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If there is any doubt in the minds of clinical trials administrators and coordinators about the complexity of Medicare and insurer reimbursement in clinical trials, then they need look no further than what happened when the National Academy of Sciences convened a task force to address the subject five years ago: Its main proposals never were adopted.
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One way an institution can promote research and provide support to clinical trials coordinators and investigators is through the formation of a clinical trials support office.
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Pharmaceutical companies conducting clinical trials in the United States tend to focus their regulatory attention solely on the requirements imposed by the FDA. This can be a mistake. Focusing on FDA regulations to the exclusion of state regulatory requirements may put the sponsor at risk. A large and increasing number of state requirements apply to clinical trials.
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In this issue, Clinical Trials Administrator begins with this issue a periodic series on clinical trials software, looking at its use, potential, and availability. The software featured in this issue is eCTM, created by CyberMedica Foundation of Kennebunkport, ME.
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When the general public pictures genetic research, they think of new screening tests to detect rare diseases, or they think of cutting-edge gene therapy experiments that have the potential to completely reverse a previously fatal condition. However, the real promise of genetic knowledge, say many experts, is in the potential to target drug therapy for common diseases, such as heart disease and cancer, that affect huge numbers of people.
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Hypothyroidism and Pregnancy; Anti-Depressants and the Risk of Suicide; FDA Actions; Brief Notes.
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