22. February 2010 by harshit.

Definition of Clinical Data Capture

Collection of clinically significant data by the Investigator/s for clinical trials on behalf of the Sponsor in a sequential manner (per protocol) to process the same and generate reports at a later stage for submissions to regulatory authorities for various purposes
• Procedures for gathering and recording data from or related to subjects in the study
• Paper based OR Electronic Data Capture (EDC)
• Promise of increased efficiency has led to increasing movement toward  implementation of the electronic medical record and to computerized automation in general

Paper Based Data Capture
• Most widely used form of data capture
• Traditional paper Case Report Forms (CRFs)
• Manual entry by site personnel on three-part NCR paper CRFs
• 1 copy retained at investigator site, 2 copies sent to Sponsor or CRO’s Data Management department

Paper Based Data Capture
• Easy to enter data
• Requires simple training
• Logistically patient’s bedside may not be the right place for a computer to enter data.

Draw Backs of Paper CRF
• Storage problem
• Time consuming
• Cost of printing and distribution/ Imaging
• Lack of real-time reporting
• Increasing pressure on sponsors to get drugs into market faster
• Confidentiality and Security

Electronic Data Capture (EDC)
• Capability to collect data electronically
• Also known as Remote Data Entry (RDE)
• Online and offline
• Becoming more common than paper technology

Definition of EDC by the Clinical Data Interchange Standards Consortium (CDISC):
• “Collecting or acquiring data as a permanent electronic record with or without a human interface (eg., using data collection systems or applications that are modem-based, web-based, optical mark/character recognition, or involve audio text, interactive voice response, graphical interfaces, clinical laboratory interfaces, or touch screens). Note: ‘Permanent’ in the context of these definitions implies that any changes made to the electronic data are recorded via an audit trail.”

EDC Tools
• Internet
• Interactive Voice Response (IVR)
• Pen Tablet
• Personal Digital Assistant
• Fax
• Image Recognition Technology (OCR & OMR)
• eCRF

Internet
• Programs and databases located on centralized website
• Data keyed in with access to a browser
• Online
• Real-time reporting possible
• Good solution for small providers who cannot afford software costs

Interactive Voice Response (IVR)
• Interactive speech or touch-pad menu-driven system that takes the caller through a series of prompts
• Responses entered through a telephone keypad
• Real-time reports generated
• Almost maintenance free
• Limited interface
• Typically used in select areas such as patient randomization, adverse event reporting, drug supply management, tracking visit milestones, assisting with study startup or collecting subject diary information

Pen Tablet
• Reduce paper costs by allowing full-size form filling, signature, and simultaneous form inking Ex: ClipGem Pen Tablet
• Users affix a paper form under the clip and sign each individual signature field
• User’s signature and biometric data captured, software binds it to the electronic copy of the document in real time, and the inking tip of the pen makes a paper record
• Powered by computer’s serial or USB port, hence no batteries or bulky wall transformers  needed

Personal Digital Assistant (PDA)
• Replace paper-based subject diaries
• Stores data until transfer to study database
• Hotsyncing to a computer where the data is downloaded and stored
• Typically operates in offline mode
• Eliminates data entry

Fax
• Software scans faxed patient forms and faxes back a report, eliminating the need for data entry at the clinic level

Limitations:
a) Confidentiality
b) Maintenance and monitoring
c) Availability of clerical staff to verify submissions
d) Slow turn around time

Image Recognition Technology
• Image-recognition systems, including optical character recognition and optical mark recognition, provide a means of capturing data from printed sources
• Data on paper chart à Scan à OMR/OCR software àEMR

Optical Character Recognition (OCR) technology
• Translation of printed text on each page to electronic text documents
• OCR software converts scanned image to machine-readable and editable text
• Equivalent to keying in text by hand
• Less costly and faster compared to manual keying in
• Scanning preprinted paper forms to convert marks in checkboxes, text printed in block form, and barcodes into machine readable text
• Questionnaire format commonly used in post-marketing trials
• Fast and time saving

Representation of process of using a flatbed scanner and OMR or OCR software. A flatbed scanner with a sheet feeder is the rate-limiting step in the conversion of printed documents and forms to machine-readable data.

eCRF
• Direct entry into eCRFs that have some form of in-built real-time data validation checks. Updates to data done electronically
• Transmission of data to sponsor accelerated
• Faster and more active management of the data gathering and processing workflow
• Ensures “cleaner data faster”
• User interface to be designed with user characteristics in mind
• Validation inputs to be taken into account during initial designing
• Integration of EDC with other corporate systems to be included in designs from the start, as well as information messaging and workflows

Advantages of eCRF Over Paper CRF
• Automated data edit checks alert the site to possible errors in data entry
• Faster correction of issues and immediate site education. Hence cost saving
• Immediate viewing by sponsor to review and analyse the data and provide online feedback to the site.
• Shortens time between ‘last patient last visit’ and ‘database lock’

Advantages of eCRF
• Project Manager: access to real-time project metrics
• Clinical Monitoring Staff: less time spent in site visits
• Investigator Sites: less query resolution and less storage issue
• Data Management: eradication of double data entry and faster turn around

Limitations of eCRF
• Resistance to change
• Integration of multiple systems and groups
• Indecision and fear among Sponsors

eSource
• Data directly entered into eCRF without paper source
• Eliminates errors and delays that occur in transcription from source to CRF
• Single data entry

eSource Data
Definition per ICH (International Conference on Harmonization):
   “Source data captured initially into a permanent electronic record. Note: ‘Permanent’ in the context of this definition implies that any changes made to the electronic data are recorded via an audit trail.”
Definition per ICH:
  “All information in original records, certified records, and certified copies of original records of clinical findings; observations; or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies).”

