INTRODUCTION TO CLINICAL RESEARCH
The Process from discovering a new drug to registering it for marketing is very complex and lengthy. There are several people involved in the Process of drug discovery and development includes Scientists, Clinicians, Statisticians as well as Data managers and SAS Programmers. It is estimated that, on average, a drug takes 10-12 years from initial research to reach the market. Drug discovery and development are mainly carried out by pharmaceutical companies and research agencies. The pharmaceutical market is very competitive. It is imperative that pharmaceutical companies discover and develop drugs efficiently and within the shortest time span to remain competitive.
Drug Development Process
The Drug development Process has different stages:
Clinical Research, Clinical Trials
Clinical research is a branch of healthcare science that determines the safety and effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use.
Clinical Research Process:
INDUSTRY REGULATIONS AND STANDARDS FOR CLINICAL TRIALS
Every trial has to be approved and carried out under regulatory compliance to comply with GCP requirements. Different countries have different requirements for clinical trials. Two organizations that carry significant regulatory weight are the combined forces of the US Food and Drug Administration (FDA) and International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use ( ICH).
Departments and Roles in a CRO:
Contract Research Organization: CRO is an organization that provides support to the Pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis. A CRO may provide such services as Pre Clinical Research, Clinical Research, Clinical Trials Management, Clinical Data Management, Bio statistics and SAS Programming.
A Typical Clinical Research Organization may contain the following departments:
Process Flow in a Typical Clinical Trial
Every clinical investigation begins with the development of a clinical protocol. The protocol is a document that describes how a clinical trial will be conducted and ensures the safety of the trial subjects and integrity of the data collected.
After preparing the protocol we go with CRF designing, The Case Report Form is a data-reporting document used in a clinical study. CRF Collects relevant data in a specific format in accordance with the protocol and compliance with regulatory requirements which Allows efficient and complete data Processing, analysis and reporting and Facilitates the exchange of data across projects and organizations through standardization. CRF designer should always remember that Protocol determines what data should be collected on the CRF. All data must be collected on the CRF if specified in the protocol and Data that will not be analyzed should not appear on the CRF. CRF needs to be finalized and available before an investigator starts enrolling patients into a study. After designing and reviewing the CRF, it is a good idea to send them to sites that will be conducting the study and ask the site personnel for feedback.
Data collection is done using the CRF that may exist in the form of a paper or an electronic version. The traditional method is to employ paper CRFs to collect the data responses, which are translated to the database by means of data entry. These paper CRFs are filled up by the investigator according to the completion guidelines. In e-CRF method, chances of errors are less, and the resolution of discrepancies happens faster. The entries made in the CRF will be monitored for completeness and filled up CRFs are retrieved and handed over to the CDM team. CRF pages are entered by data entry operators. Best practice is, first pass data entry to be completed followed by a second pass or verification step by an independent operator.
Data validation is the Process of testing the validity of data in accordance with the protocol specifications. Edit check programs are written to identify the discrepancies in the entered data, which are embedded in the database, to ensure data validity. Discrepancy is defined as a data point that fails to pass a validation check. Discrepancy may be due to inconsistent data, missing data, range checks, and deviations from the protocol. If the data entered does not pass validation rules then a data query may be issued to the investigative site where the clinical trial is conducted to request clarification of the entry (Data Clarification Form). Any discrepancies between the first and second pass may be resolved such that the data entered is a true reflection of that recorded on the CRF. Where the operator is unable to read the entry the clinical data manager should be notified so that the entry may be clarified with the person who completed the CRF. After a proper quality check and assurance, the final data validation is run. If there are no discrepancies, the SAS datasets are finalized in consultation with the statistician. All data management activities should have been completed prior to database lock. To ensure this, a pre-lock checklist is used and completion of all activities is confirmed. Once the approval for locking is obtained, the database is locked and clean data is extracted for statistical analysis. This data is often referred as raw data by SAS Programmers since this data is not ready for analysis. There may be many things to perform to convert the raw data to analysis ready data which is often refereed as ADS or VAD. Subsequent to ADS creation we go with TLF/ Report generation followed by CDISC conversion and Submission.
IN THIS COURSE YOU CAN LEARN
7.CLINICAL TRIAL PROJECT
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