BS ISO 29943-2:2017 pdf free
BS ISO 29943-2:2017 pdf free.Condoms – Guidance on clinical studies
A pilot study helps to identify and evaluate the different types of acute failure events of the new female condom prior to initiation of a larger clinical investigation (see ISO 25841:2014, Clause 8). The acute failure rates obtained in the pilot study will influence the statistical calculations of power and sample size for the pivotal study. The risk assessment (see Clause 4) should be conducted prior to the pilot study and then repeated after the pilot study, with any new types of failure events reported in the pilot study to be classified as either clinical or non-clinical failures.
In addition, the pilot study can help identify potential safety concerns, including condom features that could cause abrasions or irritation during use. It is recommended that study subjects in the pilot study undergo a post-coital physical examination as soon after condom use as practicable. Such exams should be conducted by an experienced clinician.
Investigators should provide detailed verbal and written instructions on appropriate condom insertion and use to all study participants and demonstrate correct condom placement using a pelvic model.
Collection of user acceptability information will be useful to evaluate product acceptability and to guide further product improvements prior to the larger clinical investigation.
For additional information, see 6.15 and 6.16.
Annex B contains a sample outline for a pilot clinical study.
The protocol should state the purpose of the study, e.g. to evaluate the performance of a new female condom (test condom) during vaginal intercourse compared to a control female condom. The protocol should clearly state the hypothesis being tested (i.e. whether the non-inferiority margin between the total clinical failure rates for test and control condoms complies with the requirements specified in of ISO 25841:2014, 8.3).
The secondary objectives of the research should also include safety and acceptability. Safety will be determined by the proportion of women reporting adverse events reported during condom uses and by condom type. Acceptability will be measured by the calculated frequency of key acceptability end points including ease of insertion and removal, like or dislike of product attributes, adequacy and feel of lubrication, etc.BS ISO 29943-2 pdf download.
