A patient registry study can be defined as an observational study where the treatment, drug, or device under evaluation is prescribed to patients by their treating physicians. The outcome of this data is then recorded. Unlike clinical trials, registry studies do not include any intervention or comparison against a control group.
In a registry study, the doctor is told to treat the condition however they deem best. Sponsors act as passive observers and monitor patients in their natural habitat. In a clinical trial, however, you would expect the sponsors to approach the disease in a specific manner, which is the primary difference between the two.
Patient Registry Study Structure
A patient registry is quite close to a clinical study in design and structure. But the lack of consensus standards makes the implementation of a registry study difficult.
During the nascent stage, you will need to lay the basic framework. Here are a few elements that you need to decide on:
- Identify the purpose of the patient registry study
- The scope of information that is needed
- The stakeholders
- The target population
- Classify the core data
In this stage, the most important thing remains how to procure funding for the patient registry study. You may get funding from government or private grants, venture capitalist firms, or others. After the basis has been decided, you will proceed to set up a registry team.
When it comes to registry design, you have a few options at hand. The two most popular ones include cohort designs and case control designs.
- Cohort designs follow a group of people that share a characteristic to assess if they reach the same outcome
- Case control designs work backward and see the extent to which a characteristic made a difference among people with a specific shared outcome
Registry studies require the recruitment of sites. These sites need monetary compensation for their active participation and contribution to the study. A registry study could include on-site physicians or academic centers, to name a few.
Patient recruitment remains a challenge for registry studies. The best way to go around is to take the physician’s suggestions. In this phase, it is important to inform and educate patients on how their participation will not only benefit other patients’ health, but their own too. The forms or written material for patients should be in simple, easy-to-understand language. You want to ensure patient participation as much as possible.
There are three elements in the data collection process, which include:
- Case Report Forms (CRF), paper or electronic
- Data Dictionary
- Data Validation Rules
Data analysis of registry studies is pretty similar to clinical trials. However, this part should include an analysis of how closely this group represents the actual population. Secondly, there should be a plan in place to analyze the data. Lastly, there should be some mechanism for how to go about missing data.
A patient registry study is just as important as a clinical trial. It is able to determine the use of a certain treatment, device, or drug in the real world without any interference. Registry studies record data in a patient registry, which would require proper and flexible patient registry software for a high success rate.