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Article ; Online: Clinical research and drug regulation in the challenging times of individualized therapies: A pivotal role of clinical pharmacology.

Gómez-Outes, Antonio / Sancho-López, Aránzazu / Carcas Sansuan, Antonio J / Avendaño-Solá, Cristina

2023 Volume 199, Page(s) 107045

Abstract: Since the 1980s, medical specialists in Clinical Pharmacology have been playing a crucial role in the development of drug regulation in Spain. In this article we report on the activities carried out and the prospects for development in three very ... ...

Abstract	Since the 1980s, medical specialists in Clinical Pharmacology have been playing a crucial role in the development of drug regulation in Spain. In this article we report on the activities carried out and the prospects for development in three very relevant areas from the regulatory perspective: 1) the development of stable public infrastructures to facilitate non-commercial clinical research with medicines, 2) the regulatory aspects of individual access to medicines in special situations, beyond their regular access after marketing approval and funding by the National Health System, and 3) the challenges of development and access to advanced therapies, with special reference to the figure of the hospital exemption.
MeSH term(s)	Drug and Narcotic Control ; Pharmacology, Clinical ; Drug Approval
Language	English
Publishing date	2023-12-27
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	1003347-6
ISSN	1096-1186 ; 0031-6989 ; 1043-6618
ISSN (online)	1096-1186
ISSN	0031-6989 ; 1043-6618
DOI	10.1016/j.phrs.2023.107045
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Article ; Online: Gender inequity in the medical profession: the women doctors in Spain (WOMEDS) study.

Santucci, Claudia / López-Valcarcel, Beatriz González / Avendaño-Solá, Cristina / Bautista, Mari Carmen / Pino, Carmen Gallardo / García, Lourdes Lledó / Martín-Perez, Elena / López, Pilar Garrido

Human resources for health

2023 Volume 21, Issue 1, Page(s) 77

Abstract: Background: The long-standing underrepresentation of women in leadership positions in medicine is well-known, but poorly documented globally. There is some evidence of the gender gap in academia, medical society leadership, or specific problems in some ... ...

Abstract	Background: The long-standing underrepresentation of women in leadership positions in medicine is well-known, but poorly documented globally. There is some evidence of the gender gap in academia, medical society leadership, or specific problems in some specialties. However, there are no investigations analyzing all medical specialties together and reporting the glass ceiling from a 360º perspective that includes positions in academia, research, professional organizations, and clinical activity. Additionally, the majority of studies have a US perspective, and we wonder if the perspective of a European country might be different. The WOmen in MEDicine in Spain (WOMEDS) project ( https://womeds.es ) aims to describe and characterize, in a systematic and detailed way, the gender bias in the medical profession in Spain in order to monitor its evolution over time and contribute to prioritizing gender policies. Methods: We retrieved data for the calendar years 2019-2021 from several sources and selected surveys. We built four groups of indicators to describe leadership positions in the medical profession: (i) leadership in healthcare according to specialty and region; (ii) leadership in scientific and professional bodies; (iii) academic career; and (iv) leadership in clinical research activity. As a summary measure, we reported the women ratios, calculated as the percentage of women in specific top positions divided by the percentage of women in the relevant population. Results: We found gender inequity in leadership positions in all four settings. During the observed period, only 27.6% of the heads of departments in hospitals were women compared to 61.1% of women in medical staff. Ten of the 46 medical societies grouped in the Spanish Federation of Medical Societies (FACME) (21.7%) had a women president at some point during the study period, and only 4 annual congresses had ratios of women speakers higher than 1. Women were over-represented in the lower positions and underrepresented in the top academic ones. Only 26% and 27%, respectively, of the heads of departments and deans were women. The applications for public funding for research projects are led by women only in 45% of the cases, and the budget granted to women in public calls was 24.3% lower than that of men. Conclusion: In all the areas analyzed, the leadership positions are still mostly occupied by men despite the feminization of medicine in Spain. The severe gender inequity found calls for urgent interventions within a defined time horizon. Such measures must concern all levels, from national or regional regulation to changes in organizational culture or incentives in specific organizations.
MeSH term(s)	Female ; Humans ; Male ; Spain ; Gender Equity ; Sexism ; Medicine ; Europe
Language	English
Publishing date	2023-09-20
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2126923-3
ISSN	1478-4491 ; 1478-4491
ISSN (online)	1478-4491
ISSN	1478-4491
DOI	10.1186/s12960-023-00860-2
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Article ; Online: Modifications and waivers of informed consent and the Council for International Organizations of Medical Sciences guidelines.

