20190313

NEW TREATMENT OPTION FOR PATIENTS WITH SPINAL CORD INJURY

This month has been published a relevant article about a new therapeutic advance. A patient with spinal cord injury can walk again after being treated with NC1, a new cell therapy produced at Hospital Puerta de Hierro from Madrid, Spain.

The medical team from Hospital Puerta de Hierro started working in NC1 20 years ago. This therapy consists of expanded autologous mesenchymal stromal cells and autologous plasma as its excipient. APICES collaborated in project start-up and is proud of it. Congratulations to the Hospital Puerta de Hierro team and all the personnel involved who have made this possible.

For more information:

https://www.elmundo.es/salud/2019/03/01/5c79754b21efa04a668b45cf.html

20190227

CTFG KEY RECOMMENDATIONS TO CONDUCT A COMPLEX CLINICAL TRIAL

The Clinical Trials Facilitation and Coordination Group has drawn up a document that provides recommendations for sponsors regarding the authorization and conduct of complex clinical trial from a current perspective.

In this document, a complex clinical trial is considered to have a complex clinical trial design if it has separate parts that could constitute individual clinical trials and/or is characterized by extensive prospective adaptations such as planned additions of new Investigational Medicinal Products (IMP) or new target populations. These separate parts will be designated “sub-protocols” or different study cohorts and arms, depending on the context. Another option is carrying out several studies with a common master protocol between them. Examples of complex clinical trial designs are basket (one IMP or combination in several populations), umbrella (several IMPs or combinations in a single population) and platform trials (several IMPs or combinations in several populations).

The CTFG has stablished key recommendations regarding design, scientific integrity,  quality of trial conduct, clinical feasibility, safety, data integrity, benefit-risk balance and data transparency, among others.

For more information: http://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/CTFG/2019_02_CTFG_Recommendation_paper_on_Complex_Clinical_Trials.pdf

20190130_2

GUIDANCE ON ONCOLOGY ENDPOINTS: FDA REVISION

Clinical trial endpoints serve to different objectives: In early phase, clinical trials evaluate safety and evidence biological drug activity; for later phase efficacy studies evaluate the clinical benefit.

Food and Drug Administration (FDA) has revised the previous guidance on oncology endpoints published in May 2007. This guidance provides recommendations to applicants on endpoints for cancer clinical trials submitted to the FDA.

In this guidance, the FDA classifies several endpoints in base on type of endpoint and study design. Furthermore, analyses advantages and disadvantages of every endpoint referred.

In addition to the already stablished endpoints, in this revision, the FDA proposes two new endpoints to consider:

  • Blood or Body Fluid-Based Biomarkers: Generally, although biomarkers assayed from blood or body fluids have not served as primary endpoints for cancer drug approval, the FDA has accepted blood-based markers as elements of a composite endpoint. This fact has been due to the use of paraprotein levels measured in blood and urine (myeloma) or CA-125 (ovarian cancer), for example.
  •  Emerging Endpoints: FDA recognizes that owing to advances in science, new endpoints that may be used in drug approvals can be identified. As examples, minimal residual disease (lymphoblastic leukemia) and metastasis-free survival (non-metastasis castration-resistant prostate cancer).

 

For more information: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM071590.pdf

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MERRY CHRISTMAS AND HAPPY 2019 – APICES 10 YEARS OLD

Next year is very close and is time to think about results of this year, time to celebrate successes and to be enthralled with the beginning of new projects and challenges for 2019.

Moreover, 2019 is really a very special year, APICES will be 10 years old, in which APICES has not stopped growing and improving its capabilities, quality and team. During last 10 years, APICES has met all our clients objectives & milestones, which are ours, and has overcame all challenges encountered along the way, but, this is not enough, and new clients, projects and challenges are waiting for us for next 10 years.

For all these reasons, APICES team wants to thank for this wonderful past 10 years to all involved stakeholders: clients, providers, investigators, patients, HHAA and for an awesome future:

The entire APICES team wishes you a Peaceful and Merry Christmas and a healthy and successful 2019.

