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Fiona Jones talks to two clinical research scientists who have exchanged the familiar comforts of their native countries for unknown challenges abroad, and found it a thoroughly rewarding experience.  Both men initially found it hard to adjust to the fundamentally distinct approaches to work, but are now convinced that working abroad has been a positive experience leading to increased independence and receptivity to alternative working practices.


   
Fiona Jones - freelance medical writer. The unity arising from the formation of the European community is manifest in all areas, including harmonization of GCP, and the removal of employment barriers across Europe. These factors, combined with the accepted wisdom that foreign work experience is a desirable career asset, is facilitating a pan-European movement of clinical research staff. The facility of traveling between England to France in less than 2 hours by 'Le Shuttle' is resulting in many pharmaceutical companies in the South East of England conducting clinical studies in France. However, despite the ease of movement and the increasing standardization of working practices, inevitable cultural differences remain. These differences influence the human interactions, not described in SOPs, which are ultimately responsible for the efficiency and effectiveness of clinical research. Fiona Jones - freelance medical writer.
This article chronicles the experiences of a French clinician with the opportunity of working in England and an English clinical research scientist currently working in France. Two years later, both men have kindly agreed to share their experience with us. We look at how they have adapted to the change in their cultural environment and ask what have they learnt about working in another European country, and also what advice can they offer to anyone presented with a similar opportunity.

Background

In 1996, Tony Doyle lived in the industrial West Midlands and commuted weekly to Weybridge in Surrey where he was employed as a Research Manager for SmithKline Beecham Consumer Healthcare. Today he lives in a picturesque village in the heart of rural France and works as a Chargé d'Etudes en Pharmacocinétique Clinique for a French pharmaceutical company. In the same year Gilles Knecht swapped his rural French life, moving from the company's R&D site in France, where he was a Clinical Research Physician (Project Leader) to become their Medical Director at the company's Slough office.

What they do

Tony's role within the Clinical Pharmacokinetics Group includes all areas of phase I clinical study co-ordination, from protocol design to analyzing and reporting results. Gilles position is at the other end of the clinical trial process. He has a very broad responsibility including phase III and IV study management; pharmacovigilence; medical and regulatory affairs and marketing support. He also has input in training the medical sales force and validating promotional literature.

Why they moved

The reasons why Tony and Gilles decided to move are quite different. Tony applied to a job advertisement for a Clinical Study Manager to be based in Burgundy, France. His reasons for applying were two-fold. Firstly, from a career perspective, Tony wanted to work in ethical pharmaceuticals to complement his OTC experience and he thought that overseas experience would benefit his long-term employability. However, apart from the career considerations, Tony adds:

'…the idea of moving to France conjured up pleasant connotations, wine, food and clean air, and the element of adventure appealed to me. It seemed like a wonderful opportunity for me and my family to learn another language and to experience another culture.'

For Gilles the move was at the request of his employer who wanted to strengthen their medical group in Slough, in order to improve the company's position within the UK. The company wanted to improve links between the UK office and the parent company thereby reinforcing and strengthening their corporate culture.

Their main difficulty - the language barrier

The main difficulty experienced by both men was undoubtedly the language.

After what he refers to as a bilingual interview, 'Bonjour' in French and the remainder in the good English of his French hosts, Tony was successful in securing a permanent job offer. He then spent the next 3 months listening to tapes in the car and attending local evening classes. On his first day at work he quickly realised that he had overestimated his 'French at the Wheel' linguistic abilities.

'My French language classes and tapes had me perfectly prepared for ordering a meal at the company restaurant. The rest of the time I was completely lost. I couldn't understand a single word. It was very disorientating.'

His boss decided to ban the use of spoken English at work for the first year to enable him to get a grasp of the language. On reflection he feels that this was

'A smart move but a painful one.'

Scientific staff in the company all have English language training and are keen to practice and improve whenever the opportunity presents itself. Tony feels that given the chance at the early stages to speak English it would have been very difficult to make the transition to French. With the language difficulty, Tony describes his first 6 months as:

'……..working in a fog : I couldn't perceive more than an outline of what was happening around me, let alone discern the important nuances that one quickly establishes in English - nature of relationships, the ability to read between the lines etc. The fog gradually lifted as I learnt the sound of the language, yet speaking was still an effort and I noticed that I wasn't as effective as I was in England, especially in management and co-ordination activities.'

Thankfully for Tony most working documents; protocols, and study reports were in English. His attempts at mastering the language have also led to some embarrassing moments. When arranging an afternoon meeting with two female technicians attempts to book 'une chambre' (bedroom) instead of 'une salle' (in this case a conference room) were met with raised eyebrows.

