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The UK Dermatology Clinical Trials Network (UK DCTN) formed in 2002 with the aim of developing and supporting high quality independent national clinical trials that address prioritised research questions for people with skin disease. Its philosophy is to democratise UK dermatological clinical research and to tackle important clinical questions that industry has no incentive to answer. The network also plays a key role in training and capacity development. Its membership of over 1,000 individuals includes dermatology consultants, trainees, dermatology nurses, general practitioners, methodologists and patients. Organisational structures are lean and include a co-ordinating team based at the Centre of Evidence-Based Dermatology, and an executive with independent members to ensure probity and business progression. A prioritisation panel and steering group enable a pipeline of projects to be prioritised and refined for external funding from independent sources. The UK DCTN has supported and completed 12 national clinical trials, attracting investment of over £15 million into UK clinical dermatology research. Trials have covered a range of interventions from drugs such as doxycycline (BLISTER), silk clothing for eczema (CLOTHES) or surgical interventions for hidradenitis suppurativa (THESEUS). Trials results are published in prestigious journals and have global impact. Genuine partnership with patients and carers has been a strong feature of the network since its inception. The UK DCTN is proud of its first 20 years of collaborative work and aims to remain at the forefront of independent dermatological health technology assessment as well as expanding into areas including diagnostics, AI, efficient studies and innovative designs.

Despite legislation to stimulate pediatric drug development through clinical trials, enrolling children in trials continues to be challenging. Non-investigator (those who have never served as a clinical trial investigator) providers are essential to recruitment of pediatric patients, but little is known regarding the specific barriers that limit pediatric providers from participating in and referring their patients to clinical trials. We conducted an online survey of pediatric providers from a wide variety of practice types across the United States to evaluate their attitudes and awareness of pediatric clinical trials. Using a 4-point Likert scale, providers described their perception of potential barriers to their practice serving as a site for pediatric clinical trials. Of the 136 providers surveyed, 52/136 (38%) had previously referred a pediatric patient to a trial, and only 17/136 (12%) had ever been an investigator for a pediatric trial. Lack of awareness of existing pediatric trials was a major barrier to patient referral by providers, in addition to consideration of trial risks, distance to the site, and time needed to discuss trial participation with parents. Overall, providers perceived greater challenges related to parental concerns and parent or child logistical barriers than study implementation and ethics or regulatory barriers as barriers to their practice serving as a trial site. Providers who had previously been an investigator for a pediatric trial were less likely to be concerned with potential barriers than non-investigators. Understanding the barriers that limit pediatric providers from collaboration or inhibit their participation is key to designing effective interventions to optimize pediatric trial participation.

AbstractThe benefits of access to clinical trial data are related to their inestimable value from the perspective of clinical trial participants, society as a whole, public health systems and scientific progress. In light of the development of innovative data analysis technologies, access to raw clinical trial data opens up an ever-widening array of possibilities: it can profoundly facilitate machine data analysis for, inter alia, hypothesis generation, risk modelling, counterfactual simulation and – finally – drug repurposing and development. The enactment of the new Clinical Trials Regulation (EU) No. 536/2014 (CTR) and introduction of the Clinical Trials Information System (CTIS) were heralded as ensuring a level of transparency in clinical trials that is sufficient to contribute to protecting public health and fostering the innovation capacity of European medical research, while recognizing the legitimate economic interests of sponsors. This paper presents the hitherto binding rules for the disclosure of clinical trial data and, against this background, their new framework, introduced by the CTR. In addition to assessing whether the CTR's objectives are fulfilled, this paper examines whether the latest changes impact the hitherto existing rules on protection of regulatory data via regulatory exclusivities. Finally, it points out concerns regarding whether data gathered in the CTIS can be efficiently used by innovative data analysis technologies for further processing for both commercial and non-commercial purposes.

Investigational medicinal products submitted over the course of 3 years and authorized at the Clinical Trials Office of the Italian Medicines Agency as part of a request for authorization of clinical trials were scrutinized to identify those encompassing nanomedicines. The quality assessment reports performed on the documentation submitted were analyzed, classifying and discussing the most frequently detected issues. The identification of nanomedicines retrieved and the information on their quality profiles are shared to increase the transparency and availability of information, providing feedback that can support sponsors in optimizing the quality part of the documentation and of the information submitted. Results confirm that nanomedicines tested as investigational medicinal products in clinical trials are developed and authorized in agreement with the highest standards of quality, meeting safety profiles according to the strong regulatory requirements in the European Union. Some key points are highlighted and indicate that the regulatory approach to innovation in a clinical trial setting could potentially be renewed to ride the wave of innovation, particularly in the nanotechnology field, capitalizing on lessons learned and still ensuring a strong and effective framework.

In the AIDS pandemic, access to experimental treatments has become an important element of community-standard medical care. Rates of AIDS and HIV infection are significantly higher in prison and jail populations than in the U.S. population at large; however, prisoners are denied access to AIDS-related clinical trials in all but a handful of jurisdictions. The author argues for expanded prisoner access to AIDS-related clinical trials and demonstrates that such access is ethical and feasible. Enrolling prisoners in AIDS-related trials would stand to benefit not only affected prisoners but also clinical researchers seeking to gather information on the efficacy of treatments in all population groups contained within the larger HIV-infected population, including African Americans, Latinos, and IV drug users. Existing federal regulations, properly enforced, provide prisoners with adequate protection from exploitation conducted in the name of science. Barriers remain, in the form of state laws, correctional policies, and practical obstacles presented by the prison environment. However, as the author describes, research institutions in several states have succeeded in incorporating prisoners into clinical drug trials.

Purpose: The aim of the present study was to examine the influence of a supervised and regular program of aquatic activities throughout gestation on maternal weight gain and birth weight. Design: A randomized clinical trial. Setting: Instituto de Obstetricia, Ginecología y Fertilidad Ghisoni (Buenos Aires, Argentina). Participants: One hundred eleven pregnant women were analyzed (31.6 ± 3.8 years). All women had uncomplicated and singleton pregnancies; 49 were allocated to the exercise group (EG) and 62 to the control group (CG). Intervention: The intervention program consisted of 3 weekly sessions of aerobic and resistance aquatic activities from weeks 10 to 12 until weeks 38 to 39 of gestation. Measures: Maternal weight gain, birth weight, and other maternal and fetal outcomes were obtained by hospital records. Analysis: Student unpaired t test and χ2 test were used; P values ≤.05 indicated statistical significance. Cohen's d was used to determinate the effect size. Results: There was a higher percentage of women with excessive maternal weight gain in the CG (45.2%; n = 28) than in the EG (24.5%; n = 12; odds ratio = 0.39; 95% confidence interval: 0.17-0.89; P = .02). Birth weight and other pregnancy outcomes showed no differences between groups. Conclusion: Three weekly sessions of water activities throughout pregnancy prevents excessive maternal weight gain and preserves birth weight. Trial Registration: The clinicaltrial.gov identifier: NCT 02602106.