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Call for all sponsors to publish clinical trial results in EU database

The European Commission (EC), the European Medicines Agency (EMA) and the Heads of Medicines Agencies(HMA) have co-signed a letter reminding all sponsors of clinical trials conducted in the European Union of their obligation to make summaries of results of concluded trials publicly available in the EU Clinical Trials Database (EudraCT).

Transparency and public access to clinical trial results, whether positive or negative, are fundamental for the protection and promotion of public health.

EMA has since September 2018 been identifying trials with missing results on a monthly basis and sending reminders to the sponsors of those trials to ensure compliance with the transparency rules and their follow up on their results reporting obligations.

For more information: https://www.ema.europa.eu/en/news/call-all-sponsors-publish-clinical-trial-results-eu-database

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ICH Releases Draft Revision of E8 Guideline, General Considerations for Clinical Trials

Since the last update of ICH6 (R2) on 2017, ICH was working on a new release, a new revision of ICH E8 about General Considerations for Clinical Trials. The E8 last version was adopted in 1997, but changes to trial design and conduct in the last two decades have made much of the guideline out of date.

Currently, parties involved in clinical trials development have a draft version of ICH E8 available and ICH plans to release the final ICH E8(R1) by June 2020.

The new revision adds a new section about quality of clinical studies design which is focus on “critical to quality” factors adaptable to several types of clinical trials and the importance of patient centricity in clinical trial development.

Review complete draft version here: ICH E8(R1) Draft version

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Acknowledgment for APICES collaboration in a clinical trial published in The Oncologist.

Many times the work of CROs is not totally acknowledged. But, fortunately, this is not always the case.

This month, we want to share the acknowledgment that APICES has received in a recent publication in The Oncologist. This means to all APICES team an extra motivation in order to give continuity to the implication we have in every project in which we collaborate. From APICES, we are pride because of the recognition of our work and we want to thank ONCOSUR and Dr Eva Ciruelos for the opportunity they have given to APICES to appear as author as well as in the publication acknowledgments, and congratulate them for their project success.

The paper analyzes the results of a phase II clinical trial about neurotoxicity caused by three dose regimens of nab-paclitaxel in comparison with solvent-based paclitaxel as first line therapy. The clinical trial NEURABRAX has showed that, regardless of the dose, nab-paclitaxel did not differ from solvent-based-paclitaxel in terms of neurotoxicity as evaluated with the TNS. However, results from NCI-CTCAE, dose delays and reductions, and functional tools consistently indicate that 150 mg/m2 of nab-paclitaxel administered on days 1, 8 and 15 in a 4-week cycles is associated with a greater risk of chemotherapy-induced neuropathy. Thus, these results question the superiority of the TNS over NCI-CTCAE for evaluating chemotherapy-induced neuropathy and guiding treatment decisions in this context.

For more detailed information: A Pilot, Phase II, Randomized, Open‐Label Clinical Trial Comparing the Neurotoxicity of Three Dose Regimens of Nab‐Paclitaxel to That of Solvent‐Based Paclitaxel as the First‐Line Treatment for Patients with Human Epidermal Growth Factor Receptor Type 2‐Negative Metastatic Breast Cancer Ciruelos, et al. The Oncologist

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

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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Actualización de los criterios de selección de pacientes en ensayos clínicos

Estimados amigos,

En el recientemente celebrado congreso anual de la Asociación Americana de Oncología Clínica (ASCO) se ha presentado un trabajo en el que ASCO, Friends of Cancer Research y la FDA utilizaron las recomendaciones del trabajo original de ASCO para identificar los criterios de elegibilidad que con mayor probabilidad restringirían la participación de los pacientes en los ensayos y tenían menos probabilidades de afectar la seguridad de los participantes.

La intención es incluir un mayor número de pacientes de los que suelen estar poco representados en los ensayos clínicos. Pacientes pediátricos, personas con tumores previos o concurrentes, individuos con metástasis cerebrales y portadores del VIH podrán ser incluidos en los ensayos clínicos, ampliando la población de sujetos candidatos a formar parte de estos estudios.

En el vínculo siguiente se puede ver un resumen de cada una de las recomendaciones del grupo de trabajo y un análisis de los principios generales para guiar su implementación. Además incluye el lenguaje recomendado para su uso en protocolos de ensayos clínicos.

http://ascopubs.org/

OScar

Evaluación de los resultados en oncología

El VIII Seminario Fundación ECO, organizado de manera conjunta con la Real Academia Nacional de Medicina, ofreció un foro de debate y discusión en esta ocasión, sobre la evaluación y los resultados de salud en Oncología.

Oscar Salamanca, director general de APICES, reflexionó sobre las debilidades y fortalezas de los End Points en Oncología Médica, sobre la interpretación en términos de beneficio clínico de los resultados de los estudios, sobre el futuro papel de las variables reportadas por los pacientes y sobre nuevas aproximaciones estadísticas de los datos clínicos.

Para ver el video de la presentación, accede al siguiente link:

VII-seminario-evaluación-de-los-resultados-en-salud-en-oncología-1-parte-20-de-junio-de-2017/

En los siguientes enlaces pueden verse las crónicas publicadas por los distintos medios especializados:

http://www.gacetamedica.com

http://www.immedicohospitalario.es

https://herenciageneticayenfermedad.blogspot.com.es

Departamento de comunicación
APICES
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