Gilles had spent many years studying English and had frequently traveled between France and England attending meeting and conferences in English yet still the language barrier was his main obstacle. He found it extremely tiring working in English all day and found that his powers of concentration waned after a couple of hours. He felt frustrated at not being able to express his feelings, wanting to be more precise and accurate when giving advice or instruction.

'After a while I found that so many things in a language are irrelevant - there is always a lot going on around the main conversation. I concentrated on determining the real issues and, when necessary, asked people to repeat the key points. I tried to make it a positive thing. At the end of a discussion I summarized and repeated back what I thought I had understood. This took a little time but it avoided making costly mistakes.'

First impressions

Tony first impressions of working in France were how over-worked and stressed everyone was. He found the French extremely thorough with regard to their work and that they constantly checked and re-check everything. Any new thoughts or ideas then result in changes and more checking and double-checking. It appeared the French have difficulty saying no to making improvements, even if a piece of work is almost completed, they are quite willing and indeed expect to start all over again, if there is a new piece of data or idea to be incorporated. Obviously this makes formal project planning difficult, if not impossible. The French tend to 'backward plan' - if a deadline is set staff are prepared to work long hours to make it happen.

'I have had to adapt some of my working techniques, especially refining my time-management to offset the stress of a lengthy and unpredictable workload. I feel that now I have a more serious approach to the detail of the work and I realize it is not possible to check your work too much. It is the conduct of the study and not the deadline that is important.'

This thoroughness also applies to study audits. English study centers that have been audited by Tony's French colleagues have commented to him that they have never been audited in such detail.

In addition to being serious about their work the French are also serious about their holidays. French holidays are traditionally taken between the 14th July and the beginning of September (la rentrée) for at least three weeks and many businesses close down entirely for the month of August. In May there are up to 4 public holidays and where the holiday falls on a Tuesday or Thursday the day before or after are often also declared as holidays (faire le pont). This cultural difference must be taken into account when conducting clinical studies in France. The recruitment of volunteers or patients especially during the month August is virtually impossible and it may also be more difficult to find CROs that fully operative during this period. The month of May often brings logistical problems in arranging shipments of supplies and a careful record of public holidays (jour feriés) and any corresponding 'bridge days' (jour pont) must be kept.

Gilles was surprised at how totally different the French and English are in their approach to work. He found the English to be totally 'monotasked'.

'People want to work on one thing at a time and finish it before starting the next. They don't like to be disturbed when they are concentrating on something. This isn't how I am, I don't think it is how the French are - but it's been good for me. I think it's a more professional approach and I have tried to adapt a little.'

He finds that the English like to work to a strict framework. They like a set of rules and they like to apply them. Gilles feels that the whole concept of GCP with guidelines and regulations is compatible to the English way of working.

'Before doing anything I am asked: "Where is it written ?" "Where is it published ?" "Show me the guidelines !" It is a good way to be when working in clinical research and very professional. I think the French are more creative and like to be freer to work without the restrictions of a written framework.'

One of the concepts that Gilles has had to adapt to is the 'gentleman's agreement'.

'When there are no formal rules or laws, the English are able to create an unwritten and unspoken code of working. This does not exist in France and it is very strange to me. It occurs not only between friends and colleagues but through all areas of business including the Government. One example is the PPRS (pharmaceutical pricing regulation scheme). This kind of arrangement would be absolutely unthinkable in France ! There are many things that are not regulated in England but yet everyone seems to know the unwritten laws and how to apply them. These practices are very difficult for a French person to understand.'

Management

Tony has found that there is a more hierarchical system operating in France with regard to staff structure and working relationship.

'The differences that used to operate in England in the 50's and 60's between blue and white colour workers are very evident in France today. There is less contact between management and non-management and different rules apply for their working hours and conditions. It is also more difficult for non-cadre to progress within French companies.'

Gilles has also noticed this difference.

'In England staff at all levels are willing to speak out to senior management, to explain that there is a problem with a study or that they are unhappy about their salary or working conditions. It may not be what you want to hear but in the long term it's a good thing. I think that French employees are much more reserved and diffident to management.'

Company culture

Gilles feels he was very lucky being able to move from France to England while remaining working for the same company. He feels it was a great support being able to remain in contact with his former colleagues and also having the continuity of company culture. He was also lucky in that his company had previously expatriated four other colleagues from France to England so he was able to share a joke in French and learn from others' experiences.

'I think it would be more difficult if you change countries and company at the same time.'

Tony is in agreement.

'In addition to the changes in your living conditions, you are an unknown to the company. You have to prove yourself and that’s difficult when you don't speak the same language.'

