Clinical Trials as Topic ; Humans ; Information Dissemination ; ethics ; methods ; International Cooperation

Child ; Clinical Trials as Topic ; ethics ; Drugs, Investigational ; Humans

As more research work is done on eye disorders, more safety rules and regulations are required to ensure the safety of trial subjects. This is the main function of Research Ethics Committees [also known as Institutional Review Boards (IRBs) and Domain Specific Review Boards (DSRBs)]. Tragedies in research in other fields are wake-up calls, such as the death of a healthy young volunteer subject in New York, the termination of a large study sparked by breach of medical confidentiality in Singapore and the South Korean debacle of its pioneering work in cloning. Many issues are still being debated, such as what statutory changes are required to control trials; whether all trials should be reviewed by IRB; if phase IV trials should be exempted; if compensation should be paid for all trial-related injuries; and whether investigators and IRB members be allowed to hold certain amount of shares in drug or device firms. Recent measures taken to prevent ethical problems include funding organisations not approving a study unless it has been cleared by the IRB, and requiring all investigators and IRB members to pass an ethics course. More measures will need to be taken to ensure the safety of the trial subjects involved in research studies.
Clinical Trials as Topic ; ethics ; Conflict of Interest ; Ethics Committees, Research ; Ethics, Research ; Humans ; Ophthalmology ; Singapore

Researchers have an ethical responsibility to report the results of research involving human subjects. Dissemination of results ensures that patient care is based on good science and that the field of medicine advances based on complete and accurate knowledge. However, current evidence suggests that publication is often neglected or substantially delayed, especially in the case of negative and inconclusive results. Researchers, editors and reviewers should value all high-quality research regardless of the conclusiveness of the results and ensure that all research involving human subjects is registered in a publicly accessible database.
Clinical Trials as Topic/*ethics ; *Ethics, Research ; Human Experimentation/*ethics ; Publishing/*ethics ; Republic of Korea ; *Research Report ; Research Subjects

In this review, several aspects surrounding the choice of a therapeutic intervention and the conduct of clinical trials are discussed. Some of the background for why human studies have evolved to their current state is also included. Specifically, the following questions have been addressed: 1) What criteria should be used to determine whether a scientific discovery or invention is worthy of translation to human application? 2) What recent scientific advance warrants a deeper understanding of clinical trials by everyone? 3) What are the different types and phases of a clinical trial? 4) What characteristics of a human disorder should be noted, tracked, or stratified for a clinical trial and what inclusion /exclusion criteria are important to enrolling appropriate trial subjects? 5) What are the different study designs that can be used in a clinical trial program? 6) What confounding factors can alter the accurate interpretation of clinical trial outcomes? 7) What are the success rates of clinical trials and what can we learn from previous clinical trials? 8) What are the essential principles for the conduct of valid clinical trials?
Animals ; Clinical Protocols ; Clinical Trials as Topic/ethics/*methods ; Disease Models, Animal ; Female ; Humans ; Male ; Outcome Assessment (Health Care) ; Pregnancy ; Translational Medical Research

Antineoplastic Agents ; administration & dosage ; therapeutic use ; Case-Control Studies ; Controlled Clinical Trials as Topic ; methods ; Ethics, Medical ; Helsinki Declaration ; Humans ; Neoplasms ; drug therapy ; Placebos ; Randomized Controlled Trials as Topic ; methods ; Therapeutic Equivalency

For over 100 years, controlled human infection (CHI) studies have been performed to advance the understanding of the pathogenesis, treatment and prevention of infectious diseases. This methodology has seen a resurgence, as it offers an efficient model for selecting the most promising agents for further development from available candidates. CHI studies are utilised to bridge safety and immunogenicity testing and phase II/III efficacy studies. However, as this platform is not currently utilised in Asia, opportunities to study therapeutics and vaccines for infections that are important in Asia are missed. This review examines the regulatory differences for CHI studies between countries and summarises other regulatory differences in clinical trials as a whole. We found that the regulations that would apply to CHI studies in Singapore closely mirror those in the United Kingdom, and conclude that the regulatory and ethical guidelines in Singapore are compatible with the conduct of CHI studies.
Asia ; Clinical Trials as Topic ; economics ; standards ; Communicable Disease Control ; Communicable Diseases ; epidemiology ; Cost-Benefit Analysis ; Ethics, Medical ; Health Policy ; Humans ; Infectious Disease Medicine ; legislation & jurisprudence ; standards ; Quarantine ; Research Design ; standards ; Singapore ; United Kingdom