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Information technology in pharmacovigilance: Benefits, challenges, and future directions from industry perspectives.

Lu Z - Drug Healthc Patient Saf (2009)

Bottom Line: Information science promises to deliver effective e-clinical or e-health solutions to realize several core benefits: time savings, high quality, cost reductions, and increased efficiencies with safer and more efficacious medicines.Due to recent high-profile drug safety problems, the pharmaceutical industry is faced with greater regulatory enforcement and increased accountability demands for the protection and welfare of patients.This changing climate requires biopharmaceutical companies to take a more proactive approach in dealing with drug safety and pharmacovigilance.

View Article: PubMed Central - PubMed

Affiliation: Clinical Research Department, Abbott Vascular, Santa Clara, CA, USA.

ABSTRACT
Risk assessment during clinical product development needs to be conducted in a thorough and rigorous manner. However, it is impossible to identify all safety concerns during controlled clinical trials. Once a product is marketed, there is generally a large increase in the number of patients exposed, including those with comorbid conditions and those being treated with concomitant medications. Therefore, postmarketing safety data collection and clinical risk assessment based on observational data are critical for evaluating and characterizing a product's risk profile and for making informed decisions on risk minimization. Information science promises to deliver effective e-clinical or e-health solutions to realize several core benefits: time savings, high quality, cost reductions, and increased efficiencies with safer and more efficacious medicines. The development and use of standard-based pharmacovigilance system with integration connection to electronic medical records, electronic health records, and clinical data management system holds promise as a tool for enabling early drug safety detections, data mining, results interpretation, assisting in safety decision making, and clinical collaborations among clinical partners or different functional groups. The availability of a publicly accessible global safety database updated on a frequent basis would further enhance detection and communication about safety issues. Due to recent high-profile drug safety problems, the pharmaceutical industry is faced with greater regulatory enforcement and increased accountability demands for the protection and welfare of patients. This changing climate requires biopharmaceutical companies to take a more proactive approach in dealing with drug safety and pharmacovigilance.

No MeSH data available.


Related in: MedlinePlus

The interoperable clinical research and pharmacovigilance network (ICRPN). Data standard allows communications between electronic health record or medical record and clinical trial data, enabling clinicians and patients to share clinical information across institutional and geographic boundaries with industry sponsors. ICRPNs facilitate this information exchange by bringing together the groups that must participate in it to make the exchange effective. ICRPNs may also provide ongoing governance of the process of data sharing. Data exchange occurs through the information-exchange networks that provide the technical means of exchanging data between the records and databases maintained by clinicians, health care institutions, individual consumers, industry sponsors, and regulators. A systematic contextual approach must be employed to understand and address evolving pharmacovigilance issues.Abbreviations: PDC, paper based data collection; IVRS, interactive voice response system; IWRS, interactive web response system; AE, adverse event; WHO, world health organization; eHR, electronic health record; eMR, electronic medical record.
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f2-dhps-1-035: The interoperable clinical research and pharmacovigilance network (ICRPN). Data standard allows communications between electronic health record or medical record and clinical trial data, enabling clinicians and patients to share clinical information across institutional and geographic boundaries with industry sponsors. ICRPNs facilitate this information exchange by bringing together the groups that must participate in it to make the exchange effective. ICRPNs may also provide ongoing governance of the process of data sharing. Data exchange occurs through the information-exchange networks that provide the technical means of exchanging data between the records and databases maintained by clinicians, health care institutions, individual consumers, industry sponsors, and regulators. A systematic contextual approach must be employed to understand and address evolving pharmacovigilance issues.Abbreviations: PDC, paper based data collection; IVRS, interactive voice response system; IWRS, interactive web response system; AE, adverse event; WHO, world health organization; eHR, electronic health record; eMR, electronic medical record.

Mentions: Perhaps the biggest uncertainty concerning pharmacovigilance is whether it will accomplish dramatic, transformational improvement in accurately and reliably detecting clinical safety signals among the millions of haystack of voluntarily reported data. It seems reasonable that traditional pharmacovigilance approaches are still necessitated for confirming a potential signal from an autofired alert, determining a potential safety risk or any action to be taken from a signal in pharmacovigilance. It would be premature to assume that modern pharmacovigilance technology will offer such critical decision-making capability. Even if it does, a thorough manual confirmation would be required at the detailed clinical data levels. Sponsor management is already grappling with the fact that implementing pharmacovigilance corporate wide will require changing, quite dramatically, the work of many different functional groups including but not limited to: IT, clinical data management, safety, product performance, operations, CROs if applicable, clinical sites in order to create an operational safety framework and foster the gear switch to support the implementation of new technology. In the face of this challenge, the will to improve and prosper will be primary, the technology and innovation secondary, and patience and collaboration critical. Creating standards-based and interoperable clinical pharmacovigilance systems in which corporate management and safety staff can find the quality improvement in signal detection and cost reduction essential to accomplishing corporate financial and professional goals will be necessary to widespread adoption of modern pharmacovigilance and to assessing its transformative potential (Figure 2).


Information technology in pharmacovigilance: Benefits, challenges, and future directions from industry perspectives.

