Efficacy of clinical trials and generic drugs

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Published: 24 Jul 2013
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Dr William Wood – Emory University School of Medicine, Atlanta, USA

Dr William Wood talks to ecancer at the 2013 National Cancer Institute Directors Meeting (NCID 2013) in Lyon about clinical trial design and how there is a large need to provide more efficient trial designs.

As both low and high income countries are running out of funding for research, clinical trials are under more pressure to achieve results that will significantly improve treatment and lower cost. As a result of this growing challenge, the production of generic versions of drugs is taking longer and prompting trials that investigate if there is measurable difference between generic and branded agents.


Filming supported by the International Prevention Research Institute


We have had to do larger and larger and more and more expensive trials to deliver smaller and smaller benefits. And now we are running out of healthcare resources, not only in low income countries but in high income countries. The issue has to be not is something minimally better than something else but is there value in a change to something more expensive.

So what are the criteria that you would apply for a good clinical trial to do cancer research in a way which could maximise the benefit to cancer patients?

The trial has to show a very real benefit to make it worth doing. We have for years had to include people at almost no risk of failure because pharma insisted that the eligibility for the trial reflected the group to whom they hoped to sell their agents. We can get a very quick trial done with people at high risk and see if something is better.

What about agents which can get neglected because they’ve been overtaken by newer agents that are still not generic?

Great question. I believe that is essential to what we’re going to be doing in middle and low income countries. The decrement between what the most expensive programmes and protocols deliver and those that are radically less expensive is very slight, if it exists at all. So I’ve had to run trials of 10,000 women to detect a difference; how much will we pay for a difference that’s that slight?

In situations like Africa, because I know you’re concerned with places like Cameroon, Gabon, Ethiopia, Kenya, quite a few places, even maybe Tanzania soon, what sorts of criteria, what sort of trials are needed and for which cancers?

Very basic trials. We’re still gathering data on the absolute profiles of breast cancer patients, for example. The statements about the oestrogen receptor negativity being the majority probably aren’t true, at least in many of the countries. We’re doing trials that are showing that the majority of African women with breast cancer in Kenya, for example, are oestrogen receptor positive and will benefit from tamoxifen or aromatase inhibitors if they’re a little older.

So what’s your message to cancer doctors, then, about all of this? What can they do to help?

I think they need to begin, more than we have in the past, to demand value for change. That there has to be a clear improvement before we’re willing to take a larger part of the healthcare budget of any country and invest it in a new agent.

And which parts of the world do you think particularly could benefit from this? You do have this interest in low resource countries but is it across the board?

I do. It is. I think it’s worth spending a fortune and a lot of patients to detect a difference in a disease or a biological issue that we may be able to build on for the future. But to then suggest that a tiny improvement should be applied around the globe, or even across a nation, doesn’t make sense.

You had a lot of experience with the Breast Intergroup in co-ordinating things internationally. How do you think all of this can be done and how will big pharma co-operate?

I think big pharma will co-operate if they see that it’s in their interests to do so. This is a message that, through organisations like IPRI, is getting disseminated and becoming part of the belief structure of the leaders now in oncologic research.