scholarly journals Partnerships and Collaborations: The Right Alliances for Clinical Trials in Africa

2020 ◽  
pp. 954-958
Author(s):  
Olusola Solarin ◽  
Sulma I. Mohammed ◽  
Ntokozo Ndlovu ◽  
Verna Vanderpuye ◽  
Victoria Olaiya
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
New Therapies ◽  
Racial Profile ◽  
Research Organizations ◽  
Heavy Burden ◽  
Empiric Data ◽  
The Right ◽  
Global Population

Africa attracts < 1% of all trials conducted around the world. The implication is that proof of safety and efficacy in Africans is lacking for a lot of new therapies. The sizeable proportion of approximately 20% of the global population that Africa represents largely does not have empiric data to support use of new therapies in a population with a distinct genetic and racial profile. Beyond the imperative of evidence-based interventions, Africans carry a disproportionately heavy burden of certain diseases, including prostate cancer, sickle cell anemia, and malaria. It therefore provides opportunity for efficient recruitment of participants for trials for such diseases. However, this advantage has not convinced sponsors to carry out clinical trials in Africa. India and China each have roughly the same population size as Africa, but each presents just one regulatory jurisdiction for clinical trials. Africa has 54 countries, and a sponsor would theoretically need to file 54 different applications to cover the entire continent. Collaboration and partnership among all stakeholders in the clinical trial ecosystem will reduce the burden on sponsors and make Africa competitive as a destination for clinical trials. Collaboration among national regulatory agencies will enable Africa to be treated as one regulatory jurisdiction and reduce administrative burden. Sites and researchers can partner to improve quality, attain necessary certifications, and increase overall efficiency. Central to all of these are clinical research organizations that can coordinate and work across borders to make clinical trial projects seamless. Ultimately, patients will benefit as quality of clinical practice improves and access to new therapies is enhanced.

Prerequisites to support high-quality clinical trials in children and young people

2020 ◽  
pp. archdischild-2019-318677
Author(s):  
Steven Hirschfeld ◽  
Florian B Lagler ◽  
Jenny M Kindblom
Keyword(s):  
Clinical Trials ◽  
Healthcare Delivery ◽  
Paediatric Population ◽  
Ecosystem Functions ◽  
Healthcare Delivery System ◽  
High Quality ◽  
Children And Young People ◽  
The Right ◽  
Support Decision Making

Children have the right to treatment based on the same quality of information that guides treatment in adults. Without the proper evaluation of medicinal products and devices in paediatric clinical trials that are designed to meet the rigorous standards of the competent authorities, children are discriminated from advances in medicine. There are regulatory, scientific and ethical incentives to address the knowledge gap regarding efficacy and safety of medicines in the paediatric population. High-quality clinical trials involving children of all ages can generate data that will ultimately close the knowledge gaps and support decision making.For clinical trials that enrol children, the needs are specialised and often resource intensive. Prerequisites for successful paediatric clinical trials are personnel with training in both paediatrics and neonatology and expertise in clinical trials in these populations. Moreover, national and international networks for efficient collaboration, dissemination of information, and sharing of resources and expertise are also needed, together with competent, efficient and high-quality local infrastructure with effective processes. Monitoring and oversight bodies with the relevant competence, including expertise in paediatrics, is also an important prerequisite for paediatric clinical trials. Compromise in any of these components will compromise the downstream results.This paper discusses the structures and competences needed in order to perform effective, high-quality paediatric clinical trials with the ultimate goal of better medicines and treatments for children. We propose a model of examining the process as a series of components that each has to be optimised, then all the components are actively optimised to function together as an ecosystem, and the resulting ecosystem functions well with the general research system and the healthcare delivery system.

scholarly journals Calling for improved quality in the registration of traditional Chinese medicine during the public health emergency: a survey of trial registries for COVID-19, H1N1, and SARS

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Zhuoran Kuang ◽  
◽  
Xiaoyan Li ◽  
Jianxiong Cai ◽  
Yaolong Chen ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Secondary Outcome ◽  
Specific Information ◽  
Clinical Trial Registry ◽  
Data Set ◽  
Diagnosis Criteria

