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Clinical Trials: a reference for clinical research

Knowledge of the molecular biology of cancer has grown exponentially in the last decade and this in turn has meant the identification of a host of therapeutic leads for the development of selective drugs.

In the Research Unit for Molecular Therapy of Cancer –“la Caixa” phase I of clinical trials are carried out for new anti-tumor drugs.  The selection of the anti-tumor drug for each patient depends on the detailed analysis of the specific molecular alterations of each tumor.  This focus represents a change of paradigm from the classic way of treating patients.

Cancer is a complex illness and for this reason there is a continual need to improve the treatment for it and develop new drugs.  In the Vall d’Hebron Hospital work has been carried out since the 1990s to develop drugs aimed at specific therapeutic leads such as, for example: trastuzumab (Herceptin), cetuximab (Erbitux) o everolimus (Zortress or Afinitor [USA] or Certican [Europe and other countries]).

Clinical trials play a vital role in the development of new therapies for cancer as they form the basis of scientifically recognized clinical research.  Clinical trials also ensure that studies are ethical and correctly monitored.

Phase I clinical trials take place once the preclinical studies have demonstrated that a substance could be a new anti-tumor therapy or an improvement on the conventional treatments available (less toxic, specifically directed drugs etc.).  These studies allow the continued treatment of oncology patients who have not responded optimally to other therapies.

The design of these studies has undergone drastic changes, increasing both in complexity and the multidisciplinary nature of patient care.  The Research Unit for Molecular Therapy of Cancer has been set up to provide the space and organization to facilitate the development of relevant clinical trials in the Vall d’Hebron Hospital.  The unit, a pioneer in the country for the early development of drugs designed to act on specific molecular targets, can carry out its work thanks to the founding patrons of the Vall d’Hebron Institute of Oncology (VHIO) the Welfare Projects Division of the "la Caixa" Foundation through its program for support for biomedical research.

Data from the Medical Oncology Service of the Vall d’Hebron University Hospital show that the number of patients starting treatment annually under the Clinical Trials Program has increases sharply since 1997 at the Catalan hospital.  The charts confirm this but one of the most significant figures is the number of patients included in early trials, the Phase I studies.

  Included in Phase I Included in Phase II Included in Phase III nº patients included % nº total patients / nº phase I
1997 8 50 85 143 6%
1998 9 70 82 161 6%
1999 35 59 95 189 19%
2000 59 72 128 259 23%
2001 57 66 175 298 19%
2002 110 94 109 313 35%
2003 130 91 84 305 43%
2004 120 130 129 379 32%
2005 108 73 111 292 37%
2006 132 165 85 382 35%
2007 139 170 143 452 31%
2008 171 133 180 484 35%
2009 222 161 189 572 39%

The Vall d’Hebron University Hospital is a leader in the development of anti-tumor drugs and is one of the European centers with the most experience in Phase I trials.

The creation of the UITM-“la Caixa” the Vall d’Hebron Hospital aims not only improve the health care for its patients but also to increase the number of patients treated.