scholarly journals Technology for Measuring and Monitoring Treatment Compliance Remotely

2021 ◽  
pp. 1-5
Author(s):  
Richard H. Christie ◽  
Anzar Abbas ◽  
Vidya Koesmahargyo
Keyword(s):  
Clinical Trials ◽  
Clinical Study ◽  
Neurological Disorders ◽  
Treatment Compliance ◽  
Quality Of Data ◽  
Efficacy Data ◽  
Safety And Efficacy ◽  
Study Sites ◽  
Monitoring Treatment

Medication non-adherence during clinical trials is an ongoing challenge that can result in insufficient safety and efficacy data. For patients with Parkinson’s disease and other neurological disorders, symptomatology such as forgetfulness compounds traditional obstacles to adherence. Today, sponsors and clinical study sites can call upon various technology tools that improve adherence by monitoring and confirming dosage in near real-time. These tools have the potential to improve the quality of data gleaned from these studies.

scholarly journals Recent Developments in Clinical Applications of Mesenchymal Stem Cells in the Treatment of Rheumatoid Arthritis and Osteoarthritis

2021 ◽  
Vol 12 ◽  
Author(s):  
Joel Jihwan Hwang ◽  
Yeri Alice Rim ◽  
Yoojun Nam ◽  
Ji Hyeon Ju
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Trials ◽  
Clinical Applications ◽  
Clinical Settings ◽  
Positive Outcomes ◽  
Joint Function ◽  
Safety And Efficacy ◽  
High Expectations ◽  
Recent Developments

Mesenchymal stem cell (MSC) therapies have been used as cell-based treatments for decades, owing to their anti-inflammatory, immunomodulatory, and regenerative properties. With high expectations, many ongoing clinical trials are investigating the safety and efficacy of MSC therapies to treat arthritic diseases. Studies on osteoarthritis (OA) have shown positive clinical outcomes, with improved joint function, pain level, and quality of life. In addition, few clinical MSC trials conducted on rheumatoid arthritis (RA) patients have also displayed some optimistic outlook. The largely positive outcomes in clinical trials without severe side effects establish MSCs as promising tools for arthritis treatment. However, further research is required to investigate its applicability in clinical settings. This review discusses the most recent advances in clinical studies on MSC therapies for OA and RA.

scholarly journals Can prospective systematic reviews of animal studies improve clinical translation?

2020 ◽  
Vol 18 (1) ◽  
Author(s):  
Pandora Pound ◽  
Merel Ritskes-Hoitinga
Keyword(s):  
Clinical Trials ◽  
Systematic Reviews ◽  
Animal Studies ◽  
Poor Quality ◽  
Human Studies ◽  
Clinical Knowledge ◽  
Safety And Efficacy ◽  
High Quality Evidence ◽  
Animal Data

AbstractSystematic reviews are powerful tools with the potential to generate high quality evidence. Their application to animal studies has been instrumental in exposing the poor quality of these studies, as well as a catalyst for improvements in study design, conduct and reporting. It has been suggested that prospective systematic reviews of animal studies (i.e. systematic reviews conducted prior to clinical trials) would allow scrutiny of the preclinical evidence, providing valuable information on safety and efficacy, and helping to determine whether clinical trials should proceed. However, while prospective systematic reviews allow valuable scrutiny of the preclinical animal data, they are not necessarily able to reliably predict the safety and efficacy of an intervention when trialled in humans. Consequently, they may not reliably safeguard humans participating in clinical trials and might potentially result in lost opportunities for beneficial clinical treatments. Furthermore, animal and human studies are often conducted concurrently, which not only makes prospective systematic reviews of animal studies impossible, but suggests that animal studies do not inform human studies in the manner presumed. We suggest that this points to a confused attitude regarding animal studies, whereby tradition demands that they precede human studies but practice indicates that their findings are often ignored. We argue that it is time to assess the relative contributions of animal and human research in order to better understand how clinical knowledge is actually produced.

scholarly journals Cannabidiol and the Management of Pediatric Neurological Disorders: A Systematic Review

