Utilization of community health workers in Canada's Children's Oral Health Initiative for indigenous communities.

OBJECTIVE: The Children's Oral Health Initiative (COHI) is a federally funded community-based preventive dental programme implemented in geographically remote Canadian Indigenous communities. The study investigated the effect of the availability of local community health workers (COHI Aides) on access to the programme's preventive dental services for children. METHODS: Twenty-five communities were continuously enrolled in the COHI during the 7-year study period. Communities were categorized as having uninterrupted (all 7 years), intermittent (≥4 years) or sporadic (<4 years) service from a community health worker. Four outcome variables measured longitudinal changes in access to preventive dental services: (i) the number of enrolments; (ii) the number of enrolled children with multiple fluoride varnishes delivered; (iii) the number of enrolled children with sealants placed; and (iv) the number of enrolled children receiving ART. RESULTS: The general longitudinal trend for programme enrolment and each of the preventive dental service delivery outcomes was similar. Children in communities with uninterrupted service tended to have the highest rates of enrolment and service delivery, which remained constant over time. Children in communities with sporadic service tended to have persistently low rates of enrolment and service delivery over the study period. CONCLUSIONS: Community health workers were beneficial in promoting programme enrolment, as well as facilitating and augmenting the delivery of preventive dental services.

The perceptions of first nation participants in a community oral health initiative.

The Children's Oral Health Initiative (COHI) is a federally funded community-based preventive dental program for children and their caregivers living in geographically isolated Canadian Aboriginal communities. The goal of the program is to improve access to preventive dental services for children of 0-7 years of age. It utilises community health workers in collaboration with dental therapists to promote and deliver the program. Almost half of the province of Manitoba's (n=27) First Nations communities have implemented COHI since 2005. The objective of this investigation was to explore the opinions of COHI from the perspective of community members whose children had participated in the program. Purposeful selection identified caregivers of enrolled children for a semi-structured interview. The targeted caregivers had children who met at least one of the following criteria: (1) 0-2 years old; (2) 5-7 years old; (3) had two or more children either currently or formerly enrolled in COHI. Six open-ended questions guided the interview process. Content analysis was used to code transcripts and identify themes. One hundred and forty-one interviews were completed in 13 communities. Participants defined good oral health as the absence of dental cavities, which reflects a Western biomedical model of disease. The local, community-based nature of COHI was viewed as essential to its success in increasing access to preventive dental services and improving children and caregivers' oral health knowledge and behaviours. In conclusion, a local, community-based oral health prevention programme is perceived as having a beneficial effect on children and caregivers' oral health knowledge and behaviours. However, oral health preventive messages need to be further integrated into traditional Aboriginal holistic models of wellness.

PhRMA survey on the conduct of first-in-human clinical trials under exploratory investigational new drug applications.

The FDA guidance on exploratory IND studies is intended to enable sponsors to move ahead more efficiently with the development of promising candidates. A survey of PhRMA member companies was conducted in 2007 to obtain a cross-sectional industry perspective on the current and future utility of exploratory IND studies. About 56% of survey responders (9 companies of 16 survey responders) conducted or were planning to conduct clinical studies under exploratory INDs. The majority of microdosing studies are performed to characterize human pharmacokinetics or to examine target organ pharmacokinetics using PET imaging techniques. On the other hand, the majority of pharmacological end point studies conducted under exploratory IND are performed to determine whether the compound modulated its pharmacological target or to evaluate the degree of saturation of a target receptor. The present survey suggests that although the merits of exploratory INDs are still being debated, the diversity in the applications cited, the potential for early clinical guidance in decision making and the increasing pressure on containing drug development costs, suggest that the exploratory IND/CTA will be a valuable option with evolving and possibly more specific applications for the future.

The conduct of in vitro and in vivo drug-drug interaction studies: a Pharmaceutical Research and Manufacturers of America (PhRMA) perspective.

Current regulatory guidances do not address specific study designs for in vitro and in vivo drug-drug interaction studies. There is a common desire by regulatory authorities and by industry sponsors to harmonize approaches, to allow for a better assessment of the significance of findings across different studies and drugs. There is also a growing consensus for the standardization of cytochrome P450 (P450) probe substrates, inhibitors and inducers and for the development of classification systems to improve the communication of risk to health care providers and to patients. While existing guidances cover mainly P450-mediated drug interactions, the importance of other mechanisms, such as transporters, has been recognized more recently, and should also be addressed. This article was prepared by the Pharmaceutical Research and Manufacturers of America (PhRMA) Drug Metabolism and Clinical Pharmacology Technical Working Groups and represents the current industry position. The intent is to define a minimal best practice for in vitro and in vivo pharmacokinetic drug-drug interaction studies targeted to development (not discovery support) and to define a data package that can be expected by regulatory agencies in compound registration dossiers.