When you invest in a patient registry, you want it to remain viable for many years and ensure that your data can contribute to research and treatment development. Here are three key questions to consider that will help you secure the future of your investment, your patients, and your registry.
1. How do I build a strong foundation?
Right from the start, you should concentrate on building your team and setting a robust governance plan that you can review, share, and refine over time. A good governance plan helps keep the patient at the forefront. Also, it focuses on creating an effective path to the desired outcome, such as finding a treatment or cure.
Here, the term governance refers to guidance and high-level decision-making. This involves outlining the objective of the study/studies or registry, funds, and maintenance, and how it will share data and other information with researchers, physicians, patients, and potential sponsors.
A goal of proper governance and oversight should be transparency to stakeholders regarding decision-making and outcomes. Your governance plan can also include a steering group, representing the various stakeholders linked to and benefiting from the registry. The group can include a project manager, scientists or academics, doctors, patients, data analytics experts, and your technology partner. In some cases, having a legal representative in your steering group can also be an advantage.
2. Do I need more specialized oversight?
If you plan on creating just a contact registry (a database with details of patients, their condition, previous or ongoing treatment, medical team, and willingness to participate in research), then the steps listed above may be sufficient to ensure sound governance.
However, if you want to build a more specialized disease registry to collate previous research and even commission new studies, then you will need more robust oversight, such as a Scientific Advisory Board (SAB) or Institutional Review Board (IRB).
An SAB contains leading scientists studying the disease, or family of diseases, in question, who give expert guidance on how to collect the most effective data for your registry.
An IRB is an administrative body established to protect the rights and welfare of research participants. This group usually includes researchers and ethics professionals, as well as independent observers. They are responsible for reviewing all research involving patients and for protecting their welfare, rights, and privacy.
3. How do I get the most from my data?
Your registry’s effectiveness depends on having high quality, relevant data, without extraneous elements.
Aligning your data with industry standards such as the Observational Medical Outcomes Partnership (OMOP) and the Clinical Data Interchange Standards Consortium (CDISC) will make it more useful to researchers and regulatory authorities.
OMOP is a partnership between the Food and Drug Administration (FDA), pharmaceutical companies, and healthcare providers, which ensures standardized evidence collection on the effectiveness of drugs and treatments. CDISC is a set of standards for data gathering in healthcare, which reduces required resources and repetition of research.
If you build a strong foundation, find the proper oversight, and ensure your data meets these standards will prevent issues with data interpretation further in your registry journey. Additionally you and your organization will be better equipped for whatever the future brings.
For more information on how Rare Central can help you on your registry journey, visit www.pulseinfoframe.com or email our Head of Clinical Product Management, Nina at nliu@pulseinfoframe.com.
