Clinical trials report card.
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Biomedical subjects
Publications and source records attributed to Orly Tamir.
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In Israel, updating of the National List of Health Services is performed on a yearly basis by means of a systematic and structured mechanism for almost a decade. The existence of such a mechanism is vital for keeping medicine up to date, since many innovative and breakthrough medical technologies continuously and frequently evolve. The 2006 update is unique in several aspects, relating both to the mechanism and to the decision-making process. In this article we describe notable issues that arose during the current process: modifications to the update mechanism, the four-phase increase in allocated resources to fund the addition of new medical technologies (including the addition of finances at the expense of the 2007 planned budget), and public funding for high-cost therapies. Finally, we discuss the impact of medical advances on healthcare costs and a suggested constant annual addition to the budget.
The rapidly rising health care expenditures, attributed mainly to the high cost of prescription drugs, have led governments around the world to look to generics as a means of containing costs in the pharmaceutical market. Generic drugs provide a less expensive alternative to brand name drugs due to the elimination of the need to perform lengthy and costly clinical trials, as required for innovative drugs. Essentially, generic substitution of drugs may be performed only after showing unequivocally that the generic formulation is identical in its active ingredients, strength, and route of administration as its innovative counterpart, and that they are bioequivalent to each other. Although the two are in essence the same, generic substitution is occasionally a controversial matter.
Medical research is a broad discipline in which clinical trials bridge between research and practice. During the 20th century, modern concerns regarding the ethical and clinical aspects of clinical trials led to the development of international standards and regulatory procedures that guide research in clinical trials. The rapid development of pharmaceuticals, biological products and medical devices facilitates an increase in the number and magnitude of the clinical trials that are performed worldwide. This overview surveys the historical and regulatory basics of clinical trials, and provides data on the extent and costs of clinical trials conducted throughout the past years, with a special emphasis on Israel.
Protecting intellectual property rights encourages creativity and innovation, which are key measures for research and development of new drugs and also promotes the introduction of drugs to new markets. Over the past years, many countries have enacted laws implementing the protection of data in drug registration files. Until recently, Israel has not provided any form of data protection. Current moves focus on new legislation granting exclusivity in the marketing of innovative drugs. Although controversial, this legislation aims to secure balance in Israel between the innovative pharmaceutical companies and the public's interest in competitive generic drugs.
Clinical trials are a dynamic and complex research domain. Being the backbone of the clinical practice, clinical trials present a wide range of aspects. This overview deals with selected topics related to clinical trials, such as: factors influencing the choice of research issues, reasons for early termination of clinical trials, participating patients' access to experimental treatments following clinical trials, economic implications of clinical trials and the existence of publication bias in clinical research.
The present study used the epilithic fruticose lichen Ramalina maciformis to investigate the occurrence of mineral elements, including heavy metals, at a distance of up to 50 km from the industrial region in Ramat Hovav in the Negev Desert, Israel. The major objective of this study was an analytical comparison of elemental content and physiological parameters of lichen vitality, apart from a test of the applicability of this specific lichen in investigations of air pollution. The Ca, Cr, Cu, K, Mg, Na, Pb, S, Sr, and Zn content of thalli from the unpolluted Tellalim site collected in August 1997, transferred to 24 biomonitoring sites, and retrieved in April 1998 was analyzed in comparison with the following parameters: The potential quantum yield of photosystem 11 (PSII), and the integrity of cell membranes. Transplanted thalli in several sites at Ramat Hovav accumulated large amounts of most of the elements. The K content of the transplants located in the polluted sites indicated a leakage of this element, because this content was lower than that of thalli in unpolluted sites. Calcium, Cu, Mn, and Na showed an inverse correlation with the K content of the lichen. Calcium, Cu, and Sr showed an inverse correlation with the Fv/Fm ratio expressing the potential quantum yield of PSII. Calcium, Cr, Cu, Mg, Na, S, and Sr showed a positive correlation with the electrical conductivity corresponding with cell-membrane disintegration. The present study demonstrated a meaningful connection between enlarged concentrations of certain elements and physiological phenomena. The capability of the lichen to detect air pollution was found to be satisfactory. The dispersion of airborne heavy metals was found, however, to be local and limited to a few hundred meters from the source of pollution.