introduction to pharma and healthcare it-anirban
TRANSCRIPT
Introduction to Pharma and Healthcare IT- Drug, Device, Systems- The era of Human technology
Dr. Anirban Mukherjee. Phd
Agenda in Sequential Order
Our Body – Back to school
Drug, Medical Device, Clinical Trial
Clinical Trial Design and Types
IT in Clinical Trial
Healthcare
It in Healthcare
Regulation
Ideas
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A substance recognized by an official pharmacopoeia or formulary. A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. A substance (other than food) intended to affect the structure or any function of the body.
Drugs can be of different types Medication – Pharmaceutical
Spiritual/religious – Etheogenic
Self-improvement – Nootropic
Recreational
Administration: Bolus
Inhalation
Injection
Insufflation
Oral
Suppository
Sublingually
Topically
Drug
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• Clinical trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective for humans. These studies also may show which medical approaches work best for certain illnesses or groups of people
• The study can be biomedical or behavioral designed to answer specific questions about interventions (novel vaccines, drugs, treatments, functional foods, dietary supplements, devices or new ways of using known interventions), generating safety and efficacy data.
• • Clinical trials can vary in size, and can involve a single research entity in one country or
multiple entities in multiple countries.
• A full series of trials may cost hundreds of millions of dollars. The sponsor could be a governmental organization or pharmaceutical, biotechnology or medical device company.
• When the required support exceeds the sponsor's capacity, the trial may be managed by an outsourced partner, such as a contract research organization or an academic clinical trials unit.
Clinical Trials
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Customizable software systems to manage large amount of data involving the clinical trial operation
The clinical trial includes but not exclusive of following data:
Scientific data
Administrative data
Regulatory data
Demographic data
Marketing data
Trial configuration data
……………………..
Software to aid in planning, preparation, performance, and reporting (AE data), keeping up-to-date contact information for participants and tracking deadlines and milestones such as those for regulatory approval or the issue of progress reports of Clinical Trial
Clinical Trial also need to be connected to a business intelligence system, which may acts as a digital dashboard for trial managers
Need of IT in Clinical Trial
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CTMS
CDMS
CDARS
CDS
eCRF
eCTD
Medical Device Software
Clinical Trial Measure Software
Telemedicine
Could medicine
Clinical trial and IT
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Architecture of a CTMS
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eCTMS Log Ins
Study Mgt
Create
Create Like Create New
Report
Audit TrailSearch Study Report
User Mgt
Study Users
Available Users
Current Users
Permissions
GeneralSchedules
Subject Mgt. Product Mgt. Site Mgt. Financial
Mgt.
Trip report mgt and review functions
Architecture of a CTMS Component
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Accounts Views and Payment Tracking
Overall Project/Study/ Session Expenditure
Tracking
Correspondence Tracking and field Updates
Subjects
Investigators
Fiancial Calculations and Tracking
Financial Mgt.
Test time ~2-3 minutes
349 straight variable out puts
140 derived statistical variable
Typical –STM-Measure Output
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The worldwide revenue of the pharmaceutical market in 2001 was around 390.2 billion U.S. dollars. Ten years later, this figure stood at almost one trillion U.S. dollars. And it is ever growing.
Global Clinical Trial Management Systems’ Market valuation is predicted to be $1300.4 Million by 2016.
The global CTMS market is estimated to grow at a CAGR of 14.53% during period (2011-2016).
North America is leading the global CTMS market with around 62% share in 2010, as majority of the global clinical trials are conducted in North America, especially in the U.S. (around 58.5% share).
The second largest market is Europe, while growth in the Asia-Pacific region is also expected to take greater curves in the near future.
Major players in the Clinical Trial Management Systems Market include Oracle Corporation (U.S.), Perceptive Informatics (a subsidiary of Parexel International Corporation) (U.S.), Medidata Solutions (U.S.), eResearch Technology Inc. (U.S.), and BioClinica Inc. (U.S.).
Clinical Trial Management Systems (CTMS) Market: Global Trends, Opportunities, Challenge and Forecasts (2011 - 2016)
The CTMS Market
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Health care (or healthcare) is the diagnosis, treatment, and prevention of disease, illness, injury, and other physical and mental impairments in human beings.
Health care is delivered by healthcare practitioners, associates and related service providers.
Healthcare services can be extended to primary care, secondary care, and tertiary care, as well as in public health.
Total health care spending in the United States is expected to reach $4.8 trillion in 2021, up from $2.6 trillion in 2010 and $75 billion in 1970. To put it in context, this means that health care spending will account for nearly 20 percent of gross domestic product (GDP), or one-fifth of the U.S. economy, by 2021.
HealthCare
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Health information technology (HIT) provides the umbrella framework to describe the comprehensive management of health information across computerized systems and its secure exchange between consumers, providers, government and quality entities, and insurers.
Broad and consistent utilization of HIT will: Improve health care quality or effectiveness;
Increase health care productivity or efficiency;
Prevent medical errors and increase health care accuracy and procedural correctness;
Reduce health care costs;
Increase administrative efficiencies and healthcare work processes;
Decrease paperwork and unproductive or idle work time;
Extend real-time communications of health informatics among health care professionals; and
Expand access to affordable care
Examples of health IT include the following: Clinical decision support.
Computerized disease registries.
Computerized provider order entry.
Consumer health IT applications.
HealthCare IT
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EHR
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EHR Should Contain: Health information and data,
Result management,
Order entry/order management,
Decision support,
Electronic communication and connectivity,
Patient support,
Administrative processes,
Reporting and population health.
EHR is utilized for: Patient Care Delivery
Patient Care Management
Patient Care Support Processes
Financial and Other Administrative Processes
Patient Self-Management
Education
Regulation
Research
Public Health and Homeland Security
Policy Support
• European Federation of Pharmaceutical Industries and Associations (EFPIA)
• Ministry of Health, Labor and Welfare, Japan (MHLW)
• Japan Pharmaceutical Manufacturers Association (JPMA)
• US Food and Drug Administration (FDA)
• Therapeutic Products Directorate (TPD)
• Pharmaceutical Research and Manufacturers of America (PhRMA)
• --------------------------- (many more)
Controlling bodies
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• 21 CFR (Part11, Part210 and 211, Part820 or Quality System Regulation, Part 807, Part 814 etc.)
• 520(k)/PMA
• GDMP, GMP, CAPA
• The Hazard Analysis and Critical Control Points (HCCP)
• ASTM D1585, ASTM F2097, EN 868, ISO 11607, CE Marking
• HIPAA , ARRA, HITECH Act, EDI transaction and code sets
• HCP Aggregate Spend Reporting, PPACA, Physician’s Sunshine Legislation, US State and Federal regulations.
• CDISC (SDTM and ODM)
• PhRMA regulations
• CRF 42
• ISO 9001, ISO 14971, ISO 13485,
• IEC 62304
Regulations
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