Lu Z - Drug Healthc Patient Saf (2009)

The interoperable clinical research and pharmacovigilance network (ICRPN). Data standard allows communications between electronic health record or medical record and clinical trial data, enabling clinicians and patients to share clinical information across institutional and geographic boundaries with industry sponsors. ICRPNs facilitate this information exchange by bringing together the groups that must participate in it to make the exchange effective. ICRPNs may also provide ongoing governance of the process of data sharing. Data exchange occurs through the information-exchange networks that provide the technical means of exchanging data between the records and databases maintained by clinicians, health care institutions, individual consumers, industry sponsors, and regulators. A systematic contextual approach must be employed to understand and address evolving pharmacovigilance issues.Abbreviations: PDC, paper based data collection; IVRS, interactive voice response system; IWRS, interactive web response system; AE, adverse event; WHO, world health organization; eHR, electronic health record; eMR, electronic medical record.
© Copyright Policy
Related In: Results  -  Collection

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getmorefigures.php?uid=PMC3108683&req=5

f2-dhps-1-035: The interoperable clinical research and pharmacovigilance network (ICRPN). Data standard allows communications between electronic health record or medical record and clinical trial data, enabling clinicians and patients to share clinical information across institutional and geographic boundaries with industry sponsors. ICRPNs facilitate this information exchange by bringing together the groups that must participate in it to make the exchange effective. ICRPNs may also provide ongoing governance of the process of data sharing. Data exchange occurs through the information-exchange networks that provide the technical means of exchanging data between the records and databases maintained by clinicians, health care institutions, individual consumers, industry sponsors, and regulators. A systematic contextual approach must be employed to understand and address evolving pharmacovigilance issues.Abbreviations: PDC, paper based data collection; IVRS, interactive voice response system; IWRS, interactive web response system; AE, adverse event; WHO, world health organization; eHR, electronic health record; eMR, electronic medical record.
Mentions: Perhaps the biggest uncertainty concerning pharmacovigilance is whether it will accomplish dramatic, transformational improvement in accurately and reliably detecting clinical safety signals among the millions of haystack of voluntarily reported data. It seems reasonable that traditional pharmacovigilance approaches are still necessitated for confirming a potential signal from an autofired alert, determining a potential safety risk or any action to be taken from a signal in pharmacovigilance. It would be premature to assume that modern pharmacovigilance technology will offer such critical decision-making capability. Even if it does, a thorough manual confirmation would be required at the detailed clinical data levels. Sponsor management is already grappling with the fact that implementing pharmacovigilance corporate wide will require changing, quite dramatically, the work of many different functional groups including but not limited to: IT, clinical data management, safety, product performance, operations, CROs if applicable, clinical sites in order to create an operational safety framework and foster the gear switch to support the implementation of new technology. In the face of this challenge, the will to improve and prosper will be primary, the technology and innovation secondary, and patience and collaboration critical. Creating standards-based and interoperable clinical pharmacovigilance systems in which corporate management and safety staff can find the quality improvement in signal detection and cost reduction essential to accomplishing corporate financial and professional goals will be necessary to widespread adoption of modern pharmacovigilance and to assessing its transformative potential (Figure 2).

Bottom Line: Information science promises to deliver effective e-clinical or e-health solutions to realize several core benefits: time savings, high quality, cost reductions, and increased efficiencies with safer and more efficacious medicines.Due to recent high-profile drug safety problems, the pharmaceutical industry is faced with greater regulatory enforcement and increased accountability demands for the protection and welfare of patients.This changing climate requires biopharmaceutical companies to take a more proactive approach in dealing with drug safety and pharmacovigilance.

View Article: PubMed Central - PubMed

Affiliation: Clinical Research Department, Abbott Vascular, Santa Clara, CA, USA.

ABSTRACT
Risk assessment during clinical product development needs to be conducted in a thorough and rigorous manner. However, it is impossible to identify all safety concerns during controlled clinical trials. Once a product is marketed, there is generally a large increase in the number of patients exposed, including those with comorbid conditions and those being treated with concomitant medications. Therefore, postmarketing safety data collection and clinical risk assessment based on observational data are critical for evaluating and characterizing a product's risk profile and for making informed decisions on risk minimization. Information science promises to deliver effective e-clinical or e-health solutions to realize several core benefits: time savings, high quality, cost reductions, and increased efficiencies with safer and more efficacious medicines. The development and use of standard-based pharmacovigilance system with integration connection to electronic medical records, electronic health records, and clinical data management system holds promise as a tool for enabling early drug safety detections, data mining, results interpretation, assisting in safety decision making, and clinical collaborations among clinical partners or different functional groups. The availability of a publicly accessible global safety database updated on a frequent basis would further enhance detection and communication about safety issues. Due to recent high-profile drug safety problems, the pharmaceutical industry is faced with greater regulatory enforcement and increased accountability demands for the protection and welfare of patients. This changing climate requires biopharmaceutical companies to take a more proactive approach in dealing with drug safety and pharmacovigilance.

No MeSH data available.


Related in: MedlinePlus