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20181127

BIOETHICS IN CLINICAL TRIALS

The participation of a human being in a clinical trial generates a potential situation of vulnerability in which his/her rights must keep clearly protected. It is necessary that any medical investigation, which involves the human persons study, complies with several ethics requirements stablished in The Helsinki Declaration. All clinical trial protocol should be evaluated by an independent agency whose main objective is to care for clinical trial subjects rights, safety and welfare: The Clinical Research Ethics Committee.

The United States Conference built in the sixty´s the named “National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research ”. In 1978, this commission made a document, Belmont Report, which collects bioethics fundamental: Justice, Non-maleficence, Beneficence and Respect for autonomy.

Helsinki Declaration was written by the World Medical Association in 1964, it was the first document which proposed criteria and steps in order to protect subjects who are enrolling in biomedical investigation, several updates have been made, the last one was carried out in Fortaleza, Brazil. Its core principles consist in the need of clinical trial protocol must be approved by an Ethic Committee and the need of obtaining the inform consent form before subject enrolling.

The concern about Ethics in Clinical Research is increasing more and more. Directions about how carrying out any clinical investigation are been stablished with more accuracy because of there are more experts of different knowledge fields involved and are willing to share their point of view.

As can be seen in this publication: https://www.nejm.org/doi/full/10.1056/NEJMms1603756, ethics values are constantly changing over time and always there are interests involved which led carrying out a clinical research without complying Helsinki Declaration or another ethic directions. Due to all this, Bioethics has become an essential aspect that always leads to debate.

For more information:
http://www.ethics.org.au/on-ethics/blog/august-2017/thomas-beauchamp-james-childress-medical-ethics

20181018

Update of Annexes II, V and VIIIC of the AEMPS for the conduct of clinical trials in Spain

The AEMPS has updated Annexes II, V and VIIIC for the conduct of clinical trials in Spain.

  • Annex II. Security documentation that the sponsor must send to the Health Authorities of the Autonomous Communities
  • Annex V. Model of insurance certificate
  • Annex VIIIC. Instructions for updating the section of Protection of personal data in the patient information sheet regarding the General Data Protection Regulation (EU) No. 2016/679

Clicking here you can access the annexes.

20181015

Use of electronic health record data in clinical investigations

Electronic health record (EHR) systems are electronic platforms that contain individual health records for patients. EHR systems are generally maintained by health care providers, health care organizations, and health care institutions and are used to deliver care.

The EHR systems can be an interesting chance in clinical investigation: to improve data accuracy and promote clinical trial efficiency, due to EHR systems can be used to integrate real-time electronic health care information, from medical devices and multiple health care providers involved in the care of patients. A typical individual EHR may include a patient’s medical history, diagnoses, treatment plans, immunization dates, allergies, radiology images, pharmacy records, and laboratory and test results that can be combined, aggregated to others platforms, and analyzed. In addition, there are opportunities for long-term follow up of large numbers of patients, which may be of particular importance in studies where the outcome of interest occurs rarely, such as in prophylaxis studies.

For more information: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM501068.pdf

20180924

Endpoints en ensayos clínicos: Ventajas y desventajas

Los endpoints primarios en ensayos clínicos deben basarse en 3 requisitos:

  1. Ser clínicamente relevantes.
  2. Relacionados con el efecto del tratamiento.
  3. Medibles e interpretables.

Los endpoints secundarios pueden aportar una visión más global del beneficio de tratamiento que está siendo estudiado y de su relación beneficio- riesgo; pueden ser de dos tipos:

  1. Aquellos que, como los primarios, son clínicamente relevantes y podrían ser tomados en consideración para posibles indicaciones del fármaco; y
  2. Endpoints que no están dirigidos a descubrir una nueva indicación o cambio de ficha técnica pero podrían ser un refuerzo de los endpoints primarios aportando nueva información sobre la enfermedad. Algunos endpoints secundarios podrían ser análisis exploratorios, que pueden mostrar efectos biológicamente plausibles y que podrían ser generadores de hipótesis que sería necesario confirmar en estudios posteriores.

