A Guide to Patient Registries

Definition of patient registries: “Prospective observational study of patients  with certain shared characteristics (e.g. particular disease, risk factor or exposure) that collects ongoing and supporting data over time, on well-defined outcomes of interest for analysis and reporting.”[1]

There is often confusion as to whether patient registries are classed as clinical trials as there is not an IMP (Investigational Medicinal Product) involved.

Benefits to the patient population

Scientific advances over recent years have lead to substantial changes in the treatment of many diseases. New therapeutic strategies are being developed and, for some of these treatments, clinical trials are already underway. When a clinical trial is being planned, it is very important that patients suitable for that trial can be found and contacted quickly. The best way of ensuring this can happen is to make sure that patients’ details are all collected together in a single database or “registry” that contains all the information that researchers will need and other key information about their disease.

The need for patient registries

The primary objectives of the registry are to: assist the medical community with the development of recommendations and standards of care; characterise and describe the specifics of a therapeutic population as a whole, enhancing the understanding of prevalence across all areas and to accelerate and facilitate clinical trials by locating potential research participants quickly and efficiently.

The General Practice Research Database (GPRD) is a computerised database of anonymised data from patient records, in which data has been collected continuously since 1987 on approximately 3.6m patients from over 480 GPs nationwide. Leaflets are displayed in GP practices informing patients about this and patients can “opt out” of the scheme by request [2].

Ethical review of research databases

Application for ethical review is at present, voluntary when establishing a patient registry.  The Integrated Research Application System (IRAS) contains, for the first time, a specific application form for ethical review of a research database, and states the following:

“There is at present no formal requirement for research databases to apply for ethical review under NHS research governance systems, and approvals would only be required of processing identifiable data without consent. Applications for ethical review will therefore normally be made on a voluntary basis.”  [3]

It is suggested that applications should include the following:

  • Registry protocol
  • UK ethics approval application form
  • Consent form
  • Patient information sheet

Data Protection

Under the Data Protection Act 1998 [4], starting a register is a form of “processing” personal data and therefore the Information Commissioner (previously known as the Data Protection Commissioner) must be notified. The Commissioner will require a description of the data to be collected and the purposes to which the data will be used. The Information Commissioner’s Office (ICO) is responsible for regulating and enforcing the access to and use of personal information [5].

NHS Trusts

NHS Trust R&D departments are often the key decision makers in allowing a patient registry to be set-up.  The following are standard
requirements from an R&D dept:

  • Contract (trusts often use the UK national model CTA).
  • Trust R&D submission. IRAS parts A – D.
  • Site Specific Information form
  • Budget / costings
  • REC opinion
  • Final versions of all documents (incl Protocol and Patient  Information letter)

 

For more
information see the following:

www.nres.nhs.uk / www.gprd.com / www.ispor.org / www.clinicaltrials.gov

 

References:

[1]        International Society of Pharmaeconomics and Outcomes research – Patient Registry Special Interest Group – www.ispor.org(accessed July 2011)

[2]        www.gprd.com(accessed July 2011)

[3]        NRES Guidelines version 1 .5 Aug 2008 (accessed July 2011)

[4]        Data Protection Act 1998, 1998 CHAPTER 29 http://www.opsi.gov.uk/acts/acts1998/ukpga_19980029_en_1

[5]        www.ico.gov.uk (accessed July 2011) .www.ico.gov.uk/for_organisations/data_protection/notification.aspx