2021 ◽  
Author(s):  
Caio de Almeida Lellis ◽  
Marco Alejandro Menacho Herbas ◽  
João Cesar Pereira da Cunha ◽  
Samyla Coutinho Paniago ◽  
Paulo Sérgio Machado Diniz
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Neurological Disorders ◽  
Pediatric Patients ◽  
Meta Analysis ◽  
Dravet Syndrome ◽  
Motor Disorder ◽  
Safety And Efficacy ◽  
Catholic University ◽  
Complex Motor

Introduction: Due to an increase in cases of neurological disorders refractory to conventional treatments in pediatrics patients, other therapies have been sought. Objectives: To analyze the safety and efficacy of CBD in the management of neurological disorders in children. Design and setting: A systematic review conducted at the Pontifical Catholic University of Goiás. Methods: This is a systematic review carried out in PubMed, Lilacs and MedLine databases, with the descriptors: “(Pediatric OR Neurology) AND (Cannabidiol OR Cannabis)”, being selected only the randomized studies, meta-analysis and clinical trials published in the last 10 years. Results: One randomized trial concluded that daily oral CBD solution reduced the frequency of seizures in pediatric patients with Lennox-Gastaut syndrome (LGS). In addition, another study concluded that CBD (20 mg/kg/day) is associated with up to a 50% decrease in seizures in children with SLG and Dravet syndrome. Furthermore, it was pointed out that the association of oral CBD (2 to 5 mg/kg/day) with antiepileptic drugs caused a mean reduction of 36.5% of severe seizures. Finally, CBD enriched with 0.25% THC reduced spasticity, dystonia and pain intensity in children with complex motor disorder. Conclusion: CBD was shown to be safe and effective as a treatment for refractory epilepsies and complex motor disorder in pediatric patients, with no serious side effects reported.

scholarly journals COVID-19 and Its Impact on Cancer Patient’s Outcome and Cancer Research

2020 ◽  
Vol 5 (S1) ◽  
pp. 199-201
Author(s):  
Nalin Goyal ◽  
Deepak Saini ◽  
Harpreet Angural ◽  
Richa Richa ◽  
Vikrant Kaushal ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Cancer Patients ◽  
Cancer Care ◽  
Quality Of Data ◽  
Oncological Treatment ◽  
Immunocompromised Status ◽  
Coronavirus Infection ◽  
Patient’S Outcome ◽  
Care System

The current coronavirus pandemic has severely impacted the health care system in India and all around the world. All aspects of cancer care, including screening, investigations, treatment, clinical trials and research, have been affected as resources are diverted to combat the pandemic. Cancer patients are more susceptible to infections due to their immunocompromised status, either due to disease or therapy, and subsequently, this may result in in poor outcome, especially in case of coronavirus infection. Multiple studies have shown adverse impact of COVID-19 on cancer patients in form of higher mortality with haematological malignancy being worst affected, and interval between last oncological treatment and infection playing an important role in affecting the prognosis. Impact on clinical trials in oncology has been severe. Enrolment has decreased significantly, many trials have been suspended, and ongoing trials are facing problems with patient evaluations leading to impact on quality of data being generated. Telemedicine is now being used to overcome some of these problems but it has its own limitations and should be used judiciously. The pandemic has given us an opportunity to look into the shortcomings of our cancer care system and to find out ways to overcome them.

scholarly journals The Use of Narrow Diameter Implants in the Molar Area

2016 ◽  
Vol 2016 ◽  
pp. 1-8 ◽  
Author(s):  
M. Saad ◽  
A. Assaf ◽  
E. Gerges
Keyword(s):  
Clinical Trials ◽  
Clinical Study ◽  
Bone Resorption ◽  
Gold Standard ◽  
Scientific Evidence ◽  
Bone Augmentation ◽  
Narrow Diameter Implants ◽  
Bone Height

