ASK THE EXPERT
Divan Da’ve, CEO of OmniMD™, discussed with CTA the importance of adopting electronic industry standards and how electronic document solutions can better protect patient privacy and improve efficiency in clinical trials. OmniMD™ is a developer of HIPAA-compliant internetbased enterprise clinical solutions designed to automate the workflow of healthcare organizations.
Q: How can leveraging electronic document solutions make clinical trials faster and more efficient for sponsors and others?
A: The adoption of technology standards that ensure the secure exchange of electronic clinical research data and other electronic healthcare transactions between clinical research, pharmaceutical and healthcare providers is a critical aspect of the national health information technology strategy. Interfacing electronic medical record (EMR) systems with clinical trial systems eliminates the need to enter data into a stand-alone trial record system as patient symptoms and clinical features are extracted directly from the patient’s record. With one click of the mouse, physicians can receive a differential diagnosis and knowledge - diagnosis-specific investigations, treatments and journal abstracts - to help corroborate decisionmaking.
Q: Are you seeing more interest among those in the clinical trial industry when it comes to electronic data capture (EDC)?
A: Yes, the direct capture of clinical data from investigators in clinical trials is currently a topic of great interest. While the FDA discusses the possibilities of primary data entry into EDC systems, many are also considering single source data entry or the transfer of data directly from electronic medical record systems. Perhaps the most evident advantage of EMR is that it can easily identify the patients from the community who would fit the clinical research project. For example, researches can find the details of patients who have been suffering from a particular symptom within the data set.
Q: How can industry better address patient privacy issues?
A: There are four critical stakeholders in ensuring the patient’s privacy: the patient, the physician, the clinician and the information technology (IT) professional. Through an understanding of every patient’s right to privacy, clinicians and physicians hold a critical position in articulating system design and selection requirements for the IT professional. System selection and process redesign orchestrated by the stakeholders can ensure confidential capture of patient data and eliminate redundancies. Technology tools like 128 data encryption, user-based logins and access, smart cards, firewalls and audits are some of the options available to researchers today.
Q: When do you expect to see forward progress when it comes to the industry adopting electronic data standards?
A: The need for standard procedures in eclinical trials has been addressed by several organizations. The two organizations with the most widely-adopted standards are CDISC (the Clinical Data Interchange Standards Consortium) and HL7 (Health Level 7). To be useful, the patient data would need to include precise and clearly understood clinical terms about details such as recent scans, medicinal allergies and recent treatments. Interfacing EMR and clinical trials systems is gaining momentum, and IT and hardware vendors are coming together to form consortiums and associations. In the next six months or so, I think we will witness major partnerships and agreements in this field.
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