India plans to audit clinical trials.
Ontology highlight
ABSTRACT:
SUBMITTER: Mudur G
PROVIDER: S-EPMC1283225 | biostudies-literature | 2005 Nov
REPOSITORIES: biostudies-literature
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Project description: Not available
| S-EPMC10806997 | biostudies-literature
Project description:BackgroundThere are unique opportunities related to the design and conduct of pragmatic trials embedded in health insurance plans, which have longitudinal data on member/patient demographics, dates of coverage, and reimbursed medical care, including prescription drug dispensings, vaccine administrations, behavioral healthcare encounters, and some laboratory results. Such trials can be large and efficient, using these data to identify trial-eligible patients and to ascertain outcomes.MethodsWe use our experience primarily with the National Institutes of Health Pragmatic Trials Collaboratory Distributed Research Network, which comprises health plans that participate in the US Food & Drug Administration's Sentinel System, to describe lessons learned from the conduct and planning of embedded pragmatic trials.ResultsInformation is available for research on more than 75 million people with commercial or Medicare Advantage health plans. We describe three studies that have used or plan to use the Network, as well as a single health plan study, from which we glean our lessons learned.ConclusionsStudies that are conducted in health plans provide much-needed evidence to drive clinically meaningful changes in care. However, there are many unique aspects of these trials that must be considered in the planning, implementation, and analytic phases. The type of trial best suited for studies embedded in health plans will be those that require large sample sizes, simple interventions that could be disseminated through health plans, and where data available to the health plan can be leveraged. These trials hold potential for substantial long-term impact on our ability to generate evidence to improve care and population health.
| S-EPMC10363182 | biostudies-literature
Project description:Clinical audits are essential to ensure that clinical research processes align with regulatory standards and best practices. Despite this, there has been no error assessment of the relationship between the errors in investigational medicinal product (IMP) management and clinical trial workers with audit experience. This study surveyed stakeholders with experience being audited to evaluate errors in IMP management and accountability during clinical trials through online survey system. The survey focused on errors in IMP export, dosing, storage, shipping, and labeling. Errors related to IMP management or accountability were evaluated with 22 specific criteria. Analysis included descriptive statistics and Pearson's correlation. A total of 41 participants experiencing audits in clinical trial were enrolled in the current survey. The survey results revealed that the most frequent errors occurred in missing essential documents for shipment during IMP shipping and errors in label information, each accounting for 24 cases (58%). Additionally, a significant correlation was found between participants' age, work experience, and audit experience (coefficient = 0.77, p value < 0.05). A survey of individuals with auditing experience identified common errors in IMP management, particularly missing shipment documents and incorrect labeling. To address these issues, clinical trial systems should implement regular error monitoring, standardized procedures, and comprehensive staff training to ensure safer and more efficient trials.
| S-EPMC11927233 | biostudies-literature
Project description:BackgroundAudits are often performed to assess the quality of clinical trial data, but beyond detecting fraud or sloppiness, the audit data are generally ignored. In an earlier study, using data from a nonrandomized study, Shepherd and Yu developed statistical methods to incorporate audit results into study estimates and demonstrated that audit data could be used to eliminate bias.PurposeIn this article, we examine the usefulness of audit-based error-correction methods in clinical trial settings where a continuous outcome is of primary interest.MethodsWe demonstrate the bias of multiple linear regression estimates in general settings with an outcome that may have errors and a set of covariates for which some may have errors and others, including treatment assignment, are recorded correctly for all subjects. We study this bias under different assumptions, including independence between treatment assignment, covariates, and data errors (conceivable in a double-blinded randomized trial) and independence between treatment assignment and covariates but not data errors (possible in an unblinded randomized trial). We review moment-based estimators to incorporate the audit data and propose new multiple imputation estimators. The performance of estimators is studied in simulations.ResultsWhen treatment is randomized and unrelated to data errors, estimates of the treatment effect using the original error-prone data (i.e., ignoring the audit results) are unbiased. In this setting, both moment and multiple imputation estimators incorporating audit data are more variable than standard analyses using the original data. In contrast, in settings where treatment is randomized but correlated with data errors and in settings where treatment is not randomized, standard treatment-effect estimates will be biased. And in all settings, parameter estimates for the original, error-prone covariates will be biased. The treatment and covariate effect estimates can be corrected by incorporating audit data using either the multiple imputation or moment-based approaches. Bias, precision, and coverage of confidence intervals improve as the audit size increases.LimitationsThe extent of bias and the performance of methods depend on the extent and nature of the error as well as the size of the audit. This study only considers methods for the linear model. Settings much different than those considered here need further study.ConclusionsIn randomized trials with continuous outcomes and treatment assignment independent of data errors, standard analyses of treatment effects will be unbiased and are recommended. However, if treatment assignment is correlated with data errors or other covariates, naive analyses may be biased. In these settings, and when covariate effects are of interest, approaches for incorporating audit results should be considered.
| S-EPMC3728661 | biostudies-literature
Project description: Not available
| S-EPMC8819597 | biostudies-literature
Project description:Summary Globally, the need to enhance the diversity of trial participants is receiving increasingly urgent attention. We wanted to know whether trials run in India had adequately sampled the country's enormous ethnic diversity. We accessed the Clinical Trials Registry-India website to determine whether each interventional drug or biologic Phase 2 or 3 study, registered in a recent five-year period had run in each of six geographic zones. As regards Phase 3 trials conducted only in India, 61.4% ran in a single zone and just 6.8% were conducted in all six zones. Multinational Phase 3 trials had a better distribution since 3.6% had run in just one zone and 7.1% in all six. India's diverse ethnic groups are underrepresented in the majority of trials covered in this study. A trial that is conducted on non-representative groups and later discovered to be harmful or ineffective in parts of the population, is unethical. We propose various remedial steps.
