scholarly journals Research Clinical Trial- A Review

2021 ◽  
Vol 01 (09) ◽  
Author(s):  
Dr. Ishita Attri ◽  
Keyword(s):  
Clinical Trial ◽  
Healthcare Professionals ◽  
Research Study ◽  
Research Protocol ◽  
Team Members ◽  
Roles And Responsibilities ◽  
Post Marketing Surveillance ◽  
Post Marketing

Majority of healthcare professionals are struggling with conducting and writing a protocol for a research study. Thus, the purpose of this article is to summarize significant steps and necessary guidelines for producing a standard research protocol, roles and responsibilities of various team members involved in the study, and conduction of actual clinical trial including its initiation, phases (I-III), termination or post-marketing surveillance phase. It is important to note that the quality of a clinical trial largely depends on the protocol to achieve success in the research study.

scholarly journals Post marketing surveillance of suspected adverse drug reactions through spontaneous reporting: current status, challenges and the future

2020 ◽  
Vol 11 ◽  
pp. 204209862093859 ◽  
Author(s):  
Muaed Alomar ◽  
Ali M Tawfiq ◽  
Nageeb Hassan ◽  
Subish Palaian
Keyword(s):  
Adverse Effects ◽  
Health Professionals ◽  
Healthcare Professionals ◽  
Spontaneous Reporting ◽  
Future Prospects ◽  
Innovative Strategies ◽  
Post Marketing Surveillance ◽  
The Future ◽  
Post Marketing ◽  
Reporting Programs

Background: To highlight the importance of spontaneous reporting programs in post marketing surveillance of medicines. Authors also aimed at providing various dimensions of spontaneous programs, including the strengths and weakness, and providing an insight on the future prospects of pharmacovigilance systems. Methods: Various literature related to post marketing surveillance and spontaneous reporting programs were reviewed and the relevant ones highlighting the strengths and weaknesses are summarized. A balance of information on strengths and weaknesses is listed. The health professionals’ awareness regarding existing spontaneous reporting programs is highlighted. Future prospects of pharmacovigilance are discussed. Results: Though beneficial, spontaneous reporting programs encounter several limitations and difficulties in diagnosing adverse drug reaction. Under-reporting and bias are major challenges. Online signal detection tools and innovative methods are needed to strengthen the spontaneous reporting programs. We provide the various issues to be considered while depending on spontaneous reporting programs as a method of post marketing surveillance. Conclusion: To strengthen the spontaneous reporting programs as an effective post marketing surveillance method, more awareness among health professionals and innovative strategies is needed. Integrating pharmacogenetic data can be a potential aspect of future pharmacovigilance. Plain language summary Monitoring adverse effects of marketed medicines through reporting by healthcare professionals and its challenges and way forward Introduction: This article highlights the importance of safety monitoring of medicines after they are launched in the market, mainly through reporting by healthcare professionals. We also highlight the strengths and weaknesses, and provide an insight on the future prospects of pharmacovigilance systems. Methods: Various literature related to the topic were reviewed and the relevant ones highlighting the strengths and weaknesses are summarized. A balance of information on strengths and weaknesses is listed. Health professionals’ awareness regarding existing programs on reporting safety of medicines is highlighted. Results: Though beneficial, reporting of adverse effects by healthcare professionals who deal with patient lacks clarity in diagnosing the adverse effects. Under-reporting and bias are the major challenges. Online software is needed to strengthen reporting by healthcare professionals. We list the various issues to be considered while depending on healthcare professionals’ reporting of adverse effects as a method of post marketing surveillance. Conclusion: To strengthen medicine safety monitoring and reporting by healthcare professionals, more awareness among health professionals and innovative strategies are needed. Integrating the genetic data of patients can be beneficial in predicting adverse effects, therefore avoiding them and enhancing safe prescribing and dispensing by healthcare professionals.

