Nuestros problemas educativos

investigators—

physicians who can

provide reliable tests

of medications. This

article looks at the

necessary capabilities

and qualifications.

handling ethic submissions, and other preparatory efforts are not usually reimbursed financially by the contract- ing party, and can generate substantial costs for a study site.

Language Proficiency

During a three-day investigator meet- ing for a multinational study that I attended in Amsterdam recently, all the lectures were conducted in Eng- lish: How else would the Hungarians, French, Dutch, Germans, and South Africans there be able to understand each other? However, on the last day, the data questionnaires were presented and, to my great surprise, I heard a Ger- man colleague request that the ques- tionnaire be translated into German. He said that no one can expect him to complete the form in English. “Sorry,” I had to reply. Of course, it is to be expected of anyone who participates in multicenter and multinational studies that he or she has already acquired the necessary language skills. This expecta- tion can provide as much joy as it does hardship, such as the exhilaration that results from telling a joke in a foreign language and having people under- stand it and laugh (after the frustration of trying 10 times without success).

Conclusion

It’s the variety that makes life as a princi- pal investigator so satisfying. The diver- sity of responsibilities, the changing demands, the international contacts, and much more are what contribute daily to why I love my profession. I can only encourage many of my colleagues to dare to venture into a profession that has been known by so few thus far.

Bettina Bergtholdt, MD, is the managing partner

and principal investigator of emovis, an investigator site in Berlin, Germany, that specializes in conducting clini- cal Phase II and III trials in the indications of psychiatry, neurology, internal medicine, and gynecology. She began studying medicine in 1987 at the Free University of Ber- lin and earned her medical degree in 1994. From 1994 to 2001, she worked in different psychiatric wards as a junior house officer, followed by holding a professorship in social psychiatry at the University of Applied Sciences Stendal. She can be reached at [email protected]. related legal parameters go beyond the

above-mentioned laws: What types of advertising are allowed for recruiting patients? Which laws apply here? Which measures need to be taken in order to comply with the regulations concern- ing data privacy in the country where the study site is located? Are there spe- cial stipulations concerning the use of X-ray examinations or the prescription of narcotics in clinical studies?

Business Management Skills

Proper care of patients and high data quality are not the only things required for conducting successful studies; plan- ning for the recruitment and retention of enough patients is a very important component. The necessary resources include readily available personnel, office space, and financial means, and the advertising campaign to be used to recruit new center-external study participants should be presented to the ethics commission in a timely manner. All of this requires a lot of planning, as well as entrepreneurial know-how.

The principal investigator can hardly complete all the tasks neces- sary to complete a clinical trial alone. Additional personnel are vital, which places additional demands upon the principal investigator: He or she needs to know how to motivate employees and create a good work environment; work processes need to be well-orga- nized and structured; orientation for new employees needs not only to be completed, but also comprehensibly documented; further training must be organized on a regular basis; conflicts between employees need to be arbi- trated; and new employees need to be hired as well as occasionally laid off.

Furthermore, what good to the study site is even the best study implemen- tation if the study isn’t economically profitable? A principal investigator must know how high the necessary capital investments will be before a study begins, and if these expenditures can be returned through the consulta- tion fees. Attending investigator meet- ings, training employees, negotiating contracts, waiting for initiation dates, Also, the ability to relinquish exer-

cising therapeutic freedom is an essen- tial element of the investigator’s work. The protocol determines which actions are to be taken. I like to quote a lec- turer at an International Conference on Harmonization/Good Clinical Prac- tice (ICH/GCP) seminar who described investigators as trained chimpanzees. “Correct,” said a colleague of mine, “but I am proud of being well trained.”

Indication-Specific Expertise

Of course, an investigator should be thoroughly informed medically regard- ing the indication being examined, as well as be familiar with the current data for the substance being analyzed. This proposes a special challenge when the study site performs trials in a variety of medical fields, since no single investi- gator can possess practical experience with all types of indications. It remains the principal investigator’s responsibil- ity to determine if he or she is able to care for the patients in the clinical trial for the specific disease with complete competence. Investigators who are not able to answer this question with a convincing yes are best advised not to participate in that particular clini- cal trial.

Apart from the risk factor, a diver- sity of indication studies can prove to be quite appealing to a principal inves- tigator. It is very enriching to familiar- ize oneself continuously with new indi- cations, and to be able to treat so many patients with the same disease within a short period of time. Rarely, if ever, did I have the chance to get to know one disease with all its facets so well during my years as a physician in a hospital as I have while conducting clinical trials.

Legal Parameters

The ICH/GCP and the individualized country pharmaceutical laws are the bible for conducting clinical trials. An investigator should know them by heart, as well as understand their practi- cal consequences. However, this is not enough, since the activities associated with conducting a clinical trial and the

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