The Co-op at HeartWorks: The Future of New Congenital Heart Disease (CHD) Therapies
What is the Co-op at HeartWorks?
The Co-op is a database of CHD patient medical records submitted by CHD patients who proactively join the Co-Op. The data are managed in a secure, encrypted system with access to HeartWorks researchers and clinicians, and to additional CHD-focused researchers and clinicians who collaborate with HeartWorks. Participating Co-op patient members always have access to their medical record data in the Co-op.
Why is the Co-op crucial to the development and implementation of new therapies for CHD patients?
In modern medicine, the starting point for developing effective new treatments for any disease is to clearly understand specific needs for new therapies in relevant patient populations. To do this, researchers must evaluate the status of current therapies. How effective are the available therapies? Are there sub-groups of patients for whom those therapies do not work? Are there untreated patients for whom available therapies are not appropriate? Without this kind of critical information, there can be no strategic approach to new therapies.
The key to addressing these critical questions is access to medical records for large numbers of patients with the disease(s) in question. This is the basis of new therapy design in modern medicine. There are large databases of patient medical records, but most are closely held by the medical institutions collecting the data and not available to researchers outside those institutions. Further, there are few data bases focused on CHD patients and those patient records are scattered among many medical institutions. Those records are not routinely available to HeartWorks and other CHD researchers and clinicians.
HeartWorks is addressing this critical need by development of the Co-op. HeartWorks reaches out to CHD patients to explain how the Co-op functions and why it is so important for development and implementation of better CHD therapies. Patients proactively choose to join the Co-op at no cost. They establish a Co-op account and upload their medical records from institutions/practices where they have been treated into the Co-op database. Only patients can authorize the addition of their medical records data to the Co-op, and they always have access to their medical data in the Co-op.
How does the Co-op contribute to better care for CHD patients?
-The key purpose of the Co-op is to directly facilitate development and implementation of new therapeutic trials for CHD patients. This is accomplished through critical review of medical records data from CHD patients enrolled in the Co-op. HeartWorks and collaborating researchers assess the status of therapies currently to determine where new therapies could improve outcomes for CHD patients. Given the paucity of treatment options for patients with serious, life-threatening CHDs, this is the key mission at HeartWorks: bring new, effective therapies to CHD patients.
-Researchers and clinicians follow the status of patients enrolled in HeartWorks and other CHD protocols through analysis of their data in the Co-op. This assures timely and ongoing assessment of clinical trials and the ability to compare results with other therapies. The power of this analysis increases as the number of patients enrolled in the Co-op and the number of clinical trials increases.
-Patients enrolled in the Co-op are notified when they meet the criteria for entry into new HeartWorks or other CHD clinical trials. This is a major benefit for Co-op patients: they will proactively be aware of their eligibility for new trials, and just as importantly, they will know when they are not eligible for certain trials.
-Over time, the Co-op will add protocols from other CHD researchers and institutions. This will increase the value of the Co-op to enrolled CHD patients.
-The Co-op is also a valuable resource for CHD patients to maintain and centralize their medical records data. Patients are able to enter medical data from any/all providers where they have received care. They then have a single source for maintaining and accessing their medical records data.
In conclusion, the Co-op at HeartWorks represents a major step forward in the development of new therapies for CHD patients and better management and clinical care of CHD patients. If you are a CHD patient, we urge you to join the Co-op.
