Clinical research trials involve lengthy processes that can cost huge amount of money in case of any error which can deviate the protocols, data integrity and drug safety. This makes the FDA approvals difficult and it cost 2.8 billion dollars to get one FDA approval that is called R&D spend. These are the reasons for costly drugs, hospitalization and pharmacies.
Clinical research trials take long durations of time and it’s very difficult to find patients according to the criteria of research trials and patient recruitment is getting harder. There are a lot of drivers for waste of cost and delays in getting new innovations in therapies to the patients
In present days, organizations pick sites around the world to run trials without confirming their efficiencies. They deliver all the drugs, physicians, required equipments and train those research sites according to the protocols and required study trials but finally, when it’s time to recruit patients for the trials, sites fail to fulfill their promise to recruit promised number of patients for the trials. This waste a lot of drugs and investment that is the huge driver of R&D cost.
• In order to overcome all the trial barriers and cost drivers, researchers are introducing new ways as precision enrollment.
In precision enrollment, when the sites are satisfied with all the protocols, study designs and medicines of the bio-tech company and express their ability to find suitable patients for this study trial. This is the moment to first enroll required number of patient for the study trials and then providing site with all the drugs, physicians, equipments and technology and trainings to the sites for conducting the study.
In this age of genetic medicine, researchers are opening research trials for the very specific therapies to specific patients with specific genetic makeups. For this purpose they first find that specific patient and then starting the study trial with few days.