equipocesca » Methodology http://equipocesca.org Tue, 24 Mar 2026 18:26:47 +0000 en-US hourly 1 http://wordpress.org/?v=3.5 The European Alliance for Responsible R&D and Affordable Medicines transparency of clinical trials and good governance should be included in the EMA (European Medicines Agency) extended mandate http://equipocesca.org/en/english-the-european-alliance-for-responsible-rd-and-affordable-medicines-u-ransparency-of-clinical-trials-and-good-governance-should-be-included-in-the-ema-european-medicines-agency-extended-ma/ http://equipocesca.org/en/english-the-european-alliance-for-responsible-rd-and-affordable-medicines-u-ransparency-of-clinical-trials-and-good-governance-should-be-included-in-the-ema-european-medicines-agency-extended-ma/#comments Mon, 13 Sep 2021 08:56:22 +0000 Pedro Gérvas http://equipocesca.org/?p=5906653 In occasion of the ongoing trilogues on the European Medicines Agency (EMA) extended mandate, Members of the European Alliance for Responsible R&D and Affordable Medicines urge the Council to ensure the new Regulation enhances clinical trial transparency and upholds good governance.    As explained in a letter published today, it is crucial that information on clinical trials is made available in a timely, user-friendly, and complete manner. This is key to avoid unnecessary duplications and to accelerate the development of new therapies and vaccines, especially during a public health emergency.
  • The European Alliance for Responsible R&D and  Affordable Medicines transparency of clinical trials and good governance should be included in the EMA (European Medicines Agency) extended mandate. Brussels, Belgium, 9 September 2021 Download article here.
]]> http://equipocesca.org/en/english-the-european-alliance-for-responsible-rd-and-affordable-medicines-u-ransparency-of-clinical-trials-and-good-governance-should-be-included-in-the-ema-european-medicines-agency-extended-ma/feed/ 0 What has evidence based medicine (EBM) done for our patients? We do not know. We must abandon it http://equipocesca.org/en/english-what-has-evidence-based-medicine-ebm-done-for-our-patients-we-do-not-know-we-must-abandon-it/ http://equipocesca.org/en/english-what-has-evidence-based-medicine-ebm-done-for-our-patients-we-do-not-know-we-must-abandon-it/#comments Wed, 18 Sep 2019 16:05:59 +0000 Pedro Gérvas http://equipocesca.org/?p=5906493 We must admit that: a / “if the final objective of EBM (Evidence Based Medicine) is to improve patients-populations’ health, do we have evidence of succeed in this objective?” No, b / is EBM harming patients-populations’ health? We do not know. Evidence-Based Medicine (#EBM) has not demonstrated any impact on patients’ health. It is honest to think that the EBM has become harmful and it is urgent to abandon it and replace it with a Medicine Based on Living.  See also: https://www.actasanitaria.com/what-has-evidence-based-medicine-ebm-done-for-our-patients/

  • What has evidence based medicine (EBM) done for our patients? We do not know. We must abandon it. Gérvas J. Madrid. September 2019. Download article here.
]]> http://equipocesca.org/en/english-what-has-evidence-based-medicine-ebm-done-for-our-patients-we-do-not-know-we-must-abandon-it/feed/ 0 Making use of the Food and Drug Administration briefing documents to reconsider the safety of the antipsychotic sertindole http://equipocesca.org/en/making-use-of-the-food-and-drug-administration-briefing-documents-to-reconsider-the-safety-of-the-antipsychotic-sertindole/ http://equipocesca.org/en/making-use-of-the-food-and-drug-administration-briefing-documents-to-reconsider-the-safety-of-the-antipsychotic-sertindole/#comments Fri, 02 Sep 2016 15:23:08 +0000 Pedro http://equipocesca.org/?p=5906315 Sertindole (Serdolect in the world, Zerdol in Germany) is an atypical antipsychotic agent, schizophrenia. Sertindole side effects include cardiac problems as prolongation of QT interval, arrhythmia and sudden deaths (higher than for other atypical antipsychotics). The FDA analysis of SCoP, made public in April 2009, estimated the hazard ratio for sudden cardiac death with sertindole versus risperidone as 5.102 (95% CI 1.453 – 17.913). In April 2009 an FDA advisory panel voted 13-0 that sertindole was effective in the treatment of schizophrenia but 12-1 that it had not been shown to be acceptably safe.
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PsychopharmacologicDrugsAdvisoryCommittee/UCM198218.pdf

