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Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

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At least 973 records · Page 54Linked to original sources
PubMed2003

Antiepileptic drug development for "therapeutic orphans".

Epilepsy is the most common serious neurological disorder among children. Excluding the elderly, the incidence of epilepsy is highest among children. About half of children with epilepsy have epilepsy syndromes that have unique onset in childhood. Clinical drug trials of antiepileptic drugs (AEDs) among children have been primarily performed using drugs developed for the larger adult partial epilepsy market. The current AED drug development system essentially renders children with epilepsy "therapeutic orphans" who can only benefit from AED development if a drug developed for adult partial epilepsy happens to also be effective for a pediatric epilepsy syndrome. The rapid evolution of different seizure types and childhood epilepsy syndromes, and rapid changes in baseline neurological status, make distinguishing clinical changes due to study drugs in clinical trials and the natural history of the epilepsy syndrome difficult. Unique ethical issues (e.g., informed consent), practical and logistical issues (e.g., serum AED level monitoring with microassay methods), as well as major financial and regulatory disincentives for the pharmaceutical industry are additional barriers to need-based AED development for children. A government-funded pediatric epilepsy group or consortium to conduct clinical trials similar to the successful Children's Oncology Group (COG) and regulations plus financial incentives that encourage the pharmaceutical industry to develop AEDs specifically for children are needed.

Anticonvulsants↗
PubMed2001

An innovative approach to educating medical students about pharmaceutical promotion.

Prescription drugs comprise approximately 9% of the total cost of health care in the United States. The manner in which doctors obtain information about new and changing pharmaceuticals obviously has the potential to have a profound impact on health care costs, pharmaceutical companies' profits, and the quality of health care. Patterns learned in medical school undoubtedly influence physicians' future behaviors. The authors describe an educational program, in which university pharmacists portrayed pharmaceutical company representatives to model a promotional presentation, that they designed to generate critical thinking among third-year medical students regarding the influence of pharmaceutical representatives on the prescribing practices of physicians. The authors also provide information suggesting that the program increased the uncertainty many students felt about the accuracy and ethics of standard drug "detailing."

Adult↗
PubMed1990

Therapeutic challenges. Prenatal and paediatric safety considerations.

Developmental changes make the fetus and child uniquely susceptible to drug toxicities which do not occur in mature individuals. Passive exposure to maternally administered drugs during fetal life introduces the potential risk of morphological or behavioural teratogenesis. Although animal studies are useful in identifying potential teratogens, they are poor predictors of human teratogenesis. Most drugs are excreted into breast milk in insufficient quantity to cause adverse effects in the nursing infant. However, there are several exceptions. Therefore, it is important to document the extent to which a drug appears in breast milk and is absorbed by the nursing infant prior to its use by the mother. Plasticity of growing tissues and changes in body composition, the rate of drug metabolism, drug metabolic pathways and elimination rates during growth and development may alter susceptibility to unique drug toxicities. This requires that drug safety and efficacy be established in children at different ages. Ethical and technical constraints inherent in drug studies in children introduce increased effort and cost. However, there is a moral imperative for academicians, government agencies and the pharmaceutical industry to work together to ensure that drugs intended for use in children are adequately tested in children.

Animals↗
PubMed2004

[Clinical trials--historical development, regulation and updated data].

Medical research is a broad discipline in which clinical trials bridge between research and practice. During the 20th century, modern concerns regarding the ethical and clinical aspects of clinical trials led to the development of international standards and regulatory procedures that guide research in clinical trials. The rapid development of pharmaceuticals, biological products and medical devices facilitates an increase in the number and magnitude of the clinical trials that are performed worldwide. This overview surveys the historical and regulatory basics of clinical trials, and provides data on the extent and costs of clinical trials conducted throughout the past years, with a special emphasis on Israel.

Clinical Trials as Topic↗
PubMed1975

Safeguards for healthy volunteers in drug studies.

Safeguards for healthy volunteers in drug studies have not been as strict as those involving patients. The shortcomings include the lack of surveillance over the scientific validity of the protocol and its ethical review, and over the financial inducements to volunteers. Recruitment is open to abuse because the volunteers may have some allegiance to the investigators. There is an urgent need to institute checks on these aspects. Most important, however, is the lack of legal safeguards for volunteers taking part in research done outside the pharmaceutical industry. The suggested procedure for obtaining consent, for health checks, and for providing compensation can be equitable to all concerned, and yet not restrict initiative, nor curtail research aims.

Biomedical Research↗
PubMed1998

Information contents of drug advertisements: an Indian experience.

OBJECTIVE: To critically analyze the drug information contained in Indian pharmaceutical advertisements. DESIGN: Analysis of pharmaceutical advertisements supplied by drug representatives (DRs) to prescribers from July 1, 1995, to June 30, 1996. SETTING: A university-affiliated urban teaching hospital in India. PARTICIPANTS: 585 pharmaceutical ad pamphlets. MAIN OUTCOME MEASURES: The ads supplied by DRs to physicians in different clinical departments of the hospital were collected. These were distributed to different systems/categories and a special reference to fixed-dose drug combinations was given. The drug information contained in these ads was evaluated by using a checklist, framed by incorporating the World Health Organization ethical guidelines for medicinal drug promotion and some relevant items from other studies. RESULTS: The most frequently occurring ads were for antimicrobial agents. The ads on fixed-dose drug combinations constituted 37.9% of the total. More than 85% of the ads mentioned the generic name, brand name, contents, and pharmaceutical dosage forms, as well as the name and address of the company. The information concerning adverse effects, precautions, contraindications, warnings, major interactions, ingredients known to cause problems, pharmacology, drug overdose, references, drug storage, and cost was present in less than 40% of these ads. CONCLUSIONS: There has been inadequate information in pharmaceutical ads supplied by DRs to the physicians in India. The current scenario could be improved by formulating some definite legislative guidelines for the minimum level of information to be included in pharmaceutical ads and adhering to that legislation.

Advertising↗
PubMed1994

Gift-giving or influence peddling: can you tell the difference?

Physical therapists are faced with an ever-increasing array of advertising ventures, "free" gifts, and enticing offers from equipment and supply companies and various health care agencies. Concerns are raised about the ethical implications of gift exchange in professional activities. Basic motives governing gift exchange are examined from a sociological standpoint. The obligation of the professional to act in the best interest of the patient and to guard against the impression of impropriety to the public is paramount in decisions concerning gifts. Opinions from the medical and pharmaceutical professions are explored to glean criteria that have applicability to physical therapy. These criteria are presented in the form of questions that may be helpful for physical therapists.

Advertising↗