Podéis encontrar información más detallada en el siguiente vínculo:

https://www.omicsonline.org/open-access/endpoints-in-clinical-trials-advantages-and-limitations-ebmp-1000e111.pdf

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Comunicación de Reacciones Adversas a Medicamentos a eudravigilance.

Desde el pasado día 22 de noviembre de 2017 está disponible la nueva versión de EudraVigilance y comenzó un nuevo flujo de envío de sospechas de reacciones adversas a medicamentos en la Unión Europea. Esto implica que según lo que establece el Real Decreto 577/2013, por el que se regula la farmacovigilancia de medicamentos de uso humano, los titulares de autorización de comercialización (TAC) deben enviar por medios electrónicos a la base de datos EudraVigilance todas las sospechas de casos individuales de reacciones adversas a medicamentos tanto graves como no graves, atendiendo a las directrices europeas sobre buenas prácticas de Farmacovigilancia.

Esto quiere decir que es obligatorio el envío por parte de los TAC, de todas las sospechas de reacciones adversas graves ocurridas en la Unión Europea y en terceros países, en los quince días naturales siguientes al día en el que haya tenido conocimiento de éstas. Y por otra parte, también tiene obligación de enviar todas las sospechas de reacciones adversas no graves ocurridas en la Unión Europea en los noventa días naturales siguientes al día en el que haya tenido conocimiento de éstas.

En el departamento de Farmacovigilancia de APICES, estamos al día de este cambio de flujo y teniendo en cuenta que sólo es de aplicación en el ámbito post-autorización, nos afecta solamente en aquellos casos de reacciones adversas a medicamentos procedentes de estudios post-autorización (no ensayos clínicos) en los que se requiera notificación por parte de los TAC.

Para más información, se pueden consultar los siguientes enlaces:

https://sede.aemps.gob.es/usoHum/farmacovig/docs/preg_resp-transicion-flujo-EudraVigilance.pdf

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/q_and_a/q_and_a_detail_000165.jsp&mid=WC0b01ac0580a69263

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La protección de datos – Nueva regulación adaptada a la era digital

El Reglamento General de Protección de Datos (RGPD), que regula el tratamiento que realizan las personas, empresas u organizaciones de los datos personales relacionados con personas en la Unión Europea, fue aprobado por el Parlamento Europeo en abril de 2016, su ámbito de aplicación se extiende a todos los países miembros de la Unión Europea y se aplica directamente en todos ellos a partir del 25 de mayo de 2018.

Este cambio regulatorio pretende devolver a los ciudadanos el control de sus datos personales y garantizar en toda la UE unos estándares de protección elevados y adaptados al entorno digital. Los ciudadanos pueden decidir por sí mismos qué información quieren compartir.

Entre otras disposiciones, el reglamento incluye:

  • el derecho al “olvido”, mediante la rectificación o supresión de datos personales,
  • la necesidad de “consentimiento claro y afirmativo” de la persona concernida al tratamiento de sus datos personales,
  • la “portabilidad”, o el derecho a trasladar los datos a otro proveedor de servicios,
  • el derecho a ser informado si los datos personales han sido pirateados,
  • lenguaje claro y comprensible sobre las cláusulas de privacidad.

Desde APICES nos hemos adaptado a la nueva regulación y hemos implementado las medidas necesarias para cumplir con la misma, respetando los principios de la protección de datos y permitiendo que las personas ejerzan sus derechos. Puedes acceder a nuestra política de privacidad a través del siguiente vínculo: http://www.apices.es/privacy/.

En el vínculo siguiente puedes acceder al Reglamento (UE) 2016/679 relativo a la protección de las personas físicas en lo que respecta al tratamiento de datos personales y a la libre circulación de estos datos.

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