By Stanley P. L. Leong
Scientific trials stay an important car for making improvements to the care of melanoma sufferers. this article offers the elemental parts and demanding situations related to scientific investigations. best specialists talk about the serious concerns protecting the spectrum of significant subject matters from making plans to program.
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Extra info for Cancer Clinical Trials: Proactive Strategies (Cancer Treatment and Research)
Similarly, some researchers (and funding agencies) have argued for inclusion of non-treatment (placebo) control arms in international studies, even where an effective treatment is available in the industrialized home country of the researcher^^-^ because the "standard of care" in the developing country might be no treatment at all. Both sides in these debates have claimed to be acting out of beneficence. In favor of these studies, researchers argue that some of the subjects may benefit directly from the study's active regimen that would not otherwise be available, while the entire population will benefit if research identifies inexpensive, effective alternatives to regimens used in industrialized countries.
Often, even simpler language should be used. If the subjects are likely to have lower levels of education, the language level should be adjusted accordingly. Consent forms that are overly complex or technical are likely to be rejected by the IRB and neither read nor understood by the potential subjects. If the investigators desire to try and convey complex topics such as the molecular biology of the new agent, this can easily be presented in additional documents supplementary to the ICF. Researchers must also be aware that modern IRBs consider informed consent a process, not just a document.
For example, if a drug is only tested in postmenopausal women, even if it is found to be effective, it might not be used in pre-menopausal women because of the lack of data on safety and efficacy. Similarly, drugs for diseases such as hypertension have been shown to have differing efficacy depending on the race of the patient. If the clinical trial does not include enough subjects of different racial backgrounds, then those patients are deprived of the benefits of the research. Until recently there were very few clinical trails on the safety and efficacy of numerous drugs in children.
Cancer Clinical Trials: Proactive Strategies (Cancer Treatment and Research) by Stanley P. L. Leong