Learn before Action
A glance at potential problems to be encountered in the implementation process
Why are the fees caused by SAE afforded by the sponsor?
The SAE treatment fees and compensation cannot be predicted, and the SAE occurrence probabilities of different projects vary a lot.
Why does it take so long for the final version of the trial protocol?
The final version needs repeatedly communication among sponsor, researchers, and CRO. Design of some details might affect the overall efficacy of the study drug. It is vital in the whole clinical trial that the protocol design is scientific reasonable, and operable. Therefore, the final version cannot be a quick success; rather, its every key point need careful discussion and serious discussion with the relevant personnel.
When will the dosage of the reference listed drug be decided?
The trial design will be determined as soon as the draft of the protocol abstract is finished. The dosage of the reference listed drug can be calculated according to the trial design and the research cycle. Additionally, as for the sample retention of BE trial design, the rule is that if the 5 times of the total inspection quantity is fewer than 300 tablets, the sample retention is decided as per the 5 times; or it is decided as per 300 tablets.
When will the sample size be determined?
Generally, we will propose the number of cases according to the lowest case number of GCP chemical medicine for the quick research of the Clinical and Market Departments. After Market Department signs the contract with the sponsor and the implementation of the project is officially confirmed, we will communicate with statistical personnel when the protocol draft is basically confirmed, and submit the sample size in compliance with GCP and the statistical requirements within 3-5 working days.
When will the dosage be determined?
The clinical dosage is submitted within 1-2 working days after the clinical trial protocol and the sample size with statistical significance are basically determined.
Why is a center closed?
Generally it is closed due to the recruitment progress, data quality, etc.
Why is the monitoring of some projects long with high frequency?
In order to ensure the quality of the clinical trial as well as the authenticity, validity and completeness of the data, the monitoring length and times differ according to the specific conditions of the trial project, such as its difficulty and treatment period.
Why is it difficult for some projects to recruit patients?
The length of the trial cycle depends on the difficulty of the indications in the project, the length of the clinical observation period, seasonality of specific diseases, competition from similar projects, drug clinical efficacy, and patient sources in the hospital, etc.