Parallels between drug development and reducing community-based cancer health disparities Free

B35

There are parallels between the process of drug development and the development of community-based participatory disparities-reducing interventions. Typically, 12-15 years is needed to bring a drug to market. Review of data on the reduction in cancer mortality rates associated with early detection by mammography shows that 12 years elapsed from the beginning raise in incidence rates associated with the screening to 3 consecutive declines in annual breast cancer mortality rates. Second, the preclinical phase of the development of drugs is analogous to the capacity building phase in developing community-based participatory research. Understanding the carcinogenic pathway to find the target sites and developing a drug that can affect the site tests is simlar to the process of developing community partnerships and gaining the trust of the community so that they will participate in community-based studies. Similar to the developmental laboratory work needed to understand pathways and mechanisms, this process may involve needs assessments, key informant surveys (surveys of the health providers), and focus groups to determine the disparities and interventions to be undertaken by the community. The development of phase I clinical studies of toxicity and dose setting has parallels with the community participating in developing the disparities reducing intervention. As a full member of the research team, the community helps to shape the disparities reducing intervention. This phase ends when the community approves of the protocol for the disparities reducing intervention (DRI). The development of phase II clinical studies for efficacy has parallels in the full implementation of the DRI in the community. The DRI is implemented to determine effectiveness in reducing disparities, largely through producing behavior change in participants. The ideal endpoints are changes in specific behaviors, such as increasing screening rates. In drug development, after in phase I and II studies, there are phase III clinical studies to determine the general efficacy of the new drug compared to a standard drug. The analogous activities in disparities research is to perform controlled studies to determine if the DRI is more effective than standard or usual procedures. Typically, there is a control group that is used for comparison to the DRI group. Endpoint are factors that affect disparities, such increases in knowledge, attitudes and behaviors, quit rates in smoking, and increases in screening rates. The final stage for the drug is the dissemination and adoption, assuming that it is shown to be beneficial. Similarly, there is dissemination and adoption of the DRI, if it is shown to reduce disparities.