Use of internet technologies for data acquisition in large clinical trials.

Non-bleeding side effects of clopidogrel: Have large multi-center clinical trials underestimated their incidence?

Increasing burden of institutional review in multicenter clinical trials of infertility: the Reproductive Medicine Network experience with the Pregnancy in Polycystic Ovary Syndrome (PPCOS) I and II studies

Rationale and design of the TAILOR-PCI digital study: Transitioning a randomized controlled trial to a digital registry

<p indent="0mm">A clinical trial is a key step in the process of pharmaceutical research and development (R &amp; D). It is a key indicator of the innovative potential of the pharmaceutical industry. ClinicalTrials.gov shows that the average annual growth rate of the total number of clinical trials globally in the past decade (2012–2021) was 20.7%, mainly distributed in Europe and the United States, and the total number of clinical trials registered in China accounted for 6% of the world. According to the statistics of IQVIA Institute for Human Data Science, the global proportion of early-stage R &amp; D pipelines from China-headquartered companies increased from 1% in 2005 to 12% in 2020, which was still far behind that of European and American companies. Among 871 new active substances approved for marketing globally in the past two decades, 522 were for marketing in China, with the high number driven by regulatory acceleration mechanisms from National Medical Products Administration, such as breakthrough and orphan designations and priority reviews. Considering the gap in clinical research strength between China and developed countries such as Europe and the United States, the clinical trial research capacity and level should be improved to assist China in the R &amp; D of innovative drugs. According to the Registration and Information Disclosure Platform for Drug Clinical Studies and the clinical trial institution filing management information platform in China, in the last five years (2017–2021), the average annual growth rates of the total number of new drug clinical trial registration and clinical trial units in China reached 26.9% and 12.6%, respectively. However, clinical trial resources are mainly concentrated in major institutions, municipalities, or provincial capital cities in the eastern and central regions of China, with distributions becoming increasingly polarised. Under the background of China’s new medical reforms, the strategic direction of national political support is to motivate equitable access to high-quality clinical trial resources and cross-regional collaborative development of medical institutions by means of medical unions, national clinical medical research centres, Chinese national major projects for new drug innovation and so on. In the context of this background, clinical trial research unions (CTRUs) have been built in China. A CTRU is defined as a consortium formed by medical institutions, sponsors and third-party service institutions of various levels and functions, led by a national clinical medical research centre or clinical trial medical institutions undertaking major national science and technology projects or supporting projects of national key R &amp; D plans, radiating and driving the improvement of clinical trial research capacity in multiple regions. CTRUs develop a multi-level clinical research centre system and collaborative network by vertically and horizontally combining multi-level medical institutions, sponsors and third-party service institutions. All participants of CTRUs are crucial. The leading clinical trial research medical institution, as the core, is responsible for establishing institutional system standards in CTRUs, designing and leading high-quality multi-centre clinical trials, central ethics and personality training. The major clinical trial research medical institutions are responsible for implementing high-quality, multi-centre, complex and high-risk clinical trials. The other member institutions are responsible for implementing basic clinical trials. The sponsors, contract research organizations (CROs), site management organizations (SMOs) and other enterprises are responsible for funding, supporting and promoting the construction of a clinical trial centre system and collaborative network. The specific construction contents of CTRUs include building a clinical trial research resource sharing platform, homogenising clinical trial quality management, constructing a rapid clinical trial process platform, diversified multi-level and multi-form talent training, information interconnection, deepening strategic cooperation and designing and leading high-level trials. CTRUs have established the selection criteria and assessment exit mechanism and conducted work performance assessments from the dimensions of organisation and implementation, division of labour and cooperation, the connection of clinical trial resources from top to bottom, efficiency and benefit and sustainable development to ensure their good and sustainable development. Through CTRUs, we can achieve high-quality clinical trial resource sharing, improve the clinical trial research capability of member institutions, cultivate high-level skills, such as principal investigators (PIs), sub-investigators, institutional managers and clinical research coordinators (CRCs), and promote the development of clinical trials, economically and with high-quality. Through the trial operation with one member of CTRUs, it was found that the key points should be strengthened in deepening resource sharing, implementing central ethics review, interconnecting information platforms and leading high-quality clinical trials. The construction of CTRUs is an effective means for China’s clinical trial research to solve the current problems and change from a ‘follow-on pattern’ to leading high-level and high-quality international multi-centre trials. However, the construction of CTRUs is a complex systematic project. In addition to performing an excellent job in the top-level design and overall planning, CTRUs’ specific implementation process and measures need to be continuously explored in the practice process.

This Issue at a Glance

Recently, a novel data acquisition method has been proposed and experimentally implemented for differential phase‐contrast computed tomography (DPC‐CT), in which a conventional X‐ray tube and a Talbot‐Lau‐type interferometer were utilized in data acquisition. The divergent nature of the data acquisition system requires a divergent‐beam image reconstruction algorithm for DPC‐CT. This paper focuses on addressing this image reconstruction issue. We have developed a filtered backprojection algorithm to directly reconstruct the DPC‐CT images from acquired fan‐beam data. The developed algorithm allows one to directly reconstruct the decrement of the real part of the refractive index from the measured data. In order to accurately reconstruct an image, the data need to be acquired over an angular range of at least 180∘ plus the fan angle. As opposed to the parallel beam data acquisition and reconstruction methods, a 180∘‐rotation angle for the data acquisition system does not provide sufficient data for an accurate reconstruction of the entire field of view. Numerical simulations have been conducted to validate the image reconstruction algorithm.

The authors posit the need for rapid evaluation of therapies for COVID-19 as an inflection point spurring a much-needed rethinking of our research enterprise.

