In praise of academic cancer treatment studies

roger Wilson

Guest blogger – Roger Wilson, Honorary President of Sarcoma Patients Euronet

 

 

 

 

 

 

 

 

 

As a patient working in cancer research for over ten years now, one thing has slowly become more and more apparent.

 

The greatest patient benefit accrues from studies which are academically led. A

bold statement which needs a bit of unpicking.

 

Pharmaceutically led studies dominate our attention because of the scale of

investment and the power of the public relations team. They may well be led by

talented academic clinicians but the protocol has been driven by commercial

requirements even if it is an early phase study. The reality is that larger and

larger amounts of money are being committed to studies which benefit fewer

and fewer patients.

 

I am not decrying all that effort. My personal view is that if a new drug can

benefit just one patient let us have that drug. However I don’t have deep

pockets, any more than any healthcare system does, so that principle has some

weaknesses – as does the current pharmaceutical business model.

 

Beyond numeric significance

Academically led studies, which draw funding from government, charities or

philanthropic sources, may have a component from pharma providing free

access to drugs. These studies can also draw on treatments more widely

available in the market such as generic versions of previously patented drugs.

 

Academic studies will be seeking to find better ways of treating patients using

more clinically relevant outcomes and taking fuller account of the whole patient.

They are not seeking solely to identify the numeric significance of a treatment.

This sets academic studies apart from highly publicised drug studies with

registration objectives.

 

The EORTC (a charity) is an important provider of academic studies. The

European Commission is funding studies through its R&D programme.

Governments support studies, often providing funding to a university hospital.

An important source for such studies is the UK, where local funding from Cancer

Research UK is a critical component. Occasionally one trial will stand out.

 

Two extra years from an off-patent drug

STAMPEDE is a ‘basket’ study looking at a range of drugs in treating advanced

prostate cancer. It is a 7,000 patient multi-arm study. It could not be run by

pharma. Its first results published at ASCO 2015 looked at docetaxel, which is

now off patent. The drug was given earlier than it is in current practice. An OS

(overall survival) improvement of 24% and ‘failure free’ survival of 38%

translates into significant clinical benefit, improving patient longevity by a

median of just under two years.

 

The Chief Investigator, Professor Nick James from University of Warwick, said

“Our headline conclusion would be that docetaxel should be considered as

routine practice in men with newly diagnosed metastatic disease. With non-

metastatic disease, there remains uncertainty as to whether there’s a survival

benefit or not but it certainly improves failure-free survival by a substantial

amount.”

 

Pharma company researchers would give their right arms for results like that in

a cohort of patients as large as this. It will change clinical practice without

truckloads of expensive documentation being required by EMA.

 

So let’s pay more attention to academic studies. They can change things in big

ways and have the potential to provide patient benefit far beyond the seemingly

eternal procession of pharma company registration studies targeting smaller and

smaller cohorts of patients.

Roger Wilson blogs at http://rogerwilson.me.uk/

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