IMPORTANCE OF IT IN CLINICAL TRIALS

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IMPORTANCE OF IT IN CLINICAL TRIALS

Posted On : Oct-16-2010 | seen (419) times | Article Word Count : 802 |

Clinical trials are vital processes for pharmaceutical companies to test the safety and efficacy of new drugs before they are declared viable and can be legally prescribed.

The sensitivity of the processes implies that clinical trials are long drawn processes, often lasting more than seven years from designing and planning of protocols to the final report. Every additional month or year of delay implies millions of dollars in costs and lost revenues for pharmaceutical companies; not to mention the high risk of ensuring the sanctity of the data from clinical trials. A streamlined and speedy process for clinical trials impacts positively the economics of companies, and often times dramatically.
Pharmaceutical companies, have, therefore always been on the lookout to boost the productivity of clinical trials. Some of these initiatives have included adoption of new scientific approaches to refine design of trials, globalization of trials for broader pools of patients and researchers and technological capabilities. Despite all these innovative approaches, end-to-end improvements in trial performances have been hard to achieve. Primary among the reasons towards this have been:

•Lack of proper coordination between trials across the organization resulting in loss of transparency
•Inability to leverage historical work, specially pertaining to design of trials; instead of re-using and learning from experience, teams continue to re-create protocol designs from scratch each time, resulting in a lot of wasted time and effort
•Unreliability of EDC Study SETUP systems has meant numerous hours spent verifying and matching electronic data against actual physical data
•Incomplete performance measurement programs that fail to look at programs holistically and focus on specific parts only

As the search for productivity continues, organizations have increasingly found that re-doing IT systems and increasing their effective usage in clinical trial programs can address a lot of the above concerns and challenges.

How IT helped clinical trial efforts

Leading pharmaceutical companies that have undertaken programs to re-align their IT systems have reported as much as 10% reduction in trial durations. Companies have focused on improving speed, quality and costs through a combination of activities: focusing on the right and accurate data, managing workflows and data transparency across the activity chain.
With costs skyrocketing, companies are turning to computerized systems and IT solutions to increase productivity and maximize the efficiency of clinical trials. The adoption of such solutions will be integral in enhancing and transforming the data collection and management aspects of a trial.
Another key activity that has immensely benefited from this wave of applying new technology has been in information and process design. Critical ways where technology can and has begun to play a role include:
•Integrated planning of clinical trials across the organization enabling the best leverage of resources and their allocation as needed to teams
•Use of modular design, leveraging past work to create electronic case-report forms
•Use of electronic data capture systems at the origin point of data, i.e. by physicians
•Integrated data system that gives management an end-to-end view of trials, enabling better and quicker decision making
An IT focus on the following areas in clinical trials can deliver immense value to pharmaceutical companies and other stakeholders and build a more efficient value chain:
Clinical data management: this could include databases of investigators and their preferences to support design of electronic forms, standard interface to integrate third party systems and automated data checks to maintain data integrity acting as a bar code for the clinical trials/ subjects
•Safety data management to enable real-time monitoring of trials towards early detection of adverse reactions
•Document management across all stakeholders with a single point to ensure version control and better information flow
•Clinical trials management: probably the area with the deepest potential for IT in activities like modular design and construction of consent and case report forms, converting study design forms to electronic forms and databases with little manual work, electronic invoicing, tracking drug supply flow, study planning and budgeting, patient management etc
•Project & resource management: use of traditional and customized project management tools including models to work with third party contractors, track project progress etc
•Clinical trials data Management/Bioinformatic tools would help in constriction of the time period for the proceesing of various outcomes which includes accelerating the drug discovery process, the eCTD, CTMS, Sharepoint, MOSS 2007, IVRS/IWRS for the randomization.
In today’s world, fragmented IT systems in most pharmaceutical companies make data and trial management a difficult and challenging process with little real-time view of all relevant data on a trial. As the industry evolves and global clinical trials mature, the role of IT will become increasingly important not just for the pharmaceutical companies but for all concerned in the process, including physicians, statisticians, clinicians and third-party contractors.
And to its highest potential all stakeholders in the clinical trial process need to be educated on the true features and benefits of modern clinical technologies and be willing to make the necessary mental and cultural switch and support the adoption of such solutions.

