Statistics/ SAS programming in Drug Development
Programmers and biostatisticians working in the clinical research industries have successfully used SAS for many years to transform data, generate safety and efficacy results, and submit data to FDA. SAS in Drug Development provides innovative capabilities to not only meet the historic needs of the industry, but to efficiently collaborate across trials, phases, therapeutic areas, departmental organizations and technologies, and ultimately get drugs, biologics and devices to market faster.
What is a Clinical Trial?
- An Investigation of a new pharmaceutical product or a new chemical entity in order to find out the safety and efficacy of the drug. On an average it takes 12 years for a drug to be approved for marketing. A clinical trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments.
Drug Approval Process: Before Conducting Clinical Trials:
- Before the company starts its program of running clinical trials, it has to prepare an Investigational New Drug (IND) Application with the FDA. The IND application must contain information in three broad areas:
Manufacturing Information This information is assessed to ensure that the company can adequately produce and supply consistent batches of the drug.
Animal Pharmacology and Toxicology Studies – Preclinical data to permit an assessment as to whether the product is reasonably safe for initial testing in humans.
Clinical Protocols and Investigator Information – Detailed protocols for proposed clinical studies to assess whether the initial-phase trials will expose subjects to unnecessary risks.
- Pre-IND Meeting: Pharmaceutical Company meets with the FDA prior to submitting an IND. At least 30 days prior to scheduled meeting, the IND applicant submits to FDA a meeting package consisting of
background information
list of questions grouped by type (Product, Preclinical, Clinical and Regulatory)
