Despite the increasing investment and interest in drug development, the amount of time and resources needed to develop a new drug continues to rise. Biomarkers are an important tool with the potential to decrease the time, cost, and failure rate of drug development. Given the role of biomarkers in drug development, it is important to understand ho
The development of new drugs and biologics is critical to ensuring that the U.S. population continues to enjoy improvements in quality and length of life. However, pharmaceutical companies must balance this imperative with the need to earn economic returns when making investment decisions. Some drugs, although desirable from a societal perspecti
Partnerships involving public sector organizations, academia, non-profits, and pharmaceutical companies have demonstrated their potential for addressing unmet needs in medical product research and development (R&D). Effective partnerships can enhance access to innovation, reduce risk, manage costs, and may provide a means for steering R&D
It is widely accepted that reimbursement policies and practices are important considerations in the research and development (R&D) decisions of potential innovators of healthcare technologies, and the investors who finance them. The decision by a public program or health plan to subsidize use of a technology (often referred to as a coverage dec
Contents Demonstrating Clinical Validity and Utility Demonstrating Value Reducing Health Disparities Educating and Engaging Providers and Consumers Using Databases to Build Evidence, Inform Decisions
Pharmaceutical companies conduct clinical trials for many reasons. The most obvious goal of clinical trials is to demonstrate safety and efficacy to gain Food and Drug Administration (FDA) approval. FDA provides guidance to developers about what constitutes acceptable clinical trials and appropriate outcomes. Improving the drug development process
Identifying Opportunities to Maximize the Utility of Genomics Research Data Through Electronic Health Information Exchange
This report is a summary of the presentations and discussions at the workshop held by the Office of the Assistant Secretary for Planning and Evaluation, the National Cancer Institute, the Food and Drug Administration, and the Office of the National Coordination for Health Information Technology on October 15, 2009.
Developing a Framework to Guide Genomic Data Sharing and Reciprocal Benefits to Developing Countries and Indigenous Peoples: A Colloquium
The O'Neill Institute for National and Global Health Law invited twelve thought leaders with extensive experience in the conduct of biomedical research among indigenous peoples and developing countries to a colloquium at Georgetown University on January 7-8, 2009. The colloquium addressed a basic question: as genomic science develops across the w
The Office of the Assistant Secretary for Planning and Evaluation (ASPE) commissioned the Lewin Group to convene an Expert Panel on Personalized Health Care (PHC) for a one-day meeting to provide input to the Office of the Secretary, HHS, toward realizing the integration of PHC into clinical and public health practice. The Expert Panel identified
Examination of Clinical Trial Costs and Barriers for Drug Development. E.4 Analysis of Barriers to Clinical Trials
In selecting barriers to analyze in the context of the clinical trial decision-making model developed, we considered whether each proposed strategy could be alleviated by policies, whether the appropriate policies could be implemented or encouraged by FDA, and whether there was evidence in the literature that could be used to quantify the potentia
Examination of Clinical Trial Costs and Barriers for Drug Development. E.3.9 Barriers Related to the Globalization of Clinical Research
The clinical research footprint is shifting overseas. There are a number of factors, including cost savings and shorter timelines, driving this shift and making it cheaper and easier to conduct trials outside the U.S. Ethical and scientific concerns may arise when conducting studies in other countries. Conducting trials at multiple sites
Examination of Clinical Trial Costs and Barriers for Drug Development. E.3.8 Barriers at Academic Institutions
Sponsors might be compelled to select academic centers as sites due to the presence of key opinion leaders or specific patient populations. Ethical and Regulatory Requirements Academic institutions can take their responsibility to provide ethical and regulatory oversight to extremes and create excessive barriers to conducting clinical trial
Examination of Clinical Trial Costs and Barriers for Drug Development. E.3.7 Disconnect Between Clinical Research and Medical Care
Community physicians are largely uninvolved in the clinical research process. Many healthcare professionals do not receive training in research methods.
Examination of Clinical Trial Costs and Barriers for Drug Development. E.3.6 Drug Sponsor-Imposed Barriers
Excessive risk-aversion leads to unnecessary steps being taken. In multicenter trials, uncertainty and inconsistent enrollment success across sites creates a need to over-enroll and plan trials “defensively.” Internal review processes for organizations conducting/sponsoring clinical trials can delay a trial’s start.
Examination of Clinical Trial Costs and Barriers for Drug Development. E.3.5 Regulatory and Administrative Barriers
U.S. regulations pertaining to clinical research could benefit from revisions. They were written at a time when the clinical trials enterprise was smaller and before multicenter trials became common. Ethical / Institutional Review Board (IRB) Approval (21 CFR 56) There is often a lack of clarity regarding the roles and responsibilities of v
Examination of Clinical Trial Costs and Barriers for Drug Development. E.3.4 Increasing Competition for Qualified Investigators and Sites
According to some, there is a shortage of biostatisticians and informaticists across academic medicine, industry, and government; others say researchers exist but are difficult to find, often due to competition. There is more widespread agreement that there is a shortage of investigators who can enroll high-quality patients. There is also compe
Examination of Clinical Trial Costs and Barriers for Drug Development. E.3.3 Difficulties in Recruiting and Retaining Participants
Patient recruitment requires a substantial investment of time and money. Failure to recruit can cause costly delays or trial cancellation, wasting resources. There is competition for limited patient pools for certain conditions, such as rare cancers and multiple sclerosis. Clinical trial sites are often selected based on the location of i
According to one study, the average length of time from the start of clinical testing to marketing is 90.3 months (7.5 years). Longer timelines increase costs and decrease revenues. Longer studies are needed to see if any safety issues arise when drugs are taken long-term to manage chronic diseases. The “one-off” nature of trial organ
Studies estimate that it now costs somewhere between $161 million and $2 billion to bring a new drug to market.
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