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Designing and Running a Clinical Trial
Published in Trevor F. Cox, Medical Statistics for Cancer Studies, 2022
The European Medicines Agency (EMA) has a role to guarantee the scientific evaluation, supervision and safety monitoring of human and veterinary medicines in the EU. The European Union Drug Regulating Authorities Clinical Trials Database (EudraCT) is the European database for all interventional clinical trials on medicinal products authorised in the EU.
Clinical Trials
Published in Michael Ljungberg, Handbook of Nuclear Medicine and Molecular Imaging for Physicists, 2022
Once all the necessary documentation is in place, the approval process begins. The minimum for a clinical trial involving a medicinal product is approval by the “national competent authority,” meaning the medicines agency in the country in which the trial is conducted, and the ethics committee(s). If it is an international multicentre trial, it will require approval in each country. In the European Union, a unified process is being implemented that will require only one application per trial for both medicines agency and ethics committee, independently of the number of participating member states. It is the intention that this unified and electronic process will reduce the time and effort needed to start a clinical trial, thereby improving the conditions for clinical research in Europe. Independently of the number of participating member states, any trial conducted within the EU has to be reported through the European Union Drug Regulating Authorities Clinical Trials (EudraCT) database system (https://eudract.ema.europa.eu/). Once registered, a unique trial identifier (EudraCT number) is given to the trial, which can then be sent to the regulatory authorities for approval.
Drug evaluation in children
Published in Evelyne Jacqz-Aigrain, Imti Choonara, Paediatric Clinical Pharmacology, 2021
Evelyne Jacqz-Aigrain, Imti Choonara
An additional, considerable legislative measure for any country would be to require registration of trials in an established register, before granting approval by an ethics committee or institutional review board [31]. In Europe, with the creation of the EudraCT database, a first step has been made, although access to its contents will be limited, at least for now. The United States also seem to be moving in this positive direction [32]. In the meantime, a register of clinical trials in Europe dedicated to children is being set up [33].
Success stories of AI in drug discovery - where do things stand?
Published in Expert Opinion on Drug Discovery, 2022
Kit-Kay Mak, Madhu Katyayani Balijepalli, Mallikarjuna Rao Pichika
BenevolentAI has designed and developed a drug candidate, BEN2293, to treat of atopic dermatitis (AD). It is a potent and selective small-molecule pan-Trk (tropomyosin receptor kinase) antagonist. It was formulated for topical delivery with a pharmacokinetics profile for low systemic exposure for optimal safety and efficacy. A randomized, adaptive design, double-blind, placebo-controlled, first-in-human, two-part study (Phase 1/2, NTC04737304) to investigate the safety, tolerability, pharmacokinetics and preliminary efficacy of multiple topical doses of BEN2293 in adult patients with mild-to-moderate AD is registered. It is also registered in the EU clinical trial register (EudraCT number, 2020–003143-28). However, we could not find any reported studies on BEN2293 to confirm its activity, safety profile, pharmacokinetics, etc.
Transthyretin stabilization activity of the catechol-O-methyltransferase inhibitor tolcapone (SOM0226) in hereditary ATTR amyloidosis patients and asymptomatic carriers: proof-of-concept study#
Published in Amyloid, 2019
Josep Gamez, María Salvadó, Núria Reig, Pilar Suñé, Carles Casasnovas, Ricard Rojas-Garcia, Raúl Insa
An open-label interventional phase IIa proof-of-concept clinical trial was designed, with the primary objective of assessing whether treatment with tolcapone (referred to herein as SOM0226) induced TTR stabilization by evaluating prevention of urea-induced denaturation of tetrameric TTR in plasma samples from patients with ATTR amyloidosis, asymptomatic TTR mutation carriers and healthy volunteers. The secondary objective was to determine the drug molar ratio in plasma that must be reached to induce maximum stabilization of TTR. The study protocol was approved by the Ethical Committee for Clinical Research of Hospital Universitari Vall d’Hebron, Barcelona, Spain. The study was conducted in accordance with the principles of the Declaration of Helsinki for the protection of human subjects. Before entering the study, all subjects provided written informed consent to their participation, following an explicit explanation of the trial’s purpose and potential adverse side effects. The study was registered at https://eudract.ema.europa.eu/ (EudraCT trial number 2012–003431-37) and https://clinicaltrials.gov/ (ClinicalTrials.gov Identifier: NCT02191826).
Population pharmacokinetics of PF-06438179/GP1111 (an infliximab biosimilar) and reference infliximab in patients with moderately to severely active rheumatoid arthritis
Published in Expert Opinion on Biological Therapy, 2019
Rameshraja Palaparthy, Muhammad I. Rehman, Oliver von Richter, Donghua Yin
This multinational, double-blind, randomized study (ClinicalTrials.gov identifier: NCT02222493; EudraCT number: 2013–004148-49) consisted of an initial 30-week treatment period and two subsequent 24-week treatment periods, during which patients were evaluated following a single transition from ref-IFX-EU to PF-SZ-IFX after 30 or 54 weeks of treatment (Figure 1). Eligible patients were randomized 1:1 to receive IV PF-SZ-IFX or ref-IFX-EU, each in combination with MTX. PF-SZ-IFX or ref-IFX-EU (3 mg/kg) was given as an induction regimen at Weeks 0, 2, and 6, followed by maintenance treatment with 3 mg/kg starting at Week 14 and continuing every 8 weeks thereafter.