| S-EPMC10442962 | biostudies-literature
Project description:In the recent past, there has been an impressive growth in the number of clinical trials launched worldwide, including India. Participation in well-designed oncology clinical trials is of advantage to Indian healthcare system in general, and cancer patients in particular. However, the number of clinical trials being run in India is not commensurate with the cancer burden prevailing in the country. In this article, the authors investigate the reasons for this discrepancy, highlight critical bottlenecks, and propose ways to ameliorate the situation.
| S-EPMC3876625 | biostudies-literature
Project description:ObjectiveTo determine levels of public registration for a cohort of clinical trials reviewed and given a favourable opinion by research ethics committees in the United Kingdom.Study designAudit of records.SettingClinical trials receiving a favourable ethics opinion between 1 January 2016 and 30 June 2016.Main outcome measuresCorrelation between trials on the UK research ethics committee database and any primary registry entry on the WHO International Clinical Trials Registry Platform or clinicaltrials.gov as of 29 August 2017 (14 to 20 months after the favourable ethics committee opinion).ResultsOver the study period 1014 trials received a favourable ethics opinion, with 397 (39%) registered on the European Union Drug Regulating Authorities Clinical Trials database, and 18 with an agreed clinical trial registration deferral. Excluding these trials, the total number subsequently requiring registration was 599, and of these 405 (40% of total) were found to be registered. Follow-up with the 194 investigators or sponsors of trials not found to be registered produced 121 responses with a further 10 (1%) trials having already registered, 55 commitments to register and a variety of other responses. The overall registration rate was therefore 80%.ConclusionsDespite researchers and sponsors being reminded that registration of clinical trials is a condition of the research ethics committee (REC) favourable opinion, one-fifth of clinical trials either had not been registered, or their registration could not easily be found, 14 to 20 months after receiving the favourable opinion letter. The methodology trialled here proved effective, and although there are positive indications of a culture change towards greater registration, our results show that more still needs to be done to increase trial registration.
| S-EPMC6398673 | biostudies-literature
Project description:BackgroundAudit and feedback entails systematic documentation of clinical performance based on explicit criteria or standards which is then fed back to professionals in a structured manner. There are potential significant returns on investment from partnerships between existing clinical audit programmes in coordinated programmes of research to test ways of improving the effect of their feedback to drive greater improvements in health care delivery and population outcomes. We explored barriers to and enablers of embedding audit and feedback trials within clinical audit programmes.MethodsWe purposively recruited participants with varied experience in embedded trials in audit programmes. We conducted qualitative semi-structured interviews, guided by behavioural theory, with researchers, clinical audit programme staff and health care professionals. Recorded interviews were transcribed, and data coded and thematically analysed.ResultsWe interviewed 31 participants (9 feedback researchers, 14 audit staff and 8 healthcare professionals, many having dual roles). We identified barriers and enablers for all 14 theoretical domains but no relationship between domains and participant role. We identified four optimal conditions for sustainable collaboration from the perspectives of stakeholders: resources, that is, recognition that audit programmes need to create capacity to participate in research, and research must be adapted to fit within each programme's constraints; logistics, namely, that partnerships need to address data sharing and audit quality, while securing research funding to ensure operational success; leadership, that is, enthusiastic and engaged audit programme leaders must motivate their team and engage local stakeholders; and relationships, meaning that trust between researchers and audit programmes must be established over time by identifying shared priorities and meeting each partner's needs.ConclusionSuccessfully embedding research within clinical audit programmes is likely to require compromise, logistical expertise, leadership and trusting relationships to overcome perceived risks and fully realise benefits.
| S-EPMC8772016 | biostudies-literature
Project description:In multinational trials that have run in India, we wished to determine whether there was too much (60% or higher) recruitment from India. We downloaded all trial records from Clinical Trials Registry-India, CTRI, and stored them in a local SQLite database. We queried records registered in a recent 8-year period, ie 2013-2020 and evaluated the fraction of local participants in interventional Phase 2 or Phase 3 studies. 62 trials were completed, with completion dates available. Five trials (8%) had 60% or more planned recruitment from India. Four of the five (7% of 62) had a foreign sponsor, and therefore there was an unfair burden-benefit ratio on the Indian population. Seven trials (11%), of which six (10% of 62) had foreign sponsors, had 60% or more (of the total) actual recruitment from India, and for two trials (both with foreign sponsors), the data were meaningless. There were 362 studies that were listed as not completed, although, given their start date and estimated duration, some of them ought to have been. Twenty five cases (7% of 362) had 60% or more planned recruitment from India. Of these, 18 (5% of 362) had foreign sponsors and were potentially problematic. Even allowing for some delays in completion, 128 (35% of 362) studies ought to have been completed by the time of our study. As such, we identified several problematic trials for which the planned recruitment from India in multinational studies was 60% or more. We also identified trials in which the actual recruitment was significantly higher than the planned recruitment. Further, the records of several studies that were probably completed were not updated in CTRI in a timely manner. The Indian drug regulator needs to be particularly alert to the planned, or actual, over-recruitment of participants from India. Further, CTRI, alone or in collaboration with the regulator, needs to ensure that multinational trial records for the enrollment fields in particular are updated, in a timely manner.
| S-EPMC10511072 | biostudies-literature