A clinical trial completed within six months: Making a hard task possible

Paul Duxbury

Interview with Paul Duxbury

 Managing DirectorNasaleze International Ltd

What is your experience with clinical trials?
We’ve been involved since 2003 when we formed the company. We realised that, if we wanted to be taken seriously, we needed evidence-based trial work.

Where did it begin?
An old family friend – Mike James – still comes to the factory. He was making a gel filled face mask for Body Shop. One of the ingredients was Nasaleze. During manufacturing, it created lots of dust but no one ever sneezed. His elder son was suffering from pollen allergy. When Mike administered it to his son’s nose, he stopped sneezing immediately. Mike is an inventor, not a marketing person. We came on the scene and took on the worldwide rites – that’s what brought us to using clinical trials to get people to take us seriously.

Other experience: We worked with a start-up guy called Peter Josling, then the Clinical Director of Herbal Research Centre in Battle, Sussex, and did a successful trial. In 2004/2005. We then contacted Jean Emberlin, then Director of the National Pollen and Aerobiology Research Unit at Worcester University. She thought Nasaleze was a great idea and led research into its value through four clinical trials.

You have had experience with running clinical trials in Western Europe and Eastern Europe. How would you compare your experiences?
The problem of clinical trials in the UK is the length of time taken to get approvals, for example from the ethics committee or NHS hospital’s R&D department. It’s a bureaucratic mess! The reason we became involved with Nik is that we had to do a research study for the FDA in six months. I realised in the UK it would probably take six months to get the ethics proposal submitted, let alone approved. From our first meeting at the end of November 2012 to June the following year, Nik had finalised the study and pulled in the results. The study was published in May 2014. If you spoke to most people today and asked for a start to finish clinical trial within six months – with proper ethics and regulatory approval – they’d laugh at you.

Some believe that placing studies in Eastern Europe is associated with higher risks. What is your impression of the quality of clinical trial data acquired in Eastern Europe/Ukraine specifically?
We’d done four in the UK, two in Greece, one in Sweden and four in Russia. We did one in the Ukraine with 108 patients. Sweden is also slow like the UK. It is tied down with red tape. The US is as bad as well. There is some suspicion over conducting trials in Eastern Europe. Many people believe that they are not always performed to the same standard as in the US. However, it depends a lot on the organization which runs your studies – Nik’s organization strictly follows FDA and EMA standards and rules, his staff are trained to work to the standards expected by international customers, and they have a robust quality management system in place. Also you get very senior doctors working on trials in countries like the Ukraine or Russia, which you don’t get in the UK because they think they are too important. I’m sure a lot more work will go on in these locations in future.

The most impressive thing for us about the Ukraine is patient compliance. There was only one drop-out in our trial, and reporting of results was close to 100%. In some countries, you can struggle to get patients, let alone 100% compliance. In Canada, a company I heard about couldn’t progress a study as it enrolled no patients. In Russia and the Ukraine, most people need to pay for their healthcare so they are really motivated and see it as a privilege to take part in clinical trials, which helps both recruitment and retention.

I’ve been to many academic sites in the UK, Sweden and the Ukraine, and to Nik’s office in the Ukraine. The thing I most remember about Nik’s office is his staff – they are superb. For example – one day, the study managers came into work after their holiday was cancelled due to problems when the phone system failed. They came in straight away and fixed the problem during the bank holiday weekend to prevent any loss of potential data.

Do you have any concerns about the effects of recent conflicts on clinical trials in Russia and the Ukraine?
As you say, politics has been quite hot recently in the Ukraine, with unrest in a couple of regions. It is understandable, as politically some of these countries have to go through a process of democratization, which many Western countries went through many years ago. A better political system will emerge when the dust settles. As far as I know all the projects that are being run by Clinical Accelerator in the Ukraine at the moment are progressing well, and their office is functioning as usual. Things should settle there (politically) soon.

Trials are also less costly in areas such as China and India; however, these are associated with less verified risks. What are your thoughts on that?
I’ve no experience in India and China, but I hear suspicious things. Nik was personally trained as a physician and clinical investigator in the NHS in the United Kingdom; he was a cardiologist at the University of Hull. He understands how the Western mind works and so can apply Western working practices in the Ukraine with low cost and investigators of high standard. A lot of people don’t understand Russia and the Ukraine. They don’t understand the high level of academic ability found there. There are significantly more doctors per capita of population in those countries than in most developed Western countries as well as a large number of academic institutions running both academic and commercial clinical research.

Clinical accelerator is an advocate of using proactive patient enrolment strategies to ensure timely study completion. What are your thoughts on that? 
That’s what it’s all about. If you don’t get the numbers and on time, you can’t do the study.

How did you first discover Nik?
I was very fortunate to meet him. We both attended a government meeting. They were trying to bolster the biomed sector within the Isle of Mann – it was pure chance.

Clinical Accelerator’s brand aims to highlight company’s strengths and to better differentiate itself from other CROs. Do you think it is the right message?
Yes. For people who don’t know how the Ukraine, Russia or other Eastern European countries work, it shows the strengths Nik’s organization provides through their work there.  

This entry was posted in Central and Eastern Europe, Clinical Accelerator, Patient Enrolment and tagged . Bookmark the permalink.

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