Beyond paper based PRO and now.. even beyond ePRO

Why should a sponsor look beyond ePRO?

It is a known fact that it take huge amount of capital, usually in billions of dollars to conduct and finally launch a dug into the market. It is also known that there are several studies that are either terminated or stopped half way due to several reasons technical and non-technical associated with it resulting in wastage of time and money both. Patient related data capture during a clinical trial plays an important role in the making of a drug. Through out the different phases of clinical trials information from patients are taken for efficacy, BA, BE measurements and make a considerable part of the trials or study. A lot of sponsors have been using ePRO to collect patient reported outcome, still makes only 30-40 % of studies being conducted using EDC and further less using ePRO.

It is time that sponsors look at more cost effective ways to gather PRO from subjects under trials and keep abreast with the pace of developing technologies. The next big wave in capturing PRO for clinical trials is the use of mobile phones and I am sure there are many a company that are working on it. Mobile phones are going to be the next computers that would enable users to manage all their communication and information transfer over mobile phones.

What can a sponsor look at from a mobile phone based PRO?

Well there are quite a few things for a Sponsor or for that matter a CRO to be looking at, when it comes to mobile based PRO system.

1. Faster reported outcome
2. Compliant to international regulatory bodies
3. Cost effective
4. Patient safety
5. Logistically simpler
6. Less erroneous data
7. Data integrity and security
8. New and improved features
9. An information management system that allows sponsors CROs to have instant access and action at different stages of the trial.