Improving the Quality of Healthcare Research Data Sets

2011 ◽  
pp. 305-320
Author(s):  
Biswadip Ghosh
Keyword(s):  
Research Study ◽  
Clinical Care ◽  
Healthcare Research ◽  
Research Data ◽  
Data Sources ◽  
Data Sets ◽  
Team Members ◽  
Secondary Sources ◽  
Patient Health

The goal of many healthcare research projects and evidence based medicine programs within healthcare organizations is to support clinical care team members by mining evidence from patient outcomes to support future treatment recommendations. In these research studies, the data is often extracted from secondary sources such as patient health records, benefits systems, and other nonresearch data sources. Good data is important to facilitate a good research study and to support clinical decisions using the results. Often multiple applicable healthcare data sources are available for a research study, some of which may be internal to the organization, while others may be external, such as state or national databases. This chapter attempts to develop an understanding of how the quality of data for healthcare research data sets can be established and improved when using secondary data sources, such as clinical or benefits databases, which were created without primary intentions for research use.

scholarly journals OC 8469 REVIEWING INVESTIGATIONAL PRODUCT’S QUALITY ASSURANCE DOCUMENTATION IN MAJOR CLINICAL TRIAL REGISTRIES FOR POST-MARKETING CLINICAL TRIAL STUDIES

2019 ◽  
Vol 4 (Suppl 3) ◽  
pp. A8.2-A8
Author(s):  
Joachim Doua ◽  
Hanneke Dominicus
Keyword(s):  
Clinical Trial ◽  
Developing Countries ◽  
Quality Assurance ◽  
International Committee ◽  
Clinical Trial Registries ◽  
Good Manufacturing Practices ◽  
Quality Testing ◽  
Post Marketing ◽  
Adequate Data

BackgroundThe proven worrisome quality of medicines marketed in developing countries also affects clinical trials (CTs) as they may be used as Investigational Medicinal Products (IMPs). By regulation, CT sponsors should assure IMP’s quality and describe their quality measures in CT protocols that should be registered in a CT Registry (CTR). To check compliance with this regulation, we reviewed major CTRs to assess the availabilities of data fields on IMP quality for post-marketing CTs.MethodsTwo reviewers independently assessed English versions of CTRs of International Committee of Medical Journal Editors (ICJME) and WHO platforms in July 2017. Each CTR was checked for availability of data fields on: brand name; manufacturer’s name; regulatory approval status; approving regulator; manufacturer’s compliance with Good Manufacturing Practices (cGMP); and quality testing (IMP appearance, impurities, microbial contamination, dosing). In case of discrepancy, consensus was sought.ResultsOf 19 CTRs identified, 8 and 6 belonged to WHO and ICMJE, respectively, and 5 were equally part of both platforms. All CTRs had an ‘intervention’ data field to capture data on IMPs and IMP comparators. Unlike all others, the Canadian CTR used ‘drug name’ rather than ‘intervention’. Only the EU CTR had data fields for ‘manufacturer’s name’, ‘product approval status’, and ‘approving authority’. None of the CTRs had data fields on ‘cGMP’ or ‘quality testing’.ConclusionNone of the CTRs of ICMJE and ICTRP has adequate data fields to establish that the source of post-marketing IMPs is of assured quality. This is astonishing given the extensive requirements in WHO and ICMJE guidelines. The gap of quality assurance fields should be bridged by adding them to CTRs. Specifically, IMP quality testing should be conducted before, during, and after clinical trial completion. Until adoption of these measures, EU-CTR should be favoured for registration of CTs conducted in developing countries.

scholarly journals The risk of malignancy is not increased in patients with multiple sclerosis treated with subcutaneous interferon beta-1a: analysis of data from clinical trial and post-marketing surveillance settings

2011 ◽  
Vol 17 (4) ◽  
pp. 431-440 ◽  
Author(s):  
Magnhild Sandberg-Wollheim ◽  
Gabrielle Kornmann ◽  
Dorina Bischof ◽  
Margaretha Stam Moraga ◽  
Brian Hennessy ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Safety Data ◽  
Data Set ◽  
Safety Database ◽  
Post Marketing Surveillance ◽  
Risk Of Malignancy ◽  
Post Marketing ◽  
Medical Dictionary

