CROs in the driving seat when outlining research direction
The view at Vitafoods suggested CROs’ role was transitioning from a traditional support role to one that was setting the research agenda.
Dietary supplement and functional food companies now look to CROs to set the clinical trial standard taking lessons learnt from the pharmaceutical industry to strengthen the evidence of a health ingredient claim.
Offering an industry view of the CRO’s evolution, Dr Jérôme Le Bloch, scientific project manager in health and nutrition at NutraVeris, said today’s trial management was adapted from pharma standards, from the recruitment (blinding, randomisation, inclusion/exclusion criteria, sample size calculation, etc) to the final statistical analysis.
According to Dr Le Bloch, CROs specialising in “nutritional research” have increased the quality of their studies through the recruitment of experts.
It’s a view shared by Dr Volker Spitzer, managing director of analyse and realize, who believed that in the last few years a shift in trends has seen certain clinical trial types adopted to ensure a higher success rate.
“The quality needed is that of a double blind placebo-controlled trial because otherwise you’re not competitive in the market,” he explained.
“It’s mainly used for marketing purposes in the pharmaceutical circle, talking to consumers in a ‘nutra’ way because it’s not always easily possible due to regulatory constraints.”
Dr Spitzer touches on the business purposes behind investing in high-quality research.
Most European countries do not permit communication on clinical trials directly to consumers if no health claim has been approved by EFSA or the European Commission.
Therefore, firms have to find solutions to present positive results, but to be compliant with the regulation 1924/2006.
“In Europe, health claims are not the main goal of companies due to the difficulties in obtaining positive opinions,” said Dr Le Bloch.
“Companies still conduct trials. In fact this science is now mandatory in the business to business market. Only in a few cases will you find these trials are conducted to satisfy a health claim application.”
But with the need to satisfy health claims with a set of highly-focused clinical trials, does the drive to innovate and explore new directions concede?
Not necessarily so according to analyse and realize’s founder and chief scientific advisor, Dr Joerg Gruenwald.
“Sometimes clinical trials are too expensive to do basic research when finding out something new. So you go one step down and conduct more in-vitro and in-vivo studies. You can therefore check and plan new ingredients in a less expensive way.”
“This can be done through different models,” he continued. “What pathways does the ingredient influence or which hormonal system. So that can be found on that in-vitro/in-vivo level.“
The view from Vitafoods and its attendees suggests the ongoing uncertainty in the health claim arena has not helped relations between the industry and The European Food and Safety Authority (EFSA).
“It will not go away, their principles, which are very tough,” said Dr Spitzer. “They’ve even increased the principles previously claiming one clinical trial is enough and later saying two would be needed.”
“The relationship will not get better so long as they’re so straight in their approach.”
Dr Le Bloch added that EFSA were also closed to any discussion before the submission of an application.
Consequently it was not possible to validate a specific population or a marker prior to the submission.
“There is therefore always a doubt on the acceptability of a clinical trial by EFSA,”he said. “However, with experience, it’s possible to have a perfect knowledge of EFSA requirements and functioning.”
“For me, it’s essential in the future to work with partners in order to obtain positive opinions: the manufacturer, which has a perfect knowledge of the ingredient, with consultants who have the experience and perfectly known EFSA requirements, and a CRO which can conduct well-designed studies.”