Radiation therapy quality assurance in clinical trials – Global harmonisation group

Early Endophthalmitis Incidence and Risk Factors after Glaucoma Surgery in the Medicare Population from 2016 to 2019

Clinical trials a must

Use of nasal potential difference and sweat chloride as outcome measures in multicenter clinical trials in subjects with cystic fibrosis.

Key content A doctor’s duty to reduce uncertainty in the provision of care requires their participation in well‐developed and ethically approved clinical trials. Compared to non‐participation, collaboration in a clinical trial improves the quality of care of women. Successful recruitment into multicentre trials is achieved through enthusiastic involvement of several principal investigators (PIs). Allocation of NHS patient care costs for clinical research supports those engaged in recruiting women into studies. Consultants need to acquire basic mandatory research training for the role as a PI leading research. An awareness of support mechanisms locally, regionally and nationally, such as NIHR Clinical Research Network, aids in the execution of PI duties. PI contribution to research is a recognised professional and personal development activity and forms an integral part of appraisal, revalidation and clinical excellence award scheme. Learning objectives To recognise the added benefits to care of women through participation in research. To ascertain the roles and responsibilities of a PI engaged in a multicentre clinical trial. To identify ways to overcome barriers and avail support mechanisms offered to consultants in their role as PI. To increase awareness of the various means by which consultants can attain recognition and rewards for their responsibility as PI. Ethical issues It is the responsibility of the principal investigator to ensure that all eligible women are offered the opportunity to participate in clinical studies.

Objective: To analyze the incidence and influencing factors of postoperative endophthalmitis after cataract surgery in the Guangming Project, and to recommend precautionary actions. Methods: In this retrospective study of cases from January 2004 to December 2016 in Jinhua Eye Hospital, we collected clinical data of cataract surgery patients who developed postoperative endophthalmitis. Then we analyzed the incidence, clinical features, and possible preventive measures. The effects of different surgical procedures and different perioperative management protocols were analyzed. The Fisher exactness test was used for statistical analysis. Results: Sixteen cases of postoperative endophthalmitis occurred after 20, 131 cataract surgeries during the study period; thus, the cumulative incidence was 0.079%. After 5, 371 cases of small incision extracapsular cataract extraction, there were two cases of postoperative endophthalmitis (0.037%). After 14, 760 cases of phacoemulsification, there were 14 cases of postoperative endophthalmitis (0.095%). There was no significant difference in the incidence of postoperative endophthalmitis between the two surgical methods (P=0.265). There was also no difference in the incidence of postoperative endophthalmitis between procedures in which the eyelashes were trimmed (incidence 0.121%) or not trimmed (incidence 0.062%, P=0.29). The incidence of postoperative endophthalmitis for patients using 0.5% povidone iodine to wash the conjunctival sac before surgery was 0.059%, while the incidence for patients not using the povidone wash was 0.174%, P=0.04). According to the description of the cause of the disease, we found that 4 cases of male patients have a clear incentive, accounting for 25%, of which one patient shampoo a day before the disease occurring; one patient dismantle the old wall of its own roof collapse one day before the disease occurring; One patient covered surgery eye by their own buied gauze; One patient droped the surgery eye only with one of the discharged medicine, and only once a day. There were no obvious causes in the remaining 12 patients. In addition, follow-up intravitreal surgery found that the clear corneal incision was oblique and poorly closed in two patients. Conclusions: The incidence of postoperative endophthalmitis after cataract surgery is 0.079%. Pre-surgical washing of the conjunctival sac with 0.5% povidone iodine before the operation can reduce the incidence of postoperative endophthalmitis. The incidence of postoperative endophthalmitis can probably be further reduced by providing patients with clear pre- and postoperative medical and behavioral instructions to ensure that medications are taken properly, and that inappropriate activities are avoided. Key words: endophthalmitis; phacoemulsification; cataract extraction; postoperative complications

Obstructive sleep apnea (OSA) is a serious and costly public health problem. The main medical treatment, continuous positive airway pressure, is efficacious when used, but poorly tolerated in up to 50% of patients. Upper airway reconstructive surgery is available when medical treatments fail but randomized trial evidence supporting its use is limited. This protocol details a randomized controlled trial designed to assess the clinical effectiveness, safety, and cost-effectiveness of a multilevel upper airway surgical procedure for OSA. A prospective, parallel-group, open label, randomized, controlled, multicenter clinical trial in adults with moderate or severe OSA who have failed or refused medical therapies. Six clinical sites in Australia randomly allocated participants in a 1:1 ratio to receive either an upper airway surgical procedure consisting of a modified uvulopalatopharyngoplasty and minimally invasive tongue volume reduction, or to continue with ongoing medical management, and followed them for 6 months. Primary outcomes: difference between groups in baseline-adjusted 6 month OSA severity (apnea-hypopnea index) and subjective sleepiness (Epworth Sleepiness Scale). Secondary outcomes: other OSA symptoms (e.g. snoring and objective sleepiness), other polysomnography parameters (e.g. arousal index and 4% oxygen desaturation index), quality of life, 24 hr ambulatory blood pressure, adverse events, and adherence to ongoing medical therapies (medical group). The Sleep Apnea Multilevel Surgery (SAMS) trial is of global public health importance for testing the effectiveness and safety of a multilevel surgical procedure for patients with OSA who have failed medical treatment. Multilevel airway surgery in patients with moderate-severe Obstructive Sleep Apnea (OSA) who have failed medical management to assess change in OSA events and daytime sleepiness. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366019&isReview=true Australian New Zealand Clinical Trials Registry ACTRN12614000338662, prospectively registered on 31 March 2014.

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