Regulation Of Clinical Trials Research Articles

Improving knowledge and trust in vaccines: A survey-based assessment of the potential of the European Union Clinical Trial Regulation No 536/2014 plain language summary to increase health literacy

The European Clinical Trial Regulation No 536/2014 is the first mandate for a non-technical, publicly disclosed, plain language summary (PLS) of clinical trial results. This easy-to-understand summary has the potential to inform the public about clinical trial results and thereby improve health literacy in vaccines.To investigate the utility of the PLS, we undertook 2 online surveys (July/October 2020) in the United Kingdom, the United States and India. Participants were selected by quota sampling to ensure representation of gender, age and parental status. Those lacking interest in vaccine clinical research were excluded. In survey 1, participants were questioned about their interest in and expectations of vaccine trial results. In survey 2, the perceptions of participants to a range of written communication styles used in publicly available PLSs were evaluated.A total of 66 (13%) and 122 (29%) individuals were excluded solely due to lack of interest in vaccine clinical research in surveys 1 and 2, respectively; 450 respondents (150/country) completed survey 1 and 300 (100/country) completed survey 2. In survey 1, there was a correlation (p < 0.01) between claimed knowledge of and trust in vaccines. Healthcare professionals were the most trusted source for vaccine information, while vaccine companies were ranked relatively low. In survey 2, infographic PLS formats were considered easiest to understand, most engaging and the strongest communicators. Emphasizing the main points of the infographics in the text did not improve comprehension or recall. Most respondents (86%) indicated that they would like to see this type of communication in the future.Overall, this research suggests that the PLS, by optimizing content and format, has a potential to increase health literacy, and thereby, as part of a wider integrated communication strategy, build vaccine knowledge and confidence.

Ensaios clínicos, movimentos sociais e bioativismos: notas para uma (outra) genealogia do sistema brasileiro de ética em pesquisa

Abstract A significant part of the literature on the genesis of the Brazilian institutions devoted to the ethical regulation of scientific research involving human beings usually recalls international events, such as those that occurred during and after the II World War, as triggers of a global ethical conscience of which Brazil would have taken part. Based on review of literature, and a genealogical approach, this assay investigates how certain events that occurred in Brazil, such as the actions of social movements in face of clinical trials with Norplant in the 1980s and with antiretrovirals in the 1990s, are fundamental for understanding the different moments of institutionalization of research ethics in Brazil, and its political orientations. Based on the reconstruction of these episodes, it is argued that particular contents of public agendas on biomedical scientific practices were anchored in specific contexts of contestation led by social movements, whose political demands were described in notably ethical terms. The historical configuration of research ethics in Brazil gathers subjects, factors, and political struggles that provide it with a dynamic character. Understanding this context demands considering the actions of social movements aimed at the regulation of clinical trials.

Clinical trials challenges - impact of the new clinical trial regulation on the conduct of clinical trials

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Revising the legislation of Ethics Committees to ease biomedical research in humans across the world: lessons from the COVID-19 emergency.

As a legislative domain that considerably influences implementation of biomedical research, the need to improve the legal rules surrounding the organization and functioning of Ethics Committees in public health, toxicology, and clinical medicine is widely recognized within and outside the European Union. Given the often-heard complaints by researchers about the complexity and length of both the application and the review process by Ethics Committees in the authorization of new studies, adjustments to their legislation appears to be warranted. Within the European Union this seems also all the timelier, given the upcoming new regulation of clinical trials to become effective in early 2022. For this process, valuable lessons can be gleaned from the COVID-19 pandemic and the changes in the functioning of Ethics Committees that were adopted to cope with the exceptional circumstances imposed by the health emergency. The pandemic experience clearly indicates that a more responsive and practical system of applications’ review by the Ethics Committees can be squared with acceptable levels of transparency and reliability in ethical accountability. For this reason, countries like Italy should consider undertaking a significant revision of the public law rules that govern the review processes of Ethics Committees in light of the pandemic experience. (www.actabiomedica.it)

