They review a participant's health history and current medical intakes before the trial begins. They impart adequate information and instructions about the clinical trial, monitor each participant in the conduct of the trial and may contact the participant after the conduct of the trial.
Clinical trials or researches may also be open-label, placebo-controlled, double-blinded or randomized. They consist of four phases. Phase I establishes the maximum safe dosage; Phase II, its effectiveness; Phase III, its use on a broad population; and Phase IV, post-FDA insights on the effects of its long-term use (NWHRC).
From 1999 to 2000 alone, the Food and Drug Administration approved 73 new medications (NWHRC 2005). These included drugs for HIV, cancer, heart attack and Alzheimer's disease. As of 2000, Medicare covers many of the costs involved in participation in clinical trials or researches. The Institutional Review Board, in addition to the FDA, has to approve new drugs in case of oversight by the FDA. Participants in clinical trials can require more doctor visits and tests than if they did not take part. Researchers need to obtain detailed data on the progress of the treatment. From 1977 to 1993, the FDA prohibited women of child-bearing age from participating in early testing of most drugs to avoid birth defects. But today, they have been allowed again, as long as they are informed about the risks. When a particular drug proves exceptionally promising, the FDA puts it in "priority review" status. If accelerated scrutiny finds the drug suitable for treatment, it can be sent to market much sooner (NWHRC).
New medical devices, procedures and approaches to the treatment of diseases must also prove their worth (NWHRC 2005). Some studies seek to discover if a specific drug is better than surgery alone or earlier treatments can have better outcome. Health professionals who have doubts or questions about the diagnosis or treatment of a medical condition can settle them through the conduct of a clinical trial or research. Even the results of clinical tests must prove their mettle. They must provide "statistically significant" safety and/or effectiveness from mathematical analysis that they are highly likely to be true and not the mere product of chance. Clinical trials may be sponsored by government agencies, pharmaceutical or medical companies, individual physicians or health care institutions. These may be conducted in different locations or settings (NWHRC).
Issue 4: Rationing Health Care
Politicians and educators have not been too willing to confront the looming probability of the need to ration health care (Scott 2004). They refused to admit or even consider it in order to preserve the current health care system. But many healthcare policy leaders have been coming to terms with the dread. And the new Medicare bill signed into law by President Bush was a timely response to the dread. The NAIM was aimed at reviewing the costs of healthcare and limiting them when positive outcomes also seemed limited. It explored into a looming scenario when patients could be denied healthcare services, based on cost benefit analyses. The analyses could decide that the marginal benefit to the patient would not be worth its cost to the country. This would then call for rationing (Scott).
Section 1013, Title X of the NAIM charges the Health and Human Services Secretary to assess healthcare guidelines, reduce scientific uncertainty in healthcare delivery, allocate resources efficiently, and analyze financial effects of a change in incentives and allocation of resources on the healthcare marketplace (Scott 2004). The nation's growing budget deficit would bring the attention to social security and Medicare. The government cannot afford to continue paying benefits at the same level to those who demand...
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