Clinical trial self-examination: higher risk point varieties and institutions will be focused on verification.


Release time:

2015-08-18


On the morning of August 12, the food and drug examination and inspection center of the State Food and drug administration (hereinafter referred to as the inspection center of the State Administration of food and drug administration) held a promotion meeting on self inspection and verification of drug clinical trial data in Beijing, and arranged the self inspection and verification of drug clinical trial data of imported drugs listed in the annex of the announcement (No. 117 of 2015) (hereinafter referred to as No. 117), Urge enterprises to submit self inspection reports as soon as possible.
Our reporter learned at the scene of the meeting that CFDA will organize personnel to analyze the data of the self-examination materials submitted by the applicant, and carry out flight inspection in a targeted manner. Drug clinical data verification can be divided into two ways: verification by variety organization and verification by organization. Varieties and institutions with higher risk points will be focused on verification.
Enterprises should "raise their hands" and submit the report as soon as possible. Don't wait for the end.
Document No. 117 clearly states that starting from July 22, all drug registration applicants who have declared and are pending in CFDA must, in accordance with the relevant requirements such as the "Quality Management Standard for Drug Clinical Trials" and in accordance with the clinical trial plan, carry out self-examination on the clinical trials of pending drug registration applications that have been declared for production or import, so as to ensure that the clinical trial data are true and reliable and the relevant evidence is intact.
The General Administration's Verification Center has established the "Drug Clinical Trial Data Self-examination Report Filling System" and completed its debugging. Starting from August 3, enterprises can log into the system in www.cfdi.org.cn for online filling. Enterprises need to submit electronic self-examination reports, scanned clinical trial contracts, key personnel of the research team and other materials, as well as the authenticity commitment signed by the legal representative.
As of the day of the meeting (August 12), no imported pharmaceutical company has formally submitted a self-examination report on drug clinical trial data to the General Administration's Audit and Inspection Center.
"The self-examination report reporting system for drug clinical trial data will be closed at 24:00 on August 25 and the declaration will be stopped." The project manager of CFDA Food and Drug Audit and Inspection Center pointed out at the meeting, "If all the cards are filled in in the last day or two, the submission may be delayed due to network congestion. The applicant should submit the electronic data as soon as possible after completing the variety self-examination and send the written information to the audit and inspection center."
Some representatives of participating enterprises pointed out that there are sometimes more than 100 multi-center clinical trial institutions involved in one variety, and if enterprises have more than one variety that needs self-examination, the workload is relatively large. Especially for imported varieties, it also involves foreign production agencies, domestic agencies, and domestic registration and reporting agencies. The time required for document exchanges is not short.
Focus on checking "perfect object"
The heads of food and drug regulatory agencies of 30 provinces (cities) in China and more than 200 imported pharmaceutical companies participated in the meeting. For the participants, they are also concerned about how the flight inspection after self-inspection will be carried out..
The above-mentioned person in charge said: The currently determined drug clinical data verification methods can be divided into two types: one is to organize verification by variety for varieties with more repeated declarations. First, collect variety data, compare the application data of different applicants, select suspicious "perfect objects" from them, and formulate verification plans to carry out verification. The other is to organize verification according to the organization, sort the units that undertake clinical trials according to the number of trials, select the top institutions, list the varieties, and formulate verification plans to carry out verification. BE tests will give priority to the organization.
Another big focus question is, which varieties or institutions may be verified?
"Project screening based on risk." The above-mentioned person-in-charge further said that many problems were found in the registration project verification of the provincial bureau. The same applicant applied for multiple bioequivalence tests of generic drugs at the same time. The same testing institution undertakes multiple bioequivalence tests (BE) of the same variety at the same time. The data of BE test project is too "perfect"; Effectiveness and safety data are obviously better than other similar products; Repeated declaration of more varieties; the trial contract amount is significantly lower than similar standards, etc., these are the risk points that will be focused on.
For drug clinical trial institutions, the principle of random inspection is adopted, and the main factors considered by random inspection institutions are as follows: first, the effectiveness results are significantly higher than those of other centers or clinical trial centers of the same kind; second, the safety data (adverse events, expected serious adverse events) are significantly lower/higher than those of other centers or clinical trial institutions of the same kind; third, the rate of trial enrollment is significantly faster than that of clinical trial centers in other centers; fourth, the success rate of trial screening is significantly higher than that of regular clinical trial institutions; fifth, the rate of trial drop-out is significantly higher than that of regular clinical trial institutions; sixth, the clinical trial center with the largest number of trial enrollment; seventh, the clinical trial institution serving as the team leader.
The reporter also learned at the meeting that the goal of this data self-examination and verification work is: through the self-examination of clinical trial data, the sponsor will find out the authenticity and serious violations of the trial and voluntarily withdraw a batch of registration applications; Through screening a batch of items with doubtful authenticity for verification, effectively investigate and deal with data fraud, so as to standardize the clinical trial behavior of drugs; Expose researchers/sponsors/CRO (contract research and development organizations) who have deliberate fraud, greatly increase the cost of its fraud, to achieve the deterrent effect, the establishment of self-examination-spot check-exposure of drug clinical trial data verification long-term mechanism, to purify the overall environment of drug clinical research.
"For filers, the red line is authenticity and integrity." CFDA pharmaceutical registration department officials said.