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Therapeutic Innovation (therapeutic + innovation)

Distribution by Scientific Domains

Medical Sciences	57%
Business, Economics, Finance and Accounting	28%

Selected Abstracts

Does quality assurance apply to development planning?

QUALITY ASSURANCE JOURNAL, Issue 1 2002
Claude Bentzinger
Abstract New product development planning is a complex process and the quality of the planning will have a profound effect on time to market(s) and the commercial success of a therapeutic innovation. Quality assurance has an important role in the planning process. We have drawn up a list of quality assurance criteria applicable to the planning process in R&D, clinical investigation and new business development. The list is by no means exhaustive and we welcome thoughts and comments on other criteria and other areas. Perhaps the present review will stimulate interest and raise readers' awareness of the formidable array of different considerations that must be taken into account if we are to create better therapies for tomorrow's patients. Copyright © 2002 John Wiley & Sons, Ltd. [source]

Current directions at the juncture of clinical and cognitive science: A commentary on the special issue

APPLIED COGNITIVE PSYCHOLOGY, Issue 3 2010
Colin MacLeod
The 12 experimental papers presented in this special issue brilliantly illustrate the creative and exciting ways in which the exchange of theoretical concepts and experimental methodologies, between cognitive and clinical science, is serving both to deepen our understanding of psychopathology, and to identify new ways of potentially remediating such dysfunction. These papers are not only individually excellent, but collectively they communicate some of the major themes that are presently driving new developments within this rapidly evolving field. In this brief commentary, I reflect upon the contributions made by the current studies to these important themes. I also share some suggestions concerning how future work might profitably build upon this present research, to further enhance theoretical progress and enrich therapeutic innovation. Copyright © 2010 John Wiley & Sons, Ltd. [source]

An update on the first decade of the European centralized procedure: how many innovative drugs?

BRITISH JOURNAL OF CLINICAL PHARMACOLOGY, Issue 5 2006
Domenico Motola
What is already known about this subject ,,We recently proposed an algorithm to assess the degree of therapeutic innovation of new therapeutic agents. It was based on the disease seriousness, the availability of previous treatments and the extent of the therapeutic effect, and was applied to all therapeutic agents approved by the EMEA in the period 1995,2003. ,,A low percentage (32%) of important therapeutic innovation was found. This figure may be an underestimate of the actual level of innovation, because common biotechnological products, such as recombinant human insulins, must follow the centralized procedure. What this study adds ,,Details for each agent, focusing on the comparison of the degree of therapeutic innovation between biotechnological and nonbiotechnological therapeutic agents approved by EMEA during the its first decade of activity (1995,2004). The underlying hypothesis was that the latter have a higher degree of innovation because they followed the centralized procedure on the assumption that they are innovative. ,,The percentage of important therapeutic innovation was low not only for biotechnological products (25%), as expected because they include many already known products such as insulins, but also for nonbiotechnological therapeutic agents (29%). Aims In a previous paper, we proposed an algorithm to assess the degree of therapeutic innovation of the agents approved by the European centralized procedure, which must be followed by biotechnological products and is optional for drugs claimed as innovative. A low overall degree of therapeutic innovation (about 30%) was found. This figure may be an underestimate of the actual level of innovation, because common biotechnological products, such as recombinant human insulins, must follow this procedure. To test the hypothesis that therapeutic innovation prevails among nonbiotechnological products, we evaluated separately the degree of therapeutic innovation of biotechnological vs. nonbiotechnological agents in the first decade of European Medicines Agency activity, also studying a possible time trend. Methods We assessed, for each drug: (i) the seriousness of the target disease, (ii) the availability of previous treatments, and (iii) the extent of therapeutic effect according to the previously proposed algorithm. Results Our analysis considered 251 medicinal products corresponding to 198 active substances, classified according to four main areas as therapeutic agents (88.9%), diagnostics (5.5%), vaccines (5.1%) and life-style drugs (0.5%). Among all therapeutic agents, 49 out of 176 agents (28%) were classified as having an important degree of therapeutic innovation. Fifteen out of 60 biotechnological therapeutic agents were considered important therapeutic innovations (25%), whereas this figure was 29% for nonbiotechnological agents. Conclusions Among active substances claimed as innovative by the manufacturers, only a minority deserve this definition according to our algorithm. [source]

A NEW ROLE FOR CONSUMERS' PREFERENCES IN THE PROVISION OF HEALTHCARE

ECONOMIC AFFAIRS, Issue 3 2006
Harry Telser
In the present allocation of resources in healthcare, preferences of consumers as the ultimate financiers of healthcare services are judged to be of little relevance. This state of affairs is being challenged because the past decade has seen great progress in the measurement of preferences, or more precisely, willingness-to-pay (WTP) as applied to healthcare services. This article reports evidence on WTP of the Swiss population with regard to three hypothetical modifications of the drug benefit to be covered by social health insurance: delaying access to the most recent therapeutic innovations (among them, drugs) by two years in exchange for a reduction of the monthly premium; substituting original preparations by generics, again in return for a lowered premium; and the exclusion of preparations for the treatment of minor complaints from the drug benefit. Using discrete-choice experiments, WTP and its determinants are estimated. Average WTP for avoiding such a delay (which acts across the board) is much higher than for eschewing the exclusive use of generics (which are claimed to be largely equivalent to the original) or the retention of ,unimportant' drugs in the list of benefits , a rating predicted by economic theory. In addition, a great deal of preference heterogeneity between the French-speaking minority and the German-speaking majority was found, pointing to considerable efficiency losses caused by uniformity of social health insurance. [source]

On Being a Good Listener: Setting Priorities for Applied Health Services Research

THE MILBANK QUARTERLY, Issue 3 2003
JONATHAN LOMAS
In the last decade, explicit priority setting has become an integral part of health care systems. Indeed, there is even an International Society on Priorities in Health Care, created in 1997 (Ham 1997). Whether it is Oregon's priority ordering of symptom treatment pairs to maximize the impact of a limited Medicaid budget (Fox and Leichter 1991), England's National Institute for Clinical Excellence's assessing priorities for new therapeutic innovations in the National Health Service (Rawlins 1999), or New Zealand's setting priorities for patients' access to cardiovascular treatment (Hadorn and Holmes 1997), techniques for judging the relative worth of different health service investments abound. As these techniques are refined, the most common addition is the incorporation of public values as part of the assessment. Priority setting is increasingly seen as combining an objective assessment of costs and effects with a more subjective assessment of patient or public preferences (Lenaghan, New, and Mitchell 1996; Lomas 1997; National Institute for Clinical Excellence 2002; Stronks et al. 1997). [source]