Leadership Commitments to Improve Value in Health Care Finding Common Ground: Workshop Summary (2009) / Chapter Skim
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8 Healthcare Product Developers
8 Healthcare Product Developers
Pages 187-216
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From page 187... ...
; Barry Gershon, Wyeth; Kathryn Gleason, National Pharmaceutical Council; Page Kranbuhl, Stryker; Jerry McAteer, Siemens Medical Solutions Diagnostics; Newell McElwee, Pfizer; Scott McKenzie, Ortho Biotech, Johnson & Johnson; Gary Persinger, National Pharmaceutical Council; Wayne Rosenkrans, AstraZeneca; Lisa Saake, Covidien (formerly Tyco Healthcare) ; Phil Sarocco, Boston Scientific; Hemal Shah, Boehringer-Ingelheim; David Sugano, Schering-Plough; Steve Teutsch, Merck; Karen Williams, National Pharmaceutical Council SECTOR OVERVIEW The companies in the healthcare products industry represent a unique sector of health care focused on the development and implementation of innovative medical products.
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From page 188... ...
market. Medical technology innovation typically consists of incremental improvements to existing technologies; therefore, the product life cycles in this sector range from about 18 months to 2 years (Advanced Medical Technology Association, 2007)
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From page 189... ...
Pharmaceutical and biotechnology manufacturers provide data in new drug applications or biologicsrtrait view Po license applications. The diversity of medical devices and diagnostics has led to a risk-based classification system, andfig 7-1 uses established standards to evaluate that system device safety and effectiveness distinct from those that FDA uses to evaluate drug safety and effectiveness.
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From page 190... ...
Marketing approval requires randomized controlled trials, starting with dosing and safety studies, typically conducted with healthy volunteers (Phase I studies) , and progressing to increasingly larger and logistically more complex studies with patients with the disease to demonstrate safety and efficacy (Phase II and Phase III studies)
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From page 191... ...
Finally, use of the "gold standard" type of clinical study, randomized clinical trials, is not always feasible for medical devices and diagnostics, for multiple inherent reasons. Thus, it is essential that the evolution of a consensus on the value and limitations of studies be explored by using current methodological standards.
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From page 192... ...
This may involve the need for studies focused on real-world utilization and outcomes to supplement the findings of clinical trials that have established the defined populations, dosing, and treatment durations. Most recently, stakeholders have expressed a strong interest in information on real-world comparative effectiveness, resulting in requests for additional evidence, including the systematic collection of data from and analysis of the scientific literature,
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Comparative Effectiveness Program Centers (Agency for Healthcare Research and Quality, 2007b) ; and various private health technology assessment groups, including the Blue Cross Blue Shield Technology Center (BlueCross BlueShield Association, 2007)
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From page 194... ...
Appropriate product use is informed by the data that have been generated before the launch of the product, the information on the product label, data from supplemental research and case report studies, information obtained through informal and formal medical education, and most importantly, the personal experiences of the providers themselves. The use of the product beyond the product indication can be common and sometimes evolves into a recommended or best practice determined on the basis of that fact that use of the product as treatment for a reason other than its original indication has become well established within the medical community, even in the absence of a formal labeled indication (i.e., off-label use)
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From page 195... ...
They can, however, use these data in response to specific inquiries by providers and payers and can publish the findings of industry-sponsored clinical trials at scientific meetings and in peer-reviewed journals. Information dissemination from sources other than the industry are not subject to these regulatory restrictions, and evidence can therefore be disseminated through the broadest possible means, including continuing medical education classes, academic forums, the development of guidelines, published case studies, Internet chat rooms and blogs, pharmacist brochures, and health information websites.
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The best evidence available from clinical practice guidelines is disseminated to healthcare professionals by publication in medical journals and through continuing medical education and other postgraduate coursework, including relicensure and specialty recertification examinations. The evidence base for effectively treating patients, however, is constantly evolving, and best practices change over time.
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From page 197... ...
Additionally, those stakeholders responsible for generating evidence for medical practice and the use of medications must receive feedback on the types of evidence to be generated for future practice and the safe and appropriate use of medications. Although the dissemination of evidence to health policy decision makers and healthcare providers for patient care decisions is critical, the availability of evidence for consumers is also necessary to support consumers' increasing role in making decisions about their health management.
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From page 198... ...
Additionally, clinical practice guidelines are often slow in adopting new evidence-based practices, and the dissemination of new guidelines and their recognition by healthcare providers are often delayed. Without rapid access to new evidence at the point of care, physicians will continue to rely on the opinions of their colleagues and their own practice experience in patient care decision making.
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Summary: Healthcare Product Developers' Role in Evidence-Based Medicine In summary, the healthcare product industry has a rich experience base and competency in the development and the dissemination of evidence about their products. However, the majority of evidence development in this sector is driven by the product learning curve and the regulatory requirements for approval.
