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Evaluating risk, safety and efficacy of novel reproductive techniques and therapies through the EuroGTP II risk assessment tool

2020; Oxford University Press; Volume: 35; Issue: 8 Linguagem: Inglês

10.1093/humrep/deaa146

1460-2350

Esteve Trias, Martine Nijs, Ioana Rugescu, Francesco Lombardo, Gueorgui Nikolov, Veerle Provoost, Annelies Tolpe, Nathalie Vermeulen, Zdravka Veleva, Rita Piteira, Ricardo P. Casaroli‐Marano, Kelly Tilleman, Anna Vilarrodona, Ana Rita Piteira, Elba Agustí, Elisabet Tahull, Esteve Trias, Eva Maria Martinez, Ivan Miranda, Jaime Tabera, Maria Luisa Pérez, Marta Torrabadella, Nausica Otero, Óscar Fariñas, Patrícia López‐Chicón, Sergi Querol, Ricardo Casaroli, Akila Chandrasekar, Kyle Bennett, Paul Rooney, Richard Lomas, Mar Carmona, Esteban Molano, Myriam Ormeño, Branka Golubić Ćepulić, Ivan Rozman, Marijana Dragović, Cristina Pintus, Eliana Porta, Fiorenza Bariani, Letizia Lombardini, Liliam Santilli, Mariapia Mariani, Paola Di Ciaccio, Silvia Pisanu, Artur Kamiński, Izabela Uhrynowska‐Tyszkiewicz, Ewa Olender, Anne Marie van Walraven, Arlinke Bokhorst, Ingrid van Veen, Kelly Tilleman, Tolpe Annelies, Veerle Provoost, Lieve Nuytinck, Maryana Simeonova, Daniela Staneva-Petkova, Dessislava Tzoneva, Tsvetelina kircheva-Nikolova, Violetta Marinkova, Valery Georgiev, Yoran Peev, Elizabeth Manova, Cecília Surján, Éva Belicza, Gábor Szarvas, Judit Lám, László Csaba Bencze, Martin Börgel, Mareike Derks, Sibylla Schwarz, Ramadan Jashari, Richard N Noumanje, R Rodriguez, Tiia Tallinen, Hanna Kankkonen, Toni-Karri Pakarinen, Gilbert Verbeken, Jean‐Paul Pirnay, Thomas Rose, Jean-Pierre Draye, Simone Hennerbichler, Jill Davies, Jacinto Sánchez Ibáñez, M. Cristina Magli, Nathalie Vermeulen, Monserrat Boada, Eoin McGrath, J.C. Armitage, Gary E. Jones, M.C.C.A. Fraga, Dulce Roldao, Josefina Oliveira, Adolfo Paolin, Diletta Trojan, Giulia Montagner, Diego Ponzin, Stefano Ferrari, Francesco Lombardo, Carlijn Voermans, Nelleke Richters, Ioana Rugescu, Gianpaolo Azzena, Assunta Fabozzo, Helene Schoenmans, José Luís Pomar, Pablo Eduardo Gelber, Katalin Rajczy, Boris Calmels, Stephan Mielke, Tanja Netelenbos, M. Ragazzo, Gueorgui Nikolov, Elisabetta Marton, Martine Nijs, Antonella Franch, Gianluca Piovan, Francesco Dell’Antonia, Martyn Snow, Ines Bojanić, Zdravka Veleva, Grezgorz Basak, Margarida Amil, Sandra Shaw, Aurora Navarro, Tim Spalding, Peter Verdonk,

Prenatal Screening and Diagnostics

Can risks associated with novelties in assisted reproduction technologies (ARTs) be assessed in a systematic and structured way?An ART-specific risk assessment tool has been developed to assess the risks associated with the development of novelties in ART (EuroGTP II-ART).How to implement new technologies in ART is well-described in the literature. The successive steps should include testing in animal models, executing pre-clinical studies using supernumerary gametes or embryos, prospective clinical trials and finally, short- and long-term follow-up studies on the health of the offspring. A framework categorizing treatments from experimental through innovative to established according to the extent of the studies conducted has been devised. However, a systematic and standardized methodology to facilitate risk evaluation before innovations are performed in a clinical setting is lacking.The EuroGTP II-ART risk assessment tool was developed on the basis of a generic risk assessment algorithm developed for tissue and cell therapies and products (TCTPs) in the context of the project 'Good Practices for demonstrating safety and quality through recipient follow-up European Good Tissue and cells Practices II (EuroGTP II)'. For this purpose, a series of four meetings was held in which eight ART experts participated. In addition, several tests and simulations were undertaken to fine-tune the final tool.The three steps comprising the EuroGTP II methodology were evaluated against its usefulness and applicability in ART. Ways to improve and adapt the methodology into ART risk assessment were agreed and implemented.Assessment of the novelty (Step 1), consisting of seven questions, is the same as for other TCTPs. Practical examples were included for better understanding. Identification of potential risks and consequences (Step 2), consisting of a series of risks and risk consequences to consider during risk assessment, was adapted from the generic methodology, adding more potential risks for processes involving gonadic tissues. The algorithm to score risks was also adapted, giving a specific range of highest possible risk scores. A list of strategies for risk reduction and definition of extended studies required to ensure effectiveness and safety (Step 3) was also produced by the ART experts, based on generic EuroGTP II methodology. Several explanations and examples were provided for each of the steps for better understanding within this field.A multidisciplinary team is needed to perform risk assessment, to interpret results and to determine risk mitigation strategies and/or next steps required to ensure the safety in the clinical use of novelties.This is a dynamic tool whose value goes beyond assessment of risk before implementing a novel ART in clinical practice, to re-evaluate risks based on information collected during the process.This study was called EUROGTP II and was funded by the European Commission (Grant agreement number 709567). The authors declare no competing interests concerning the results of this study.