Costly Protocols Unnecessary? How much you gain by cutting them out of your clinical development

In Clinical Trials, Drug Safety, Regulation and Compliance by Simon Crompton-Reid1 Comment

Medidata and Tufts University School of Medicine have recently concluded in their report that unnecessary procedures in clinical trials costs the industry up to $5bn a year.

Does this call for changes in the way protocols are formulated? But which self-respecting individual would risk undermining his team's years of efforts in the different phases of clinical trials by carrying out fewer procedures and endangering the chances of drug approval positive rating by the country's FDA all because of insufficient information due to the lack of processes conducted?

The costs have been rising steadily over the past decades when it comes to conducting clinical trials be it in the States, EU or APAC so this is definitely a cause for concern regardless of the size of your R&D budget. It is an indisputable fact that innovation is of critical importance in the pharmaceutical industry. Yet the notorious black-hole nature of R&D work in pharmas does not encourage business leaders' excitement towards innovation. It is a necessity, no longer a passion because big pharmas have to answer to their shareholders and plug their drying pipelines. Saving the world is still the rule of the day but heck, who cares about that when your company is collapsing and you might be about to lose your job?

That may sound a bit extreme but we have to really think about what we can do now to avoid going down that road. Let’s seriously reassess our clinical programmes – are we focusing on the right issues? Or are there more important factors that we have failed to see? Such studies aid our decisions in focusing on important factors or to guide us in eliminating them in our considerations. So let's not treat these articles as light reading materials but really consider the value they have to improving our clinical programmes and eventually, help us make our way towards truly saving our fellow man from the pain of diseases and death.

Check out FierceCRO’s statement on the study here

Let us know what you think of this topic! Post your comments below.

At Pharma Trials World Asia at the BioPharma Asia Convention 2013 on 19 – 20 Mar 2013 in Singapore, we will be discussing similar issues in our dedicated session on Pharmacovigilance & Drug Safety. Find out more about the event at our website today!

Comments

  1. KOUNG

    We should manage new and low cost protocol and procedure and discuss in panel expertise.

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