Courses in clinical trials and SAS-programming needed in pharmacy education
Thursday, January 17, 2002 11:16 IST Dr Sandeep Kumar Bagga
Pharmacy education in India is primarily focused on pharmaceutics, pharmaceutical chemistry, pharmacology and pharmacognosy. Some institutions have taken vast initiatives in restructuring course curricula and introducing new courses namely pharmaceutical management, clinical pharmacy, pharmaceutical medicine and regulatory affairs etc. at B.Pharm, M.Pharm, as well as PhD level.
Typically, job scenarios involve pharmacist, medical representative, product management, teaching, and research & development positions. Our pharmacists can have a vital role in monitoring clinical trials, patient data management and Statistical Analytical Software (SAS)-programming which involves United States FDA regulations.
Discovering and developing safe and effective new medicines is a long, difficult and expensive process: Preclinical Testing --> Investigational New Drug Application (IND) --> Clinical Trials, Phase- I --> Phase-II --> Phase-III --> New Drug Application (NDA) --> Approval --> Phase-IV.
SAS-programming is very important from preclinical testing to approval stages. Here, when you see the sequence of drug development and approval process you can yourself realize how important clinical trials and SAS-programming areas are and there is an urgent need of starting training programs in these areas. How?
Training program on how to effectively monitor clinical trials can be designed based on Good Clinical Practices and ICH guidelines. Various topics may include: design of protocol, case report forms, reporting serious adverse events, early phase clinical evaluation, processing clinical research data, clinical database, data display, report and analysis plan, clinical trial report, standard operating procedures in regulatory affairs, auditing of clinical trials and new drug application etc.
Clinical trials data arriving on case report forms is fairly standard, for example demography, adverse event, medications, laboratory etc hence can be stored in fairly standard data structures. Designing clinical data structures for data entry is important, but it should be done with some understanding of the analysis that will be performed. Once an appropriate clinical data structure is arrived at for data entry, it is important to then determine how to best use the data in the SAS analysis environment.
US FDA considers SAS validation an important component of the quality assurance, reliability & accuracy of much of the information used to approve & develop drugs and medical devices. Hot spots and crucial points in pharmaceutical research & developments are submission of various clinical reports to FDA and these clinical reports need to be created using SAS-programming techniques. Our educational institutions must create structured training program in these high tech areas so as to create pharmacist + IT (SAS) manpower for future. Here is an outline depicting in which direction we need to proceed further so that our professionals can play at international level and enjoy a unique & challenging job profile: (1) Clinical Report Generation for example: (a) Adverse Event tables and listings, (b) Demographics, (c) Safety, (d) Efficacy, (e) Lab Data, (2) Custom Derived SAS data sets, (3) SAS-Programming for NDAs (New Drug Applications), (4) Experience with Phases I-IV, (5) Data Cleaning, (6) Statistical Analysis using SAS tools and (7) Data Warehousing.
After acquiring a combination of B.Pharm, or M.Pharm, or even PhD and Clinical SAS-Programming technical know-how; what kind of job profile is prevailing in pharmaceutical industry is a logical question which our graduates may have in mind. The answer is job description may include U.S. and International regulatory submissions, Creation of data marts for data mining, Analysis of clinical trial, pharmacokinetic, epidemiological and product stability data using statistical analysis software, Development of integrated data analysis systems, Design of complex graphical reporting software with SAS/GRAPH, Validation of applications software and data, Creation of user friendly interfaces with SAS/FSP and SAS/AF, Extensive use of the SAS macro facility to provide reusable software, UNIX system administration and networking with Novell and TCP/IP.
About the author:
-- The author is associated with Pharmaceutical Research and Clinical Trials, P.R.A.C.T. Advisory Service, Alexandria, VA, USA
