ARE REGISTRIES THE NEW “GOLD STANDARD”?

There are multiple definitions associated with a registry and any future sponsors can feel anxious when it is time to endorse the responsibility of this type of study. Indeed, “Registries” gather not only observational studies at the initiative of one sponsor but also include Post-Authorization Safety or Efficacy Studies (PASS & PAES) required by competent authorities or more globally it might refer to a general data collection.

For many years, sponsors considered randomized clinical trials as the “gold standard” which should allow the collection of robust data and should help them to move forward with their development plans. Nevertheless, they faced hurdles with these studies beyond the cost and the long period of time before bringing a new drug to the market. This is particular impacting when there are unmet medical needs and a real necessity to get the product on the market. Thus, they have to think about new approaches to generate evidence to support more efficiently and effectively their drug development.

What needs to be kept in mind is the main difference between a registry and an interventional trial. As a general consideration: a registry is observational, and a clinical trial is interventional. “a registry is a type of study in which the investigator can’t control the condition studied” (Rothman & Greendland, 1998). This simple but concrete definition means that the investigator must follow the rules imposed by a protocol in terms of patient’s visits and assessments in a clinical trial. On the opposite, a registry will aim to collect data in a real-life mode to get a better understanding of how the patient is treated in current practice. So, the investigator simply records what happens in that case.

Having this definition in mind, registries can be an answer to gather data in a fashion manner. They can be a very powerful tool if sponsors manage to understand their framework and requirements.

 

Emmanuel_Prades

Emmanuel Prades, Director of Clinical Trial Submission and Operations

After 22 years in many diverse clinical research departments, in both pharmaceutical and medical device industries, Emmanuel has significant experience in the management of international clinical studies (all phases) from protocol writing to reporting. He also has experience in overall project management, Clinical Quality Assurance, pre-market vigilance for Medical Device and coordination of multiple functional teams and subcontractors.

Adeline Darchy

Adeline Darchy, Clinical Project Manager

Adeline has gained more than 10 years of experience in clinical research from both the CRO and sponsors sides. As a project manager, she was in charge of managing the clinical project while taking into account the research limitations, GCP and local regulations. She has focussed expertise in working with projects from phase II to phase IV, in oncology endocrinology, neurology, aesthetic and pediatric fields.

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