Dal-Ré, Rafael / Abad-Santos, Francisco / Avendaño-Solà, Cristina

Medicina clinica

2018 Volume 152, Issue 2, Page(s) 78–79

Title translation	Modificaciones y exenciones del consentimiento informado y las guías Council for International Organizations of Medical Sciences.
MeSH term(s)	Biomedical Research ; Informed Consent
Language	Spanish
Publishing date	2018-05-18
Publishing country	Spain
Document type	Letter ; Comment
ZDB-ID	411607-0
ISSN	1578-8989 ; 0025-7753
ISSN (online)	1578-8989
ISSN	0025-7753
DOI	10.1016/j.medcli.2018.04.013
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Article: Uso compasivo de medicamentos: un cambio necesario en España.

Avendaño Solá, Cristina

Medicina clinica

2009 Volume 133, Issue 11, Page(s) 425–426

Title translation	Compassionate use of off-label drugs: need for a change in Spain.
MeSH term(s)	Compassionate Use Trials/legislation & jurisprudence ; Humans ; Off-Label Use/legislation & jurisprudence ; Spain
Language	Spanish
Publishing date	2009-09-26
Publishing country	Spain
Document type	Editorial
ZDB-ID	411607-0
ISSN	1578-8989 ; 0025-7753
ISSN (online)	1578-8989
ISSN	0025-7753
DOI	10.1016/j.medcli.2009.07.003
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Article ; Online: Mesenchymal stromal cell therapy for COVID-19 acute respiratory distress syndrome: a double-blind randomised controlled trial.

Martínez-Muñoz, María E / Payares-Herrera, Concepción / Lipperheide, Inés / Malo de Molina, Rosa / Salcedo, Isabel / Alonso, Rosalía / Martín-Donaire, Trinidad / Sánchez, Rocío / Zafra, Rocío / García-Berciano, Miguel / Trisán-Alonso, Andrea / Pérez-Torres, Manuel / Ramos-Martínez, Antonio / Ussetti, Piedad / Rubio, Juan J / Avendaño-Solà, Cristina / Duarte, Rafael F

Bone marrow transplantation

2024

Abstract: Mesenchymal stromal cells (MSC) have immunomodulatory and tissue-regenerative properties and have shown promising results in acute respiratory distress syndrome (ARDS) of multiple causes, including COVID-19. We conducted a randomised (1:1), placebo- ... ...

Abstract	Mesenchymal stromal cells (MSC) have immunomodulatory and tissue-regenerative properties and have shown promising results in acute respiratory distress syndrome (ARDS) of multiple causes, including COVID-19. We conducted a randomised (1:1), placebo-controlled, double-blind clinical trial to assess the efficacy and safety of one bone marrow-derived MSC infusion in twenty patients with moderate to severe ARDS caused by COVID-19. The primary endpoint (increase in PaO2/FiO2 ratio from baseline to day 7, MSC 83.3 versus placebo 57.6) was not statistically significant, although a clinical improvement at day 7 in the WHO scale was observed in MSC patients (5, 50% vs 0, 0%, p = 0.033). Median time to discontinuation of supplemental oxygen was also shorter in the experimental arm (14 versus 23 days, p = 0.007), resulting in a shorter hospital stay (17.5 versus 28 days, p = 0.042). No significant differences were observed for other efficacy or safety secondary endpoints. No infusion or treatment-related serious adverse events occurred during the one-year follow-up. This study did not meet the primary endpoint of PaO2/FiO2 increase by day 7, although it suggests that MSC are safe in COVID-19 ARDS and may accelerate patients' clinical recovery and hospital discharge. Larger studies are warranted to elucidate their role in ARDS and other inflammatory lung disorders.Trial Registration: EudraCT Number: 2020-002193-27, registered on July 14th, 2020, https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-002193-27/ES . NCT number: NCT04615429, registered on November 4th, 2020, https://clinicaltrials.gov/ct2/show/NCT04615429 .
Language	English
Publishing date	2024-02-26
Publishing country	England
Document type	Journal Article
ZDB-ID	632854-4
ISSN	1476-5365 ; 0268-3369 ; 0951-3078
ISSN (online)	1476-5365
ISSN	0268-3369 ; 0951-3078
DOI	10.1038/s41409-024-02230-5
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Article ; Online: Bronchopulmonary penetration of isavuconazole in lung transplant recipients.

Caballero-Bermejo, Antonio F / Darnaude-Ximénez, Ignacio / Aguilar-Pérez, Myriam / Gomez-Lopez, Alicia / Sancho-López, Aránzazu / López García-Gallo, Cristina / Díaz Nuevo, Gema / Diago-Sempere, Elena / Ruiz-Antorán, Belén / Avendaño-Solá, Cristina / Ussetti-Gil, Piedad

Antimicrobial agents and chemotherapy

2023 Volume 67, Issue 10, Page(s) e0061323

Abstract: Isavuconazole's (ISA) pharmacokinetics was studied among lung transplant recipients to evaluate its bronchopulmonary penetration. This study included 13 patients and showed mean serum concentrations of 3.30 (standard deviation [SD] 0.45), 5.12 (SD 1.36), ...

