Mar 08


(Integrated Summaries of Safety and Efficacy)

Clinical trials (or clinical research trials) are a process by which new therapies and new drugs are studies to determine their safety and efficacy. The health organizations of each country, such as the FDA in the U.S. will use those data to decide if the product or treatment will be approved. Because each clinical trial is unique and have a specific design and different objectives, several reasons require the integration and summary of all the data. Hence while some clinical trials gather small safety studies in a small group of normal volunteers, other trials are efficacy studies that are carried in a large group of patients.

The first reason to generate ISE ISS is to allow a way to compare and discriminate small variations in the results of the study, therefore being able to create a review of the benefits and the risks profile of the investigational drug or treatment.

The second reason to generate ISS ISE is to reach solid statistical verdicts and conclusions. Ingrated data will allow to give the most accurate results in the statistical analysis of results, that no other hypothesis can achieve.

The third reason to generate and use ISE ISS is that the combination of data from various studies will give tools to find rare trends in some subgroups of patients, such as the elderly or people with specific diseases or people with different states of the targeted disease (i.e. mild vs moderate vs severe).

Finally, the use of ISE and ISS is required by health authorities when submitting a new drug application.

ISS is considered the most important document when filing a new drug application, and needs to cover data from phase I healthy volunteers to all data found in patients throughout the rest of the trials. ISS need to be extremely concise and must include the extent of the exposure of drug by the patient, several characteristics of all patients enrolled in the study, a listing all the deaths that occurred during the study, how many patients were drop-outs from the study, any potential serious adverse events, and adverse events and all lab results.

ISE usually summarize the data from phase II to IV, phase I studies usally being a safety control study.
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ISS ISE can be used to
Serves as a good detailed integrated description of the clinical section of the application
Give a comprehensive “overall picture” or sense of the clinical development program with regard to safety or efficacy; its strengths and weakness
Helps identify which studies require more in depth review.

ISE ISS can also be use to
Review the individual studies first and do his/her own independent integration of the results
later compare the reviewers integrated safety and efficacy findings with those of the applicant

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