ACT Oncology has developed significant expertise in the design and conduct of oncology registries and observational cohort studies, including five major programs for Sponsors since 2005. Implementing and maintaining patient registries allows us to utilize the data we help collect to extract valuable insights above and beyond our original scope.
The registry services we offer include:
- optimizing input from an advisory panel;
- determining site and subject criteria;
- selecting and refining data instruments;
- defining and incorporating clinical, economic and patient-reported endpoints;
- overseeing regulatory issues and risk management.
The development of targeted therapies represents a shift in the treatment paradigm for cancer. As survival continues to improve with advances in treatment, patients may receive long-term therapy; therefore, it is imperative to have a complete and thorough understanding of the safety and effectiveness of these drugs in the community practice. Clinical cancer studies are primarily designed to evaluate the efficacy of the agents within the confines of the trial construct, and it is not until post-approval use in larger numbers of patients that rare, but serious, drug-related events may emerge. Anecdotal case reporting of such events, while serving an important role in their recognition, is an insufficient method of determination. Prospective Observational Cohort Studies can provide valuable clinical information about the safety and effectiveness of cancer therapies and represent an additional source of clinical information that complements Randomized Controlled Trials and other types of studies. (Spigel, D. Biotechnol Healthc. 2010 Summer; 7(2): 18–24)