Abstract Objective To assess the registration quality of traditional Chinese medicine (TCM) clinical trials for COVID-19, H1N1, and SARS. Method We searched for clinical trial registrations of TCM in the WHO International Clinical Trials Registry Platform (ICTRP) and Chinese Clinical Trial Registry (ChiCTR) on April 30, 2020. The registration quality assessment is based on the WHO Trial Registration Data Set (Version 1.3.1) and extra items for TCM information, including TCM background, theoretical origin, specific diagnosis criteria, description of intervention, and outcomes. Results A total of 136 records were examined, including 129 severe acute respiratory syndrome coronavirus 2 (COVID-19) and 7 H1N1 influenza (H1N1) patients. The deficiencies in the registration of TCM clinical trials (CTs) mainly focus on a low percentage reporting detailed information about interventions (46.6%), primary outcome(s) (37.7%), and key secondary outcome(s) (18.4%) and a lack of summary result (0%). For the TCM items, none of the clinical trial registrations reported the TCM background and rationale; only 6.6% provided the TCM diagnosis criteria or a description of the TCM intervention; and 27.9% provided TCM outcome(s). Conclusion Overall, although the number of registrations of TCM CTs increased, the registration quality was low. The registration quality of TCM CTs should be improved by more detailed reporting of interventions and outcomes, TCM-specific information, and sharing of the result data.

scholarly journals The appearance and increase in the quantity and proportion of the clinical research coordinator's service fee in drug clinical trial research fund and its impact on trial quality

2020 ◽  
Author(s):  
Liran Chen ◽  
Zhimin Chen ◽  
Huafang Chen
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Structural Changes ◽  
Continuous Increase ◽  
Clinical Trial Research ◽  
Clinical Research Coordinator ◽  
Research Coordinator ◽  
Drug Clinical Trial

Abstract Objective: The changes of absolute value and relative value of clinical research coordinator service fee and its influence on the quality of drug clinical trial were analyzed.Methods: This study compared the amount and structural changes of drug clinical trial costs in before 3 years and after 3 years of self-examination and inspection initiated by the China Food and Drug Administration, identified the increase number and composition of each individual cost of a clinical trial research funds which including clinical research coordinator service fee, investigator labor fee, subjects examination fee, subjects traffic subsidy, documents management fee, drug management fee, etc.Result: The most significant appearance and increase in volume and proportion were the clinical research coordinator service fee. From the initial few to the global multicenter tumor drug clinical trials RMB31,624 or 34.92% of the proportion and domestic multicenter tumor drug clinical trials RMB16,500,accounted for 33.74%.Discussion: It has become common for more money to be spent on clinical trials to be accompanied by improved quality, but the occurrence and continuous increase of clinical research coordinator service fee were divided into two aspects, On the one hand, the quality of clinical trials was promoted by the large amount of low-skill trivial work undertaken by clinical research coordinator; on the other hand, the quality of clinical trials was undermined by the fact that clinical research coordinator did too much treatment evaluation work that should have been done by the investigator.

Heroin-assisted Treatment for drug dependents’ assistance / Los programas experimentales con heroina en la atención de la población drogodependiente

2012 ◽  
Vol 12 (1) ◽  
Author(s):  
Alina Danet ◽  
Joan Carles March Cerdá ◽  
Manuel Romero Vallecillos
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Literature Review ◽  
Clinical Studies ◽  
Therapeutic Use ◽  
Medical Prescription ◽  
Calidad De Vida ◽  
Survey Results ◽  
Therapeutic Possibilities

Objetivo. Los ensayos clínicos con heroína (diacetilmorfina-DAM) han aportado al arsenal terapeútico disponible una alternativa en la atención a drogodependientes. El objetivo del presente artículo es conocer las experiencias y resultados clínicos de los estudios sobre el uso terapéutico de la heroina.Metodo. Revisión bibliográfica de los diferentes estudios y ensayos clínicos realizados hasta el presente a nivel mundial, sobre la intervención con pacientes dependientes de opioides. Se han consultado las bases de datos: EMBASE, ScienceDirect, Wiley-Blackwell, PubMed, Bio-Med Central, Medline, Ovid, y los descriptores «heroin», «diacetylmorphine», «clinical trial», «survey».Resultados. Se detectan 42 referencias, 16 presentan los resultados de ensayos clínicos de Suiza, Holanda, Alemania, Canadá, España y Reino Unido, comenzando con 1994. El resto de estudios se refieren a: captación y participación de los drogodependientes, mortalidad, calidad de vida, efectos secundarios y necesidad de nuevas investigaciones y ensayos clínicos.Conclusiones. Los estudios clínicos llevados a cabo hasta la actualidad muestran heterogeneidad en los métodos y variables empleadas, pero los objetivos son comunes (parten de evaluar los efectos del uso terapéutico de la heroina) y los resultados constatan la seguridad y efectividad de la prescripción médica de la diacetilmorfina. AbstractObjective. Clinical trials with heroin (diacetylmorphine) bring an alternative to the available therapeutic possibilities for addict people. The purpose of this article is to describe the experiences and results of clinical studies centered on the therapeutic use of heroin.Method. Literature review of studies and clinical trials, centered on the intervention with opiois- dependent patients. The databases consulted were : EMBASE, ScienceDirect, Wiley-Blackwell, PubMed, Bio-Med Central, Medline, Ovid. The descriptors : «heroin», «diacetylmorphine», «clinical trial», «survey».Results. The literature review revealed the existence of 42 references, of which 16 presented the results of clinical trials in Switzerland, Holland, Germany, Canada, Spain and United Kingdom, starting with 1994. Other references are centered on uptake and involvement of the drug, mortality quality of life/ side effects and need for further research and clinical trials.Conclusions. Clinical studies carried out until the present show heterogeneity in the methods and variables used, but the objectives are the same (based on assessing the effects of the therapeutic use of heroin) and the results confirm the safety and effectiveness of medical prescription of diacetylmorphine.

