Conducting clinical trials over the internet: feasibility study.
Ontology highlight
ABSTRACT:
SUBMITTER: McAlindon T
PROVIDER: S-EPMC188386 | biostudies-literature | 2003 Aug
REPOSITORIES: biostudies-literature
Publications
Conducting clinical trials over the internet: feasibility study.
McAlindon Tim T Formica Margaret M Kabbara Karim K LaValley Michael M Lehmer Melissa M
BMJ (Clinical research ed.) 20030801 7413
Similar Datasets
Project description:This article provides an overview of the recent literature on the use of internet-based testing to address important questions in perception research. Our goal is to provide a starting point for the perception researcher who is keen on assessing this tool for their own research goals. Internet-based testing has several advantages over in-lab research, including the ability to reach a relatively broad set of participants and to quickly and inexpensively collect large amounts of empirical data, via services such as Amazon's Mechanical Turk or Prolific Academic. In many cases, the quality of online data appears to match that collected in lab research. Generally-speaking, online participants tend to be more representative of the population at large than those recruited for lab based research. There are, though, some important caveats, when it comes to collecting data online. It is obviously much more difficult to control the exact parameters of stimulus presentation (such as display characteristics) with online research. There are also some thorny ethical elements that need to be considered by experimenters. Strengths and weaknesses of the online approach, relative to others, are highlighted, and recommendations made for those researchers who might be thinking about conducting their own studies using this increasingly-popular approach to research in the psychological sciences.
| S-EPMC4517966 | biostudies-literature
Project description:BackgroundImplementation trials aim to test the effects of implementation strategies on the adoption, integration or uptake of an evidence-based intervention within organisations or settings. Feasibility and pilot studies can assist with building and testing effective implementation strategies by helping to address uncertainties around design and methods, assessing potential implementation strategy effects and identifying potential causal mechanisms. This paper aims to provide broad guidance for the conduct of feasibility and pilot studies for implementation trials.MethodsWe convened a group with a mutual interest in the use of feasibility and pilot trials in implementation science including implementation and behavioural science experts and public health researchers. We conducted a literature review to identify existing recommendations for feasibility and pilot studies, as well as publications describing formative processes for implementation trials. In the absence of previous explicit guidance for the conduct of feasibility or pilot implementation trials specifically, we used the effectiveness-implementation hybrid trial design typology proposed by Curran and colleagues as a framework for conceptualising the application of feasibility and pilot testing of implementation interventions. We discuss and offer guidance regarding the aims, methods, design, measures, progression criteria and reporting for implementation feasibility and pilot studies.ConclusionsThis paper provides a resource for those undertaking preliminary work to enrich and inform larger scale implementation trials.
| S-EPMC7603668 | biostudies-literature
Project description:Rare cancers account for 27% of neoplasms diagnosed each year, and 25% of cancer-related deaths in the United States. However, rare cancers show some of the highest response rates to targeted therapies, probably due to identification of oncogenic drivers with little interpatient variability. Although the low incidence of rare cancers makes large-scale randomized trials involving single histologies difficult to perform, drugs have been successfully developed in rare cancers using clinical trial designs that combine microscopic histologies. Such trials are being pursued within the National Clinical Trials Network (NCTN), which possesses unique qualifications to perform widespread molecular screening of tumors for patient enrollment onto therapeutic clinical trials. When larger clinical trials are needed to determine optimum treatment strategies in rare cancers, the NCTN's broad reach in North America and internationally, and their ability to partner with both United States-based and international research organizations, can make these challenging studies feasible.
| S-EPMC4673983 | biostudies-other
Project description:Most tobacco-focused clinical trials are based on locally conducted studies that face significant challenges to implementation and successful execution. These challenges include the need for large, diverse, yet still representative study samples. This often means a protracted, costly, and inefficient recruitment process. Multisite clinical trials can overcome some of these hurdles but incur their own unique challenges. With recent advances in mobile health and digital technologies, there is now a promising alternative: Remote Trials. These trials are led and coordinated by a local investigative team, but are based remotely, within a given community, state, or even nation. The remote approach affords many of the benefits of multisite trials (more efficient recruitment of larger study samples) without the same barriers (cost, multisite management, and regulatory hurdles). The Coronavirus Disease 2019 (COVID-19) global health pandemic has resulted in rapid requirements to shift ongoing clinical trials to remote delivery and assessment platforms, making methods for the conduct of remote trials even more timely. The purpose of the present review is to provide an overview of available methods for the conduct of remote tobacco-focused clinical trials as well as illustrative examples of how these methods have been implemented across recently completed and ongoing tobacco studies. We focus on key aspects of the clinical trial pipeline including remote: (1) study recruitment and screening, (2) informed consent, (3) assessment, (4) biomarker collection, and (5) medication adherence monitoring. Implications With recent advances in mobile health and digital technologies, remote trials now offer a promising alternative to traditional in-person clinical trials. Remote trials afford expedient recruitment of large, demographically representative study samples, without undo burden to a research team. The present review provides an overview of available methods for the conduct of remote tobacco-focused clinical trials across key aspects of the clinical trial pipeline.