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<h1>IMPORTANCE OF IT IN CLINICAL TRIALS		 </h1> Author: <a href='http://www.articleseen.com/profile_Ragalahari.aspx'>Ragalahari</a> The sensitivity of the processes implies that clinical trials are long drawn processes, often lasting more than seven years from designing and planning of protocols to the final report. Every additional month or year of delay implies millions of dollars in costs and lost revenues for pharmaceutical companies; not to mention the high risk of ensuring the sanctity of the data from clinical trials. A streamlined and speedy process for clinical trials impacts positively the economics of companies, and often times dramatically.
Pharmaceutical companies, have, therefore always been on the lookout to boost the productivity of clinical trials. Some of these initiatives have included adoption of new scientific approaches to refine design of trials, globalization of trials for broader pools of patients and researchers and technological capabilities. Despite all these innovative approaches, end-to-end improvements in trial performances have been hard to achieve. Primary among the reasons towards this have been:

•Lack of proper coordination between trials across the organization resulting in loss of transparency
•Inability to leverage historical work, specially pertaining to design of trials; instead of re-using and learning from experience, teams continue to re-create protocol designs from scratch each time, resulting in a lot of wasted time and effort
•Unreliability of EDC Study SETUP systems has meant numerous hours spent verifying and matching electronic data against actual physical data
•Incomplete performance measurement programs that fail to look at programs holistically and focus on specific parts only

As the search for productivity continues, organizations have increasingly found that re-doing IT systems and increasing their effective usage in clinical trial programs can address a lot of the above concerns and challenges.

How IT helped clinical trial efforts

Leading pharmaceutical companies that have undertaken programs to re-align their IT systems have reported as much as 10% reduction in trial durations. Companies have focused on improving speed, quality and costs through a combination of activities: focusing on the right and accurate data, managing workflows and data transparency across the activity chain.
With costs skyrocketing, companies are turning to computerized systems and IT solutions to increase productivity and maximize the efficiency of clinical trials. The adoption of such solutions will be integral in enhancing and transforming the data collection and management aspects of a trial. 
Another key activity that has immensely benefited from this wave of applying new technology has been in information and process design. Critical ways where technology can and has begun to play a role include:
•Integrated planning of clinical trials across the organization enabling the best leverage of resources and their allocation as needed to teams
•Use of modular design, leveraging past work to create electronic case-report forms
•Use of electronic data capture systems at the origin point of data, i.e. by physicians 
•Integrated data system that gives management an end-to-end view of trials, enabling better and quicker decision making
An IT focus on the following areas in clinical trials can deliver immense value to pharmaceutical companies and other stakeholders and build a more efficient value chain:
Clinical data management: this could include databases of investigators and their preferences to support design of electronic forms, standard interface to integrate third party systems and automated data checks to maintain data integrity acting as a bar code for the clinical trials/ subjects
•Safety data management to enable real-time monitoring of trials towards early detection of adverse reactions
•Document management across all stakeholders with a single point to ensure version control and better information flow
•Clinical trials management: probably the area with the deepest potential for IT in activities like modular design and construction of consent and case report forms, converting study design forms to electronic forms and databases with little manual work, electronic invoicing, tracking drug supply flow, study planning and budgeting, patient management etc
•Project & resource management: use of traditional and customized project management tools including models to work with third party contractors, track project progress etc
•Clinical trials data Management/Bioinformatic tools would help in constriction of the time period for the proceesing of various outcomes which includes accelerating the drug discovery process, the eCTD, CTMS, Sharepoint, MOSS 2007, IVRS/IWRS for the randomization.
In today’s world, fragmented IT systems in most pharmaceutical companies make data and trial management a difficult and challenging process with little real-time view of all relevant data on a trial. As the industry evolves and global clinical trials mature, the role of IT will become increasingly important not just for the pharmaceutical companies but for all concerned in the process, including physicians, statisticians, clinicians and third-party contractors.
And to its highest potential all stakeholders in the clinical trial process need to be educated on the true features and benefits of modern clinical technologies and be willing to make the necessary mental and cultural switch and support the adoption of such solutions.About the Author: This article is a short review on Clinical IT systems from MakroCare is a <a rel="nofollow" href="http://www.makrocare.com/index.php/en/clinical-functional-services"title="CRO India">Clinical Research Organization</a>(CRO). Makrocare provides Functional Services like site management, clinical monitoring, CDM, medical affairs to Pharmaceutical, Biotechnology and Medical Device industries in India, Japan and Singapore. Article Source: <a href='http://www.articleseen.com/Article_IMPORTANCE-OF-IT-IN-CLINICAL-TRIALS_37925.aspx'> http://www.articleseen.com/Article_IMPORTANCE OF IT IN CLINICAL TRIALS		 _37925.aspx</a>

Article Source : http://www.articleseen.com/Article_IMPORTANCE OF IT IN CLINICAL TRIALS _37925.aspx

Author Resource :
This article is a short review on Clinical IT systems from MakroCare is a Clinical Research Organization(CRO). Makrocare provides Functional Services like site management, clinical monitoring, CDM, medical affairs to Pharmaceutical, Biotechnology and Medical Device industries in India, Japan and Singapore.

Keywords : edc, electronicdatacaprture, croindia, cro, ITsystem, clinicalfunctionalservices ,

Category : Health and Fitness : Health and Fitness

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