scholarly journals Results availability and timeliness of registered COVID-19 clinical trials: interim cross-sectional results from the DIRECCT study

BMJ Open ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. e053096
Author(s):  
Maia Salholz-Hillel ◽  
Peter Grabitz ◽  
Molly Pugh-Jones ◽  
Daniel Strech ◽  
Nicholas J DeVito
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Journal Article ◽  
Cross Sectional Study ◽  
Sensitivity Analyses ◽  
Cross Sectional ◽  
Registration Data ◽  
Clinical Trial Registries ◽  
Treatment And Prevention

ObjectiveTo examine how and when the results of COVID-19 clinical trials are disseminated.DesignCross-sectional study.SettingThe COVID-19 clinical trial landscape.Participants285 registered interventional clinical trials for the treatment and prevention of COVID-19 completed by 30 June 2020.Main outcome measuresOverall reporting and reporting by dissemination route (ie, by journal article, preprint or results on a registry); time to reporting by dissemination route.ResultsFollowing automated and manual searches of the COVID-19 literature, we located 41 trials (14%) with results spread across 47 individual results publications published by 15 August 2020. The most common dissemination route was preprints (n=25) followed by journal articles (n=18), and results on a registry (n=2). Of these, four trials were available as both a preprint and journal publication. The cumulative incidence of any reporting surpassed 20% at 119 days from completion. Sensitivity analyses using alternate dates and definitions of results did not appreciably change the reporting percentage. Expanding minimum follow-up time to 3 months increased the overall reporting percentage to 19%.ConclusionCOVID-19 trials completed during the first 6 months of the pandemic did not consistently yield rapid results in the literature or on clinical trial registries. Our findings suggest that the COVID-19 response may be seeing quicker results disclosure compared with non-emergency conditions. Issues with the reliability and timeliness of trial registration data may impact our estimates. Ensuring registry data are accurate should be a priority for the research community during a pandemic. Data collection is underway for the next phase of the DIssemination of REgistered COVID-19 Clinical Trials study expanding both our trial population and follow-up time.

scholarly journals Results Availability and Timeliness of Registered COVID-19 Clinical Trials: A Cross-Sectional Study

2021 ◽  
Author(s):  
Maia Salholz-Hillel ◽  
Peter Grabitz ◽  
Molly Pugh-Jones ◽  
Daniel Strech ◽  
Nicholas J DeVito
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Journal Article ◽  
Cross Sectional Study ◽  
Sensitivity Analyses ◽  
Cross Sectional ◽  
Registration Data ◽  
Clinical Trial Registries ◽  
Treatment And Prevention

Objective: To examine how and when the results of COVID-19 clinical trials are disseminated Design: Cross-sectional bibliographic study Setting: The COVID-19 clinical trial landscape Participants: 285 registered interventional clinical trials for the treatment and prevention of COVID-19 completed by 30 June 2020 Main outcome measures: Overall reporting and reporting by dissemination route (i.e., by journal article, preprint, or results on a registry); time to reporting by dissemination route. Results: Following automated and manual searches of the COVID-19 literature, we located 41 trials (14%) with results spread across 47 individual results publications published by 15 August 2020. The most common dissemination route was preprints (n = 25) followed by journal articles (n = 18), and results on a registry (n = 2). Of these, four trials were available as both a preprint and journal publication. The cumulative incidence of any reporting surpassed 20% at 119 days from completion. Sensitivity analyses using alternate dates available and definitions of results did not appreciably change the reporting percentage. Expanding minimum follow-up time to 3 months increased the overall reporting percentage to 19%. Conclusion: COVID-19 trials completed during the first six months of the pandemic did not consistently yield rapid results in the literature or on clinical trial registries. Our findings suggest that the COVID-19 response may be seeing quicker results disclosure compared to non-emergency conditions. Issues with the reliability and timeliness of trial registration data may impact our estimates. Ensuring registry data is accurate should be a priority for the research community during a pandemic. Data collection is underway for Phase 2 of the DIRECCT study expanding our trial population to those completed anytime in 2020.

