past to seek a future foothold in drug development

Finishing/Grey Soy

2015 is a special year.

Number of CDE1 new drug applications (unit: piece)

(Source CDE—2020 Drug Evaluation Report)

Volume purchases began in 2019.

01 The history of GCP

The full name of GCP is Good Clinical Practice, which is a standard regulation that regulates the entire process of drug clinical trials, including plan design, organization and implementation, supervision, inspection, recording, analysis, summary, and reporting

GCP is not only applicable to personnel who undertake various phases (phase I-IV) of clinical trials (including hospital administrators, ethics committee members, experts in various research fields, professors, physicians, pharmacists, personnel and laboratory technicians), but also applicable For drug supervision and management personnel, clinical researchers of pharmaceutical companies and related personnel

Before the emergence of GCP, the phenomenon of the abuse of subjects by researchers was already controversial.

Starting from the US FDA, the drug administrations of other countries have followed suit and issued their own GCPs.

China has introduced, promoted and implemented GCP for nearly ten years

Since 1986, China has begun to learn about the development of international GCP; in 1992, it sent staff to participate in the finalization meeting of the WHO GCP guidelines; in 1993, it collected GCP guidelines from various countries and invited foreign experts to China to introduce the status of GCP implementation abroad; In 1994, a GCP seminar was held and the drafting of China’s GCP specifications began; in 1995, a drafting group composed of 5 clinical pharmacological experts was established, and China’s "Regulations for Drug Clinical Trial Management" (Draft for Review) was drafted, and it began to be used nationwide.

02 The current version of GCP

Correction: 2019 is R3, here is a PPT error

Since the first edition was issued in 1996, the complexity and scale of clinical trials have changed greatly, and due to the introduction of new technologies and changes in risk processes, ICH has considered formulating a second edition of the guidelines to supplement the first edition and make it It is more in line with the current clinical situation

The main changes of the R2 version are reflected in the above four aspects.

Risk Management:

Quality risk management

Clinical trial risk

Quality risk management runs through the entire process

Risk-based monitoring:

Traditional monitoring is more dependent on the relationship between PI and CRA, focusing on the verification of original data, and more stringent inspections for high-risk clinical trials

The R2 version puts forward a concept of central supervision.

PI's responsibility:

The current research situation is more complicated, and more and more departments are involved.

Electronic Information System:

With the development of information technology, the R2 version also considers cloud computing, including data processing hardware, data collection software, and electronic medical records
.

The source data should be attributable, legal, contemporaneous, original, accurate, and complete, so that it can support accurate description reports and analysis tests
.
For data to be compliant, it needs to meet the prescribed principles, such as ALCOAC.
As for the instrument that produces the data, there are no requirements
.

For the risk of electronic data, the R2 version has also taken into account the risk assessment
.
This requires the sponsor to establish its own SOP to standardize the use process when doing electronic system evaluation and when doing electronic system certification
.

It can be seen from the implementation of the R2 version that it can be said that the R2 version has been generally accepted among ICH regulatory member states.
This widely adopted standardized clinical trial can help mutual recognition of data between each other, and the purpose is to avoid as much as possible.
Scientifically unreasonable repeated experiments
.

When ICH released GCP R2 in 2017, the third edition of the drafting committee was established, and GCP ushered in a new change in which quality comes from design as the core
.

03 New changes in GCP

The R3 version still retains various measures and methods based on risks, and considers the new clinical trial environment, new data sources, and the diversification of data that can be collected
.

The modification of the basic principles is divided into two steps.
The first part of the modification only considers the routine clinical trial part connected with the R2 version, mainly to update and refine the second version, and the second step of modification is mainly for unconventional Intervention trials are discussed
.