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10 keys to supplying global clinical trials

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Getting clinical trials right, and right the first time, is crucial for biopharma companies, especially as the cost of getting a drug to market is skyrocketing--a piece in Forbes estimates drug development costs have reached the eye-watering level of somewhere between $4 billion and $11 billion. R&D returns have therefore fallen drastically and are around half what they were 10 years ago, Ian Shott, managing director and principal consultant at Shott Consulting, explained to FierceBiotech: "Attrition is the overriding driver of cost, with a preclinical success rate of 0.01% and a success rate in the clinic of 10% or less."

The larger part of the cost of clinical-stage drug development comes from clinical trials. Phase II costs can range from $4,000-$20,000 per patient. So, the last thing a drug developer wants is any kind of interruption of a trial, or to have to start a trial all over again. These could delay a launch, which in the case of a blockbuster drug could mean thousands or millions of dollars a day in lost revenue.

Having a sufficient drug supply for the clinical trial is very important for the patient as well. Problems with manufacturing can affect patients' welfare; clinical trials can be vital stages in patients' treatment, especially those with advanced disease or with diseases for which there are few other available treatments.

Clinical trial supply isn't just an issue for investigational drugs. Some clinical trials compare the study drug against a placebo; however, others, particularly those for serious diseases for which it would be unethical to withdraw active treatment, compare with a marketed drug or another investigational drug. Other trials combine an investigational drug with another drug in a combination therapy. It's vital for these trials that there is a constant supply of the comparator or combination drug as well as the investigational drug. Maintaining this kind of reliable clinical trial supply needs a robust supply chain. -- Suzanne Elvidge (email)

Editor's note: This is an updated version of a special report published in May 2012 and has been made available on FierceBiotech's website for the first time. To view the original report, please click here.