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Opportunities in the Development of Evidence To attain the vision of achieving a fully evidence-based healthcare system by 2020, the healthcare product sector can make significant contributions to a number of issues in the area of evidence development: Explore standards for evidence development. There is no consensus • on the kinds of evidence that are best suited to guide various kinds of healthcare decisions.
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Develop new methodologies and standards for application of the • evidence. Randomized controlled trials comparing one treatment modality with another are very costly and require significant invest ments by product developers, patients, and providers.
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Although this is an important endeavor, there are trade-offs between developing evidence and supporting the healthcare product industry's continued ability to bring innovative products to market. This is particularly true given that the evidence required for product approval often differs from the evidence that payers, healthcare professionals, and other decision makers are now requesting.
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The sector can contribute to the generation of standards for the conduct of observational studies along the lines of the good clinical practice level standards currently used for ran domized controlled trials. The published literature describes a host of other methodologies.
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Moving toward the 2020 vision of having 90 percent of the health care provided be evidence based by 2020 will require unprecedented cooperation among the sectors if this process is to be efficient and still create meaningful evidence to guide patient-centric decision making. Opportunities in the Interpretation of Evidence The responsibility for ensuring integrity in healthcare decisions is broadly distributed in U.S.
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The use of evidence in health policy decision making, coverage and reimbursement decisions, and patient care decisions requires different approaches to evaluating the evidence. All stakeholders must have a better understanding of the means of application of the evidence if they are to incorporate the evidence into their own decision-making processes.
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The various healthcare system stakeholders should partner with payers to develop processes for setting coverage and payment poli cies that are seen to be open, transparent, and trustworthy in their consideration of a wide variety of evidence, including a scientific review of the effectiveness of a product, consultation with many stakeholders, and the specific needs of the populations served. Support for educational initiatives for physicians and other pro • viders in applying evidence to patient care decisions, including consumer-based decision making.
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With that in mind, some ongoing challenges remain as the various healthcare sectors try to align their efforts toward achievement of a common goal while focusing on areas in which the greatest gains in the quality of patient care and the efficiency of the healthcare system can be achieved. Focus of Evidence-Based Medicine Activities on the Entire Spectrum of Health Care The entire spectrum of healthcare delivery and overall treatment must be considered in order to achieve the greatest efficiency and impact.
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Given resource limitations, it will not be possible for the healthcare product sector to generate an evidence base that will meet a limitless range of needs. The harmonization of evidence standards will facilitate the understanding and use of data.
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Health Care's Capacity for Sustainability in Evidence-Based Medicine The nation's capacity for clinical research is currently inadequate to provide the information needed for regulatory approval and effectiveness research goals. Randomized controlled trials, on which the healthcare system currently depends, take too much time and are too expensive, and their findings are not always generalizable.
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Several research designs should be explored to determine whether the find ings of that research are adequate for healthcare decision making, including practical clinical trials, clinical registries, observational studies, and model development. A balance between population-based evidence and the evidence • needs for an episode of care (i.e., the individual's interaction with his or her physician)
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From page 211... ...
Additionally, many industry employees have expertise in statistical analysis, database aggregation and synthesis, and the communication of results to healthcare professionals and patients. It is important to recognize the dynamic nature of evidence development, beginning with the conduct of randomized controlled trials for regulatory purposes and continuing through the collection of data from real-world experiences in the postmarketing phase.
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From page 212... ...
The priority areas for collaboration are described in the next section. NEXT STEPS Evidence Development The development of standards of evidence for product approval, • health policy decision making, and patient care decisions will allow consensus on the types of evidence that are best suited to inform various kinds of healthcare decisions.
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In partnership with consumers-patients, healthcare delivery organizations, clinical investigators-evaluators, and insurers, healthcare product developers can assist with the development of best practice standards for evi dence integration by initiating a transparent research agenda on the basis of the interpretation and application of the evidence. Understanding the proper role of evidence in healthcare decision • making at the patient care level versus the proper role of evidence at the health policy level requires collaborative work by product developers, consumers-patients, healthcare delivery organizations, clinical investigators, and insurers.
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The development and implementation of an agenda of research on • the systems changes and behavioral approaches needed to improve the translation of evidence-based guidelines into clinical practice and factors influencing adherence to regimens is another important area for improving the application of evidence. To collaborative discussions and work involving healthcare professionals, healthcare delivery organizations, and insurers, healthcare product developers can contribute knowledge about the behaviors affecting adherence to guidelines and standards of medical practice.
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Work might include collaboration with patients and consumer groups, healthcare delivery organizations, and insurers. REFERENCES Advanced Medical Technology Association.
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