Abstract	Isavuconazole's (ISA) pharmacokinetics was studied among lung transplant recipients to evaluate its bronchopulmonary penetration. This study included 13 patients and showed mean serum concentrations of 3.30 (standard deviation [SD] 0.45), 5.12 (SD 1.36), and 6.31 (SD 0.95) at 2 h, 4 h, and 24 h respectively. Mean concentrations in the epithelial lining fluid were 0.969 (SD 0.895), 2.141 (SD 1.265), and 2.812 (SD 0.693) at the same time points. ISA is a drug with a tolerable safety profile that achieves adequate concentrations in the lung.
MeSH term(s)	Humans ; Bronchoalveolar Lavage Fluid ; Transplant Recipients ; Lung/surgery ; Triazoles/pharmacokinetics
Chemical Substances	isavuconazole (60UTO373KE) ; Triazoles
Language	English
Publishing date	2023-10-03
Publishing country	United States
Document type	Journal Article
ZDB-ID	217602-6
ISSN	1098-6596 ; 0066-4804
ISSN (online)	1098-6596
ISSN	0066-4804
DOI	10.1128/aac.00613-23
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Zs.A 809: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
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Article: Biosimilar therapy for inflammatory bowel disease.

Avendaño-Solá, Cristina / Panés, Julià / Calvo, Gonzalo

Revista espanola de enfermedades digestivas : organo oficial de la Sociedad Espanola de Patologia Digestiva

2014 Volume 106, Issue 1, Page(s) 65–66

MeSH term(s)	Biosimilar Pharmaceuticals/therapeutic use ; Humans ; Inflammatory Bowel Diseases/drug therapy
Chemical Substances	Biosimilar Pharmaceuticals
Language	English
Publishing date	2014-03-28
Publishing country	Spain
Document type	Letter ; Comment
ZDB-ID	1070381-0
ISSN	1130-0108 ; 0212-7512
ISSN	1130-0108 ; 0212-7512
DOI	10.4321/s1130-01082014000100014
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Article: Bronchopulmonary Penetration of Isavuconazole in Pulmonary Transplant Recipients (PBISA01): Protocol for a Phase IV Clinical Trial With a Single Treatment Arm.

Darnaude-Ximénez, Ignacio / Caballero-Bermejo, Antonio F / Ruiz-Antorán, Belén / Aguilar-Pérez, Myriam / Gómez-López, Alicia / Sancho-López, Aranzazu / García-Fadul, Cristian / Diago-Sempere, Elena / Valle Falcones, Manuel / Ussetti-Gil, Piedad / Avendaño-Solá, Cristina

JMIR research protocols

2022 Volume 11, Issue 9, Page(s) e37275

Abstract: Background: Aspergillosis is the most frequently observed invasive fungal disease (IFD) in lung transplant recipients. Isavuconazole (ISA) has shown a better safety profile and noninferiority to voriconazole in the treatment of patients with IFD.: ... ...

Abstract	Background: Aspergillosis is the most frequently observed invasive fungal disease (IFD) in lung transplant recipients. Isavuconazole (ISA) has shown a better safety profile and noninferiority to voriconazole in the treatment of patients with IFD. Objective: The aim of this study is to describe the bronchopulmonary pharmacokinetic profile of oral ISA by analyzing the degree of penetration in the epithelial lining fluid and alveolar macrophages in patients receiving lung transplantation with a diagnosis of IFD. Methods: A total of 12 patients aged ≥18 years receiving a lung transplant with an IFD diagnosis and indication for ISA treatment and follow-up bronchoscopy will be included in the study. After 5 days of treatment with ISA and before the treatment is discontinued, the patients will be randomized (1:1:1:1) to perform the scheduled bronchoscopy at various times after the administration of ISA (2, 4, 8, and 12 hours). In total, 4 blood samples will be obtained per patient: at 72 hours after treatment initiation, on the day of the bronchoscopy, at the time of the bronchoalveolar lavage (simultaneously), and at 7 days after treatment initiation, to analyze tacrolimus and ISA plasma levels. ISA concentrations will be measured in plasma, epithelial lining fluid, and alveolar macrophages by a high-performance liquid chromatography/UV coupled to fluorescence method. Results: Enrollment for the PBISA01 trial began in October 2020 and was completed in October 2021. All samples will be analyzed once recruitment is complete, and the results are expected to be published in October 2022. Conclusions: There are no clinical studies that analyze the bronchopulmonary penetration of ISA. Bronchoalveolar lavage performed routinely in the follow-up of lung transplant recipients constitutes an opportunity to analyze the bronchopulmonary penetration of ISA. Trial registration: European Clinical Trials Register 2019-004240-30; www.clinicaltrialsregister.eu/ctr-search/trial/2019-004240-30/ES. International registered report identifier (irrid): DERR1-10.2196/37275.
Language	English
Publishing date	2022-09-14
Publishing country	Canada
Document type	Journal Article
ZDB-ID	2719222-2
ISSN	1929-0748
ISSN	1929-0748
DOI	10.2196/37275
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Article ; Online: Measurement of the passage of mycophenolic acid into breast milk in a patient with lupus nephritis.