Clinical Trial Conduct

The ICH GCP guidelines are not intended to impose stringent requirements but exist to provide a framework within which to operate. Within the guidelines member countries can adapt and impose their own standards. As a result several differences remain between France and England when conducting clinical studies. For example, the CTX (Clinical Trial Exemption) system does not operate in France. Gilles had experience of CTX's before moving to England and is quite comfortable with the idea.

'Although it takes a little longer, the CTX system is useful as by formalizing the application you prepare a detailed document which is useful later on.'

However, when asked about the system of 'Ethics Committees in England', Gilles was emphatic.

'In France we have a Central Ethics Committee, no matter how many study sites there are for a study you only have to submit to the central committee and to gain approval. The system is simple and effective. In the UK when we conduct a multi-centre study in less than 5 centers it is necessary to submit the protocol and to gain approval from each of the centers. When there are 5 or more centers we must first submit to the relevant MREC (multicentre research ethics committee) and then to each of the LREC's (Local Research Ethics Commitees) involved in the study. The system is too complicated and can take too long. Another problem arises if you receive approval from the MREC but get a rejection from one of the LREC - the rule in this situation is not clear.'

Gilles has found that there are many benefits in conducting clinical research in the British NHS.

'Employment laws mean that it is easier in the UK to pay a hospital department to recruit a Clinical Research Fellow to conduct a study. This system works very well, it means you have a dedicated specialist on site. This makes it easier to manage a study and also aids the recruitment of patients.'

Tony referred to the 'thoroughness of the French' and the trait is found in aspects of their clinical study procedures.

'For phase I studies in France the details of all participating volunteers are kept in a centralized file. This information includes the number of studies a volunteer has participated in and the amount of money earned, which is limited to 25,000FF per year. The aim of this system is to protect the volunteer and to ensure that a correct washout period is maintained between studies and also to prevent participation in two studies at the same time. It's an effective system that seems to work well.'

Some clinical research professionals' feel that there is more red-tape to be negotiated before conducting phase I clinical studies in France. Tony believes that at the moment this is not true.

'The main regulatory hurdle is the 'Déclaration d'Intention' which must be submitted to the French ministry after Ethics Committee approval has been received. It is not necessary to wait for a reply before commencing the study and the submission of the document is easily handled. However, there is talk of this procedure changing so that a response to 'la declaration' will be required to authorize commencement of the study. Fears are that the culture within the ministry are such that staff will find problems in applications and that such a system will become a real burden. Certainly CROs performing phase I studies see this as a real threat to their activities.'

Working conditions

Despite the insistence on following procedures, maintaining management-non-management differences and working extremely hard, the French take a much more relaxed approach when it comes to their expectations of working conditions. The large office suite with leather chair and mahogany desk are not a common site in France for even the highest level of management. Company cars are also strictly reserved for those with a definite need. However when it comes to the social and medical conditions provided by the government both men whole-heartedly agree that conditions in France are superior.

Would they do it again

When asked would they do it again both men are unanimous. Tony believes it was the best move he has made both in terms of his career and for his family. For Gilles the answer is also a definite 'YES !'. Gilles believes that working abroad, away from the comfort of his usual environment, has made him more independent and open to new ideas and different ways of working.

'There are of course times when it is very difficult. It is impossible to explain the disruption to your family life. Overnight everything changes and you find yourself a foreigner in a strange land. We left our home, our friends and family and my wife Carol also left her job as a psychiatrist. She had to make all the effort to integrate our family into England but without any of the immediate benefits. Luckily for me Carol was incredibly supportive. In fact through her great efforts, she now speaks English very well and has obtained work at a private practice treating French people living in London. I am very proud of her.'

Tony understands this sentiment.

'When you are working, you are immediately surrounded by people and you have a role to fulfill. It is difficult for the rest of your family they have to give up a lot and the rewards are not as immediate. I was lucky there were individuals within the organization who were very understanding and where able to help my wife obtain work. That made a big difference in making our move a success. If a foreign move is to be successful the whole family has to work hard at it. Companies must realize that they are relocating a family not just one employee. If they want a good return for their investment, it is essential for them to ensure that the employee's family is happy.'

Their advice

Tony's advice for anyone considering a move from England to France is:

'Don't be surprised by anything and don't expect it to be easy ! Read everything you about living and working in France, speak French to anyone who will listen to you and be prepared to work very hard. American management writers advise us to develop by stepping out of our 'comfort zone' and this is one way to step right out of it ! Keeping a sense of humor and a positive attitude greatly helps a successful integration.'

Gilles says:

'I can only speak of London, but if you get the opportunity take it ! London is a fantastic place to be right now and there are a lot of opportunities in the area of clinical research.'


 

 
 
 
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