scholarly journals Knowledge of medical students on clinical trials

2019 ◽  
Vol 8 (7) ◽  
pp. 1484
Author(s):  
Ravi Shankar Kanna ◽  
Jagadeesh Alla ◽  
Krishnakanth K.
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Medical Students ◽  
Basic Research ◽  
Thinking Skills ◽  
Cross Sectional Study ◽  
Critical Thinking Skills ◽  
School Students ◽  
Cross Sectional ◽  
Institutional Ethics

Background: Basic research can help medical school students improve critical thinking skills required by medical practice. In this era of evidence-based medicine, the combination of medical education with clinical research is the key to ensure scientific discoveries are translated into clinical practice. This study’s objective was to know the awareness about clinical trials among undergraduate medical students.Methods: After obtaining approval from the Institutional Ethics Committee of NRI Academy of Medical Sciences, Guntur, India, this cross sectional study was conducted in second year medical students after taking their consent. A sample of 90was considered for statistical analysis. A structured questionnaire was used to measure the objective of this study, which had general, regulatory and ethical questions related to clinical trials. Qualitative data variables were expressed by using frequency and Percentage (%).Results: Out of 90 students, it was observed that in the general questions category, 70% of students were aware of the purpose of conducting clinical trials, 50% were aware of the pre-requisites for a participant before participating in a clinical trial and 50% were aware of the parameters evaluated in a clinical trial. 95% of students did not know the response for regulatory questions. The students’ awareness regarding ethics related to clinical trials was better than the other two categories.Conclusions: The overall awareness of clinical trials was low among students though they demonstrated good awareness regarding few aspects of clinical trials.

Willingness of patients with pancreatic cancer to participate in clinical trials.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 4055-4055
Author(s):  
Pelin Cinar ◽  
Anitra W. Talley ◽  
Jimmy Hwang ◽  
Daniel Paul Dohan ◽  
Margaret A. Tempero
Keyword(s):  
Pancreatic Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Cross Sectional Study ◽  
Trial Participation ◽  
Trial Recruitment ◽  
Chi Square ◽  
Cross Sectional ◽  
Recruitment Methods ◽  
Clinical Trial Recruitment

4055 Background: Recruitment of oncology patients into clinical trials continues to be a challenge as <5% of patients are accrued. Low accrual rates may be due to reduced awareness of trial availability and eligibility by physicians/patients. Our objective was to study the attitudes of patients with pancreatic cancer (PC) regarding clinical trial participation and to identify possible barriers to recruitment. Methods: In this cross-sectional study, we collaborated with Pancreatic Cancer Action Network (PanCAN) and invited patients with PC or their caregivers to complete a survey. The survey that was developed consisted of 22 questions and inquired about patients’ previous clinical trial enrollment experiences and their views on participation. The surveys were collected over a 6-month period via the PanCAN website and regional meetings. Comparison analyses between groups were done by Chi-square and Fisher’s test using STATA software. Results: Of the390 surveys received, 149 were included in the final analyses. 30% of the patients were offered to participate in a trial by their physicians. When asked to participate, 62% of the patients agreed. Of the patients who were not enrolled in a clinical trial, 61% were offered to participate in a trial but did not agree. This suggests that these patients were eligible to participate but declined. Conclusions: Majority of the patients with pancreatic cancer were not offered to participate in clinical trials by their physicians but would have agreed if asked. While low clinical trial recruitment rates for PC may be multifactorial, further research may focus on the important role of physicians in clinical trial recruitment efforts. [Table: see text]

scholarly journals An FDA Analysis of Inspected Entities After Receiving Official Action Indicated Letters for Good Clinical Practice Violations

2021 ◽  
Author(s):  
Miah Jung ◽  
Rachelle M. Swann ◽  
Michelle S. Anantha ◽  
Faranak Jamali
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Drug Evaluation ◽  
Good Clinical Practice ◽  
Cross Sectional Study ◽  
Voluntary Action ◽  
Cross Sectional ◽  
Depth Analysis ◽  
The Status