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8. February 2010 by rahul.

India: Hub for clinical research

• Large number of patients
• Faster recruitment
• Highly qualified professionals
• Global quality medical care
• Low trial costs
• Highly developed IT and data collection
• More and more global sponsors are moving to India for clinical trials
• Exponential growth in no. of CTs and the industry

India and clinical research..

Until recently, there were few clinical trials conducted in India by Western pharmaceutical and biotech companies, primarily because of regulatory hurdles. In January 2005 it was recognized that the significant advantages that India offers to multinational companies and the potential and benefits of conducting clinical trials in India, should be utilized. The Government of India upgraded Schedule Y of the Drugs and Cosmetics Act of India, the equivalent of the sections of the Code of Federal regulations applicable to the FDA, to harmonize it with U.S. and International Conference on Harmonization (ICH) standards.

These changes removed a number of regulatory barriers to performing clinical trials in India

• The changes formalized the definition and conduct of clinical trials

• Specified the responsibilities of the sponsor, the investigators, and the Ethics Committees

• Developed guidelines and procedures for importing drugs for clinical trials

• Instituted required compliance with GCP

• Specified the requirements for informed consent

• Defined the structure, content and formats of clinical study reports

• In addition, the Indian Government provided increased protection for intellectual property (IP).

India….Clinical Trial costs                                                                                                                                                             The cost per patient for trials in India is approximately 40 to 60% of the cost in Western nations. More importantly, patient recruitment can be greatly accelerated, and this provides a major advantage in terms of shortening the time to market for a new drug. Based on these many advantages, the number of clinical trials in India is expected to grow exponentially over the next five to ten years. The average cost of running a US-based clinical trial per patient is $5,404 for Phase I, $6,538 for Phase II and $7,635 for Phase III.According to an analysis in 2006, conducting a clinical trial in a lower-cost destination such as India, for example, can cost up to 60 per cent less than in the US. However, while quickly gaining momentum, India’s much hyped clinical research industry is still yet to really take off. Since the introduction of patent protection laws in 2005, the industry has been growing three digits. However, this growth has not been as fast as many have predicted.

While deciding the costs for a clinical trial several factors are taken into consideration by the sponsor

In house costing plus out sourcing costs.
In house costing, all infrastructural expenditure has to be accounted for.
For outsourcing costs: CROs have come to play a crucial role in clinical research. The government plays a crucial role in regulating clinical trial costs. A report by analysts estimated that clinical research in India will be a $1bn (€800,000m) industry by 2010.Although many analysts expect it will be closer to half that

The government initiative.
Indian govt. recently announced a tax exemption on all services carried out by its contract research and clinical trials industry – a saving of 12.24 percent. The decision removes a previous stumbling block that international pharmaceutical sponsors faced when considering contract research organisations (CROs) in India. This is designed to give a boost to this budding market. Cost-savings are a significant draw card for many pharmaceutical companies when deciding to outsource clinical research to countries in emerging markets such as India and Latin America. In the last 10 years, skyrocketing costs of R&D have led to a growth explosion in the clinical services industry as pharma companies scramble to cut costs

Tax exemption…in Clinical Research
It is hoped that this move by the Indian government will give the industry the kick that it needs to live up to expectations. To make India a preferred destination for drug testing.
This includes technical testing and analysis for testing of new drugs, vaccines and herbal remedies, on human participants by a CRO approved to conduct clinical trials by the Drugs Controller General of India. This will attract more clinical trial outsourcing as the pharmaceutical sponsors will heavily benefit on their cash outflows on account of their expenses on CRO fees

CROs and clinical research
CROs are rapidly emerging as important contributors in clinical research Currently; CROs are having to ask sponsors for reimbursement of this service tax and paying it to the government. This relaxation by the govt. has sent positive signals for the growth of the clinical trial industry

The pharma industry…
A biopharmaceutical company discovers, develops, and commercializes therapeutic medicines for the treatment of serious medical conditions. It has therapeutic candidates in clinical trials for the potential treatment of diseases. It has the ability to understand thoroughly the biology of specific disease states, discover potential therapeutic candidates and evaluate product candidates in clinical trials.

How the industry manages costs ?
Financing, budgeting and cost control are essential aspects of clinical trial management
Specifically trained professionals, like CAs, MBAs, etc. are employed by the industry to handle this problem. Responsibilities include estimating, budgeting, forecasting, monitoring, planning, and allocating resource for clinical operations.

The need….
Ability to analyze clinical financial data and prepare management reports and forecasts, including earned value management reports. Effective documentation and communication for interacting with and making an impact on functional teams .Accurate and timely financial budgets, forecasts, actual and variance analyses under tight deadlines. The ability to manage multiple competing priorities

So, Clinical trials are not only a scientific exercise but also involve administrative and financial aspects. Need for focused expertise, innovative processes, and integrated technology. High quality, efficient and cost effective service solutions are needed to address many of the critical financial and administrative issues that affect the clinical trial proces

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