New regulations from the EU could both help and hinder European companies performing clinical trials. Some new legislation, intended in theory to integrate regulations, should help, although there are concerns about how it will increase delivery times. At the same time, there is an attempt to combat the trend towards industry sponsors hiding unfavourable results, by mandating that all trial outcomes are published in a short amount of time. However, this raises industry concerns over privacy and intellectual property, potentially making Europe a less attractive place for clinical trials in early drug development.
Appletree CI Group is a specialised contract service organisation (CSO), offering services in clinical research and regulatory affairs. Appletree is the only contract research organisation (CRO) in Europe that has a combined expertise in medical devices and ophthalmology. Alongside these areas, Appletree focuses on the development of dermatological medicines, as well as on paediatric investigations. European CEO spoke with Georg Mathis, President and CEO of Appletree, to talk about the changes to the clinical trial industry in Europe.
Continued education of staff, on and off the job, is a must for any service provider in order to credibly advertise its expertise
How do you see the legislative landscape for clinical research in the EU changing?
Generally, the requirements on clinical data quality are changing, but also the exigencies for proof of efficacy and the safety of potential medical therapies have been constantly growing over the past two decades. The new Clinical Trial Regulation (536/2014), which is expected to come into effect late next year, will have dramatic implications on how clinical trials are authorised and regulated within the EU. For the first time since 1996, the ICH Good Clinical Practice Guideline, the de-facto constitution of clinical research, is being updated, with an emphasis on clarification and enforcement of the rights and duties of clinical trial stakeholders, such as patients, investigators, authorities and industry sponsors.
The new regulation, which replaces the current EU directive, will elevate the standards for the development of medical devices. An important commercial area which is impacted by the upcoming Clinical Trial Regulation is transparency of clinical trial outcomes. Industry sponsors of clinical trials are being suspected of hiding unfavourable outcomes and only publishing positive data. To counter this, the legislation requires the publication of any and all trial outcomes within relatively short timeframes, which may conflict with the innovator industry’s intellectual property and confidentiality rights.
What impact does this have on clinical trials undertaken in Europe?
There is a general notion that clinical research in Europe is losing ground when compared to other areas, including the US. One reason for this is the fragmentation of the clinical trial authorisation process, whereby multinational trials are still regulated country by country. The new Clinical Trial Regulation attempts to improve this by implementing a mandatory, centralised electronic authorisation submission procedure, and by coordinating the clinical trial review process within the EU. However, authorisation will remain the responsibility of the individual countries.
The process leaves the impression of being rather tedious and inflexible, with extremely short response timelines for applicants. Given the complexity of the process, the industry is afraid that clinical trial authorisations may take significantly longer than they do now. It is doubtful that this aspect of the legislation will increase the attractiveness of Europe as a clinical research destination. If transparency rules are implemented as planned, they may even lead to the industry avoiding Europe for early clinical development. As far as medical device manufacturers are concerned, the new Medical Device Regulation will result in increased development expenditure and duration, leading to higher production costs. While the intention of all these legislative initiatives is laudably to further product quality and improve patient protection, from a European industry perspective, a fair balance between these objectives and the corresponding burden on product development should be struck.
What advantage is there to outsourcing regulatory advice, as opposed to using in-house advisors?
The advantage of using external consultants, be they regulatory, clinical or in any other area, is that these individuals (by virtue of their work with multiple clients and products in different stages of their lifecycle) are bound to have broader experience and more in-depth expertise than in-house staff, who often work on few products within a limited area of indication.
Continued education of staff, on and off the job, is a must for any service provider in order to credibly advertise its expertise. Education may not always be of the same high priority for in-house staff. Furthermore, small and medium-sized companies often choose to rely on external expertise from the beginning. Thus, without any prior investment they have access to highly qualified staff and they can choose the provider depending on their needs. Larger companies usually resort to service providers in peak times, when their resources are exhausted.
What services does the Appletree CI Group offer to its clients?
In the context of clinical research, we are focusing on two specific areas of expertise: ophthalmology and medical device development. Our scope includes all activities, from planning to implementation, as well as performance and evaluation of clinical trials. We also have a subsidiary focusing on data management and biostatistics. We offer the entire spectrum of regulatory activities, with an emphasis on Europe with global support as requested. Appletree is organised around projects with dedicated project leaders and multinational teams. This structure is very flexible, adaptable and will be tailored to the client’s specifications.
What sets the Appletree CI Group apart from rivals in the field?
We have followed a niche strategy from our foundation and focused on areas which are underserved in the pharmaceutical and biotech industry. We never claim to be a full-service CRO, which many of our competitors (often unjustifiably) do, but we always specify clearly what we are able to do and what we are not, to the extent of refusing services we do not feel fully competent to provide. We are recognised as the number-one destination in Europe for clinical research and consulting services in all areas of ophthalmology, as well as experts in medical device development and regulatory affairs. We are a small but multinational organisation, firmly rooted in the countries we provide services in, a claim which none of our direct competitors can make. Our well-established Swiss label of quality, together with our multinational presence, is unique.
What does the future look like for the industry?
It is well known that the healthcare industry is under enormous cost pressure. Services not considered essential are increasingly being outsourced – an attractive option from a cost perspective. Thus, the demand for CRO services will continue to increase globally. The pharmaceutical and biotech services industries are, at present, growing faster than the industries they serve. Naturally, this beneficial market environment for service providers results in rather high competitive pressure among them. However, competition stimulates the market and is welcome, at least to Appletree