Nature and extent of changes in the patient's information sheets of international multicentre clinical trials as requested by Spanish Research Ethics Committees
Tipo y magnitud de los cambios requeridos por los Comités Éticos de Investigación Clínica en las hojas de información para el paciente en los ensayos clínicos multicéntricos internacionales
Rafael Dal-Ré**
, Elena Morejón, Rafael Ortega
Corresponding author
rafael.dal-re@gsk.com
Corresponding author: Dr. R. Dal-Ré.Medical Department. GlaxoSmithKline SA.Parque Tecnológico de Madrid.C/ Severo Ochoa, 2. 28760 Tres Cantos. Madrid. Spain
Corresponding author: Dr. R. Dal-Ré.Medical Department. GlaxoSmithKline SA.Parque Tecnológico de Madrid.C/ Severo Ochoa, 2. 28760 Tres Cantos. Madrid. Spain
Medical Department. GlaxoSmithKline SA. Tres Cantos. Madrid. Spain
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GlaxoSmithKline SA. Tres Cantos. Madrid. Spain" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "**" "correspondencia" => "Corresponding author: Dr. R. Dal-Ré.Medical Department. GlaxoSmithKline SA.Parque Tecnológico de Madrid.C/ Severo Ochoa, 2. 28760 Tres Cantos. Madrid. Spain" ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Tipo y magnitud de los cambios requeridos por los Comités Éticos de Investigación Clínica en las hojas de información para el paciente en los ensayos clínicos multicéntricos internacionales" ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "PalabrasClave" => array:2 [ "en" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Key words" "identificador" => "xpalclavsec222459" "palabras" => array:5 [ 0 => "Multicentre clinical trials" 1 => "Informed consent" 2 => "Patient's information sheet" 3 => "Research ethics committees" 4 => "Requested changes" ] ] ] "es" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Palabras clave" "identificador" => "xpalclavsec222460" "palabras" => array:5 [ 0 => "Ensayos clínicos multicéntricos" 1 => "Consentimiento informado" 2 => "Hoja de información para el paciente" 3 => "Comités éticos de investigación clínica" 4 => "Cambios solicitados" ] ] ] ] "tieneResumen" => true "resumen" => array:2 [ "en" => array:1 [ "resumen" => "<span class="elsevierStyleSectionTitle">Background and objective</span><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">In the assessment of every clinical trial protocol, one of the critical tasksperformed by research ethics committees (RECs) is an in depth review of the patient's informationsheet (PIS). The objective of the study was to review the assessment of RECs in Spain regarding thePIS through the changes to be done in them in order to obtain RECs approval. Differences betweenchanges requested by different RECs may provide some measure of the existing homogeneity amongstRECs as far as evaluation of PIS is concerned</p> <span class="elsevierStyleSectionTitle">Material and method</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">This was a prospective study of 187 applications of multinational clinical trials (MCT)submitted in 2002-03 and for which the RECs and Spanish Medicines Agency evaluation process wascompleted by July 2003, reviewed by 62 RECs, for 85 hospitals and 29 primary care centres. The mainassessment measures were PIS-related features and type of changes asked by RECs to be done in PIS</p> <span class="elsevierStyleSectionTitle">Results</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">One hundred and one of 183 approved applications of 24 protocols submitted had 307queries raised from 41 RECs, of which 118 were related with changes in PIS. These 118 queries wereraised by 38 RECs (61%; 38/62) in 66 applications (36%; 66/183). There were queries for all 24protocols, but only for 2 studies (8%; 2/24) there were no queries related with PIS. In seven protocolsall queries were associated with the PIS (29%; 7/24). 