ПРОГАЛИНИ У РЕГУЛЯЦІЇ ПРОВЕДЕННЯ КЛІНІЧНИХ ДОСЛІДЖЕНЬ МЕДИЧНИХ ВИРОБІВ ТА МЕДИЧНИХ ВИРОБІВ ДЛЯ IN VITRO ДІАГНОСТИКИ В УКРАЇНІ

The article summarizes the arguments and counterarguments within the scientific debate on the issue of gaps in the regulation of clinical research of medical devices and medical devices for in vitro diagnostics in Ukraine. The main goal of the conducted research is to identify an exhaustive list of such gaps and develop recommendations for improving the mentioned regulations. The systematization of literary sources and approaches to solving the problem of gaps in the regulation of clinical research of medical devices and medical devices for in vitro diagnostics in Ukraine proved that the scientific discussion on this topic is not conducted in Ukraine, despite the presence of WHO recommendations on the revision of relevant legal acts . The urgency of solving this scientific problem lies in the fact that filling the gaps in the relevant regulations and harmonizing the regulations with the relevant regulations of the European Union is an integral part of the recognition of clinical evidence on the effectiveness and safety of medical devices obtained during research in Ukraine by European regulatory authorities. Filling these gaps could potentially lead to increased demand for clinical trials of medical devices and medical devices for in vitro diagnostics in Ukraine. The results of the empirical analysis of the market of clinical research of medical products in Ukraine, in comparison with clinical research of medicinal products in Ukraine, proved that Ukraine is more attractive for conducting clinical research of medicinal products. This trend is explained, in particular, by the presence of specialized regulation of clinical trials of medicinal products in Ukraine, the presence of a body responsible for supervision, audit, and evaluation of the results of such clinical trials. The study empirically confirms and theoretically proves that the regulation of this area is insufficient, which leads to the need for additional examination of research materials abroad, and therefore to lower interest in conducting clinical research of medical devices in Ukraine. The results of the conducted research may be useful to regulatory bodies for the development of a regulatory framework for conducting clinical trials of medical devices and products for in vitro diagnostics in Ukraine, sponsors of such trials and contractor companies performing such trials in Ukraine

Analysis of serious adverse events reports: Review by an Institutional Ethics Committee of a tertiary care teaching hospital.

Managing of SAE by all stakeholders i.e. principal investigator (PI), sponsor, and Institutional Ethics Committee (IEC), in an ethical manner is the most important indicator of participant safety during clinical trial. The present study was conducted with the objectives to assess the extent of regulatory compliance in reporting SAEs, relatedness and financial compensation given/recommended by various stakeholders. This was a retrospective observational study which involved analysis of SAE's reviewed by IEC. Administrative approval for accessing the documents was obtained and complete confidentiality was maintained. A total of 66 SAE of 34 regulatory clinical trials reported from January 2014 to March 2020 were analyzed. When analyzed for relatedness, 16 (24.24%) of the reported SAEs were found related to the clinical trial and out of these, 7 were SAE of death. Among the remaining 50 SAEs, 48 (72.7 %) were not related to clinical trial .65 (98.48%) SAEs, initial report and final report were submitted to EC within timelines. All the 66 SAE reports were sent by EC within stipulated time as required by regulation. The study concludes that 66 SAE reports were identified and there was no deviation in reporting timelines in initial reporting and due analysis report by PI and initial review by IEC in 65 SAE's. Similarly, analysis of SAE by IEC for relatedness, and provision of compensation to participant was achieved in majority of SAE. The study is unique in a way that qualitative and quantitative analysis of SAE reports was performed.

Informed consent and assent guide for paediatric clinical trials in Europe

ObjectiveClinical trial sponsors spend considerable resources preparing informed consent (IC) and assent documentation for multinational paediatric clinical trial applications in Europe due to the limited and dispersed patient populations, the...

Recommendations for Standardizing Clinical Trial Design and Endoscopic Assessment in Postoperative Crohn's Disease.

