P rof. Adam Cohen is director of the Centre for Human Drug Research (CHDR) in Leiden, the Netherlands. CHDR provides consultancy to pharmaceutical industries, with special emphasis on early drug development. Cohen also teaches clinical pharmacology at Leiden University and is the executive editor of the British Journal of Clinical Pharmacology as well as a member of the central ethics committee of the Netherlands.

The Centre for Human Drug Research (CHDR) in Leiden, the Netherlands, is a nonprofit organisation created in 1987 to promote research with new medicines in Leiden. Clinical research in general and with new medicines in particular is a highly regulated area of research.

The regulation is there to protect patients and research subjects against risks of the research but also to ensure integrity of the data that may be used for the marketing approval for these new drugs. At CHDR we perform early studies with new drugs. There are many organisations that do this--some of them are very large (10,000-plus employees). They are called Contract Research Organisations (CRO's). CHDR is a specialised CRO but unusually with a very strong academic involvement. This is demonstrated by the fact that we publish virtually all our work and a regular stream of PhD graduates leaves our organisation. In addition to the performance of studies we also advise many pharmaceutical companies about the early development of their new compounds. In addition we are responsible for teaching pharmacology to medical students.

My own involvement in this area was more or less logical. I studied pharmacy in Leiden and am in fact a card-carrying pharmacist, although they should not set me loose in a pharmacy! I also studied medicine in Leiden and after graduating went to work at the experimental clinical pharmacology unit of Wellcome (a pharmaceutical company in England). I subsequently did internal medicine in England and worked for another period at Wellcome, this time in later development of a thrombolytic drug. The job in Leiden was an ideal place for my training and interests.

The future for doctors and scientists who want to work in clinical research is bright. There are worldwide shortages in almost all areas, in the pharmaceutical industry, in hybrid organisations like ours, and in government. A potential candidate would need to carefully examine their career plans. Work in clinical research can be mainly operational. This is boring for some people but fascinating for others. Running a large clinical trial requires good skills in communication as you will have to work with many people and many organisations. Organising it well and managing the logistics is a difficult job and people who are good at it are in high demand. Even though operational matters may dominate your day, solid understanding of the science is essential!

Clinical research also requires a more scientific approach, generally done by people closer to the discovery side of a company or in academic units. You cannot do without the rules and quality requirements, but it is less dominant--you will be able to publish and work with students and research fellows. You may acquire less air miles, but if you have chosen well this will not bother you.

Starting a career is not difficult as there is a lot of demand from the operational side and one can join this immediately after graduation (in a CRO or pharmaceutical industry). If you want to be in charge of the scientific side, a PhD or MD-PhD is a prerequisite.

If you trained in pharmacy, pharmaceutical sciences, medicine, or biomedical sciences in any university in the Netherlands and have the right personal qualities you will be highly regarded, both in the Netherlands and internationally. Try to write some publications during your study and if you can find an elective in a clinical research organisation this will help a lot.

All large CRO's have subsidiaries in the Netherlands (Quintiles, Covance, Kendle, Pharma Bio-Research). Pharmaceutical companies with early research in the Netherlands are Organon, Solvay, and Yamanouchi Europe. Most university hospitals require staff for clinical research on a regular basis and many medical centres now have research departments specially geared toward clinical research (AMC Research BV, Julius Centre UMC, etc).

Skills and Education

A clinical researcher should have a biomedical degree and preferably a PhD (for the scientific stream) or additional business training (for the operational career ladder). Perhaps more important than the technical skills is the ability to work in large teams, and with a variety of people of different cultural backgrounds. If you are a researcher who likes to be on his own in the lab, clinical research may not be your thing. Clinical research also makes you collect data for a long time without seeing the results--this is quite a shock if you always have done lab research. However, if you like to be in an area where your efforts in making all these people work together pays off in fascinating results that actually help patients, clinical research may be for you.

The technical skills can be picked up anywhere--the personal qualities have to be developed and the best way to do this is by doing some clinical research during your studies. Many people work in organisations like ours during their university education, either as an elective or just as a job.

Most people at my level would be delighted to talk to potential candidates, even if there is no vacancy. The job market for clinical researchers is going to be a buyer's market in the next 10 years and you can expect a very cordial response from any decent organisation you send your CV to!

Studying what happens to patients is fascinating. The drug I studied for my PhD and gave to a human for the first time in 1986 (lamotrigine) is now a widely used anti-epileptic and there are many successful interventions on the market I have been associated with over the years. In doing what I do, I may have been more useful to patients than when I would have practised as a full-time doctor. Perhaps more importantly, the daily association with many others over fascinating new concepts that mean something to patients is a strong inspiration.