Science and Technology

Examination of Clinical Trial Costs and Barriers for Drug Development. E.3 Barriers to Clinical Trials

The major obstacles to conducting clinical trials in the United States identified through this research include: high financial cost, the lengthy time frames, difficulties in recruitment and retention of participants, insufficiencies in the clinical research workforce, drug sponsor-imposed barriers; regulatory and administrative barriers, the disc

Examination of Clinical Trial Costs and Barriers for Drug Development. E.2 Analysis of Costs

The model uses detailed cost information made available by Medidata Solutions, a global provider of cloud-based solutions for clinical research in life sciences. The cost information is specific to the U.S. and presented by therapeutic area and clinical trial phase. Key findings with respect to costs include the following:

Examination of Clinical Trial Costs and Barriers for Drug Development. E.1 Clinical Trial Decision-making Model

Using data from a variety of sources, we model the decision-making process for a drug sponsor as a stylized decision tree that looks at the process for formulating a clinical trial from the point of view of an expected-revenue-maximizing sponsor in the face of uncertainty (or risk). The simplified clinical decision-making model incorporates the fo

Examination of Clinical Trial Costs and Barriers for Drug Development. Executive Summary

Examination of Clinical Trial Costs and Barriers for Drug Development. List of Acronyms

Acronym Meaning

Examination of Clinical Trial Costs and Barriers for Drug Development. Acknowledgments

We gratefully acknowledge Hui-Hsing Wong (ASPE) and Amber Jessup (ASPE) for their leadership, guidance, and input throughout this study. We also would like to thank Patrick Archdeacon (FDA) and Trini Beleche (FDA) for their insightful comments and advice. Medidata Solutions provided the data for the analysis of clinical trial costs. We would like

Health Care Cost Containment and Medical Innovation

ASPE ISSUE BRIEF Health Care Cost Containment and Medical Innovation May 2012 By: Amber Jessup, Ph.D.

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Identifying Opportunities to Maximize the Utility of Genomics Research Data Through Electronic Health Information Exchange

Identifying Opportunities To Maximize the Utility of Genomics Research Data Through Electronic Health Information Exchange Meeting Summary Andrew Dorfmann and Jessica Nadler 10/15/2009

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Developing a Framework to Guide Genomic Data Sharing and Reciprocal Benefits to Developing Countries and Indigenous Peoples: A Colloquium

Developing a Framework to Guide Genomic Data Sharing and Reciprocal Benefits to Developing Countries and Indigenous Peoples: A Colloquium January 7-8, 2009 Georgetown University, Washington, DC Hosted by ONeill Institute of National and Global Health Law Georgetown University and Personalized Health Care Initiative U.S. Department of He

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Examination of Clinical Trial Costs and Barriers for Drug Development. Appendix D: Additional Data Cleaning Steps

We performed the final cleaning and compilation of the various clinical trial data elements using the statistical software STATA. For some combinations of cost component, phase, and therapeutic area, Medidata did not have enough underlying trial data to provide means and variances while still maintaining confidentiality of client information. Beca

Examination of Clinical Trial Costs and Barriers for Drug Development. Appendix C: Features of Operational Model

Upon launching the operational model in Microsoft Excel, the user is automatically taken to the first page of the user form, which prompts the user to indicate whether he intends to examine the impacts of mitigating barriers to clinical trials, or go directly to the examination of clinical trial costs (see Figure C - 1). If “Barrier Impacts” i

Examination of Clinical Trial Costs and Barriers for Drug Development. Appendix B: Medidata Data Element Descriptions

Data Element Data Element Description Unit Source Administrative Staff Costs Non-clinical administrative staff cost associated with managing the study at the sites Month CROCAS ® (Medidata Solutions, 2012a)

APPENDIX A: DRAFT INTERVIEW GUIDE<sup>14,15

Examination of Clinical Trial Costs and Barriers for Drug Development. Appendix A: Draft Interview GUIDE^14,15

Company Name: _________________________________________ Company Sector: Pharmaceutical / Biotechnology Company Size: Small / Large (based on revenue / number of employees) QUESTIONS 16 1 DECISION-MAKING

Examination of Clinical Trial Costs and Barriers for Drug Development. 6 References

Adams, C., & Brantner, V. (2006). Estimating The Cost Of New Drug Development: Is It Really $802 Million? Health Affairs, 25 (2). Adams, C., & Brantner, V. (2010). Spending on new drug development. Health Economics , 19(2), 130- 141. Angell, M. (2004). Introduction: Drugs are Different. In M. Angell, The Truth About the Drug Comp

Examination of Clinical Trial Costs and Barriers for Drug Development. 5.9 Conclusions

In considering the conclusions that may be drawn based on our evaluation of barrier mitigation strategies, it is important to recognize that establishing clear links between barriers and specific model parameters and their ex-post magnitudes requires extensive research, and our analysis was constrained by the limited availability of this type of i

Examination of Clinical Trial Costs and Barriers for Drug Development. 5.8 Improvements in FDA Review Process Efficiency and More Frequent and Timely Interactions with FDA

This approach is somewhat difficult to quantify due to the highly variable results it is likely to have across review divisions and trials. For example, as one recent paper points out, there are considerable differences among review divisions in the length the NDA review and approval process, and to some extent, these differences are driven by dif

Examination of Clinical Trial Costs and Barriers for Drug Development. 5.7 Priority REVIEW/PRIORITY Review Vouchers

The basis for this policy option comes from a paper by Ridley, Grabowski, & Moe published in Health Affairs in 2006. The authors propose that developers of treatments for neglected diseases receive a “priority review voucher” to incentivize production of these therapies. If a treatment meets certain criteria, the developers would be awar

Examination of Clinical Trial Costs and Barriers for Drug Development. 5.6 Wider Use of Lower-cost Facilities AND/OR At-home Testing

This approach was suggested in the course of our interviews with drug sponsors. If FDA can successfully encourage sponsors to utilize lower-cost facilities (such as local clinics and pharmacies) for data collection purposes whenever possible, the need for costly infrastructure and overhead can be reduced. Furthermore, sponsors could conduct follow

Examination of Clinical Trial Costs and Barriers for Drug Development. 5.5 Wider Use of Mobile Technologies Such as Electronic Data Capture (edc)

Electronic data capture (EDC), described in Section 4.6.3 above, can streamline the patient screening and recruitment processes and allow for central statistical monitoring (Kramer & Schulman, 2011). While is it likely that adoption of EDC would impact many aspects of clinical trials, including site monitoring timelines and costs; site managem

Examination of Clinical Trial Costs and Barriers for Drug Development. 5.4 Reduced Source Data Verification (sdv)

As discussed in Section 4.6.3 above, many sponsors continue to perform 100 percent source data verification (SDV) in spite of the fact that it is not required by FDA and evidence suggesting that it is not efficient. Thus, the central idea behind this alternative is to encourage industry to reconsider this practice and instead adopt more efficient

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