The lack of standardized methods for clinical trial design and disease activity assessment has contributed to an absence of approved medical therapies for the prevention of postoperative Crohn's disease (CD). We developed recommendations for regulatory trial design for this indication and for endoscopic assessment of postoperative CD activity. An international panel of 19 gastroenterologists was assembled. Modified Research and Development/University of California Los Angeles methodology was used to rate the appropriateness of 196 statements using a 9-point Likert scale in 2 rounds of voting. Results were reviewed and discussed between rounds. Inclusion of patients with a history of completely resected ileocolonic CD in regulatory clinical trials for the prevention of postoperative recurrence was appropriate. Given the absence of approved medical therapies, a placebo-controlled design with a primary end point of endoscopic remission at 52 weeks was appropriate for drug development for this indication; however, there was uncertainty regarding the appropriateness of a coprimary end point of symptomatic and endoscopic remission and the use of currently available patient-reported outcome measures. The modified Rutgeerts Score, endoscopic assessment of the anastomosis, and a minimum of 5cm of neoterminal ileum were also appropriate; although the appropriateness of other indices including the Simple Endoscopic Score for CD for endoscopic assessment of postoperative CD activity was uncertain. A framework for regulatory trial design for the prevention of postoperative CD recurrence and endoscopic assessment of disease activity has been developed. Research to empirically validate end points for these trials is needed.

Clinical trials with investigational medicinal products consisting of or containing genetically modified organisms: implementation of Clinical Trials Regulation EU 536/2014

Although originally applicable to genetically modified crops, advanced therapy medicinal products (ATMPs), such as gene therapies, that consist of or contain genetically modified organisms (GMOs) and also viral-based vaccines, need to comply with the European Union (EU) GMO legislation, as implemented in each EU Member State before a clinical trial can commence. Under the European Clinical Trials Regulation 536/2014 (CTR) due to&#160;go live&#160;on 31st&#160;January 2022, a single electronic clinical trial application dossier will need to be submitted to all the Member States involved in the trial, via the European submission portal (Clinical Trials Information System, CTIS). However, national documents, such as informed consent forms, will still need to be submitted, as part II of the dossier, to each&#160;Concerned&#160;Member State, also via CTIS. There will be a single coordinated and harmonized assessment of the clinical trial application between the involved Member States, with one country leading the coordination of the assessment (the&#160;Reporting&#160;Member State). The CTR has as yet not addressed GMO documentation (ERA, common application form, etc) required for an IMP with a genetic component. There is no defined interplay between the CTR and the current GMO legislative framework. There is no specified procedure, nor structure for submission of a GMO application via CTIS, as part of the new single submission and coordinated evaluation procedure for clinical trials defined by the CTR. Upcoming challenges to clinical trial sponsors under the CTR across Member States are identified in this article. Further, national GMO competent authorities are called upon to adopt a pragmatic and simple approach as a first step to facilitate the GMO assessment and its coordination with approval of a clinical trial application.

Peripheral nerve stimulation and immunity: the expanding opportunities for providing mechanistic insight and therapeutic intervention.

Pre-clinical research advances our understanding of the vagus nerve-mediated regulation of immunity and clinical trials successfully utilize electrical vagus nerve stimulation in the treatment of patients with inflammatory disorders. This symbiotic relationship between pre-clinical and clinical research exploring the vagus nerve-based 'inflammatory reflex' has substantially contributed to establishing the field of bioelectronic medicine. Recent studies identify a crosstalk between the vagus nerve and other neural circuitries in controlling inflammation and delineate new neural immunoregulatory pathways. Here we outline current mechanistic insights into the role of vagal and non-vagal neural pathways in neuro-immune communication and inflammatory regulation. We also provide a timely overview of expanding opportunities for bioelectronic neuromodulation in the treatment of various inflammatory disorders.

