Our mission at ELIAS Animal Health is to improve cancer treatment outcomes in veterinary patients through the advancement of innovative therapies. To do that, it is imperative to understand the long-term outcomes of dogs who undergo the ELIAS Cancer Immunotherapy (ECI®). Following our randomized controlled trial (RCT) for canine osteosarcoma, we recently launched a long-term patient registry which will collect both long-term survival and quality of life data on dogs who participated in our clinical trials or received ECI outside of clinical trials.
What Are Long-Term Patient Registries?
Long-term patient registries allow us to observe real-world ongoing outcomes after clinical trials have concluded. ELIAS’ patient registry will provide insight into the quality-of-life dogs experience post-treatment, help us understand the long-term impact of ECI, and deliver data points that may (or may not) impact our understanding of the patient’s outcome. It will also inform our future product development. Specifically, the registry will collect data on the dog’s general quality of life post-treatment, breed, age, longevity, and geography as well as any additional diagnoses, cancer or otherwise. Combined with clinical data from the trial, we are able to examine the data for possible correlations among patients. The hope is that we can identify factors which will improve treatment responses and outcomes in the future.
How Do Long-Term Patient Registries Supplement Data Collected in Clinical Trials?
In order to mitigate bias and allow for precise statistical analysis, RCTs must strictly control admission with very detailed inclusion and exclusion criteria, as well as adhere to specific timelines for data collection. These factors provide the best information about whether a product is safe and effective in that population of patients. Expanding data collection to a broader patient population for an extended period of time can be useful in assessing how that product performs in a broader patient population and allows for evaluation of patient outcomes in situations where longer outcome assessment periods are desired, such as in cancer.
Long-term patient registries allow for broader data collection than RCTs, both in the type of data collected and the timeframe in which it is collected. Ultimately, this can support a deeper understanding of how a therapy or drug will perform in a larger patient population. For ECI, we believe the registry will provide insight into which patients may experience a more pronounced response to treatment, and why, in some dogs, cancer never returns.
“Studies from patient registries and randomized controlled trials (RCTs) have important and complementary roles in evaluating patient outcomes. Ideally, patient registries collect data in a comprehensive manner (with few excluded patients) and therefore produce outcome results that may be generalizable to a wide range of patients. […] RCTs are controlled experiments designed to test hypotheses that can ultimately be applied to real-world care. […] Patient registries, RCTs, other study designs, and other data sources should all be considered tools in the toolbox for evidence development, each with its own advantages and limitations.”
Source: Gliklich RE, Dreyer NA, Leavy MB, editors. Registries for Evaluating Patient Outcomes: A User’s Guide [Internet]. 3rd edition. Rockville (MD): Agency for Healthcare Research and Quality (US); 2014 Apr. Available from: https://www.ncbi.nlm.nih.gov/books/NBK208616/
Why Should Pet Parents Participate in Patient Registries?
In 2012, the Morris Animal Foundation began a golden retriever lifetime study of 3,000 dogs to identify “nutritional, genetic and environmental risk factors for cancer and other important diseases in dogs. Results will provide comprehensive data on diseases and other health challenges, including cancer. Findings will be used as a launching point for multiple health studies in dogs.” Where clinical trials must limit the number of participants due to constraints, long-term patient registries can look at more factors and a much larger patient population.
Participation in long-term patient registries will provide critical insights to the future of cancer treatment. With the ability to evaluate patients over time after their treatment, we will be able to extract important information to enhance treatment strategies and empower veterinarians to provide the best care possible for their patients.