Why clinical CROs hate eCRF systems – and why you should love them

Everything from banking to government services, from shopping to gambling has moved on-line in the past decade, yielding huge efficiency gains for suppliers and (for the most part) an improved experience for the customer.  Suppliers that have failed to adjust their business model are being slowly (or not slowly) ejected from the marketplace. Against this

Constructing better multivariate biomarker composites

The earliest biomarkers, such a body temperature or blood pressure, were single measurements that reflected multiple physiological processes.  Today, though, our reductionist approach to biology has turned up the resolution of our lens: we can measure levels of individual proteins, metabolites and nucleic acid species, opening the biomarker floodgates. But this increased resolution has not

The HDL myth: how misuse of biomarker data cost Roche and its investors $5billion

On May 7th 2012, Roche terminated the entire dal-HEART phase III programme looking at the effects of their CETP inhibitor dalcetrapib in patients with acute coronary syndrome.  The immediate cause was the report from the data management committee of the dal-OUTCOMES trial in 15,000 patients that there was now no chance of reporting a 15%

Combinatorial animal study designs

It is sometimes assumed that government regulations governing the use of animal models in drug development hamper good science, either by accident or design. But reality is rather different: focus on the 3Rs of replacement, reduction and refinement can lead to more reliable results, quicker, at lower cost and with improved animal welfare and reduced

The interleukin lottery: playing the odds on numbers 9 and 16

The interleukins are an odd family.  One name encompasses dozens of secreted proteins that are linked by function rather than by structure.  And even that common function is very broadly defined: cytokines that communicate between cells of the immune system. Defined in such a way, its perhaps not surprising that the interleukins have yielded some

Environmental Pollutants: Opening a Soup-Can of Worms

They are everywhere: so called ‘present organic pollutants’, or POPs for short.   Since almost all the everyday items that make modern life so much easier emerged from a chemical factory, its not surprising that environmental contamination with organic chemicals is increasing all the time – even ‘environmentally aware’ Western countries.  But maybe it will surprise

Smoke Screen: The intensifying debate about population screening generates more heat than light

If a test with prognostic value exists, should it be used for population screening? On the face of it, it’s a simple question, but it doesn’t have a simple answer.  Like most things in life, it depends on the context: how prevalent and how dangerous is the disease?  How invasive and how expensive is the

Personalized Medicine Demands Investment in Innovative Diagnostics: Will the Returns be High Enough?

Several very senior pharma executives were recently overhead by a journalist discussing what each of them viewed as the most important changes in the way healthcare will be delivered over the coming decade.  Each of them listed several such factors, including increased payor pressure on prices, the mounting regulatory burden and the shift toward orphan

Ultra-sensitive NMR-based diagnosis for infectious diseases: the tortoise races the hare again

Obtaining rapid and reliable diagnosis of infectious diseases is usually limited by the sensitivity of the detection technology.   Even in severe sepsis, accompanied by organ failure and admission to an intensive care unit, the causative organism is often present at a level of less than one bacterium per milliliter of blood.  Similarly, in candidiasis the

Chemokines as biomarkers for cancer: Time to revisit an old friend?

A wide-ranging study pre-published on-line in Nature last month points the finger at the chemokine CCL2 (also known as MCP-1, or JE in mice) as a key regulator of tumour metastasis.  Intriguingly, CCL2 seems to participate in the generation of clinically-relevant metastatic disease on multiple levels: it promotes seeding of the shed metastatic cells, but it

Total Scientific

Total Scientific Ltd. is a contract research organisation that specialises in biomarkers.

The use of biomarkers is playing an ever-increasing role in both the pre-clinical and clinical phases of drug discovery, as well as its more traditional role as a core activity for many diagnostic companies. From target identification and validation, through pre-clinical and early clinical phases, the ability to predict or follow drug effects in vivo can significantly reduce the cost and time taken to develop new drugs.