An Interview with Professor Florence Bourgeois: on Policy and Regulation of Clinical Trials

For more than 20 years, Dr. Florence Bourgeois, MD, MPH has held multiple positions at the intersection of pediatrics, therapeutics, regulatory science, health informatics and research integrity. A graduate of Yale University, Harvard School of Public Health and Washington University School of Medicine in St. Louis, Dr. Bourgeois’ record transcends academia and medicine. In addition to being a faculty member at Harvard Medical School and the Division of Emergency Medicine and the Computational Health Informatics Program (CHIP) at Boston Children’s Hospital, she is the Director of PedRx, which aims to advance the development and evidence-based use of novel therapeutics for children globally. As the Scientific Director of the Boston Children’s Hospital Biobank, Dr. Bourgeois’ efforts focus on expanding physicians’ capacity to conduct research in pediatric populations. As the Co-Director of the Harvard-MIT Center for Regulatory Science, Dr. Bourgeois also spearheads cross-disciplinary collaborations between academia, biotechnology and pharmaceutical companies, and regulatory agencies. She is the recipient of an Innovation in Regulatory Science Award from the Burroughs Wellcome Fund and has served as an Expert Visitor to the European Medicines Agency to analyze the EU’s pediatric drug legislation. As part of this interview, we examine the relationship between clinical trials and drug development in pediatrics as well as their ethical and social impacts.

Should Deep-Sequenced Amplicons Become the New Gold Standard for Analyzing Malaria Drug Clinical Trials?

ABSTRACTRegulatory clinical trials are required to ensure the continued supply and deployment of effective antimalarial drugs. Patient follow-up in such trials typically lasts several weeks, as the drugs have long half-lives and new infections often occur during this period. “Molecular correction” is therefore used to distinguish drug failures from new infections. The current WHO-recommended method for molecular correction uses length-polymorphic alleles at highly diverse loci but is inherently poor at detecting low-density clones in polyclonal infections. This likely leads to substantial underestimates of failure rates, delaying the replacement of failing drugs with potentially lethal consequences. Deep-sequenced amplicons (AmpSeq) substantially increase the detectability of low-density clones and may offer a new “gold standard” for molecular correction. Pharmacological simulation of clinical trials was used to evaluate the suitability of AmpSeq for molecular correction. We investigated the impact of factors such as the number of amplicon loci analyzed, the informatics criteria used to distinguish genotyping “noise” from real low-density signals, the local epidemiology of malaria transmission, and the potential impact of genetic signals from gametocytes. AmpSeq greatly improved molecular correction and provided accurate drug failure rate estimates. The use of 3 to 5 amplicons was sufficient, and simple, nonstatistical criteria could be used to classify recurrent infections as drug failures or new infections. These results suggest AmpSeq is strongly placed to become the new standard for molecular correction in regulatory trials, with potential extension into routine surveillance once the requisite technical support becomes established.

Clinical Trial Design for Disease-Modifying Therapies for Genetic Epilepsies.

Although trials with anti-seizure medications (ASMs) have not shown clear anti-epileptogenic or disease-modifying activity in humans to date, rapid advancements in genomic technology and emerging gene-mediated and gene replacement options offer hope for the successful development of disease-modifying therapies (DMTs) for genetic epilepsies. In fact, more than 26 potential DMTs are in various stages of preclinical and/or clinical development for genetic syndromes associated with epilepsy. The scope of disease-modification includes but is not limited to effects on the underlying pathophysiology, the condition's natural history, epilepsy severity, developmental achievement, function, behavior, sleep, and quality of life. While conventional regulatory clinical trials for epilepsy therapeutics have historically focused on seizure reduction, similarly designed trials may prove ill-equipped to identify these broader disease-modifying benefits. As we look forward to this pipeline of DMTs, focused consideration should be given to the challenges they pose to conventional clinical trial designs for epilepsy therapeutics. Just as DMTs promise to fundamentally alter how we approach the care of patients with genetic epilepsy syndromes, DMTs likewise challenge how we traditionally construct and measure the success of clinical trials. In the following, we briefly review the historical and preclinical frameworks for DMT development for genetic epilepsies and explore the many novel challenges posed for such trials, including the choice of suitable outcome measures, trial structure, timing and duration of treatment, feasible follow-up period, varying safety profile, and ethical concerns.

