Course is divided into 7 different sections :

1. Drug development and discovery
2. Familiarization to Clinical Research
3. TCS Vision
4. Role of Biostatistician and Statistical Programmer
5. Biostatistical programming
6. Clinincal Trial Process
7. BSP Milestone and activities

Can take a long time.

1. Formulation
2. Pre-Clinical Trials
3. Clinical Trial Phase 1(Investigate reaction)(20-30 population size)
4. Clinical Trial Phase 2(Dosing requirements test)(100-300 population size)
5. Clinical Trial Phase 3(300-3000 people)
6. Regulatory Approval
7. Independent experts review for safety
8. Clinical Trial Phase 4(Post marketing surviellance trial)

1 in 5000 drugs pass pre-clinical trials.

Biostatistics and statistical programming is for

1. Planning of clinical studies
2. Analysis and reporting of the findings
3. Interpretation of data received from the trials

Study set-up

1. Statistical Programming input to protocol trial design and CRF development and edit checks
2. Randomization schedule generation
3. Sample Size determination
4. Statistical Analysis Plan(SAP) and output mock shells
5. SDTM mapping specifications

Study Conduct

1. SAP execution
2. Analysis Datasets(ADaM) programming specifications
3. Programmin and Validation of CDISC compliant SDTM/ADaM datasets
4. Programming and validation of Tables Listings and Figures
5. Creation of input files for non-compartmental analysis
6. Dry runs and Data review meetings
7. Interim Analysis

Study Close-Out

1. Support for Topline results
2. Statistical input/review of clinical study report(CSR)
3. Generation of CDISC compliant datasets and TLFs
4. Generation of submission ready CDISC compliant datasets and TLFs
5. Generation of submission ready CDISC compliant datasets and e-submission package
6. Generation of CSR statistical appendices

Project level activities

1. DSMB charters and analysis plan & execution
2. Project planning and coordination
3. Planning for integrated data analysis (ISS/ISE) and execution
4. Statistical input/review of ISS/ISE dossier
5. Project level standard creation and maintenance
6. Statistical and Programming support for a. DSUR and RMP b. Health authority request and advisory committee meetings c. Publication support

Specialized services

1. Data de-indification and anomyzation of patient level data
2. Support for electronic submissions(eCTD, ClinicalTrials.gov, EudraCT, etc.)
3. Standards management for client specific global CDISC standards metadata driven solutions.
4. Statistical support for Chemistry Manufacturing and Controls(CMC)
5. Patient profile creation for narratives and data reviews activities

BSP services

1. Statistical analysis for Chemistry Manufacturing and Controls
2. Statistical consulting in drug development
3. CDISC consultancy is provided by Biostatisticians as required

Phases of Clinical Research

1. Phase 0 : Pharmacodynamics and Pharmacokinetics particularly oral availability and half-life of the drug. 10 patients tested for sub-therapeutic effect. Very short months
2. Phase 1 : Testing of drug on healthy volunteers for dose-ranging. 20-100 patients for Safety and dosage. Several months
3. Phase 2 : Testing of drug on patients to assess efficacy and safety. 100 - 300 patients for efficacy and side effects. Several months to 2 years
4. Phase 3 : Testing on patients to assess efficacy, effectiveness and safety. 300-3000 patients tested for efficacy and adverse reactions. Takes 1 - 4 years
5. Phase 4 : Post-marketing surveillance, watching drug use in public, commitment trials and label updates. Several thousands tasted for safety and efficacy in wider population in a non-regulated environment. Long term.

Common terms

1. GCP and ICH guidelines approved by ethics committee
2. Case report form(CRF) modernized to electronic(e-CRF)
3. Statistical Analysis Plan(SAP)
4. SAS programmer uses mock Shells for generating clinical study reporting outputs
5. Clinical Data Interchange Standards Consortium(CDISC)
6. Study Data Tabulation Model(SDTM)
7. Analysis Data Model(ADaM)
8. CDISC Submission Data Standards(SDS) team to provide a model for submission of tabulation data in a study

Clinical Trial Process

Planning

1. Obtaining Client requirements
2. Protocol/SAP CRF creation
3. Regulatory and Ethics Approval
4. Documents and Materials
5. Pre-selected investigators
6. Pre-Study visits
7. Initiation Visits

Execution

1. Patient Recruitment
2. Routine Monitoring
3. CRF retrieval
4. Database design
5. Data Entry
6. SAP Execution
7. Report Layout creation
8. Data review query production and resolution
9. Drug disease coding

Reporting

1. Programming tables, figures and Listings
2. Tables figures and listings review
3. Audit and Database lock
4. Final tables, figures and listings productions
5. Statistical Analysis
6. QA of report
7. Final report

Statistician Responsibility

1. Obtain Client Requirements
2. Protocol/SAP CRF creation
3. SAP Excecution
4. Statistical Analysis
5. Preparation of Internal reports

Programmer's responsibility

1. SAP execution
2. Report Layout Creation
3. Programming tables, figures and listings
4. tables, figures and Listings review
5. Final Tables, Figures and Listings Production
6. Statistical Analysis

BSP milestones

Planning

1. Clinical Development Plan(CDP)
2. Protocol Development
3. CRF setup
4. Database development
5. Data handling plan
6. Data validation plan
7. Statistical Analysis Plan a. Statistical methodology b. Mock Shells c. Analysis dataset specifications
8. Investigator brochure or equivalent document for study intervention

Execution

1. First Patient First Visit(FPFV)
2. First Data Generated(FDG)
3. Blinded interim data review for cleaning and monitoring
4. Programming Dry-run a. Setup programs for value added datasets/analysis for table listings and figures b. Setup programs for Tables listings and figures c. Validation d. Testing of programs for correctness and meeting the SAP requirements
5. Last data Generated(LDG)
6. Complete Data Check(CDC)
7. Database Lock(DBL)

Reporting

1. Checking of the randomization scheme
2. Execution of programs for generation of analysis datasets and TFLs on the un-blinded DB
3. Release of the Key(decision making) reports to the management team within 5 working days of the DBL. These can be released to HA as well, in case of breakthrough trials.
4. Final release of all outputs to medical write for development of CSR
5. Generation of study data-reviewer's guide
6. Generation of analysis data reviewer's guide
7. Creation of Annotated CRF for e-submissions
8. Generation of Define.xml
9. Archival of the final deliverables