Huerta, Ana / Caballero Bermejo, Antonio F / de Villa, Luis F / Sedano, Rosa / Ruiz-Antorán, Belén / Avendaño-Solá, Cristina / Portoles Pérez, José / Sancho-López, Aranzazu

Kidney international

2021 Volume 100, Issue 3, Page(s) 711

MeSH term(s)	Female ; Humans ; Lupus Nephritis/drug therapy ; Milk, Human ; Mycophenolic Acid
Chemical Substances	Mycophenolic Acid (HU9DX48N0T)
Language	English
Publishing date	2021-08-22
Publishing country	United States
Document type	Letter
ZDB-ID	120573-0
ISSN	1523-1755 ; 0085-2538
ISSN (online)	1523-1755
ISSN	0085-2538
DOI	10.1016/j.kint.2021.05.010
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Zs.A 797: Show issues

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Article ; Online: A limited number of medicines pragmatic trials had potential for waived informed consent following the 2016 CIOMS ethical guidelines.

Dal-Ré, Rafael / Avendaño-Solà, Cristina / de Boer, Anthonius / James, Stephan K / Rosendaal, Frits R / Stephens, Richard / Ioannidis, John P A

Journal of clinical epidemiology

2019 Volume 114, Page(s) 60–71

Abstract: Objectives: European regulations do not allow modification or waiver of informed consent for medicines randomized controlled trials (RCTs) where the three 2016 Council for International Organizations of Medical Sciences (CIOMS) provisions are met ( ... ...

Abstract	Objectives: European regulations do not allow modification or waiver of informed consent for medicines randomized controlled trials (RCTs) where the three 2016 Council for International Organizations of Medical Sciences (CIOMS) provisions are met (consent would be impractical or unfeasible, yet the trial would have high social value and pose no or minimal risk to participants). We aimed to identify whether any such trials of medicines were being conducted in Europe. Study design and setting: This is a survey of all phase 4 "ongoing" RCTs on the EU clinical trial register between July 1, 2016 and June 30, 2018, to identify those with potentially high levels of pragmatism. Trials that were excluded were as follows: those conducted on rare diseases; conducted on healthy volunteers (except those assessing vaccines); masked (single-, double-blind) trials; single-center trials; those where one could expect to lead patients to prefer one intervention over the other; and miscellaneous reasons. The degree of pragmatism of the RCTs was self-assessed by trials' investigators by means of the PRECIS-2 tool. Investigators of those trials considered to be highly pragmatic assessed the fulfillment of the three CIOMS provisions. Seven patients assessed the social value of the RCTs. Finally, 33 members of 11 research ethics committees (RECs) assessed the social value of the trials and whether they posed no more than minimal risk to participants. Investigators, patients, and REC members assessed the fulfillment of the CIOMS provisions as "yes," "not sure" or "no." Results: Of the 638 phase 4 trials, 420 were RCTs, and 21 of these (5%) were candidates to be pragmatic. Investigators of 15 of these 21 RCTs self-assessed their trial's degree of pragmatism: 14 were highly pragmatic. Of these 14, eight fulfilled the three CIOMS provisions. Assessments by patients and RECs were inconsistent for several trials. Conclusions: We found few low-risk participant-level pragmatic RCTs that could be suitable for modified or waived participants' informed consent. European regulators should consider amending the current regulation and encouraging the conduct of such trials.
MeSH term(s)	Clinical Trials, Phase IV as Topic/legislation & jurisprudence ; Clinical Trials, Phase IV as Topic/statistics & numerical data ; Europe ; Government Regulation ; Humans ; Informed Consent/legislation & jurisprudence ; Patient Selection ; Pragmatic Clinical Trials as Topic/legislation & jurisprudence ; Pragmatic Clinical Trials as Topic/statistics & numerical data ; Randomized Controlled Trials as Topic/legislation & jurisprudence ; Randomized Controlled Trials as Topic/statistics & numerical data ; Risk Assessment
Language	English
Publishing date	2019-06-15
Publishing country	United States
Document type	Journal Article
ZDB-ID	639306-8
ISSN	1878-5921 ; 0895-4356
ISSN (online)	1878-5921
ISSN	0895-4356
DOI	10.1016/j.jclinepi.2019.06.007
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