Role of IT in reducing cost and increasing Data Accuracy for CRO's for planning and conducting Clinical Trials

Role of IT in reducing cost and increasing Data Accuracy for CROs (Contract Research Organizations) for planning and conducting Clinical Trials

Pharmaceutical companies spend enormous amount of money in developing a drug with expenditures touching at times more than Rs 4000 Crore and the time taken in the entire process right from the stage of the drug’s inception in the laboratory to the stage of introducing the product in the market for the consumers can be as high as 12 to 15 years.. The drugs have to pass through various stages including clinical research and development, planning and conducting clinical trials of the drugs and final acceptance of the drug by regulatory authorities before it reaches the market to the patients for benefit of the mankind.

Well the stakes are high and as such there is a fierce competition among pharmaceutical companies and their research and development department to be the first to launch the new drugs in the market for consumers as the rewards to pharmaceutical companies are huge if the drug has been successfully introduced in the market. Speedy development of the drugs is therefore a much sought after arena for pharmaceutical companies. CROs remain under increasing pressure to reduce the entire cycle time of drug development and Information Technology is being used increasingly during the process of clinical research and trials for the purpose of ensuring accuracy of data and reduction of process cycle time.

Among various stages of drug development and introduction, Clinical trial is the most crucial and important stage which are normally outsourced to CROs (Contract research organization) by the pharmaceutical companies. The CROs further hire investigators from medical community to conduct the clinical trials on volunteers or patients. The process to conduct clinical trial goes through a long process involving various activities like Protocol Design and Study Start Up, Patient and Investigator Recruitment, Clinical Trial Management, Clinical Data management, Data Analysis, Clinical Supplies and  Regulatory and Safety.

At present there is still a lot of scope of improvement in the entire process of clinical trial due to inefficiencies in manual methods often adopted for data capture and data analysis in India and lot of unnecessary paper work in form of case report forms used for data collection can be avoided by introduction of suitable and relevant IT applications at various stages.

The application of Information technology in various forms can be summarized broadly as under.

1.Clinical Trial Management System (CTMS)

2.Clinical Data Management system ( CDMS)

3.Electronic Data capture system(EDC)

4. Interactive voice Response System (IVRS) as part of EDC mentioned above

5.RFID ( Radio Frequency identification technology) as Data tracking system.

6. Web based Clinical Trial Portals

In our further study of above system , we shall now focus on each of the above applications very briefly as each application described above  is a subject in itself.

1.Clinical Trial Management System (CTMS)

CTMS is a software developed and customized to application of  clinical trials and is used by pharmaceutical industry to manage the large amount of data captured during the operations of clinical trials. It maintains and manages the planning, preparation, performance, and reporting of clinical trials, with emphasis on 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. Data captured by CTMS is further used for creating business intelligence (BI) which acts as dash board data at a glance for trial managers.

 2.Clinical Data Management system ( CDMS)

While CTMS is a centralized system for reporting and supervision, CDMS is a tool used in clinical research to manage the data of a clinical trial at the investigator site.. The clinical trial data gathered at the investigator site in the CDMS as storage system. To reduce the possibility of errors due to human entry, the systems employ data verification techniques to maintain the integrity of the data.
In  CDMS the investigators directly uploads the data on CDMS and the data can then be viewed by the data validation staff. Once the data is uploaded by site, data validation team can send the electronic alerts to sites if there is any issue.

3.Electronic Data capture system(EDC)

EDC system is mainly used in late phases where the clinical trial data is huge due to more number of volunteers/patients. Typically, EDC systems provide:

• A PC connected to a central server for data entry
• Data validation component in form of software  to check user data
• Reporting system analysis of the collected data

EDC systems are also used for Pharmacovigilance and post market safety surveillance.

4.  Interactive voice Response System (IVRS) as part of EDC

IVRS system lets the patient/volunteer dial a telephone number and access the IVRS system in form of a computer system which has the capability to convert the voice in digital data and  allows the dialer to interact with the digital voice offered by the computer. The volunteer is asked pre-recorded questions and instructions after the dialing and getting connected with the IVRS system. The volunteer replies its response to the digital voice generated from computer and he is thus able to record his response in voice form on the storage system of IVRS system.

The benefits of IVRS system IVR / IVRS is a simple tool that has many benefits, such as

·         Facilitation of collection of data from a Remote Patient

·         Simplification of clinical trial data input, clinical trial management and output

·         There is no manual intervention and as such is less prone to errors.

·         Larger amount of clinical trial data can be collected/dispensed and the target audience of patients can be increased during subsequent phases of the clinical trial run.

·         It makes the whole process less time consuming.

5.RFID ( Radio Frequency identification technology) as Data tracking system.

 RFID solution for the clinical trials process involves tagging clinical samples or specimens  of patients/volunteers collected in test tubes with RFID tags helping to track its movement wirelessly and read its tracking through RF readers.

.Another area of applicability is for patient/volunteer management where a constant track of the patient can be done by issuing an RFID wrist - tag to the patient. This would help keep track of patients within the premises.

Benefit of RFID tracking

·          Increase the efficiency of operations at all locations and in effect reduce operational expenditure.

·          Ability to track temperature sensitive samples and be able to take corrective action to immediately preventing degradation of samples in transit.

·          Ability to measure performance based on time taken for samples moving between locations

·          Removing manual intervention in tracking and hence, cost reduction in item tracking

·         Automated tracking of patients within site premises.

·          Increased ability to share information between partners in the clinical trials

·         For CROs, removal of delays leads to better service and higher customer satisfaction levels.

6. Web based Clinical Trial Portals

Clinical trial portals allow volunteers/patients and investigators to connect with each other through the  internet and they share their knowledge and experience in a collaborative manner. Clinical Study-Portal is a generic solution and is ideal to handle and share information on multiple Clinical Trials carried out at different locations. The access to the Portal for all Parties involved in a Clinical Trial is role based .The emphasis of the portal solution remains on keeping access and sharing of information in a user friendly manner.


Conclusion
The role of IT in clinical trial is crucial and unavoidable and shall only increase in future due to cost optimized solutions offered by information and communication technology and the foremost attraction is that it enhances the accuracy of data handled during clinical trials reducing the risk of missing useful information which may be detrimental to the health of patients post marketing of the drugs and its consumption. The cost benefits are also attractive as it reduces manual work and offers a more systematic and organized approach for clinical trial runs. The clinical trial process is often plagued with inefficiencies and IT solutions are proving a boon to CRO industry.

Written by
Professor Akhil Chandra
B.E. Electronics and Communications, IIT Roorkee, MBA
Indian Clinical research Institute,A 201 Okhla Phase I
New Delhi