Advances in IT combined with business model transformation could combine to form a critical step in attaining transformation of the Clinical Trial Enterprise through lower cost, faster, and better data excellence of clinical trials. The entities involved in the conduct of clinical trials have not followed the cost-reduction route of other technology-intensive industries and thus have not attained a business transformation adequate to gain the economic benefits of technologic adoption. Instead, rapidly rising costs of clinical trials contribute to cost increases in developing innovative health products. The subsequent high cost of conducting clinical trials narrows the pipeline for new drug development, limits the accretion of knowledge about drugs that are produced, deters a focus on innovation and enhancements in trial design and conduct, and obstructs the study of important public health inquiries.
Snowballing costs stem in part from obstacles that exist within regulatory pathways or stem from administrative inadequacies, including increasingly complex clinical trial protocols, abundant requirements issued by various levels of government and different governments and not harmonized to ensure consistency, and excessively risk-averse understandings of regulations by trial sponsors. Some new structures, such as CROs, have arisen to help trial sponsors operate in the complex research environment. CROs are focused on efficiently conducting clinical trials according to current standards and client expectations.
According to a study, new information technologies conceivably could alter the conduct of clinical trials. For instance, electronic data capture (EDC)—using a computerized system to gather clinical data in a clinical trial—has the potential to reduce total costs, prevent errors, and conserve the time expended by physicians, nurses, and data coordinators by replacing multiple paper entries on patients’ clinical progress with onsite, electronic entry. Research entities continue to rely on legacy systems, such as freestanding site-specific monitoring mechanisms and IRBs, rather than having these functions centralized among all or most sites involved in the same trial. So long as research organizations persist in overlaying the old business model without technological transformation, many potential efficiencies are not realized.
A comprehensive approach to ensure the business model for clinical trials keeps pace with technology and information needs and capabilities could be based on a research agenda that examines how research is conducted today. This research would point the way forward in terms of identifying potential issues, and pathways, to reach business transformation of clinical trials. Suggested pathways and opportunities for moving research business models forward would therefore reflect findings that come from a forward-looking research agenda that considers the seamless integration of technology into trials. Also, harmonization of regulations among multiple agencies, including different levels of government in different countries, could reduce the cost of monitoring trials. Regulatory relief also could come in the form of the establishment of safe harbors for business process innovation—to allow sponsors to follow certain promising pathways before regulations have been developed and finalized.
Furthermore, enhanced clinical technology education of health professionals could equip practitioners to contribute to strategic efforts to develop new ways to streamline clinical trials into technology clinical practice. Organizations that play a role in clinical research could reorient themselves toward economic efficiency, shed costs such as legacy systems that no longer are needed, avoid overly cumbersome mechanisms for applying regulatory controls, and adopt new information technologies.
Selected Possible Approaches for Avoiding Needless Costs in Clinical Trials.
- Enhance clinical research technology education of health professionals, so they can help design more efficient and meaningful research programs;
- Apply new information technologies, such as web-based clinical trials and smart phones, in place of outmoded mechanisms;
- Use EDC and EHRs to apply clinical data to research, replacing paper-based legacy systems;
- Reconsider costly regulatory controls, such as the Health Insurance Portability and Accountability Act (HIPAA) regulations applied to clinical research, and provide safe harbors for business process innovation;
- Engage in more strategic planning and consider new organizational structures for entities conducting clinical trials; and
- Focus compliance monitoring and other oversight on areas of greatest risk and introduce expedited review and flexibility as appropriate.