The corporate logo of the U.S. Food and Drug Administration (FDA) is shown in Silver Spring, Maryland, November 4, 2009. U.S. health officials unveiled plans to fight avoidable injuries from medication errors or misuse, a problem that harms hundreds of thousands of people each year and can be deadly.    REUTERS/Jason Reed   (UNITED STATES HEALTH) - RTXQCTX

EMA AND FDA MARKETING AUTHORIZATIONS: CONCORDANCES AND DISCORDANCES

EMA and FDA have published in joint an article entitled “A comparison of EMA and FDA decisions for new drug marketing applications 2014-2016: concordance, discordance and why”. Most of information were sourced from EMA´s European Public Assessment Reports (EPARs) and FDA reviews. The study consisted of comparing decisions on 107 new medicine applications at the EMA and FDA between 2014 and 2016.

The result of the analysis is the EMA and FDA alignment in more than 90% of marketing authorization decisions for new medicines. The most common reasons for discordance were differences in conclusions about efficacy and differences in clinical data submitted in support of an application.

For more information: EMA/FDA analysis shows high degree of alignment in marketing application decisions between EU and US

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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

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AEMPS UPDATES GCP SECTION

On April 24th 2019, AEMPS updated the contents of GCP section. Two points were updated:

  • New version of serious protocol breaches notification form.
  • Prohibition of FDA 1572 form in clinical trials carried out in Spain. Those clinical trials must follow Spanish laws 2001/20/EC, 2001/83/EC y 2005/28/EC and Regulation (EU) No. 536/2014 (when come into force). The non-compliance of this direction will be considered by inspectors a major finding attributable to clinical trial sponsor and principal investigator.

 

For more information:

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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

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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

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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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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

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