In addition to answering an important scientific question for the care of heart failure patients, the TRANSFORM-HF study was designed to transform the way medical research and clinical trials are done. Clinical trials are the foundation for how the medical profession learns which treatments work best in taking care of patients. However, although clinical trials are very important for improving patient care, traditional clinical trials face many challenges.
Challenges for traditional heart failure clinical trials
- Several Eligibility Criteria: Clinical trials generally have several criteria that patients must meet to be eligible. Oftentimes, a very small percentage of patients with a given health condition are eligible for a clinical trial for that condition. As a result, it is not always clear if results from a clinical trial are applicable to all patients with the medical condition.
- Extra Responsibilities for Patients: Many trials often ask patients to have extra tests and office visits, which can be a significant burden and can be difficult for many patients to complete.
- Extra Responsibilities for Medical Staff Enrolling Patients: Most trials require study staff at each local site to collect extensive patient information and complete extensive “paperwork.” This can take up a lot of time and can limit the site’s ability to enroll patients.
- Slow Enrollment Rates: The combination of few patients being eligible and the extra responsibilities for patients and enrolling sites often result in clinical trials having slow enrollment rates. This often results in the trial taking a long time to find the answer the medical question it set out to examine.
- Very expensive: Because most trials include a large number of tests and office visits and require collection of a lot of data, coordinating and arranging this can be very expensive for the trial sponsor and can limit the number of clinical trials that can be ongoing.
TRANSFORM-HF is different
Recognizing the challenges facing traditional clinical trials, TRANSFORM-HF was designed to improve the clinical trial experience for patients and enrolling hospitals...while simultaneously improving the way we answer an important scientific question for patient care.
Key aspects of TRANSFORM-HF that differentiate it from other trials for patients with heart failure include:
Broad and inclusive entry criteria to better ensure the results of the study will apply to a wide range of heart failure patients that healthcare providers see in their routine everyday practice.
Streamlined data collection to only collect the most important things. This aims to decrease the workload for the staff at each specific study site and the patients enrolled.
No extra in-person follow-up visits or tests for patients after they leave the hospital. Instead, patients follow-up with their healthcare providers and get further testing as they normally would, whether they were in the study or not. Instead of extra visits, the study team will periodically call patients by phone.
Moving research and patient care forward...the TRANSFORM-HF way
With these innovative strategies in place, TRANSFORM-HF has the potential to:
- enroll patients more efficiently
- produce results that apply to the broad heart failure population
- answer the scientific question faster
- answer the scientific question at a fraction of the cost
- be a model for how to design clinical trials in the future!