Role of laboratory in Clinical Trials
Role of Laboratory in Clinical Trials
Laboratory data forms the backbone of all the clinical trials. Hence it is important to have good laboratory support and interaction with the laboratory in all the clinical trials.
Clinical trials typically include two kinds of activity
a) evaluation and validation of new clinical laboratory testing systems or
b) laboratory evaluation of patients subjected to new clinical products or protocols, particularly those related to new drug development. The first type of trial is an extension of a traditional laboratory function. As research and development has moved from hospital laboratories to the diagnostics industry, companies have had to seek partners in the clinical laboratory setting to evaluate their new products using the samples for which they were designed. This kind of "real-world," or field testing, of new equipment or systems is well suited to the environment of a clinical service laboratory
Most of the phase III clinical trials are multiple center trials. The trials are usually conducted in many clinical sites. The laboratory examinations can consequently be performed in different laboratories, using different methods and applying different concepts for normality. Some normal range criteria also vary with age and gender. A robust, simple and valid approach, which implements laboratory normal ranges from different labs and is valid for different methods, age groups and gender, is of great importance in the lab data management. The general way of managing the laboratory normal ranges information involves collecting the data from different bio-analytical centers or laboratories (the data include lab names, the names of the examinations, and the normal criteria of the examination by age group and gender), and pooling all the data into a normal ranges data. The data contain the variables of lab-number, examination code (name), gender, the lower and upper age group boundaries, and
Laboratory data forms the backbone of all the clinical trials. Hence it is important to have good laboratory support and interaction with the laboratory in all the clinical trials.
Clinical trials typically include two kinds of activity
a) evaluation and validation of new clinical laboratory testing systems or
b) laboratory evaluation of patients subjected to new clinical products or protocols, particularly those related to new drug development. The first type of trial is an extension of a traditional laboratory function. As research and development has moved from hospital laboratories to the diagnostics industry, companies have had to seek partners in the clinical laboratory setting to evaluate their new products using the samples for which they were designed. This kind of "real-world," or field testing, of new equipment or systems is well suited to the environment of a clinical service laboratory
Most of the phase III clinical trials are multiple center trials. The trials are usually conducted in many clinical sites. The laboratory examinations can consequently be performed in different laboratories, using different methods and applying different concepts for normality. Some normal range criteria also vary with age and gender. A robust, simple and valid approach, which implements laboratory normal ranges from different labs and is valid for different methods, age groups and gender, is of great importance in the lab data management. The general way of managing the laboratory normal ranges information involves collecting the data from different bio-analytical centers or laboratories (the data include lab names, the names of the examinations, and the normal criteria of the examination by age group and gender), and pooling all the data into a normal ranges data. The data contain the variables of lab-number, examination code (name), gender, the lower and upper age group boundaries, and