Abstract Background Limited research has been conducted to examine whether clinical investigators (CIs), sponsors (SPs), contract research organizations (CROs), and sponsor-investigators (SIs) continue conducting clinical trials following issuance of FDA Official Action Indicated (OAI) letters. FDA issues OAI letters for significant regulatory violations. The objective of this study was to evaluate the status of inspected entities who received OAI letters in the conduct of Center for Drug Evaluation and Research (CDER)-regulated clinical trials (CRCTs). Methods This cross-sectional study included an analysis of inspectional data from CDER’s Good Clinical Practice (GCP) inspections for OAI letters issued from October 1, 2010, to September 30, 2015, with an in-depth analysis of post-OAI status of inspected entities, including OAI follow-up inspections. Results Of the 2248 GCP letters issued during this period, 104 (4.6%) OAI letters were sent: 95 (4.2%) to CIs (91% of OAIs), 7 (0.3%) to SPs (7% of OAIs), and 2 (0.08%) to SIs (2% of OAIs). Majority of OAI letters were issued as a result of a for-cause inspection. Five CIs were excluded from analysis. No OAI letters were sent to CROs. Only 30% of CIs (27 out of 90) continued to conduct CRCTs. OAI follow-up inspections were completed for these CIs resulting in 16 No Action Indicated (NAI), 11 Voluntary Action Indicated (VAI), and no OAI letters. Majority (64%) of the VAI letters noted repeated but not significant violations. Conclusions Majority (70%) of CIs who received an OAI letter were no longer conducting CRCTs at the time of follow-up. Of the 27 CIs continuing CRCTs, 16 (59%) OAI follow-up inspections resulted in NAI classifications and 11 (41%) in VAI.

scholarly journals Characteristics of COVID-19 Clinical Trials in India Based on the Registration Data on CTRI (Clinical Trials Registry- India): a cross-sectional analysis

2020 ◽  
Author(s):  
P Sathiyarajeswaran ◽  
MS Shree Devi ◽  
K Kanakavalli ◽  
NP Vinod
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Multiple Drug ◽  
Trial Registry ◽  
Clinical Trial Registry ◽  
Cross Sectional ◽  
Cross Sectional Analysis ◽  
Registration Data ◽  
Post Marketing Surveillance ◽  
Sectional Analysis

AbstractObjectivesThe 2019 pandemic of coronavirus disease (COVID-19) has prompted several efforts to find safe and effective drugs, but little is understood as to where early efforts were centered. Several clinical trials, both Allopathy and AYUSH medicines have been registered in the Clinical Trial Registry of India (CTRI). We aimed to characterize and extract relevant data registered under CTRI for COVID-19.Materials and MethodsA cross-sectional analysis was performed of clinical trials for the treatment of COVID-19 that were registered in the Clinical Trial Registry of India (CTRI) from 1st March 2020 to 22nd June 2020. Relevant trial records were downloaded, deduplicated, and independently analyzed by three reviewers.Main outcomesTrial intervention, design, sponsorship, phase of the trial, and indicated outcomes.Results233 COVID-19 clinical trials, was registered from India in CTRI. Out of these, 146 were Interventional trials, 84 Observational trials, and three Post-marketing surveillance. Questionnaire and survey-based intervention occupy a significant portion. Randomized control trials are large in number 37.8% than non-randomized. 20% of the trials were recruiting patients, and the Research institution (34%) sponsored more than half of the trials. Global trials are minimal, occupying 3% of total trials and Indian trials were 97%. In most of the trials, the interventional agent is either multiple drug combinations or compound drug formulations compared to single drug administration. Among the trials, 46 Allopathic interventions, 41 Ayurveda interventions, 14 Homeopathy interventions, one in Unani, and 2 in yoga and Naturopathy.ConclusionThis study will provide a background of COVID-19 clinical trials registered in CTRI and provide specific issues observed related to clinical trial designs, which offer information to perform clinical trials on COVID-19

scholarly journals Translation and Validation of the Greek Version of a Questionnaire Measuring Patient Views on Participation in Clinical Trials

2021 ◽  
Author(s):  
Dimitrios Karampatakis ◽  
Angeliki Kakavouti-Doudos ◽  
Panagiotis Oikonomidis ◽  
Polychronis Voultsos
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Cross Sectional Study ◽  
Willingness To Participate ◽  
Validity And Reliability ◽  
Greek Version ◽  
Factor Solution ◽  
Cross Sectional ◽  
Risks And Benefits ◽  
Patient Views