Call for More Effective Regulation of Clinical Trials with Advanced Therapy Medicinal Products Consisting of or Containing Genetically Modified Organisms in the European Union.

Advanced therapy medicinal products (ATMPs), such as gene therapies that consist of or contain genetically modified organisms (GMOs) need to comply with the European Union (EU) GMO legislation, as implemented in each EU Member State, before a clinical trial can commence. Complying with GMO requirements is complex, varies significantly across EU Member States and is leading to delays to clinical trials with ATMPs. Such delays and varying implementation of the GMO legislation makes the EU less attractive as a region to conduct clinical trials with investigational gene therapies. This is detrimental to EU patients, since their timely access to these transformative potentially curative medicines is delayed. Despite recent initiatives coordinated by the European Commission (EC) to facilitate and reduce discrepancies across the EU regarding the application of the GMO requirements, it remains particularly difficult to conduct multicenter clinical trials with ATMPs containing or consisting of GMOs involving several EU Member States. The recent decision for the EC to temporarily derogate potential coronavirus disease 2019 treatments and vaccines from some provisions of the GMO requirements was made on the basis of a clear recognition of such complexities and resulting delays to clinical development. The Alliance for Regenerative Medicine, the European Federation of Pharmaceutical Industries and Associations, and the European Association for Bioindustries call upon the EC, together with national competent authorities, to exempt ATMPs containing or consisting of GMOs from the GMO legislation. Such a simplification will eliminate the delays currently reported to occur when submitting environmental risk assessments and GMO applications to the national competent authorities. An exemption from GMO requirements will make the EU a more attractive region for clinical development of gene therapies and could accelerate European patients' access to these potentially life-saving medicines. Maintaining a system for GMO assessment that is different across countries may also prevent ATMPs from realizing the full benefits of a harmonized clinical trial approval process under the Clinical Trials Regulation. The undersigned organizations to this publication urge the EC to use its right of initiative to put forward a legislative proposal to exempt ATMPs in clinical development from the EU GMO legislation, within the timeframe proposed in the 2020 EU Pharmaceutical Strategy (by 2022). Implementation of a GMO exemption scheme before the end of the transition period for the Clinical Trial Regulation (the end of 2023) is important to avoid new Clinical Trial Application submissions for ATMPs under the Clinical Trial Regulation having to conduct the whole GMO assessment process in parallel. It is considered that ATMPs pose negligible risk to the environment. Such ATMPs include the following: human somatic cells modified ex vivo; recombinant virus-based vectors, including those containing genome editing nucleic acid sequences (which may also be delivered nonvirally); and bacterial vectors. Outside of controlled storage conditions, gene therapies cannot survive for any appreciable length of time. Upon clinical administration, any recombinant gene therapy viral vector particles that do not enter host cells are diluted within the body and if excreted are in such low multiplicity to no longer be viable or considered infectious to persons, animals, or living organisms within the environment. Any nucleic acids released into the environment are rapidly degraded.

From sandbox to pandemic: Agile reform of Canadian drug regulation

Public health urgency for emerging COVID-19 treatments and vaccines challenges regulators worldwide to ensure safety and efficacy while expediting approval. In Canada, legislative amendments by 2019 Omnibus Bill C-97 created a new "agile" licensing framework known as the "Advanced Therapeutic Pathway" (ATPathway) and modernized the regulation of clinical trials of drugs, vaccines, and medical devices. Bill C-97′s amendments are worthy of attention in Canada and globally, as health product regulation bends to COVID-19. The amendments follow reforms elsewhere to accommodate health product innovation, however, the Canadian ATPathway is broader and more flexible than its counterparts in other jurisdictions. In addition, Bill C-97 informed Canada's COVID-19 response in important ways, particularly in relation to clinical trials. The measures adopted by the drug regulatory authority, Health Canada (HC) during COVID-19 may become the new norm in Canadian regulatory practice insofar as they help achieve the amendments introduced by Bill C-97. Finally, despite government rhetoric of transparency, the agenda-setting, formulation, and implementation of the amendments have occurred with little opportunity for scrutiny or public engagement.

