Management of Chronic Diseases in Clinical Trials
Having two or more co-morbid conditions is often an exclusion criterion for clinical trials. However, many patients who will ultimately be prescribed medications studied in these trials have multiple chronic conditions, and there is uncertainty about how these co-morbid conditions could affect drug efficacy and toxicity. Planning activities to develop novel models to manage chronic diseases in clinical trials are being explored within the existing Common Fund Health Care Systems (HCS) Research Collaboratory program. How should clinical trials be conducted so that patients with co-morbid chronic diseases are represented in study populations? What data collection and analysis tools will be needed to provide information on the biological and clinical consequences of clinical intervention on chronic diseases?
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