Research Involving Long-Term Survivors of Childhood and Adolescent Cancer: Issues Impacting Design and Conduct of Clinical Trials

摘要

In its landmark 1999 report on the quality of cancer care in America, the National Cancer Policy Board (NCPB) pointed to a need for data in areas that are integral components of the quality of cancer care, including quality of life (QOL) perceptions and patient-focused outcomes, emphasizing that cancer care quality measures should span the cancer continuum to include survivorship.1 To improve the quality of care and quality of life for cancer survivors and their families, more research and expanded participation in controlled clinical trials is needed. Understandably, the field of cancer clinical trials has mainly aimed at extending survival and increasing cure rates (ie, primary outcomes easy to measure and indisputably important). A much smaller body of clinical trials and more limited evidence is available related to trials that include health-related QOL outcomes as a primary or secondary objective of the overall study, and much of what is available is merely descriptive. Little evidence and scant clinical research is directed to underserved and vulnerable populations, including those with low literacy or low income, those from differing cultures, the elderly, and rural populations.