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International Clinical Trials

Editorial Comment

Developing new drugs, or old drugs for new indications, is all about running clinical trials. It is widely acknowledged that the current process is at best inefficient and, for the future economic health of the pharmaceutical industry, is in dire need of improvement. That being said, over the last 25 years, we have seen very little progress in the conduct of studies. What developments there have been have come as a result, to some extent, of electronic aids for design, management and reporting.

In this edition of ICT, we have a number of contributions which touch upon the impact of what one might call electronics in clinical trials. Evjatar Cohen at Appian discusses how mobility and collaboration might be key to ensuring high quality in studies. He highlights how mobile devices have become embedded in our daily lives; but, while the industry is committed to transforming trials electronically, only 14% report that they are fully migrated in all areas. Marc Desgrousilliers and Eric Morrie at ClinCapture regard digital technology as a way of streamlining data collection, transmission and monitoring, and review what is available on the market today. Dr Chris Watson at Exco InTouch also explores what sponsors and CROs can gain by implementing electronic technology advances.

Some time ago, a colleague of mine noted that the failure of a particular clinical trial in the US was due to the fact that the inclusion and exclusion criteria for the study meant that there were a total of only six eligible patients in the whole of the US. Tigran Arzumanov, Bernhard Bodenmann and Le Vin Chin at Clinerion compare the search for patients with suitable profiles to participate in clinical research with the proverbial search for the needle in the haystack. In their paper, they examine how electronic health records (EHRs) can significantly aid this process: companies that have access to such records are more capable of carrying out feasibility studies, and better at identifying patients and recruiting them. The challenge in such utilisation of EHRs is one of data protection, and I have noted a recent debate where patients seem more willing to share personal data on Facebook than they do when altruistically participating in clinical research.

Patient retention is always a challenge in clinical trials, even when enrolment has gone smoothly. As many as 30% of participants may drop out before the study is complete, according to Franc Jeffrey at EQ Travel. He observes that the logistics of travel and expense reimbursement to patients is yet another area of clinical trials which is beginning to be outsourced. He further claims that improved travel management can help reduce the number of patients that drop out of studies.

One of the reasons subjects may drop out is an unacceptable adverse event. The accurate identification and reporting of such events is a crucial part of the drug development process – it is little wonder, therefore, that the FDA has placed this area under increased scrutiny in the form of stricter pharmacovigilance (PV) regulations supported by inspections. Dr Mitchell Gandelman at Sciformix Corporation points out that failure in PV can have serious consequences for all stakeholders in the drug industry. Thus, all partners in the drug development process need to play an active role in PV. Dr Brian Edwards and Olga Björklund at NDA Group further reveal that the FDA is not satisfied with the quality of data in clinical trials, and they report on how the new FDA PV guidance is impacting on clinical safety data. What is more, a system-wide buy-in and implementation of guidelines is required to ensure efficient PV.

In this issue, we also have interesting contributions on clinical trial design for biosimilar testing and standard operating procedures. I hope you enjoy your summer reading.

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