How can we master the current and future challenges of personalized medicine? (Part 3/4)

TCN® Technologies

In terms of patient recruitment for clinical trials, the approach of personalized medicine represents among others:

  • a special challenge for data protection, since the genotype information of each patient is of a particularly volatile nature and requires extreme safeguards
  • an increase in the amount of data that is collected and analyzed in each study, because the diagnostic information alone can be very complex and comprehensive
  • a more complex patient selection, since a lot of information gathered from diagnostics and lab results could complicate the recruitment
  • a challenge for doctors and patients in terms of communication regarding the clinical trial: what criteria do I mention to the patient, so that not too many ineligible patients are unnecessarily approached, but as many eligible patients as possible are being informed. etc.

This is why it will be crucial for pharmaceutical companies in this field to run an extremely effective patient recruitment in order to keep the cost of clinical trials, which represent one of the largest items in the development of a new drug, under control.

First, we need a high-performance software system that can store these extensive data volumes in need of special protection absolutely safely. Furthermore, we need highly sensitive communications in dealing with each patient, which includes the development of professional, customized tools for providing information about the given clinical trial. If necessary, this may require cultural adaptation if the study is to be conducted internationally.

Before we address the important issue of communication in another blog, we want to report on the TCN® system, which is a possible solution to the current and future challenges in patient recruitment for clinical trials. This system allows very large amounts of data collected in the process of patient recruitment to be managed and analyzed in an extremely transparent manner and in real time, in order to get a crystal clear view of the latest recruitment information at any time. One can, for example, find out in one step if further efforts are necessary or useful to achieve the recruitment goals on time, or if a sufficient number of patients are already included in the study.

TrialCentralNet<sup>SM</sup> (TCN®): The highly professional web-based system for effective patient recruitment

The question is: How can we manage the recruitment campaign for a clinical study as efficiently as possible, especially in view of the fact that more and more data will be collected in future? On the one hand, certain information collected as part of the campaign has to be shared within defined groups, on the other hand, other data must only be made available to certain people, but all information must be protected with the utmost security. The management of all information having to do with patient recruitment alone is already a major challenge.

Many years ago, BBK's partner TCN Technologies developed the TCN® system (TrialCentralNet<sup>SM</sup>) to meet this challenge and to be able to optimally control and monitor the campaign- from planning to implementation and reporting. In a first step, the software is customized so that the roles and rights of all parties involved in the campaign are defined. Whether sponsor, CRO or SMO: every person in all groups involved has his/her own insight in "his/her" TCN® , so that he/she can enter and view exactly the data that is needed - but not any other.

The complete data are centrally collected and managed in the system and may at any time be analyzed and monitored by defined individuals in real time according to highly specific criteria. This makes it possible to take the latest developments in the campaign into account and, if necessary, to decide whether the strategy concerning media planning and the selection of study centers needs to be adapted to bring the campaign to a successful conclusion. The fact that the software is highly customizable is also evidenced by the many possibilities to include additional features on request.

The system also simplifies the implementation of international campaigns significantly, since it allows for an extremely transparent management of all the necessary tools, including versioning for any country and in any language. The TCN® system has been used successfully for years in numerous recruitment campaigns and, as we have seen, the trend towards personalized medicine will probably make the use of such systems inevitable, since the amount of data - in terms of the data in the pre-screener and the information concerning diagnoses and diagnostic tests alone - will pose an even greater challenge, which this system can manage transparently and with great security.

Autor: Cécilia Mesa, 16.04.2014