To better understand the needs of the outcomes research community relating to patient registries, the ISPOR Patient Registry Special Interest Group (PR SIG) conducted a survey of ISPOR members. The survey was developed to: a) assess the involvement of ISPOR members in patient registries, b) assess types of patient registries used, c) assess use of patient registries, d) assess use of standard operating procedures, and e) assess use of electronic data capture for patient registries.

 

Of the 295 survey respondents (12% response rate), 37% were from the pharmaceutical industry, 25% from academia, 22% from contract research organizations (CROs), 3% from hospitals/health care providers, 2% each from managed drug or health care organizations, government, medical device industry and the remaining 7% from associations, software, information technology, data supplier organizations.

 

Personal Involvement in Patient Registries
Survey participants were given multiple options to characterize their own involvement in patient registries. Of the 377 responses, 60% of responses indicated involvement in a patient registry, either personally, professionally or both: 28% of responses indicating the use registries in work and finding them useful for work, 16% of responses indicating job responsibilities involving patient registries, and 15% of responses indicating personal participation in a patient registry. Less than 1% of responses indicated that registries were not useful personally or professionally.

 

Organizational Involvement in Patient Registries
Survey participants were asked to characterize their organization’s involvement in patient registries. For all respondents, 35% indicated no involvement by their organization with patient registries, 21% indicated their organization is exploring involvement with patient registries, and 44% indicated that their organization is involved in one or more patient registries now (with 37% involved in more than one registry and 7% involved in only one registry).
 

Organizational involvement in patient registries from industry, CRO, and academia were:

Organizational Involvement in Patient Registries in the Future
When asked if their organization will be involved in patient registries in the future, of the 295 respondents, 50% replied that their organization will be involved in the future; 34% replied that their organization may be involved in the future; 15% did not know, while 1% responded that their organization will not be involved in patient registries in the future.

Responses from industry, CRO, and academia concerning future involvement with patient registries were:

Types of Patient Registries
If the respondent’s organization was currently involved in registries, they were asked to categorize the patient registry. Respondents were allowed multiple options. Of the 431 responses, the registries were characterized as: disease specific (36%), country specific (22%), productspecific / branded (15%), global (14%) and/or community-based / regional registries (13%).

Types of patient registries responses from industry, CRO, and academia are:

Use of Patient Registry Information
If the respondent’s organization was currently involved in registries, they were asked why their organization was involved and were given multiple options from which to choose. Of the 533 responses, “compile additional outcomes data” (33%) and “explore ‘real world’ product use” 32%) scored highest, followed by “compile safety data” (15%), “meet specific regulatory agency mandate(s)” (12%), and (8%) other reasons, such as: “to assess long-term costs/resource utilization”, “establish practice patterns”, “explore opportunities for patient-care quality improvement”, “use at point of care”, “generate and validate treatment guidelines”, “study epidemiology data”, “provide feasibility for randomized clinical trials”, “to understand treatment patterns”, “unmet medical needs”, “cost data”, & “budget impact analysis.”

Use of patient registry information responses from industry, CRO, and academia were:

 

Patient Registry Standard Operating Procedures
If the respondent’s organization was involved in registries, when asked if their organization has specific standard operating procedures (SOPs) regarding patient registries, of the 193 responses, 34% have SOPs, 21% were developing them and 45% had no SOPs.

 

Patient registry SOP responses from industry, CRO, and academia were:

 

Patient Registry Electronic Data Collection
If the respondent’s organization was involved in registries, when asked about their utilization of electronic data collection (EDC) for patient registries, of the 192 responses, 34% indicated that their organization utilizes EDC; 36% will utilize more EDC in the future and 30% do not utilize EDC for patient registries.

 

Patient registry EDC use responses from industry, CRO, and academia were:


ISPOR Patient Registry SIG Next Steps
When asked, ‘What can the ISPOR Patient Registry SIG do for you?’ (allowing multiple options), the following were the recommended actions out of 603 responses:
• Develop guidelines for data analysis (32%)
• Establish standards for data management (27%)
• Develop ISPOR position papers (19%)
• Develop educational sessions on patient registries (12%)
• Develop guidelines for regulatory issues (privacy, IRB, consent) (9%)
• Other (1 %)

 

Patient Registry Survey Results Summary
The results of this ISPOR Patient Registry SIG survey indicate that patient registries are used extensively by the outcomes research community with a growing need for them in the future. Disease-specific and country-specific patient registries were the most common type. Outcomes research and exploring ‘real world’ product use were the most common use of patient registries. The use of EDC is growing and SOPs are not common.

These survey results also indicate that the ISPOR Patient Registry SIG can assist in the development of: a) guidelines for data analysis; b) standards for data management; and c) guidelines for regulatory issues through ISPOR position papers and education sessions. For more information about the ISPOR Patient Registry SIG, or to join this SIG, see: http://www.ispor.org/sigs/patient_registr.asp.