More clinical trials a win-win for all

Carola Lemne, General Director of the Confederation of Swedish Enterprise, was Chairman of the recently concluded IVA project “Trails for Swedish Medicine.” The project was an initiative to turn the negative trend in Sweden around.

What sort of system do we need to increase the number of clinical trials in Sweden again? Finding the answer to this was a clear goal for the IVA project. More clinical studies would make winners out of all those involved.

“The healthcare system gets direct early access to the best medicines and equipment when we’re involved in the evaluation process. Patients benefit as well,” says Carola Lemne.

The standards of all care are raised at the participating clinics. Even patients that are not directly involved in the trials benefit from them.

 “The clinics have to work in a structured way and be up-do-date on the very latest in their treatment areas. This results in better quality across the board.”

For the pharmaceutical and medtech companies conducting the research, testing their discoveries on actual patients is, of course, absolutely critical if they are to be able to establish them in the market. Clinical studies are an essential tool for researchers at universities as well.

 “Since a lot is going on in this area, our project, launched in autumn 2012, started by finding out if there was anything that no one else was working on. And there was.”

The project participants represented researching companies, local authorities, healthcare and academia.

There is no simple fix to turn the trend around. Rather, numerous conditions need to be changed among all of the players involved. One of the most important areas of focus is promoting industry-financed pharmaceutical trials, an area that seen the biggest decline.

“The number of studies run by academics at universities or commissioned by county councils has not fallen as much.”

But there is a problem with academic-driven research. The things that complicate academic trials are essentially the same as those that complicate things for private sector clinical trials. It usually takes a long time before patients benefit from the results. Researchers publish their results and in many cases not a lot happens after that.

“Companies have another type of vested interest in turning knowledge into products or services. They want so see a return on their investment a soon as possible.”

Unfortunately, Sweden is no longer the home of some global, big pharma companies doing research.

“When they were in Sweden they conducted a lot of their trials here. However, the foreign-owned former Swedish companies have Swedish employees who would like to see more studies conducted here. They feel strongly for Sweden,” says Carola Lemne.

And there certainly is still enough pharmaceutical research going on in Sweden for it to be possible to have more trials here.

“The number of trials taking place globally is huge. Now we need to get international companies interested in Sweden.  It’s true that we can’t compete on price and the market is small – we can’t attract them that way. But if we can offer top notch quality across the board, it should be possible.”

“We should compete with high-class healthcare and we are well-positioned to do so. We have highly qualified researchers and healthcare professionals.”

The latter can, however, be slightly hesitant about working with companies in the industry.

“They’re afraid of not having enough time. It’s no longer self-evident that healthcare personnel should spend time on clinical trials, even if creating new knowledge and developing care is actually part of their mandate.”

Another of Sweden’s competitive advantages is the existence of comprehensive registers.

“If we are to succeed we need to cooperate at the national level. Also, Swedish patients have a positive attitude towards participating in medical studies. Confidence in the healthcare system is in general very high.”

 “I think we are in a strong position.”

The Swedish government commission report presented to the Government in December was entitled “Strengthen Together.”

“Within the framework of our project we should, of course, discuss in detail our position on the commission’s proposals. Personally, I think we can agree with it on many points. It was good timing that the commission coincided with our project.”

It is not sufficient for only the Minister for Education and research to act. The Ministries for Enterprise and Health and Social Affairs also have a stake in this.

“It makes the whole thing more complicated. The local authorities, the independent county councils as well as the universities and all of the healthcare producers have a stake in it as well.”

It’s not just drugs that need to be tested and quality assured before then can be released for use. The same applies to other forms of therapies and for medical equipment.

“The trial procedures for these are beginning to resemble the ones used for medicines. Invasive medical equipment is becoming increasingly common, and it needs to be thoroughly tested. This is slightly painful realisation for the companies producing it. Also, healthcare players are not as used to testing medical equipment in the same rigorous way as drugs.”

Another circumstance worth considering is whether private and public healthcare providers are equally willing to conduct clinical studies.

“As far as I know there are no statistics on this. A lot of trials are conducted at hospitals and St. Göran Hospital in Stockholm is the only private one. So that alone means there will be fewer studies conducted in the private sector.”

However, according to Carola both research and studies are being conducted in an effective way at St Göran Hospital.

In outpatient care there is much less research being carried out in general.

“My impression is that there is still relatively little research being done in private outpatient care. There are exceptions to this, like our own Stockholm Heart Center which has been active in advanced research for a long time. But unfortunately it’s not that common in either public or private outpatient care.”

The issue of businesses making profits in the healthcare sector is a hot political topic. According to Carola Lemne, there is no risk of this debate spilling over into the clinical trial issue.

“It hasn’t so far at least. Taking part in a clinical trial and testing new drugs under very organised and regulated conditions like this can, I believe, stand up to all conceivable scrutiny. It’s not the individuals conducting the tests that are compensated, but the clinics where they work. And most of the costs are covered so it seems unlikely that any problems will arise.”

Photographer: Daniel Roos