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Building a trial ready cohort

12.10.2019 by Valérie Lizen

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

Implementing a solution to build a trial ready patient cohort or trial readiness cohort, for a top 10 pharmaceutical company (NDA). 

The Challenge

It is important and difficult to recruit so-called "active" patients to carry out a clinical study. An "active" patient is a patient who suffers from a chronic disease and who can provide current data on their condition at the time when symptoms arise.  

Crohn's disease is a good example of such a situation since it is a disease with unpredictable events. Indeed, the patient has the disease but the inflammation, if it happens, only occurs at a certain point in time, called a "flare-up". At that time, it is very important to detect the event and put the patient on a clinical trial as soon as possible. 

Being able to detect this precise moment in order to start a clinical study is very beneficial for the quality of the responses received and the follow-up of the patient. The goal of this project is to establish a patient cohort meeting a set of specific criteria, i.e. a group of patients in a position to be able to join a clinical study very quickly, as soon as specific symptoms appear. 

Our solution

The Andaman7 app is given to all Crohn's disease patients in the gastroenterology department of the partner hospital. Patients report the occurrence of various symptoms by completing a short questionnaire (e. g. level of pain, fever, blood in stool, etc.). If the inclusion criteria to activate the clinical study are present, the doctor and Andaman7 invite the patient to join the study and send him/her appropriate questionnaires. This type of solution is beneficial for the patient, the hospital, and the pharmaceutical company conducting the clinical study. 

  • Benefits or the patient: Patients are regularly monitored despite the fact that he or she is not at the care facility. They feel better supervised and reassured.
  • Benefits for the hospital: Better quality of care for patients without having to bring the patient to the hospital. To prevent hospitals and doctors from receiving too much direct information on patient status, we work with companies that specialize in processing information sent by patients so that there is a first filter. These external companies have developed real expertise and precise algorithms that allow the scoring of the patient's condition. The physician is then informed of the seriousness after the relevant information has been filtered. 
  • Benefit for the pharmaceutical company: This type of flare-up monitoring allows the establishment of a "patient ready cohort" and thus a real saving of time and cost for the study sponsor.   

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