The What, When, and How of Clinical Registries

The What, When, and How of Clinical Registries

Why a registry?

Patient registries are an excellent data collection tool to use in today’s health care environment, particularly when there is a need to characterize or expand a patient population for a treatment, to develop new information which can be used to expand product labeling, or to obtain long-term health care information of individuals with specific diseases.  Regulatory bodies are highly supportive of well-designed and operationalized registries, which can be shared across country boundaries.  Many registries are required to be established after product approval to further develop the product’s safety profile.  Registries in many instances reflect the ‘real world’ experience for a treatment, a patient, or a disease process.  It is a treasure trove of scientific and practical information when it is correctly designed for the intended purpose and then executed with efficiency.

The single most important key to a successful registry is planning.  Planning includes defining what type of registry to be developed and then executed, following appropriate guidance, understand how the data will be utilized once collected, and develop an execution strategy that included the key stake holders.

What defines a registry?

There are many types of registries that are used to collect patient clinical information, which are developed and maintained by a wide variety of groups:

  • Medical & Health Care Organizations / Associations – American Heart Association, National Cancer Institute, National Multiple Sclerosis Society, American Medical Association, to name a few
  • Patient Advocacy Organizations – National Organization for Rare Disorders, American Society of Hematology, and others
  • Medical Companies – Public and private, established and start-up, pre-market and post-market

What is the common denominator?  The interest to collect patient outcome information in an effort to learn more about a specific disease or treatment.  Clinical registries are typically observational in design, as opposed to clinical trials, which are designed to investigate a specific hypothesis.

The meaningful definition of a registry is an organized system for the collection, storage, retrieval, analysis, and dissemination of information on individual persons exposed to specific medical intervention who have either a particular disease, a condition (e.g., a risk factor) that predisposes [them] to the occurrence of a health-related event, or prior exposure to substances (or circumstances) known or suspected to cause adverse health events.

There are a number of reference documents that can be used to guide the development of a registry, depending on the purpose of the registry.  Among the list of regulations, guidelines, and standards that can be referenced are:

When are registries used and what considerations should be given?

There are various reasons registries are used, which include the need for additional information to understand how a treatment, whether pharmacologic or device, effects a disease, or to track trends of a specific patient population with certain conditions.  Registries should be conducted in a rigorous manner in order to have useful and meaningful data for analysis.  The rigors of registry execution are dependent on the use of registry information and can be influence by the country the registry is collecting data.  Examples of this are when registries are associated with a FDA required post-market evaluation, or in accordance with a notified body requirement to address issues linked to residual risks.

The key consideration when developing a registry must be effective PLANNING.  Whether a few or 1000s of patients are enrolled, whether patients are enrolled from the U.S. or from other countries, or whether the registry will cost little or a significant amount, thoughtful planning is necessary to obtain the desired outcomes.

Key things to consider when identifying the purpose of a registry includes how the information will be used:

  • Post-approval effectiveness
  • For reimbursement purposes
  • To fulfill the FDA requirements of Section 522 in the regulations
  • To develop new information for potential new labeling indications

Understanding the purpose or goal of the registry provides the basis for remainder of elements that need consideration to perform the registry, such as:

  • Target population – specific disease or treatment, age, etc.
  • Scope of study – participation of specific geographic areas, length of time patient is followed, hospital vs. non-hospital, etc.
  • Stakeholders – physician, nurses, specialized therapists, clinics, hospitals, home-care professionals, insurance companies, CMS, industry sponsors, etc.
  • Feasibility to execute and operationalize the registry – data collection via electronic remote database access vs. paper, patient generated data vs research professional involvement, community based hospitals vs. university based hospitals, etc.
  • Study closure – for studies that do not have a finite sample size, having clarity to determine when enough data has been collected
  • Funding – development of a realistic budget that encompass every aspect of development, execution and finalization of the registry, confirmation that funding exists, inclusion of various funding partners that may be stakeholders, etc.

How to accomplish the execution of a registry?

The design of the registry will be the foundation from which all other elements of study execution will develop.  Having clarity as to the goal or purpose of the registry helps the design team focus the registry outcomes being sought.  This also assists in determining the use of Institutional Review Boards (IRB) or Ethics Committee (EC), the selection and eligibility criteria of the patient population, determining sample size (if applicable) and/or the need for comparator cohorts (if applicable), various operational requirements (assessments, tests, patient materials, etc.), the data elements to collect and the sources where the data is found (medical records, existing databases, etc.), the need for auditing or monitoring to improve the cleanliness of data for analysis, and the final analysis process.

Selecting the source of patients, whether from clinical settings, via internet access, etc., will aid in determining recruitment rates, retention of patients should data need to be collected over time, and the potential quality of the data that will be provided.  Consideration should be given to the usefulness and impact of various recruitment methods, such as advertising methods (internet, newspaper, radio, societies, etc.), incorporating fair market value for patient reimbursement for their time to participate or travel expenses, or providing patients with newsletters with up-to-date registry analysis.

Time is well spent when considering data elements to collect, how to collect the data, and the data analysis process.   Knowing the goal of the study is key to identifying the outcome data necessary to meet the registry objective and to further specify data elements needed for collection.  Beware: Data creep is a common occurrence when defining variables to be collected.  As possible, collect what is necessary versus desirable.  The burden for the data collector, costs, data accuracy and completeness of data requested all increase the more data that is collected.

Data quality is a key factor to consider when planning the registry.  Data quality impacts the use of the results, i.e. publications, presentations, regulatory purposes, etc.  To favorably impact data quality, several important items should be included in the planning discussions:

  • How data is collected
  • How personnel are trained to collect data
  • How data is managed
  • How to maximize the accuracy of data collected

When initiating a registry, rules pertaining to ethics and privacy do apply.  The Common Rule (1991, 45 CFR 26) provides regulations for the protection of human research subjects.  In 2000, the Health Insurance Portability and Accountability Act (HIPPA), was enacted providing privacy guidelines for the use of subject’s health information.  To bridge the use of personal information between the US and Europe, the Safe Harbor Act (1997) was passed in an effort to maintain the same level of personal data handling and privacy between the continents which are involved in many research endeavors.  Finally, in most instances, an IRB or EC will be necessary, as it is their responsibility to protect the safety and rights of subjects participating in a registry and to approve the informed consent form the subjects will use.

Though registries in most instances are less rigorous than investigational trials, planning remains central to the development, conduct and final outcome of the study.

The pharmaceutical, medical device and biotech industries are ever changing and the need for current and accurate data are paramount.  Registries can be effective ways of obtaining impactful data that will inform business decisions and impact patient lives.  Boston Biomedical Associates assists companies in developing and executing patient registries.

Please contact us by email at or fill out our contact form.

Paulette Niemyski


No Comments

Post A Comment