Internet in clinical research based on a pilot experience.
Computing has become an integral part of many disciplines nowadays, turning it into an evermore necessary working tool. Internet provides a fast and easy way to collect scientific data and is becoming a more and more effective and safe way to transmit data. It is also an efficient means for interaction and information sharing within a work group that provides the necessary flexibility. A pilot project was conducted replacing the traditional hardcopy version of the case report form for an electronic one (e-CRF) and with access to Internet within the Naturalistic Randomized Clinical Trial of the Effectiveness of Olanzapine and Risperidone in the Treatment of Schizophrenia. Carrying out this pilot project has given us the opportunity to determine the advantages electronic data collection (EDC) by Internet has to offer both researchers and sponsors. The results have optimized time management, since it is easier to work in real time; data quality is improved, since intermediates are eliminated, and it facilitates communication amongst the different parties involved in the project. The use of this technology requires updated Internet connections and adequate personal computers, since the possibilities offered by the computer system and high-speed connection are critical in conducting the project. Obviously, this may involve a higher initial investment, but the results have revealed to us that these start-up costs are later offset by lowering personnel costs or by decreasing the number of monitoring visits. On the basis of our experience and that of the participating investigators, certain recommendations for future clinical trials using e-CRF can be made. We will go into these recommendations in greater depth throughout this paper. In short, EDC can dramatically improve the clinical trial process, opening the door to new technologies in the world of clinical research, not only for sponsors, but also for clinicians.
López-Carrero
Carmen
C
Department of Medical Research, Lilly S.A., Avda. de la Industria 30 28108, Alcobendas, Madrid, Spain. lopez-carrero_carmen@lilly.com
Arriaza
Elena
E
Bolaños
Elena
E
Ciudad
Antonio
A
Municio
Marco
M
Ramos
José
J
Hesen
Wout
W
D014150:Antipsychotic Agents / Q000627:therapeutic use; D001569:Benzodiazepines / Q000627:therapeutic use; D003628:Database Management Systems; D006801:Humans; D016247:Information Storage and Retrieval; D033183:Interdisciplinary Communication; D020407:Internet; D015337:Multicenter Studies as Topic / Q000379:methods*; D000077152:Olanzapine; D010865:Pilot Projects; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D018967:Risperidone / Q000627:therapeutic use; D012559:Schizophrenia / Q000188:drug therapy; D013996:Time and Motion Studies
D014150:Antipsychotic Agents; D001569:Benzodiazepines; D018967:Risperidone; D000077152:Olanzapine