@article{8692684,
  abstract     = {{STUDY QUESTION Can risks associated with novelties in assisted reproduction technologies (ARTs) be assessed in a systematic and structured way?

SUMMARY ANSWER An ART-specific risk assessment tool has been developed to assess the risks associated with the development of novelties in ART (EuroGTP II-ART).

WHAT IS KNOWN ALREADY 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.

STUDY DESIGN, SIZE, DURATION 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.

PARTICIPANTS/MATERIALS, SETTING, METHODS 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.

MAIN RESULTS AND THE ROLE OF CHANCE 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.

LIMITATIONS, REASONS FOR CAUTION 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.

WIDER IMPLICATIONS OF THE FINDINGS 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.}},
  author       = {{Trias, Esteve and Nijs, Martine and Rugescu, Ioana Adina and Lombardo, Francesco and Nikolov, Gueorgui and Provoost, Veerle and Tolpe, Annelies and Vermeulen, Nathalie and Veleva, Zdravka and Piteira, Rita and Casaroli-Marano, Ricardo and Tilleman, Kelly and Vilarrodona, Anna and Rita Piteira, A. and Agustí, Elba and Tahull, Elisabet and Trias, Esteve and Martinez, Eva Maria and Miranda, Ivan and Tabera, Jaime and Perez, Maria Luisa and Torrabadella, Marta and Otero, Nausica and Fariñas, Oscar and López-Chicón, Patricia and Querol, Sergi and Casaroli, Ricardo and Chandrasekar, Akila and Bennett, Kyle and Rooney, Paul and Lomas, Richard and Carmona, Mar and Molano, Esteban and Ormeño, Myriam and Ćepulić, Branka Golubić and Rozman, Ivan and Dragović, Marijana and Pintus, Cristina and Porta, Eliana and Bariani, Fiorenza and Lombardini, Letizia and Santilli, Liliam and Mariani, Mariapia and Di Ciaccio, Paola and Pisanu, Silvia and Kamiński, Artur and Uhrynowska-Tyszkiewicz, Izabela and Olender, Ewa and van Walraven, Anne Marie and Bokhorst, Arlinke and van Veen, Ingrid and Nuytinck, Lieve and Simeonova, Maryana and Staneva-Petkova, Daniela and Tzoneva, Dessislava and kircheva-Nikolova, Tsvetelina and Marinkova, Violetta and Georgiev, Valery and Peev, Yoran and Manova, Elizabeth and Surján, Cecilia and Belicza, Éva and Szarvas, Gábor and Lám, Judit and Bencze, László and Börgel, Martin and Derks, Mareike and Schwarz, Sibylla and Jashari, Ramadan and Noumanje, Richard N and Rodriguez, Rosario Daiz and Tallinen, Tiia and Kankkonen, Hanna and Pakarinen, Toni-Karri and Verbeken, Gilbert and Pirnay, Jean-Paul and Rose, Thomas and Draye, Jean-Pierre and Hennerbichler, Simone and Davies, Jill and Ibañez, Jacinto and Magli, Cristina and Vermeulen, Nathalie and Boada, Monserrat and McGrath, Eoin and Armitage, John and Jones, Gary and Fraga, Marta and Roldao, Dulce and Oliveira, Josefina and Paolin, Adolfo and Trojan, Diletta and Montagner, Giulia and Ponzin, Diego and Ferrari, Stefano and Lombardo, Francesco and Voermans, Carlijn and Richters, Nelleke and Rugescu, Ioana Adina and Azzena, Gianpaolo and Fabozzo, Assunta and Schoenmans, Helene and Pomar, Jose Luis and Gelber, Pablo and Rajczy, Katalin and Calmels, Boris and Mielke, Stephan and Netelenbos, Tanja and Ragazzo, Mirko and Nikolov, Gueorgui and Marton, Elisabetta and Nijs, Martine and Franch, Antonella and Piovan, Gianluca and Dell’Antonia, Francesco and Snow, Martyn and Bojanic, Ines and Veleva, Zdravka and Basak, Grezgorz and Amil, Margarida and Shaw, Sandra and Navarro, Aurora and Spalding, Tim and Verdonk, Peter and EuroGTP II Study Group, [missing]}},
  issn         = {{0268-1161}},
  journal      = {{HUMAN REPRODUCTION}},
  keywords     = {{Obstetrics and Gynaecology,Rehabilitation,Reproductive Medicine,risk analysis,quality management,efficacy,novel techniques,safety,validation,assisted reproduction technologies,gamete,embryo,reproductive tissue,MEDICINE}},
  language     = {{eng}},
  number       = {{8}},
  pages        = {{1821--1838}},
  title        = {{Evaluating risk, safety and efficacy of novel reproductive techniques and therapies through the EuroGTP II risk assessment tool}},
  url          = {{http://doi.org/10.1093/humrep/deaa146}},
  volume       = {{35}},
  year         = {{2020}},
}

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