| S-EPMC7454765 | biostudies-literature
Project description:The centralized and public availability of molecular sequence and clinical trial data presents an opportunity to identify potentially valuable linkages across the bench-to-bedside "T1" translational barrier. In this study, we sought to leverage keyword metadata (Medical Subject Heading [MeSH] descriptors) to infer relationships between molecular sequences and clinical trials, as indexed by GenBank and ClinicalTrials.gov. The results of this feasibility study found that approximately 30% of sequences in GenBank could be linked to trials and over 90% of trials in ClinicalTrials.gov could be linked to sequences through MeSH descriptors. In a cursory evaluation, we were able to consistently identify meaningful linkages between molecular sequences and clinical trials. Based on our findings, there may be promise in subsequent studies aiming to identify linkages across the T1 translational barrier using existing large repositories.
| S-EPMC2878930 | biostudies-literature
Project description:Background: Pediatric investigation plans (PIPs) describe how adult drugs can be studied in children. In 2015, PIPs for Amyotrophic Lateral Sclerosis (ALS) became mandatory for European marketing-authorization of adult treatments, unless a waiver is granted by the European Medicines Agency (EMA).Objective: To assess the feasibility of clinical studies on the effect of therapy in children (<18 years) with ALS in Europe.Methods: The EMA database was searched for submitted PIPs in ALS. A questionnaire was sent to 58 European ALS centers to collect the prevalence of pediatric ALS during the past ten years, the recruitment potential for future pediatric trials, and opinions of ALS experts concerning a waiver for ALS.Results: Four PIPs were identified; two were waived and two are planned for the future. In total, 49 (84.5%) centers responded to the questionnaire. The diagnosis of 44,858 patients with ALS was reported by 46 sites; 39 of the patients had an onset < 18 years (prevalence of 0.008 cases per 100,000 or 0.087% of all diagnosed patients). The estimated recruitment potential (47 sites) was 26 pediatric patients within five years. A majority of ALS experts (75.5%) recommend a waiver should apply for ALS due to the low prevalence of pediatric ALS.Conclusions: ALS with an onset before 18 years is extremely rare and may be a distinct entity from adult ALS. Conducting studies on the effect of disease-modifying therapy in pediatric ALS may involve lengthy recruitment periods, high costs, ethical/legal implications, challenges in trial design and limited information.
| S-EPMC9662181 | biostudies-literature
Project description:While clinical deprescribing trials are increasingly being performed, there is no guidance on the optimum conduction of such studies. The aim of this survey was to explore the perspectives, attitudes, interests, barriers, and enablers of conducting clinical deprescribing trials among health professionals and researchers. An anonymous survey was developed, reviewed, and piloted by all investigators and informed by consultation with experts, as well as current deprescribing guidelines. The questions were formulated around current clinical trial frameworks and incorporated identified enablers and barriers of performing deprescribing studies. The survey was sent to members of Australian and international deprescribing, pharmacological, and pharmacy organizations, and other researchers published in deprescribing. A total of 96 respondents completed the survey (92.3% completion rate). Respondents indicated the main deprescribing trial rationale is to generate evidence to optimize patient-centered outcomes (79.2%). Common barriers identified included the time and effort required (18.2%), and apprehension of health professionals involved in trials (17.1%). Studies are enabled by positive attitudes toward deprescribing of treating prescribers (24.4%) and patients (20.9%). Classical randomized controlled trials (RCTs) were deemed the most appropriate methodology (93.2%). Sixty percent of participants indicated a good clinical practice framework is required to guide the conduct of deprescribing trials. There were no significant differences in responses based on previous experience in conducting clinical deprescribing trials. In conclusion, clinical deprescribing trials should be conducted to investigate whether deprescribing medications improves patient care. A future deprescribing trial framework should use classical RCTs as a model, ensure participant safety, and target patient-centered outcomes.