22% of RECs asked for a median of 14.5 copiesof a separate PIS (in addition to those submitted with the protocol and the rest of documentation) forthe assessment of the MCT. The number of pages of the PIS ranged from 3 to 6 with a mean number of2,082 words. The type of changes in the PIS requested by the RECs were related with: risk/benefit andadverse events (27.1%), typographic changes and logistics information (19.5%), personal dataprotection (16.9%), explanation of procedures (11.9%), add some information (11.9%), word/sentencedifficult to understand (8.5%) and delete some information (4.2%)</p> <span class="elsevierStyleSectionTitle">Conclusions</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">In this study, the general content and quality of the PIS were correct enough. Indeed,although the number of RECs asking for changes in the PIS was not low (61%), most of thesechanges were minor and affected only 36% of the submissions, with a median of 1 change persubmission. Therefore, these data also suggest that there is a remarkable homogeneity across RECs intheir evaluation of PIS. RECs have special interest in such aspects as benefit/risk information andconfidentiality and data protection; in fact, almost half of the changes in PIS requested by RECsreferred to those two items</p>" ] "es" => array:1 [ "resumen" => "<span class="elsevierStyleSectionTitle">Fundamento y objetivo</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">Una de las tareas clave en la evaluación por los Comités Éticos de InvestigaciónClínica (CEIC) de cada protocolo de ensayo clínico es la revisión en profundidad de la hoja de informaciónpara el paciente (HIP). El objetivo de este estudio fue revisar la evaluación de las HIP realizadapor los CEIC en España, a través de los cambios requeridos para obtener su aprobación. Lasdiferencias en los cambios solicitados pueden dar una medida del grado de homogeneidad existenteentre los CEIC en la evaluación de HIP</p> <span class="elsevierStyleSectionTitle">Material y método</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">Es un estudio prospectivo de 187 solicitudes de ensayos multicéntricos (MCT) sometidosen 2002-2003 y para los que el proceso completo de evaluación por CEIC y la Agencia Española delMedicamento estaba completado en julio de 2003, revisados por 62 CEIC, para ensayos a realizar en 85hospitales y 29 centros de atención primaria. Las variables principales de evaluación fueron las característicasrelacionadas con las HIP y tipo de modificaciones solicitadas por los CEIC a realizar en las HIP</p> <span class="elsevierStyleSectionTitle">Resultados</span><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">En 101 de las 183 solicitudes aprobadas pertenecientes a 24 protocolos sometidos, 41 CEICrequirieron 307 aclaraciones, de las que 118 estaban relacionadas con las HIP. Estas 118 modificacionesfueron solicitadas por 38 CEIC (61%; 38/62), en 66 solicitudes (36%; 66/183). Se requirieron aclaracionesen todos los protocolos, pero en sólo 2 (8%; 2/24) de ellos no se solicitó modificación alguna en laHIP. El 22% de los CEIC solicitaron una mediana de 14,5 copias adicionales de la HIP (además de laspresentadas con el protocolo y el resto de la documentación del ensayo), para la evaluación del ensayoMCT. El número de páginas de las HIP varió de 3 a 6, con una media de 2.082 palabras. El tipo de modificacionesrequerido por los CEIC estaba relacionado con: riesgo/beneficio y acontecimientos adversos(27,1%), cambios tipográficos e información logística (19,5%), protección de datos personales (16,9%),explicación de los procedimientos (11,9%), añadir algún tipo de información (11,9%), dificultad de entendimientode palabra/frase (8,5%) y suprimir algún tipo de información (4,2%)</p> <span class="elsevierStyleSectionTitle">Conclusiones</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">En este estudio, el contenido general y la calidad de las HIP fue suficientemente correcta yaque aunque el número de CEIC que solicitaron modificaciones no es bajo (61%), la mayor parte de los cambiosfueron menores y afectaron sólo al 36% de las solicitudes presentadas, con una mediana de 1 cambiopor solicitud. Estos datos sugieren que existe una notable homogeneidad en la evaluación de las HIP entreCEIC. Los CEIC tienen un interés especial en la información del riesgo/beneficio y la confidencialidad y laprotección de datos, ya que casi la mitad de los cambios requeridos se refieren a estos aspectos</p>" ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:22 [ 0 => array:3 [ "identificador" => "bib0005" "etiqueta" => "1." "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:1 [ "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:1 [ 0 => "RJ Levine" ] ] ] ] ] "host" => array:1 [ 0 => array:1 [ "Libro" => array:3 [ "fecha" => "1986" "editorial" => "Urban & Schwarzenberg" "editorialLocalizacion" => "Balti-more" ] ] ] ] ] ] 1 => array:3 [ "identificador" => "bib0010" "etiqueta" => "2." 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| 2024 August | 0 | 5 | 5 |
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| 2024 April | 0 | 19 | 19 |
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