“How Are Observation Clinical Trial Development Challenges Overcome?”

Clinical Trial Development Challenges and What To Do About Them

A patient registry is a common study to gather data required by regulators, payers, and prescribers. 

There are three common challenges involved in performing an observational cohort clinical trial or patient registry: data ownership, data collected, and data entry. 

To overcome these challenges, ownership of data was given to the patient. Data can only be used with consent from the patient, which can also be withdrawn at any point. 

This outcome lets the patients feel like they have some control over what research is performed on the given dataset. All results and outcomes are transparent as well. 

Before an observation clinical study is performed, Real-World Evidence is planned out on a document with strategic objectives and factors the study is set to support. 

Once this is done, stakeholders are then selected through relevancy to the study. Prescribers are identified via desk research. 

The payers, however, are the easiest to identify.

The real challenge to overcome is unifying the planning process by putting Medical Affairs at the core. 

3 Key Points: 

1. The challenges involved with patient registry are all revolved around data. How it’s collected, entered, and who has ownership once it is collected.

2. Data creation revolves solely around the payers, regulators, and prescribers. Understanding the market plays a significant role as well.

3. The multi-stakeholder approach that’s been done in the past is not ideal, and coordination and unity are the way of the future for clinical trials. 

“If that mindset could be changed to a more coordinated and unified planning process, with Medical Affairs in the center, then I think we stand the best chance of providing each one of these stakeholders with the right evidence at the right time. This would avoid wasting time and resource in generating lots of individual items of evidence by the separate functions, that are limited in scope and don’t meet the full range of stakeholder needs efficiently.” – Ravi Jandhyala Consultant Pharmaceutical Physician at Medialis. 

Source: http://bit.ly/3d8rm1P

#ClinicalTrial, #ObservationalStudy, #DrugDevelopment

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