
"A few years ago, I wrote a story about a young woman who was infected with malaria by 200 mosquito bites to test a potential vaccine. At the time, it was bewildering to me that someone would be willingly agree to take on so much risk and put themselves through so much discomfort for only a modest sum of money."
"In fact, it is required in the United States medical system and throughout the world that drugs be tested on human participants in three phases of clinical trials to evaluate their safety and effectiveness before they can be approved for use. Over half a million clinical trials have been registered on the US government's ClinicalTrials.gov since the clinical-trial-tracking site launched in February 2000. And nearly $100 billion is spent every year on the business of running clinical trials."
Human drug development requires testing on human participants in three successive trial phases to evaluate safety and effectiveness before regulatory approval. Over half a million clinical trials have been registered on ClinicalTrials.gov since 2000, and the industry spends nearly $100 billion annually on trial conduct. The majority of trials and expenditures do not produce new drug approvals. Healthy volunteers often participate for compensation, altruism, or both, and challenge studies sometimes infect volunteers deliberately to assess vaccines. The clinical-trial field faces persistent ethical debates about risk, race, paternalism, economics, exploitation, and the nature of informed consent.
#clinical-trials #human-challenge-studies #informed-consent #research-ethics #dengue-vaccine-research
Read at www.npr.org
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