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Role of computer in clinical development
- 1. Role of computersin clinical development Presented By:- Shukla Divya Dayanand Id Number:- 19MPHTCH009 Department of Pharmaceutics, M.pharm Semester 1 Guided by:- Dr. Mrunali Patel (Associate Proffesor) Ramanbhai Patel College Of Pharmacy 1
- 2. Table of content:- 2 Sr.Num Title Slide num 1 Definition 03 2 Need Of Computers 05 3 Use of computers in clinical development 08 4 Type of function provided by CDM 11 5 Advantages of computers 25 6 Limitations of computers 26 7 Reference 27
- 3. Definition • Clinical development:-Also called Drug Development, is a term used to define the entire process of bringing a new drug or device to the market. • It includes drug discovery / product development, pre-clinical trials and clinical trials. • Clinical research:- It involves administering new treatment to patients and observing responses over time in order to judge the efficacy of the treatment.. 3
- 4. • Clinical Trials:-Itinvolves evaluation of effectiveness and safety of medications or medical devices by monitoring their effects on large groups of people. • Clinical data collection:- It consist of the process of collecting reliable clinical, control and administrative data from the trial’s participating sites. • Clinical data management:-It involves a set of process that must be executed successfully to turn out reliable clinical control and administrative data to a central location such as a coordinationg center, a data center and a resource center. 4
- 5. Why do weneed Computers? • Often hundreds of people on a variety of experimental treatments have to be followed with respect to a large number of response variables for months or years. • An statistical comparison of various treatment groups are frequently required for ethical as well as scientific reason. • Collection of hundreds of patient’s data on paper can sometimes create loss of documents,Paper might be torn which leads to loss of medical history of patient for clinical research. 5
- 6. • Issues relatedto randomization of patients, Controlled groups, and stratification of patients must be specifically addressed. • It is becoming mandatory for companies to submit the data electronically. 6
- 7. Computers have playeda vital role in the development of clinial practice:- • Patient record management • Entries of medication order • Patient medication profile • Drug therapy monitoring • PADIS(Pharmacy automated drug interaction screening) • Building data base 7
- 8. The broad categoriesto which computerised systems belong are • CTMS (Clinical Trial Management System) • CDMS (Clinical Data Management Systems) • Drug Safety/Pharmacovigilance Systems • EDC Tools(Electronic Data Capture Tool) 8
- 9. CTMS • A CTMSis a computerized system which helps the operation team to store, manage and analyse trial related information such as :- • No. of Patients enrolled • Site Information • Drug Accountability and dispatch • Financial information pertaining to the trial and recruitment • Examples of CTMS are Site Minder/Trial Minder (Oracle Corp.). 9
- 10. CDMS • It isa computerized system that is designed for the clinical data mangement team. • A CDMS helps the data management team to store, manage, clean, track and analyze clinical data received once the trial has been initiated. • It has capability of tracking the CRFs. 10
- 11. Type of functionprovided by CDM 1) Case report forms 2) Database design 3) Database programming 4) Medical coding 5) Status reporting 6) Forms management 7) Data entry and cleaning 8) Data locking 11
- 12. • These CDMtools ensure the audit trail(documents and records that show the history of a company's financial activities, examined by someone who is doing an audit) and help in the management of discrepancies(Any data which does not as expected data). • According to the roles and responsibilities multiple user IDs can be created with access limitation to data entry, medical coding, database designing, or quality check. • This ensures that each user can access only the respective functionalities allotted to that user ID and cannot make any other change in the database. • For responsibilities where changes are permitted to be made in the data, the software will record the change made, the user ID that made the change and the time and date of change, for audit purposes. 12
- 13. Softwares for CDMS •It include Oracle Clinical ,ClinTrial, MACRO, RAVE, and eClinical Suite and the very new SAS Drug development. • Among the open source tools, the most prominent ones are OpenClinica, openCDMS, TrialDB. • These CDM software are available free of cost and are as good as their commercial counterparts in terms of functionality. These open source software can be downloaded from their respective websites. 13
- 14. 14 Homepage of Oraclesoftware
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- 16. Features of Oracleclinical • A Global Library of reusable objects that permits the fast construction of new clinical studies to exact specifications. • A comprehensive set of tools for capturing the components of the clinical trial protocol. • A flexible way of structuring the questions that appear on Case Report Forms (CRFs) into database entities called data collection modules (DCMs) 16
- 17. • Automated proceduresfor generating and customizing data entry that correspond to the CRFs. • A discrepancy database automatically synchronized with changes to both the clinical trial data and the validation definitions. • A flexible internal data structure for holding the clinical trial data that provides the ability to reorganize data for extract. • Maintenance of lab reference ranges across multiple studies 17
- 18. CRF in Clinicaldata management • The Case Report Form (CRF) is the data collection tool for the clinical trial and can be paper or electronic. • Paper CRFs will be printed. • Electronic CRFs enable data to be typed directly into fields using a computer and transmitted electronically to Data Management. 18
- 19. Sample of casereport form (CRF) 19
- 20. Pharmacovigilace/Drug Safety System •Safety system is a computerized system that is designed for drug safety teams. • For every drug that undergoes a trial there are events encountered which may occur due to high dose of the drug. • All forms of ADRs have to be recorded,analyzed and reported to sponsor. • Thus a safety system helps in storing ,managing, analyzing and reporting information about AE, ADRs in an efficient and timely manner. • Example of safety system include Oracle AER. 20
- 21. EDC Tool • Thiscomputerized system is specially designed for making things more streamlined for the trial as a whole. • An EDC system allows access of the CDMS/CTMS to the investigator over a basic web browser which is available on all PCs. • An investigator can log on to the EDC system with his access details and enter all the patient information directly into the database rather than filling out the CRF pages. 21
- 22. Protocol Management System(PMS) •A new computer system to aid with data management in clinical research. • This represents a key function of the system from user point of view. • User will make use of the stored data not only for the periodic evaluation of the trial result, But also to aid in the day-to-day management of individual patient. • By entering data into the system, A user is not only contributing to the clinical trial, But also is making data available for easy access in day to day patient management. 22
- 23. Advantages Of Computers •Reduce book keeping. • Fewer transcription and medication error. • Reduce duplicate medication order. • Lowering cost in preparing bill. • Improves managing reports. • Reduced ordering cost. • Simplify and speed up complex task. • Increase accuracy by checking spelling, Calculation and data integrity. • Allow organization to expand operations. • Generate timely reports without repetition. 23
- 24. Limitations of computers •Expensive on IT infrastructure. • They can not assume responsibilities. • They can not make decision. • Data must has to entered regularly. • Security:- Datas should be stored that way so no other person can use it. 24
- 25. Reference:- • clinskill.com/computers-in-clinical- developmentwww.ncbi.nlm.nih.gov/pmc/articles/PMC3326906/ • www.msh.org/sites/msh.org/files/mds3-ch50-computers- mar2012.pdfwww.slideshare.net/NaveenBalaji32/clinical-data- collection-clinical-data- management • www.slideshare.net/raiwaqas/role-of-computers-in-clinical-pharmacy 25
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