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Returning data to patients after a clinical trial

12.10.2019 by Valérie Lizen
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Andaman7 is a digital and multi-pathology health platform that offers solutions for healthcare stakeholders in the broadest sense: research institutions, pharmaceutical companies, medical device manufacturers, hospitals, doctors, medical laboratories, patient associations and health professionals. 

Description

With a top 10 pharmaceutical company (NDA), Andaman7 implemented a solution to return both individual clinical data and lay patient summary results to patients who participated in a clinical study.

The FDA (Food and Drug Administration) and the EMA (European Medicines Agency) are encouraging greater respect for patients when they participate in clinical studies. One way to achieve this is by returning the health data that was collected from patients back to them at the end of the study. 

The Challenge

With this project, we were faced with three major challenges:

  1. Determining which data to return and how to present it to the patient in an easy, understandable and usable way. Study sponsors want to return both individual clinical data and a lay patient summary of the study results. 
  2. Pharmaceutical companies do not have a way to identify or contact patients. So we set up an easy way for sites to correlate the subject ID with the subject’s email.
  3. Sponsors want to keep principal investigators in the loop to maintain good relations. We designed a simple training for the PIs and developed ways for them to interact with the patients so patients can receive their data in Andaman7’s mobile health record app.

Our solution

Andaman7 solves each of these challenges in a very patient, provider, sponsor, and regulator friendly way. The fundamental principle of the Andaman7 platform is a global and complete solution which covers patient’s needs, allows clinical studies to be carried out and better supports patients by exchanging relevant data with them. 

To meet this request, Andaman7 pseudonymizes the data. This makes it possible to link the information of the same patient while preserving his anonymity.

We have implemented this solution in two languages (English and German) and in two countries (United States and Germany). The Andaman7 platform is ideal for global study sponsors since it is available in 22 languages and is GDPR and HIPAA compliant.

The study results summary is returned to the patient in the form of a PDF document while the patient's individual data are returned as structured data where possible. Unstructured data such as images, notes, and letters can also be shared using the Andaman7 health record platform.

The benefits of using Andaman7 for returning study data to patients are numerous: 

  • Better patient engagement,
  • Patients are more motivated to contribute to the studies because they know that they will receive their data in return as well as the study results summary,
  • Greater transparency for the pharmaceutical sector,
  • Compliance with Federal laws and regulations. 

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