A deep learning-based approach for simultaneously segmenting T2 lesions and T1 hypointensities in multiple sclerosis regulatory clinical trials (4379)

A deep learning-based approach for simultaneously segmenting T2 lesions and T1 hypointensities in multiple sclerosis regulatory clinical trials (4379)

A Novel Fluorescent c-Met Targeted Imaging Agent for Intra-Operative Colonic Tumour Mapping: Translation from the Laboratory into a Clinical Trial

Background: Curative resection of colon cancer requires accurate intraoperative identification of tumour margins and lymph node (LN) burden. The c-Met protein is important for cell differentiation and migration and is overexpressed in many gastrointestinal cancers. We explored EMI-137, a novel c-Met targeting fluorescent probe, for application in fluorescence-guided colon surgery, in HT-29 colorectal cancer (CRC) cell line and an in vivo murine model. This informed a first-in-man clinical trial of EMI-137. Methods: HT-29 cells were used as a representative CRC model. SiRNA was used to demonstrate the specificity of EMI-137 for c-Met. A HT-29 CRC xenograft model was developed in female BALB/c mice. Tumours were cultured for 14 days to 10mm diameter. EMI-137 (0.18mg/kg) was injected into tail veins and biodistribution analysed through in vivo fluorescent imaging. Nine patients, aged 67-77 years, received a single intravenous dose of EMI-137 (0.13mg/kg), 1-3 hours before laparoscopic-assisted colon cancer resection surgery (NCT03360461). Tumour and LN fluorescence was assessed with a modified Karl Storz® laparoscope. Immunohistochemistry with a monoclonal antibody analysed c-Met expression in eight resected samples. Findings: c-Met expression in HT-29 cells was effectively silenced and imaged with EMI-137. Strong EMI-137 uptake in tumour xenografts was observed for up to 6 hours post-administration. At clinical trial, no serious adverse events related to EMI-137 were reported. Marked background fluorescence was observed in all trial participants, 4/9 showed an increase in tumour fluorescence over background; 5/9 had histological LN metastases; no fluorescent LN were detected intraoperatively. All primary tumours (8/8) and malignant LN (15/15) exhibited moderate to high c-Met protein expression. Interpretation: EMI-137, binds specifically to the human c-Met transmembrane protein, is safe in patients and with further refinement, shows potential for long-term application in fluorescence-guided colon surgery. Trial Registration: The trial was registered with ClinicalTrials.gov identifier NCT03360461. Funding: Research was supported by internal University of Leeds funding. Declaration of Interests: The authors declare no conflict of interest. Ethics Approval Statement: Ethical approval was granted by the Yorkshire and Humber Leeds West Research and Ethics Committee (Ref 17/YH/0263), on 19th October 2017 and Regulatory approval was granted by the Medicines and Healthcare products Regulatory Agency (MHRA), under The Medicines for Human Use (Clinical Trials) regulations on 29th August 2017.

Assessing the impact on pharmacists’ time by introducing a technician screening process for clinical trial prescriptions

