The event attracted over 100 participants, including representatives of Polish hospitals, the pharmaceutical regulatory authority, the Ministry of Health, pharmaceutical industry and clinical trials associations.
If innovative medicines are to reach patients quickly, they must undergo a series of clinical trials to ensure their safety and efficacy. It is crucial that these clinical trials are conducted efficiently – and quickly. The CEO of the National Institute of Clinical Research, Dr Jonathan Sheffield, came to Poland to describe how clinical trials are organised and supervised in the UK.
He said that healthcare is a profession with a short knowledge half-life – around seven years. Much of what he learnt at medical school is now out of date, he said, supplanted by new learning. This makes it extremely important that the process of conducting clinical trials be made as effective as possible.
Dr Sheffield explained that it takes on average 17 years for a new medicine to make the journey from lab bench to patient. He contrasted this with an example from the motor industry; “Toyota cut time from blueprint to showroom from nine years to nine months,” he said. His goal was to do everything possible to speed up the process in the life-sciences industry.
Dr Sheffield said that an important part of the process was to cut the time taken to obtain all the necessary permissions to begin a clinical trial. In England, this time has been reduced significantly, and now, in the first quarter of 2015,s it is 21 working days (down from 115 days). In Poland, the meeting heard, it currently takes an average of 126 working days. The secret of the UK’s success in speeding up trial start-up times has been to apply the principles of lean manufacturing to the process, moving from a serial approach, where each step is only begun after the last one has been completed, to a parallel one, where several steps are carried out at the same time, he said.
As a result of a number of steps taken to improve the process, and to communicate the important of clinical trials to patients and doctors, the decline seen in clinical trials in the 1990s and 2000s has been halted. In terms of performance in setting up trials, the UK has advanced from 13th place in Europe to second. Three million patients have engaged in trials over the past eight years.
Dr Sheffield explained that in future, it will become much harder to organise clinical trials, as the increasing focus on personalised medicines, narrowed down by patients’ gene variant, will mean that the typical hospital ward may only have one or two patients with the same disease group. To ensure effective, statistically significant trials, there needs to be much tighter networking, closer links between academics and doctors and a collaborative approach. “From four types of breast cancer, we now have 17 – a far more specific target”, he said.
He talked about the importance of hospital intelligence, the nationwide network of 2,500 principal investigators and how vital it is to break down barriers and share responsibility between the pharmaceutical industry and medical profession to ensure joint delivery of trials. Dr Sheffield mentioned the tripartite monthly teleconferences held during trials, involving the NHS, clinical research organisations and the pharmaceutical companies.
Dr Sheffield explained the need to look at disease incidence in order to identify where to conduct trials. Databases of all English general practitioners (GPs – family doctors) link records of 55m anonymised patients. He also spoke about the OK To Ask campaign, targeting patients, informing them that they should ask whether or not there was a clinical trial available for their particular illness. This has helped boost awareness of the importance of trials as being a public good as well as giving patients the chance to be treated with the very latest generation of medications.
The OK To Ask campaign has also prompted doctors and nurses – who are traditionally very protective of their patients – to listen carefully to them. “Patient groups offer huge insight into their conditions,” said Dr Sheffield. He mentioned sufferers of rheumatoid arthritis, who surprised the medical establishment by saying that currently, their number one problem was no longer pain nor mobility – but rather chronic fatigue. Dialogue with patient groups is helping pharmaceutical companies focus on real needs, he said.
Dr Michał Gryz, director of the Department for Inspections of Medicinal Products and Medical Devices, at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, presented the statistics for clinical trials in Poland, showing a clear downward trend as well as showing that non-commercial trials are a rarity.
The Polish researchers’ perspective was presented by Prof Jan Lubiński, from the Szczecin Medical University and Read-Gene S.A. Prof Lubiński highlighted the fact that Poles are a significant group of patients for medical researchers because of the high degree of ethnic and thus genetically homogeneity.
Sophie Gillmore clinical research manager, AstraZeneca UK, said that clinical trials are important for a nation’s wealth as well as its health. “The Government recognises that 22% of all R&D activity carried out in the UK is in the pharmaceutical sector.” As a result, the Government is doing what it can to attract innovative pharmaceutical companies to the UK. One of the tools used for this is the Patent Box, which allows companies with patented technologies to pay corporate income tax at half of the normal rate.
Ms Gillmore stated that doctors and nurses should see research as part of their day job, rather than an add-on that interferes with their daily routines. She mentioned the importance of transparency in clinical trials, so patients, healthcare professionals and researchers all have the ability to check online how well a given clinical trial is going. She also stressed the importance of the NIHR’s training programme for clinical trials, as well as the fact that standard contracts exist, which help speed up the process of implementing trials.
Ms Gillmore also mentioned accountability to performance, the existence of an integrated ethics agency and targeting monitoring of trials. Trust between investigator and doctors and nurses helps ensure consistency and clarity, she said. She covered the important issue of what happens when a trial ends, and a patient who has been responding well to the new medication has to be taken off it. In the UK, there is continued access to medication – the Compassionate Use programme covers the period between the end of the trial and the introduction of the new medicine as an approved product on the market.
After a presentation about the realities on the ground faced by AstraZeneca researchers conducting clinical trials in Poland, by Marcin Borycki, Clinical Research Director at AstraZeneca Pharma Poland, all the speakers took part in a panel discussion in which they were joined by Dr Marek Świerczyński, who leads the Pharmaceutical Practice Group at Baker & McKenzie in Warsaw. The panel took questions and comments from the floor. The meeting concluded with a networking lunch, offering an opportunity for an exchange of business cards between researchers, hospital administrators and regulators.
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