Can we protect ourselves against $100 million of clinical trial mistakes?

time money

Let’s look at the greatest failures of last year’s clinical trials and consider where better processes could reduce the chances of defeat or of how much is written-down.

The ten clinical trials conducted in 2013 that resulted in most financial damage incurred costs of between $1.7 million (£1.0 million or 1.25 million euros by Ziopharm Oncology) and $525 million (£309 million or 385 million euros by Sanofi).

The findings, which were reported in Genetic Engineering and Biotechnology News, highlight that half (five) of the failed studies had been for cancer indications and that four were conducted after the licensing of a drug to a biopharma giant. Indications of the other products whose trials failed included rheumatoid arthritis, heart disease, depression and asthma.

So what went wrong?

In the majority of cases, the projects failed because the data did not meet the study’s primary endpoint. In the most devastating example, Sanofi measured the ability of benzamide (4-iodo-3-nitrobenzamide) to treat newly diagnosed, metastic (phase IV) squamous, non-small-cell lung cancer and platinum-resistant ovarian cancer when added to gemcitabine / carboplatin chemotherapy, compared with gemcitabine/carboplatin alone, in the Phase III ECLIPSE trial.

The top four Failure List of sponsors and products in order of increasing write-downs reads:

Client Product Therapeutic area Write-down
Sanofi Benzamide (4-iodo-3-nitrobenzamide) Newly diagnosed, metastatic (stage IV) squamous non-small-cell lung cancer and platinum-resistant ovarian cancer and platinum-resistant ovarian cancer $525 million
(£309 million or
385 million euros)
GSK Phase III STABILITY Oral inhibitor of lipoprotein-associated phospholipase A2 Major adverse cardiovascular event from composite of MI, stroke and cardiovascular death Postulated$255.7 million (£150 million or 187.6 million euros)
Merck & Co. Adenosine A2A receptor antagonist Parkinson’s disease Second quarter impairment charge: $181 million (132.8 million euros or £106.2 million).
AZ and Rigel Phase III OSKIRA-3 Fostamitinib plus methotrexate oral spleen tyrosine kinase inhibitor Rheumatoid arthritis $136 million pre-tax impairment
(£79.8 million or 99.8 million euros

Clearly, the cost of supporting these trials is vast and informed prevention would be invaluable.

Rescue / survival measures

Two product protection strategies reported include development of a compound in another indication and evaluation of the long-term maintenance effects of a treatment that fails to demonstrate strong improvements in priority endpoints.

Reflecting on the huge losses at stake, we wonder what the best survival strategies are that clinical trial specialists have employed to salvage investment after disappointing Phase III and Phase IV findings.

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