Reviving the SCNP Committee on clinical trials: the need to enhance its future mission.
نویسنده
چکیده
The paper by P. Bech and T. Ban is highly informative, aimed at reviewing the history of psychotropic drugs in the European Union, specifically, as regards the development of the Scandinavian College of Neuropsychopharmacology (SCNP). They cover its early successes, the UKU and the reasons for its later dissolution, and for determining that the UKU now needs to be revived with a somewhat broader mission. Although brief, the paper captures the early high expectations of the SCNP group when the new treatments were introduced, and the manner in which they went about dealing with the evaluation of the new drugs. It was clear then that a mechanism was necessary that would permit objective evaluation of these agents, while at the same time, making it possible for the science to advance and for new, even more effective, drugs to be developed. To accomplish these aims they established a clinical research committee, that is, the UKU (CRC), to oversee the standardisation and select the technology to be utilised in evaluation. The Committee bent to the use of rating scales for evaluation, and to accommodate the clinicians who would use them, would select only brief rating methods. Thus, they established use of the soundly validated brief Hamilton depression and anxiety scales (1) for the affective disorders and the broader Brief Psychiatric Rating Scale (BPRS) (2) for trials of anti-psychotic agents. The authors then trace the rise and fall of enthusiasm about the drugs and the problems of conducting clinical trials during the period of 1960–2000, alluding to the reductions in government support, the dissolution of the UKU and the European Committee for Standardization of Clinical Trials, and the increase in the dominance of industry, despite some major developments in the science, led by Arvid Carlsson and Mogens Schou. Now we view a scene where industry citing the failure during the last three decades to develop any new classes of psychotropic drugs for depression or the psychoses, and highly expensive clinical trials that have produced little information of value, have severely reduced their involvement in the development of central nervous system drugs. In order to break this ‘impasse’, to stimulate dialogue among industry and academia, the authors recommend and the SCNP will reassemble a new UKU Committee dedicated to advancing the clinical trial.
منابع مشابه
Hematopoietic stem cell transplant therapy, clinical trials, complications, and quality of life for patients with Sickle cell anemia: Clinical potential and future perspectives
Background: Sickle cell anemia (SCA) is an inherited monogenic disorder. The clinical symptoms of SCA are protean, including vaso-occlusion, hemolysis, early stroke, leg ulcers, multi-organ failure, and increased risk of premature death. Hematopoietic stem cell transplantation is the only treatment identified to reduce SCA-related organ damage. Unfortunately, graft rejection is a significant im...
متن کاملMedicinal plants for gingivitis: a review of clinical trials
Objective(s): Periodontal diseases are among prevalent oral health problems which may ultimately lead to severe complications in oral cavity. Herbal products can be designed as single or multicomponent preparations for better oral health. This study aims to review current clinical trials on the effectiveness of herbal products in gingivitis. Materials and Methods: Electronic databases, includin...
متن کاملA systematic review and meta-analysis of clinical trials on saffron (Crocus sativus) effectiveness and safety on erectile dysfunction and semen parameters
Objective: We performed this systematic review and meta-analysis study to determine saffron (Crocus sativus) effectiveness and safety in male infertility problems. Materials and Methods: The databases PubMed, Scopus, Cochrane, Google Scholar, SID, IranMedex and Magiran until July 2016 and reference section of relevant articles, were searched to find both English and Persian clinical trials on m...
متن کاملEffect of soy consumption on liver enzymes, lipid profile, anthropometry indices, and oxidative stress in patients with non-alcoholic fatty liver disease: A systematic review and meta-analysis of clinical trials
The present systematic review and meta-analysis was conducted to investigate the effects of soy intake on liver enzymes, lipid profile, anthropometry indices, and oxidative stress in non-alcoholic fatty liver disease (NAFLD). A systematic search was undertaken in PubMed, Embase, Scopus, Web of Science, and Cochrane Library covering up to 10 January 2020. A fixed-effect or random-effects models ...
متن کاملThe Effect of Metoclopramide on Prolactin Levels in Breastfeeding Mothers: A Systematic Review and Meta-Analysis
Background: Exclusive breastfeeding is beneficial to not only infants, but also mothers. Since prolactin stimulates milk production, increasing its levels through dopamine antagonists, such as metoclopramide, may enhance milk production. However, the efficacy of this method should be further studied. Therefore, this systematic review sought to determine the effects of metoclopramide on prolacti...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید
ثبت ناماگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید
ورودعنوان ژورنال:
- Acta neuropsychiatrica
دوره 26 6 شماره
صفحات -
تاریخ انتشار 2014