More than 350 biotech drug products and vaccines currently in clinical trials targeting more than 200 diseases, including various cancers, Alzheimer''s disease, heart disease, diabetes, multiple sclerosis, AIDS and arthritis. Designing, conducting, monitoring and auditing of a clinical trial phase-I to IV, as well as reporting are very sensitive areas to touch upon. Clinical trial reports are created using Statistical Analytical Software (SAS) programming techniques and SAS meet United States FDA validation requirements in the pharmaceutical and biotechnology industries.
Data protection in drug approval applications is a major challenge. Efficient clinical development process includes (1) Protocol approved by FDA. Critical areas of protocol adherence are visits, dosing schedule, adverse event reporting, inclusion/exclusion and concomitant medications (2) Case report form (CRF), a repository for data collected at site and should be designed to meet protocol objectives. SAS annotated CRF and electronic data captures are important developments in this area (3) Clinical database, an accurate representation of CRF data.
If you don''t know about your destination, how can you reach there? Periodic data review is must (4) Report and analysis plan (RAP), details of statistical analysis and templates for data displays based on study design, objectives & sample size (5) Data displays meaning patient data listing, summary and analysis tables (6) Clinical trial report (CTR), documents outcome of clinical trial. Structure and content governed by FDA/ICH regulations. Finally, (7) New Drug Application (NDA) submitted to FDA. FDA responses are: either denied or conditional approval or approval.
Creating efficient manpower as SAS programmers and clinical research monitors is the need of today in pharmacy education and is another challenge. Basic SAS procedures for producing clinical listings and summary tables (CTRs) include Proc Sort, Means, Freq, Chart, Plot, Print, Report, Tabulate, and Data_Null_ steps. Programming in SAS includes SAS SQL, SAS functions, SAS arrays and SAS macro language.
Other SAS products are SAS/STAT, SAS/GRAPH, SAS/ACCESS, SAS/PH-CLINICAL and recently introduced software are SAS Intelli Visor, SAS Drug Development for 21 CFR Part 11 and SAS Scientific Discovery Solutions etc. Serious adverse events (SAEs) are cancer, hospitalization, disabled, life threatening, overdose, congenial anomaly & deaths and clinical trial reports for safety profiles are of immense importance to FDA.
US FDA/ICH guidelines require that the possible effects of protocol violations, dropouts, missing values and patient compliance on magnitude and direction of bias be explored as fully as possible. In a nut shell, a scenario with a new drug development viz. genomic research followed by in-depth clinical development process and basic steps of how to create SAS clinical reports for final US FDA submission are the highlights of this presentation.
SAS is a registered trademark of SAS Institute, Inc., in USA and other countries.