Clinical Trial Registration and Results Disclosure: Business Process Considerations
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Clinical Trial Registration and Results Disclosure: Business Process Considerations
Poiricia Teden,
MI
Principal, Teden Consulting LLC. South Orange. New Jersey
Defining a clinical trial registration and results disclosure (CTWRD)business process is challenged by a dynamic set of expectations to be met. External stakeholder groups have dinering expectations of and uses for disclosed information about clinical trials. Regulations in the United States and internationally continue to evolve and emerge. A growing number of portals oflering varying information about the same
Key Words Clinical trial registry; Clinical trial resulfs; Clinical trial disclosure; Business process
Correspondence Address Patricia Teden. MBA, Teden Consulting LLC. South Orange, NJ (email: pafricia.feden @ fedenllc.com).
INTRODUCTION The topic of clinical trial registration and results disclosure (CTWRD) moved from a relatively academic issue to a widely recognized public health issue when the general public objected to a lack of access to study results that might have influenced treatment decisions important to their personal health. The advent of the CTWRD movement is rooted in distrust and has a goal of regaining public trust. A multitude of stakeholders exist, each possessing their own expectations of what information should be disclosed and how that information should be used. lnfluential stakeholders, such as the World Health Organization (WHO) (l),World Medical Association (2).and the International Committee of Medical Journal Editors (3) have clear expectations, although those expectations have continued to evolve in recent years. Ethics committees, investigators, and patient advocacy groups are now activists on this subject. Study registries are proliferating and new regulations are emerging across the globe. Clinical trial information disclosure is a fluid environment that requires designing and implementing a specialized business process. Flexibility to accommodate constant change and to integrate with existing clinical trial processes is required. Corporate pressure to be efficient despite an increase in the volume of work is a challenge. Increasing work volume reflects the cu-
studies have a profound eflect on the vdume of work and create pressure to keep information across portals consistent. This articlefocuses on the challenges of changing and improving CTWRD database processes in response to new expectations, new regulations, and imperatives for increused efficiency. Some keys for success are onered.
mulative effect of maintaining (ie, updating) study registration information for studies registered over the past few years, and disclosing the same study on multiple registries. Posting study results on ClinicalTrials.gov is now a reality and disclosing results on other portals will soon be a requirement. Biopharmaceutical companies have disclosed information about select clinical trials since 2002 to comply with the Food and Drug Administration Modernization Act (FDAMA 1l3) and about a much larger scope of trials si
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