Implant rehabilitations in the posterior jaw are influenced by many factors such as the condition of the remaining teeth, the force factors related to the patient, the quality of the bone, the maintenance of the hygiene, the limited bone height, the type and extent of edentulism, and the nature of the opposing arch. The gold standard is to place a regular diameter implant (>3.7 mm) or a wide one to replace every missing molar. Unfortunately, due to horizontal bone resorption, this option is not possible without lateral bone augmentation. In this situation, narrow diameter implant (NDI < 3.5 mm) could be the alternative to lateral bone augmentation procedures. This paper presents a clinical study where NDIs were used for the replacement of missing molars. They were followed up to 11 years. Special considerations were observed and many parameters were evaluated. NDI could be used to replace missing molar in case of moderate horizontal bone resorption if strict guidelines are respected. Yet, future controlled prospective clinical trials are required to admit their use as scientific evidence.

scholarly journals A New Software Development Methodology for Clinical Trial Systems

2013 ◽  
Vol 2013 ◽  
pp. 1-13
Author(s):  
Li-Min Liu
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Software Development ◽  
Quality Of Data ◽  
High Quality ◽  
Development Methodology ◽  
Software Development Methodology ◽  
The Government ◽  
New Software Development

Clinical trials are crucial to modern healthcare industries, and information technologies have been employed to improve the quality of data collected in trials and reduce the overall cost of data processing. While developing software for clinical trials, one needs to take into account the similar patterns shared by all clinical trial software. Such patterns exist because of the unique properties of clinical trials and the rigorous regulations imposed by the government for the reasons of subject safety. Among the existing software development methodologies, none, unfortunately, was built specifically upon these properties and patterns and therefore works sufficiently well. In this paper, the process of clinical trials is reviewed, and the unique properties of clinical trial system development are explained thoroughly. Based on the properties, a new software development methodology is then proposed specifically for developing electronic clinical trial systems. A case study shows that, by adopting the proposed methodology, high-quality software products can be delivered on schedule within budget. With such high-quality software, data collection, management, and analysis can be more efficient, accurate, and inexpensive, which in turn will improve the overall quality of clinical trials.

scholarly journals Comparing the quality of data from several clinical trials

1992 ◽  
Vol 160 (1) ◽  
pp. 126-126 ◽  
Author(s):  
Peter Tyrer ◽  
Jonathan Tyrer
Keyword(s):  
Clinical Trials ◽  
Quality Of Data

Extensive selective reporting of quality of life in clinical study reports and publications of placebo-controlled trials of antidepressants

2020 ◽  
pp. 1-13
Author(s):  
Asger Sand Paludan-Müller ◽  
Tarang Sharma ◽  
Kristine Rasmussen ◽  
Peter C. Gøtzsche
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Case Report ◽  
Clinical Study ◽  
Regulatory Agencies ◽  
Selective Reporting ◽  
Controlled Trials ◽  
Sf 36 ◽  
Clinical Study Reports

BACKGROUND: Selective reporting of trial results is common. OBJECTIVE: To study selective reporting in clinical study reports, company trial registers and publications of quality of life in placebo-controlled trials of antidepressants. METHODS: We compared clinical study reports of four antidepressants (fluoxetine, duloxetine, paroxetine and sertraline) obtained from two European drug regulators, data from online company registers, and publications received or retrieved from Eli Lilly and GlaxoSmithKline. Pfizer was also contacted but did not provide any publications. RESULTS: We included 15 trials (19,015 pages) and 4717 patients. Six trials had used SF-36, seven EQ-5D and two both instruments. Nine of the 15 CSRs (60%) displayed selective reporting. In the companies’ online registers, there was selective reporting for all 15 trials (100%). We received 20 publications from Eli Lilly and retrieved six from the GlaxoSmithKline register. There was selective reporting in 24 of the 26 publications (92%). Despite extensive selective reporting, we found only small differences between placebo and active drugs. CONCLUSIONS: Access to the full raw data from clinical trials and to case report forms for all patients are needed to evaluate the effect of antidepressants on quality of life. Regulatory agencies should refuse to approve drugs or new indications based on incomplete reporting.

Sign in / Sign up

Export Citation Format

Share Document