Abstract BackgroundThe increasing number of clinical research opportunities requires increasing numbers of participants in clinical trials. However, it may become increasingly problematic, as protocols have become increasingly complex. Better understanding of patients’ attitudes towards their potential participation in clinical trials is essential for developing effective clinical trial recruitment strategies. In Greece, limited research has been conducted on this topic so far. This study aims to contribute to filling this gap. MethodsA cross-sectional study was conducted. Purposive sampling was used to select participants. The Greek version of a recently developed questionnaire measuring patient views on participation in clinical trials, a 27‐item scale distributed into four factors, was tested. In addition, participants were asked to provide information regarding their socio-demographics. A demographic comparison was conducted.ResultsThe four-factor solution derived in our study consisted of the same 27 items and it was different from the six-factor solution that Arnetz et al. proposed. The factors risks and benefits, that consisted of 5 and 3 items respectively in the six-factor solution, were merged into one factor that consisted of 10 items in the four-factor solution. The four factors produced were Risks and benefits (ten items, α= 0,867), Patient’s expectations (six items, α= 0.864), Patient’s participation (five items, α= 0.827), and Cost and convenience (five items, α= 0,770). We found that demographic factors did not impact patients' opinions about clinical trials participation, except for gender. The participants reported as important for participating in clinical trial: receiving clear and adequate information (95,5%) and being given the opportunity to ask questions (97,8%), take part in discussions regarding their own treatment (94,6%), and voice their concerns and opinions (91,1%). As factors strongly associated with participants’ willingness to participate in a clinical trial were reported: concerns about the risks of being in a clinical trial (87,5%), the possible side effects of clinical trials (86,3%), the type of treatment given in a clinical trial (83,7%), and whether participation would improve their quality of life (QoL) (81,5%).ConclusionThe preliminary validation of the Greek version of the questionnaire measuring patient perceptions and expectations of participating in clinical trials demonstrated acceptable validity and reliability and could be further tested in larger samples. The findings that emerged from this study are in line with previous literature.

scholarly journals Knowledge and Attitudes Towards Clinical Trial Participation in Oman: A cross-sectional study

2018 ◽  
Vol 18 (1) ◽  
pp. 54 ◽  
Author(s):  
Hussain Al-Lawati ◽  
Khalid Al-Baimani ◽  
Mahra Al-Zadjali ◽  
Nasra Al-Obaidani ◽  
Ziyana Al-Kiyumi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Human Subjects ◽  
Cross Sectional Study ◽  
University Hospital ◽  
Trial Participation ◽  
Sectional Study ◽  
Cross Sectional ◽  
Female Ratio ◽  
Knowledge And Attitudes

Objectives: Clinical trials are prospective studies on human subjects designed to answer various clinical questions. However, only a limited number of clinical trials have been conducted in Oman. This study aimed to assess the knowledge and attitudes of Omani patients and their relatives towards participating in clinical trials. Methods: This cross-sectional study was conducted between October 2015 and March 2016 among 174 patients and relatives attending the Haematology and Oncology Outpatient Clinics and Day Care Unit of the Sultan Qaboos University Hospital, Muscat, Oman. A self-administered questionnaire was designed to elicit participants’ knowledge of and attitudes towards participation in clinical trials. Results: A total of 100 patients and relatives agreed to take part in the study (response rate: 57.5%). The male-to-female ratio was 1:1.2. Only 31.3% of the studied population knew what clinical trials were and only 6.5% had themselves previously participated in a clinical trial. The majority agreed or strongly agreed that they would participate in clinical trials related to their own condition (59.2%). Overall, 89.7% expected to be informed about potential clinical trials by their treating physicians. Conclusion: Omanis had a low level of knowledge of clinical trials and a very low rate of previous participation in such trials, despite a moderate level of interest. Patients should therefore be educated and informed of ongoing clinical trials in order to improve participation rates for clinical trials conducted in Oman.

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