In the new clinical era, how to follow the blinding principle of clinical trials?

To provide technical guidance for sponsors to correctly design and implement blinding in clinical trials , on July 25, 2022, the Center for Drug Evaluation (CDE) of the State Drug Administration issued the "Guiding Principles for Blinding of Drug Clinical Trials (Consultation for Comments)" Draft)”, the time limit for soliciting comments is 1 month from the date of publicati.

Under what circumstances is the principle of blindness applicable?

From July 1, 2020, the "Quality Management Practice for Drug Clinical Trials" will be implemented to clarify that investigators should abide by the randomization procedure of clinical tria.

What is the blind method? What are the types of blindness?

Definition of blind method

Blinding, also known as blinding, refers to keeping subjects and/or researchers unaware of treatment (treatment) grouping information in drug clinical trials, and is an important measure to control trial bi.

Classification of blind methods

Depending on the degree of blinding, the blinding methods of drug clinical trials are divided into three types: double-blind trials, single-blind trials and open tria.

In blinded research, it is necessary to formulate an emergency unblinding plan in advance

What is emergency unblinding?

Based on current viewpoints and cognitions, in blinded research, an emergency unblinding plan needs to be formulated in advan.

What are the regulations for emergency unblinding?

1) Emergency unblinding can only be done when the investigator must know the information on the treatment grouping of subjects in emergencies (such as serious adverse events or in need of rescu.

2) If it is known that the treatment group information is not necessary for the treatment of emergency situations, there is no need for emergency unblindi.

3) The sponsor should formulate detailed standard operating procedures for unblinding in advance and specify the personnel involved in unblindi.

4) In addition, if unexpected serious adverse events occur, the pharmacovigilance department also needs to unblind individual subjects according to the corresponding procedures to determine whether the unexpected serious adverse events are suspicious and unexpected serious adverse reactio.

       5) In the event of an emergency unblinding, it is necessary to record the time, reason and executive personnel of the emergency unblinding in a timely manner, at the same time notify the supervisor as soon as possible, and submit a safety incident report to the ethics committ.

       6) In the event of emergency unblinding , the subject must terminate the treatment, but continue to follow .

       references

       [1] e.