Background: Risks that are potentially associated with long-term therapies should be assessed. Objective: The present analyses were performed to determine the risk of malignancy in patients with multiple sclerosis (MS) receiving subcutaneous (sc) interferon (IFN) beta-1a, using pooled safety data from key clinical trials and data from the Merck Serono Global Drug Safety database. Methods: The standard Medical Dictionary for Regulatory Activities query “malignancies” was used to retrieve relevant cases from each data set. The incidence of malignancies per 1000 patient-years was calculated using the pooled safety data from clinical trials. The reporting rates of malignancy types were calculated for the post-marketing setting based on sales volume. Malignancies were grouped by organ localization and classified as medically confirmed or not medically confirmed according to the source of each report. The number of reported cases of each type was compared with the expected number in the general population. Results: Analysis of pooled safety data from 12 key clinical trials did not show an increased incidence of malignancy per 1000 patient-years with sc IFN beta-1a (4.0; 95% confidence interval (CI): 2.9–5.5) compared with placebo (6.4; 95% CI: 3.3–11.2). Analysis of the database shows that among the medically confirmed cases, reported to expected ratios ranged from 1 : 6 to 1 : 18 for solid tumours and from 1 : 2 to 1 : 9 for lymphohaematopoietic tumours. Conclusion: Safety data from both clinical trial and post-marketing settings suggest that treatment with sc IFN beta-1a does not increase the risk of malignancy in patients with MS.

Abstract P007: Ongoing Resuscitation Research is Associated with Higher Odds of Receiving Bystander CPR

Circulation ◽  
2014 ◽  
Vol 129 (suppl_1) ◽  
Author(s):  
Pandora L Wander ◽  
Carol Fahrenbruch ◽  
Sofia Husain ◽  
Mickey Eisenberg ◽  
Thomas D Rea
Keyword(s):  
Research Study ◽  
King County ◽  
Improve Quality ◽  
Research Protocol ◽  
Chest Compressions ◽  
Before And After ◽  
Bystander Cardiopulmonary Resuscitation ◽  
Bystander Cpr ◽  
Hospital Cardiac Arrest

Introduction: The act of conducting a research study could potentially improve quality of care by focusing providers on the study condition or detract from care by distracting providers with complex protocols. We hypothesized that odds of receiving bystander cardiopulmonary resuscitation (CPR) would be higher during a trial of dispatcher-assisted CPR instructions than during periods immediately before and after. Methods: The investigation was a cohort study of 8,626 adult subjects who suffered non-traumatic out-of-hospital cardiac arrest prior to emergency medical services (EMS) arrival in greater King County, Washington, between January 1, 1999, and December 31, 2011. Bystander CPR status was assessed through review of audio dispatch tapes and EMS reports to classify any bystander CPR (any B-CPR). Any B-CPR was further categorized as bystander CPR with dispatcher assistance (DA-CPR) or bystander CPR without dispatcher assistance (B-CPR, no DA). We used multivariable logistic regression to evaluate the odds of any B-CPR before, during, and after the Dispatcher Assisted Resuscitation Trial (DART), a randomized trial of dispatcher-assisted CPR instruction comparing chest compressions alone with compressions plus rescue breaths, which ran from June 1, 2004, to September 30, 2009. We also evaluated whether the odds varied by type-specific B-CPR. Results: Patient and arrest circumstances were similar across the study periods. Compared to the period before DART, odds of receiving any B-CPR were higher during DART (OR=1.35, 95% CI = 1.23-1.49), but no different after OR=1.11, 0.98-1.25). Similarly, compared to the before period, the odds of DA-CPR were higher during DART (OR=1.79, 1.59-2.02) but no different after (OR=0.94, 0.80-1.10) (Table 1). Discussion: Odds of bystander CPR were higher during the study compared to periods before and after. The increase seems to be largely related to higher likelihood of DA-CPR, suggesting a possible community-wide benefit from this research protocol.

scholarly journals Healthcare professionals’ perspective can guide post-marketing surveillance of artemisinin-based combination therapy in Uganda

2020 ◽  
Vol 19 (1) ◽  
Author(s):  
Helen Byomire Ndagije ◽  
Ronald Kiguba ◽  
Leonard Manirakiza ◽  
Elijah Kirabira ◽  
Allan Sserwanga ◽  
...  
Keyword(s):  
Combination Therapy ◽  
Healthcare Professionals ◽  
Post Marketing Surveillance ◽  
Post Marketing
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