A patient registry study is the collection of observational data from the use of treatments or medical drugs prescribed to patients by practicing doctors and physicians. The patient-reported outcomes are then recorded. On the other hand, an interventional clinical trial or interventional study is when a medical drug, device or treatment is used on a cohort of research participants to collect the outcome. When it comes to a patient registry study vs. interventional clinical trial, each method has something different to offer.
Patient Registry Study vs. Interventional Clinical Trial
Patient registry studies and clinical trials are both imperative for improvement in healthcare. The data collected from both is used by several stakeholders, including pharmaceutical companies, healthcare institutes, and medical researchers, to develop better medical procedures and drugs for patients.
There are a few key differences between the two:
Research Collection Method
The way this research is collected differs from a patient registry study and an interventional clinical trial. An observational study analyses people in their natural habitat, i.e., without any intervention. Researchers gather important data through routine medical tests and exams conducted by physicians on patients suffering from a particular condition or disease. All this is done in normal settings.
Clinical trials, however, target the purpose of research. The aim of an interventional clinical trial is to evaluate the effects of a certain product, whether it’s a medicine or a procedure, to see how this research group responds to said product or treatment. Through different phases of clinical trials, researchers and medical experts decipher whether the product or procedure is safe for use on patients, what quantity is optimum and whether the side effects are lesser than the existing treatment.
Observation vs. Intervention
In observational studies, researchers test the patient outcomes of a regular treatment without making any changes. In simple terms, they just observe, not intervene. In observational studies, patients might be asked to fill out questionnaires on the effects of their current treatment, without comparing their statements to a control group. The aim is to just understand how patients suffering from one particular disease react to the existing treatments and drugs available.
Interventional studies, as the name suggests, test an ‘intervention’ on a group of participants who have been enlisted for this very purpose. Their results are compared to a control group that usually receives a placebo. Most clinical trials have a structured framework and are meant to focus on the safety and efficacy of a specific product or procedure and then measure it against the existing treatment or product.
The patient registry study records data in a patient registry, which can then be used by doctors, physicians, pharmaceutical companies, and medical researchers when they want to know about a specific disease or condition. Most often, patient registry study data is used before a new product or treatment is in place. It might be used as a basis for the development of one, though.
Clinical trials are conducted to test a specific medical product, device, or procedure. The aim is to not just understand the progression of a disease but to test the efficacy and safety of a product or procedure before it can be launched in the market for public use after acquiring FDA approval.