The Registry Of Patient Registries: Streamlining Your Clinical Trial Recruitment, Collaboration Goals

By Michelle Bertagna Leavy, MPH, manager, health policy, real-world & late phase research, Quintiles

The Agency for Healthcare Research and Quality launched the Registry of Patient Registries (RoPR; https://patientregistry.ahrq.gov) to improve collaboration, transparency, and efficiency in registry-based research.  While some biopharma companies, such as GlaxoSmithKline, Synageva BioPharma, and Teva Pharmaceuticals, have listed registries on the RoPR, many industry-sponsored registries that are listed on ClinicalTrials.gov do not have corresponding RoPR records.  Companies could derive benefit from the RoPR by quickly connecting with physicians and patients in areas of interest, reducing study costs by finding existing registries to answer research questions, and learning about innovative registry designs.

A patient registry is defined as “an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure. A registry also serves one or more predetermined scientific, clinical, or policy purposes.”

Patient registries may be used for a variety of purposes, including one or more of the following:

• Effectiveness research for drugs or devices
• Natural history of disease
• Post-marketing commitments or safety monitoring
• Quality improvement programs
• Certification programs (e.g., for physicians to retain membership in a professional medical organization)
• Surveillance programs (e.g., to track vaccination status).

Since its launch in December 2012, nearly 130 registries have been listed in the RoPR. The registries cover a wide spectrum of condition areas and serve a variety of purposes, but one characteristic stands out:  relatively few – in fact, less than 20 percent – of the listed registries are sponsored by the biopharma industry.        

Many companies post information on registries on ClinicalTrials.gov, and from that web site, could go on to post registry-specific information on the RoPR. However, most industry-sponsored registries don’t take this extra step.

Listing registries offers several potential benefits, including supporting recruitment efforts and opening the door for potential collaboration opportunities.  Listing a registry can also demonstrate a company’s commitment to a specific disease area and help build connections with patients and providers in that community. These connections may be useful for identifying key opinion leaders with special expertise or for building focus groups.  Lastly, the RoPR provides registry sponsors with the opportunity to more fully describe their registry, particularly in regard to unique registry characteristics, such as progress-to-date, and open-ended follow-up.

Listing a registry is not the only way to take advantage of the RoPR, though.  In fact, companies can use the RoPR for many purposes, as described below. 

Answer research questions efficiently.  By searching for existing studies on the RoPR, companies can save money by finding registries that will either jump-start their studies or may even have the data necessary to answer most of their questions.  For example, existing disease registries may contain a wealth of information on current treatment patterns, treatment effectiveness, burden of illness, and unmet patient needs – all of which may be useful to support the value proposition for a new therapy.

Identify collaborative partners. Collaboration may take the form of nesting a study within a registry, linking registry data to other data sources (e.g., claims data, medical records data, or other registries), or analyses of the registry data to examine a new question.  In each scenario, an underlying motivation for collaboration may be reducing the time or resources required to address a research question.  Of the registries on the RoPR currently, 61 are interested in being contacted about possible collaborations, and 41 are interested in being contacted about data access. Some examples are:

• Brigham and Women's Rheumatoid Arthritis Sequential Study (BRASS; https://patientregistry.ahrq.gov/profile?rid=243&cnt=5), a large rheumatology registry that invites researchers to request access to registry data to answer new questions
• NF Patient Registry of the Children's Tumor Foundation; this registry notes that researchers may request access to de-identified data
• National Database for Autism Research (https://patientregistry.ahrq.gov/profile?start=10&RC=200&rid=2502&cnt=10), another database that encourages researchers to request access to data. This is a huge repository of information (>80,000 individuals) that could be very beneficial to autism researchers.

Identify patients for trials: Some registries, particularly in the rare disease world, collect information on patients who are interested in participating in clinical trials. These registries can help to facilitate clinical trial enrollment, which can be particularly challenging for rare diseases. The RoPR contains multiple rare disease registries at present, including:

• Neurofibromatosis (NF) Patient Registry of the Children's Tumor Foundation (https://patientregistry.ahrq.gov/profile?idRoprS=682&rid=682&cnt=0), a database of patient-reported experiences of living with NF. Patients enroll directly in the registry and indicate if they are willing to be contacted for future trials.
• Bronchiectasis Research Registry (https://patientregistry.ahrq.gov/profile?idRoprS=415&rid=415&cnt=0), a consolidated database of non-cystic fibrosis (non-CF) bronchiectasis and non-tuberculosis mycobacteria (NTM) patients from multiple clinical institutions. Patients are enrolled by providers, with the goal of identifying patients for future multi-center clinical trials.
• Alpha-1 Foundation Research Registry (https://patientregistry.ahrq.gov/profile?idRoprS=57&rid=57&cnt=0): This is a classic example of a rare disease clinical trial recruitment registry, made up of individuals diagnosed with severe alpha-1 antitrypsin deficiency (Alpha-1) or the carrier state.
• Enroll-HD: A Prospective Registry Study in a Global Huntington's Disease Cohort (https://patientregistry.ahrq.gov/profile?freeText=enroll+hd&rid=194&cnt=0): This has the same goal as the registries above, but uses a different model, with clinical data and biological specimens and research objectives for the registry, in addition to supporting clinical trial recruitment.

Support registry recruitment goals: Raising awareness about the registry can help to support recruitment goals, particularly for registries that may encounter recruitment challenges.  Of the registries included on the RoPR currently, 59 are interested in being contacted by investigators who wish to participate, and 46 are open to be contacted by patients who wish to participate. Examples of registries include: 

• Antiretroviral Pregnancy Registry (https://patientregistry.ahrq.gov/profile?rid=50&cnt=4), a longstanding initiative and possibly the most well-known pregnancy registry
• Sanofi Pasteur Quadrivalent Influenza Vaccine (QIV) Pregnancy Registry (https://patientregistry.ahrq.gov/profile?rid=1551&cnt=9), a newer example
• The National Amyotrophic Lateral Sclerosis (ALS) Registry (https://patientregistry.ahrq.gov/profile?start=20&RC=500&rid=121&cnt=21); this is not a pregnancy registry, but represents another example of a registry that is interested in raising awareness and encouraging individuals with ALS to enroll in the registry directly

Increasingly, biopharma companies are turning to patient registries to answer a wide range of research questions, develop real-world evidence that can be used to support the launch of new products, and monitor real-world safety.  While new registries could be developed to meet these needs, a more efficient approach – in terms of both time and resources – is to assess what data have already been collected and identify ways to leverage existing registry infrastructure to address new questions.  The RoPR was designed to foster this type of collaboration and transparency in registry-based research.  By listing registries and using the RoPR as a springboard to find information about registries, biopharma companies can play a key role in the development of an invaluable resource for the scientific community.   

Users are encouraged to provide direct feedback on any features that would encourage them to participate in the RoPR by contacting the RoPR support team at ropr@ahrq.hhs.gov.

Details of how to list a registry with the RoPR are available at https://patientregistry.ahrq.gov/holderinfo.