| S-EPMC6482940 | biostudies-literature
Project description:ObjectiveTo evaluate the feasibility of conducting a large clinical trial within the Rwandan mental healthcare system that would establish the safety, efficacy and benefit of paliperidone palmitate once-monthly (PP1M) and once-every-3-months (PP3M) long-acting injectable formulations in adults with schizophrenia.Study designAn open-label, prospective feasibility study.Setting/participants33 adult patients with schizophrenia were enrolled at 3 sites across Rwanda.InterventionsThe study design included 3 phases of treatment: an oral run-in to establish tolerability to risperidone (1 week), lead-in treatment with flexibly dosed PP1M to identify a stable dose (17 weeks) and maintenance treatment with PP3M (24 weeks).Primary and secondary outcome measuresFeasibility endpoints included compliance with governmental and institutional requirements, acceptable supply chain delivery and proper onsite administration of risperidone/PP1M/PP3M, adequate site infrastructure, adequate training of clinical staff and successful completion of study procedures and scales. A variety of study scales were administered to assess outcomes relevant to patients, caregivers, clinicians and payers in Rwanda and other resource-limited settings.ResultsThis study was terminated early by the sponsor because certain aspects of study conduct needed to be addressed to maintain Good Clinical Practice requirements and meet regulatory standards. Results identified areas for improvement in study execution, including study governance, site infrastructure, study preparation and conduct of procedures, study budget and study assessments. Despite the identification of areas in need of adjustment, none of these limitations were considered insurmountable.ConclusionsThis work was designed to strengthen global research in schizophrenia by building the capacity of researchers to prepare and conduct pharmaceutical trials in resource-limited settings. Although the study was ended early, modifications motivated by the results will facilitate the successful design and completion of more comprehensive studies, including an ongoing, follow-up interventional trial of PP1M/PP3M in a larger population of patients in Rwanda.Trial registration numberNCT03713658.
| S-EPMC10124215 | biostudies-literature
Project description:Cancer research and clinical trials are essential to improve cancer patients' outcomes and advance the oncology field. The United Arab Emirates (UAE) has been lagging in cancer research with many barriers, including healthcare, institutional, regulatory, patient and community, the global oncology community, and the pharmaceutical industry. In this report, we try to address these challenges from our perspective. Making clinical trials accessible for cancer patients in the UAE requires a collaborative approach from all stakeholders and serious consideration for the greater cause to improve the patient's outcome and contribute to the advancement of the cancer field worldwide. There has been significant support from the UAE government and the regulators in the UAE to facilitate and encourage research in general and cancer research in particular with recent initiatives and international collaborations. Private and public institutions must overcome their competitive moods and work together to strengthen the research network across the UAE and improve accrual for potential clinical trials. Public awareness and education must overcome long-standing perceptions about research and clinical trials in the UAE. The pharmaceutical industry must work closely with institutions across the UAE and support them in establishing accredited research programs and clinical trial units. The Emirates Oncology Society is establishing the Oncology Research Working Group to advocate and advance cancer research in the UAE. All stakeholders must be engaged to successfully implement impactful clinical trials in the UAE and the region.
| S-EPMC9680222 | biostudies-literature
Project description:Numerous drugs that the US Food and Drug Administration (FDA) has approved for use in cancer therapy are derived from plants, including taxanes such as paclitaxel and vinca alkaloids such as vinblastine. Dietary supplements are another category of natural products that are widely used by patients with cancer, but without the FDA-reviewed evidence of safety and efficacy--be it related to survival, palliation, symptom mitigation, and/or immune system enhancement-that is required for therapy approval. Nearly half of patients in the United States with cancer report that they started taking new dietary supplements after being given a diagnosis of cancer. Oncologists are challenged in providing advice to patients about which supplements are safe and effective to use to treat cancer or the side effects of cancer therapy, and which supplements are antagonistic to standard treatment with chemotherapy, radiation, and/or immunotherapy. Despite the large number of trials that have been launched, the FDA has not approved any dietary supplement or food to prevent cancer, halt its growth, or prevent its recurrence. In this article, we review the primary challenges faced by researchers attempting to conduct rigorous trials of natural products, including shortages of funding due to lack of patentability, manufacturing difficulties, contamination, and lack of product consistency. We also highlight the methods used by dietary supplement marketers to persuade patients that a supplement is effective (or at least safe) even without FDA approval, as well as the efforts of the US government to protect the health and safety of its citizens by ensuring that the information used to market natural products is accurate. We close with a summary of the most widely used databases of information about the safety, efficacy, and interactions of dietary supplements.
| S-EPMC8521639 | biostudies-literature