Privacy and Health Research. The Diversity of Data Holders
Just as varied as the types of health data, of course, are the types of individuals and organizations who hold or process the data. Data are processed by:
Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Venture Capital Evaluation of New Drug Investment Opportunities
Venture capital firms (VCs) reported market potential (e.g., projected revenues) and probability of financial success as the main factors guiding investment decisions on new products. VC interviewees suggested that the evaluation of pharmacotherapies is no different from that of any other product or business plan. These companies are most interest
Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Scenario 2: Biotech Gets Help
In this scenario, a small biotechnology firm, Company B, takes on the full product development cycle with a new class of compounds based on a recent scientific breakthrough that is highly specific to cocaine receptor neuropharmacology. The company anticipates that a new Product B from this class of compounds will have excellent compliance in the u
Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Scenarios of Company Decision Making
This report presents several scenarios of pharmaceutical company decision making regarding undertaking projects to develop pharmacotherapies for substance abuse (e.g., cocaine) under various sets of market conditions. Using a quantitative model developed by The Lewin Group, the market conditions are translated into financial and other parameters t
Medicare Part B Reimbursement of Prescription Drugs . Endnotes
1 42 C.F.R. § 405.517.
2 U.S. Department of Health and Human Services, Office of Inspector General, Excessive Medicare Payments for Prescription Drugs , Pub. No. OEI-03-97-00290, 1997.
3 U.S. Department of Health and Human Services, Office of Inspector General, Medicare Reimbursement of Prescription Drugs , Pub. No. OEI-03-00-00310, 2
Health Care in Transition: Technology Assessment in the Private Sector
Health Care in Transition:
Technology Assessment in the Private Sector
Prepared by:
Richard Rettig of the RAND Corporation
Office of the Assistant Secretary of Planning and Evaluation
Agency for Health Care Policy and Research.
July, 1996.
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
report.pdf
PDF Examination of Clinical Trial Costs and Barriers for Drug Development. Appendix A: Draft Interview GUIDE14,15
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. 4.6.2 Study Design
Enrollment Restrictions
Examination of Clinical Trial Costs and Barriers for Drug Development. 4.3 Difficulties in Recruiting and Retaining Participants
In interviews, expert consultants and representatives from pharmaceutical and biotechnology companies and CROs cited patient recruitment as one of the most significant barriers to conducting clinical trials in the United States. Failure to recruit sufficient numbers of patients can result in costly delays or even cancellation of the entire trial (
Examination of Clinical Trial Costs and Barriers for Drug Development. 2.4 Model Parameters
The clinical trial cost/decision-making model described above requires numerous data points, including phase durations, success probabilities, expected revenues, and a discount rate, as well as a full range of itemized costs associated with clinical trials, broken down by phase and therapeutic area. The model uses a real annual discount rate of 15
Examination of Clinical Trial Costs and Barriers for Drug Development. 2.1.2 Discussions with Experts, FDA Personnel, Drug Sponsors, Contract Research Organizations (CROs), and Academic Clinical Research Centers
Some of the information needed to characterize the decision process of a drug sponsor came from semi-structured discussions with our team of experts and other industry experts, FDA personnel, drug sponsors, CROs, and primary clinical research centers, including University of Massachusetts, Johns Hopkins University, University of Michigan, and the
Examination of Clinical Trial Costs and Barriers for Drug Development. 2.1.1 Publically Available Literature
Although the literature on the early stages of the pharmaceutical decision-making process is not extensive, there is some research that has characterized the process. We used this information to help define the components of the model. Some examples are the work performed at the Massachusetts Institute of Technology (MIT) Center for Biomedical Inn
Analytical Framework for Examining the Value of Antibacterial Products. 7 References
About NIAID . (2012, February 29). Retrieved November 12, 2012, from National Institute of Allergy and Infectious Diseases: http://www.niaid.nih.gov/about/pages/default.aspx
Aldy, J. E., & Viscusi, W. K. (2008). Adjusting the Value of a Statistical Life for Age and Cohort Effects. The Review of Economics and Statistics, 90 (3), 573–581
Analytical Framework for Examining the Value of Antibacterial Products. 3.2.2 Pre-clinical R&D Cost
A direct link between pre-clinical expenditures and the specific drug that ends up being commercialized is difficult to establish. For biopharmaceuticals, DiMasi and Grabowski (2007) estimate the average out-of-pocket cost of pre-clinical development that includes expenditures for both basic research and pre-clinical development at $59.9 million
Performance Improvement 1998. National Institute of Health
Contents
The Status of Biomedical Research Facilities 1996
Evaluation of the National Research Service Award Research Training Programs
National Heart, Lung, and Blood Institute Article Citation and Patent Reference Study: An Analysis of Article Citations and Patent References to Journal Articles Supported by the N
Performance Improvement 1998. Agency for Health Care Policy and Research
Contents
Publications of the Patient Outcomes Research Teams (PORTS), May 1996 and Medical Treatment Effectiveness Projects 1989 through 1995
Final Report on Changes Needed in CONQUEST's Software Based Programs
Final Report on Changes Needed in CONQUEST 1.0's Structure and Classification Scheme
Assessment of the
Performance Improvement 1998
Performance Improvement 1998 is the third annual report of the U.S. Department of Health and Human Services (HHS) on its evaluation activities. As a report to Congress, it summarizes the findings of HHS evaluations completed in fiscal year (FY) 1997. In that year, HHS agencies produced 155 evaluation reports and supported more than 335 evaluation