IntroductionVarious national guidance from the Lord Carter 2016 report to the NHS Long term plan have emphasised the need to transform traditional hospital pharmacy and make work streams more efficient.[1] A clinical trials pharmacist has historically validated clinical trial medicines. Whilst this is good practice for non-chemotherapy prescriptions, it is not a requirement of the Clinical Trial Regulations.[2] Interruption to validate trial prescriptions can have a negative impact on pharmacists’ duty and consequently patient outcomes. With limited data available, this issue has been highlighted by anecdotal evidence. Due to the often complex requirements associated with trials, the research team are responsible for assessing the suitability of treatment. This includes checking interactions with concomitant medication, reviewing blood results and patient counselling. The clinical aspect of the pharmacist validation is therefore removed, allowing technicians to be involved in the screening of suitable prescriptions. Much is written on technicians extending their roles in the clinical setting, but this service improvement focuses on enhancing their role within the pharmacy clinical trials department.AimTo evaluate the amount of pharmacists’ time saved by the introduction of technician screening of clinical trial prescriptions.MethodA risk-based proforma was created and used by a pharmacist to assess clinical trial prescriptions for the suitability of screening by a Band 7 technician. Only prescriptions with pre-printed doses, no aseptic preparation or additional medicines, were approved for technician screening. The process of screening therefore only involves the checking of patient and prescriber details, allergy status and possibly a medication randomisation. The technicians under-went an in-house training including the screening of prescriptions under pharmacist supervision. A quantitative data collection tool was used to review the screening / validation of all nonchemotherapy clinical trial prescriptions received at two sites over a two-week period in September 2020. The data collection tool was piloted and all data was analysed using Microsoft Excel.ResultsA total of 89 prescriptions were received. 56 (63%) were eligible for technician screening, of which a suitable technician validated 50%.Across both sites a total time of 360 minutes were spent validating/screening prescriptions including solving prescription related issues. Combining the time taken by a pharmacist to return from a clinical area and screening time consequently saved a total of 227 minutes of pharmacists’ time.ConclusionDistributing the workload amongst trained staff saves pharmacist’s time, which can be utilised on clinical and complex tasks. This does not eliminate the requirement of a pharmacist to validate prescriptions however; it reduces the frequency and streamlines the service. Further data collection is required to analyse the direct impact on patients’ and any changes in the number of reported errors. A limitation to the study is the lack of data prior to implementation as a comparator. Additionally, during data collection there were no suitable technicians available at one site due to the Covid-19 pandemic, resulting in only 50% of eligible prescriptions being screened by a technician. Ultimately, this does not change the outcome; enhancing technician’s roles allows pharmacists’ time to be used more efficiently.

Analysis of clinical trial agreement and insurance policy submitted to the ethics committee of a tertiary care teaching institute in central India.

Purpose:Very few studies conducted in India have analyzed insurance policies and clinical trial agreement (CTA) submitted to ethics committee (EC). This study was conducted to review and find out deficiencies in it.Materials and Methods:This was a retrospective observational study. All the protocols for regulatory clinical trials and academic research sponsored by the Indian Council of Medical Research or other funding agency were included. Insurance documents and CTA submitted with the study protocols were analyzed.Results:A total of seventy CTA and insurance policies were analyzed. CTA mentioned that parties involved in 60 (86%) forms, scope of the agreement in 15 (21%) forms, responsibilities of the party in 68 (97%) forms, and payment details in 58 (83%) forms. Nearly 88.5% of the insurance policies mentioned whether the policy covers the participants for injury due to all clauses and 91% of the policies mentioned the validity period of insurance.Conclusion:It was found that both the documents contained almost all the required elements. This was probably because this institutional EC insisted on and thoroughly reviewed the documents to ensure that adequate compensation of research-related injuries has been provided for and this fact is informed to the trial subject. As very few studies are available in the literature, we could not compare majority of the findings of this study with others.

Comparative study of updated Clinical Trial Regulations in India with respect to Australia, Europe, Japan and US

The national regulatory authorities, such as the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), Central Drugs Standard Control Organization and the Australian Therapeutic Goods Administration (TGA), approve every drug that is prescribed for patients around the world. The process of approval undertaken by pharmaceutical companies for drug candidates consists of a series of phases to ensure the product is safe and effective at treating the disease.&#x0D; In this paper, we will compare the clinical trial regulations of India with respect to Australia, Europe, Japan &amp; USA in order to determine the safety and efficacy of pharmaceutical products like drugs, biologics and medical devices in different geographical regions and to confirm the clinical trials studies follow strict scientific standards.