Internship in the Institute of Oncology Vall D´Hebron (Barcelona)

Experience of specialized internship in the leading Spanish research centre. How does the Phase I Clinical Trials Unit work?

The medical science has made significant progress recently. New medicinal products, discovered in connection with development of the molecular and biological knowledge, are available. We are speaking about the so called targeted biological drugs, also named the individualized therapy, i.e. the drugs blocking certain molecular pathways or receptors, thus having the targeted anti-tumour effect. Treatment success rises with new available drugs.

Research of a new drug includes the so called pre-clinical phase and individual phases of clinical testing, starting by the phase I, when the drug is for the first time used in the patient, when adverse effects a are examined and effective dose is determined, and ending by the final phases III and IV examining efficacy of the already tested effective drugs in the set of hundreds of patients.

Institute of Oncology Val D´Hebron
In Europe there are nowadays only few hospitals having a specialized Phase I Clinical Trials Unit. Vall d´Hebron, Institute of Oncology in Barcelona, belongs among them. It is the scientific unit focused on research in oncology. The unit is named Research Unit for Molecular Therapy of Cancer and is located in the greatest University Hospital in Barcelona, the second greatest Spanish hospital at all. It was established some two years ago by the scientific director and the leading world oncologist, professor Josep Baselga, with the objective (in his own words) to bring the so called “tailor-made therapy” to the patients as soon as possible, depending on the established molecular and biological features of the tumour disease.

How does the Phase I Study Unit work?
In September 2011 we were given the possibility to visit this workplace. The Unit is designed mainly as the out-patient centre, available for the patients 16 hours per day. It is created by several outpatients’ departments, by one inpatients’ department with twelve beds and by its own pharmacy, where the biological drugs are prepared and/or where infusions and cytostatic drugs are diluted. The Unit also has the space for study/trial coordinators and data managers. The specialized staff, incorporating the physicians trained for the phase I clinical trials, specialized nurses and study/trial coordinators, take care of the patients.
The patient can address the nursing staff from 6:00am till 10:00pm and can be treated by a specialist immediately, if needed. If the patient has problems out of the working hours of the Unit, he/she contacts the emergency service and is treated by any of the out-patients department or is hospitalized in any ward of the hospital.
The patient is taken care by the Unit absolutely, from his entry till his departure. Blood samples and other biological material are taken here, the patient is examined by the physician and by the nurses here and the drugs are prepared and applied here under continuous patient’s monitoring in the inpatients’ department. The acute emergency care goes without saying, it is ensured by continuous contact with intensive care of the hospital.
The department cooperates closely with the department of laboratory medicine, where the biological material and pharmacokinetics and pharmacodynamics is examined, and also cooperates with the molecular and biological laboratories of the hospital focused on molecular analysis of the taken samples. Cooperation with radio diagnosticians and invasive radio diagnosticians is the integral part of the complex work.

Inclusion of patients into phase I clinical studies /trials.
Nowadays the Unit offers possibility of treatment in nearly 35 clinical trials of phase I, which are recruited actively.
Upon the prior patient’s consent the oncologist can consult the state of health and documentation with the team of specialists. The patient comes to the pre-agreed meeting and during the first visit can discuss contribution as well as the known adverse effects of the examined drug with the specialized physicians. As the drug is tested clinically for the first time on the patient, this part is subject to the full free consent by the patient as well as by the Ethics Committee of the hospital. Based on the obtained information, the patient can reject participation in clinical testing.
If the patient agrees with clinical testing, he is examined in the out-patients department in the pre-agreed term. All project specialists are anxious to please the patient from the point of the time schedule. After completion of clinical testing the patient still remains in care of his/her oncologist with regular visits determined by the study protocol in the Phase I Clinical Trials Unit.

Day of the oncologist in Vall D´Hebron
Working day of the oncologist of this Unit starts by a joint meeting where the daily time schedule is discussed. In the forenoon consultations with individual patients take place, their clinical and laboratory examinations are analyzed and the time schedule of the bio-or-chemotherapy is prepared afterwards. The patient then goes to the inpatients department, where the treatment is applied under continuous monitoring of all vital functions precisely as requested by the protocol of the clinical study/trial. Afternoon activities: continuing meetings with patients, consultations with the study team members, teleconferences where the therapy is discussed with specialists of the participating centres in Europe and in the USA and/or consultations of the oncologist with researchers of the molecular laboratories or with other disciplines.

Assessment of the internship
The visit was very inspiring and useful thanks to the friendly approach of professor Taberner and his colleagues. Besides the Phase I clinical Trials Unit we were able to visit even the in-house pharmacy and the sector devoted to the pre-clinical research programme headed by Joaquín Arribas and his group focused on growth factors, further on, the sector of experimental therapeutic methods of Josep Baselga and, last but not least, the workplace of tumour biomarkers (Josep Villanueva) and the workplace modelling the clinical situation in animals (mice) ; the laboratories are headed by Laura Soucek.

Masaryk Memorial Cancer Institute increases participation in phase I clinical trials
Masaryk Memorial Cancer Institute participates in clinical studies/trials of phases II and III for a number of years already. It has the excellent background in the professional staff, in molecular and pathological laboratories. The Institute has the following departments: department of radiology equipped by two CT units, magnetic resonance, possibility of application of invasive radiological methods, department of laboratory medicine and nuclear medicine accommodating even PET/CT, department of pathology, molecular laboratories and last, but not least, pharmacy with the central dilution unit of cytostatic drugs and RFID system of communication.
Thanks to a very good background Masaryk Memorial Cancer Institute would like to offer the possibility to its patients to participate even in the earliest clinical research focused on testing new drugs for the first time in the human being, i.e. the phase I studies or the first in man studies. Internships in centres and institutes abroad, devoted to phase I clinical studies/trials, are therefore a very valuable inspiration.