Sertindole was never approved for use in the USA and was discontinued in the U.K., Australia and the New Zealand. Sertindole was approved in the European Union (and others counytries) in 2002 (
http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/Sertindole_36/WC500011855.pdf )

This manuscript is being released primarily for two reasons. First, the importance of accessing freely available FDA documents to obtain a more complete characterization of a drug’s safety and efficacy. Second, to alert patients and prescribers in other countries about the potential risks of sertindole. 

  • Making use of the Food and Drug Administration briefing documents to reconsider the safety of the antipsychotic sertindole. Sasich LD, Abi-Jaoude E. Ontario, Canada. September 2016. Download article complete here.
]]> http://equipocesca.org/en/making-use-of-the-food-and-drug-administration-briefing-documents-to-reconsider-the-safety-of-the-antipsychotic-sertindole/feed/ 0 Overdiagnosis as an extreme form of length-time bias. Breast cancer screening as an example http://equipocesca.org/en/english-overdiagnosis-as-an-extreme-form-of-length-time-bias-breast-cancer-screening-as-an-example/ http://equipocesca.org/en/english-overdiagnosis-as-an-extreme-form-of-length-time-bias-breast-cancer-screening-as-an-example/#comments Tue, 14 Oct 2014 04:49:43 +0000 Pedro http://equipocesca.org/?p=5905866

Overdiagnosis is an error of prognosis. Overdiagnosis is not an error of diagnosis. Overdiagnosis is a “true positive” diagnosis. We cannot distinguish between overdiagnosis cancer and non-overdiagnosis cancer. In this presentation the focus is on the vision of overdiagnosis as extreme form of length-time bias, and the research lines which might help in the future to resolve the problem. Please, download the presentation because it is a dynamic one.

  • Overdiagnosis as an extreme form of length-time bias. Breast cancer screening as an example.  Gérvas J. Madrid (Spain). October 2014. Download presentation here.

See more in:
The overdiagnosis of cancer: when the diagnosis undermines the quality of life. http://pharmawatchcanada.wordpress.com/2014/01/10/the-overdiagnosis-of-cancer/

]]> http://equipocesca.org/en/english-overdiagnosis-as-an-extreme-form-of-length-time-bias-breast-cancer-screening-as-an-example/feed/ 0 Minimum data set in General Practice: definitions and coding http://equipocesca.org/en/minimum-data-set-in-general-practice-definitions-and-coding/ http://equipocesca.org/en/minimum-data-set-in-general-practice-definitions-and-coding/#comments Fri, 31 Jan 2014 18:20:12 +0000 Pedro http://equipocesca.org/?p=5905699 A minimum basic data set (MBDS) was designed and used in general practice. The most important purpose and need for establishing such a data set is to assist in the provision of patient care. MBDS is designed to meet common needs for many general practitioners. Minimum means that individual programmes or the GP are free to collect as much additional data as they may wish. The MBDS includes two kinds of data: permanent and dynamic/encounter items.

  • Minimum data set in General Practice: definitions and coding. Gérvas J, Pérez Fernández M. Fam Pract. 1992; 9: 349-52. Descargar artículo completo.
]]> http://equipocesca.org/en/minimum-data-set-in-general-practice-definitions-and-coding/feed/ 0 Trials of improve care for the elderly http://equipocesca.org/en/trials-of-improve-care-for-the-elderly/ http://equipocesca.org/en/trials-of-improve-care-for-the-elderly/#comments Thu, 07 Mar 2013 09:21:29 +0000 Pedro http://equipocesca.org/?p=5905211 Clinical randomized trials are experimental situations where some patients might received excellent care. What happens after the end of the trial? This a key ethical question should be answered in all proyects and programs of clinical trial.

  •  Trials of improve care for the elderly. Gérvas, J., Pérez Fernández, M. N Engl J Med. 1996; 334: 665. Download full article here.
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