scholarly journals Quality assessment of clinical trial registration with traditional Chinese medicine in WHO registries

BMJ Open ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. e025218 ◽  
Author(s):  
Xuan Zhang ◽  
Ran Tian ◽  
Zhen Yang ◽  
Chen Zhao ◽  
Liang Yao ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Reporting Quality ◽  
Reporting Rate ◽  
Trial Registration ◽  
Clinical Trial Registration ◽  
Data Set

ObjectiveThis study aimed to assess the registration quality of clinical trials (CTs) with traditional Chinese medicine (TCM) in the WHO International Clinical Trials Registry Platform (ICTRP) and identify the common problems if any.MethodsThe ICTRP database was searched for all TCM CTs that were registered up to 31 December 2017. Registered information of each trial was collected from specific registry involved in ICTRP through hyperlink. The primary analysis was to assess the reporting quality of registered trials with TCM interventions, which is based on the minimum 20 items of WHO Trial Registration Data Set (TRDS, V.1.2.1) plus optional additional three items recommended by ICTRP, and some specific items for TCM information (including TCM intervention, diagnosis, outcome and rationale). Descriptive statistics were additionally used to analyse the baseline characteristics of TCM trial registrations.ResultsA total of 3339 records in 15 registries were examined. The number of TCM registered trials has increased rapidly after the requirement of mandatory trial registration proposed by International Committee of Medical Journal Editors on 1 July 2005, and the top two registries were Chinese Clinical Trial Registry and ClincialTrials.gov. Of 3339 trials, 61% were prospective registration and 12.8% shared resultant publications. There were 2955 interventional trials but none of them had a 100% reporting rate of the minimum 20 items and additional three items. The reporting quality of these 23 items was not optimal due to 11 of them had a lower reporting rate (<65%). For TCM details, 49.2% lacked information on description of TCM intervention(s), 85.9% did not contain TCM diagnosis criteria, 92.6% did not use TCM outcome(s) and 67.1% lacked information on TCM background and rationale.ConclusionThe registration quality of TCM CTs should be improved by prospective registration, full completion of WHO TRDS, full reporting of TCM information and results sharing. Further full set of trial registration items for TCM trials should be developed thus to standardise the content of TCM trial registration.

scholarly journals Methodological Characteristics of Clinical Trials: Impact of Mandatory Trial Registration

2019 ◽  
Vol 22 ◽  
pp. 131-141
Author(s):  
Ashish Kumar Kakkar ◽  
Biswa Mohan Padhy ◽  
Sudhir Chandra Sarangi ◽  
Yogendra Kumar Gupta
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Statistical Methods ◽  
Quality Characteristics ◽  
Allocation Concealment ◽  
Trial Registration ◽  
Control Group ◽  
Study Protocols ◽  
The Impact

Purpose: Numerous studies across multiple specialties have evaluated the impact of trial registration on quality of study reports and found significant improvements over several domains. However, the impact of mandatory trial registration on the quality of clinical trial protocols remains hitherto unexplored. Methods: We carried out a retrospective cohort study of clinical trial applications submitted to drug regulatory authority of India for initial review with the objective of comparing methodological characteristics of their protocols. Since trial registration was made mandatory in the country in June 2009, we selected two study periods as between January 2007 to May 2009 (Period I) and July 2009 to December 2011 (Period II). Seventy-five protocols were randomly selected using a computer-generated list for each study period, making a total of 150 protocols. Data on twelve key methodological characteristics were collected including clearly defined primary outcomes, randomization, blinding, use of control group, statistical methods, handling of withdrawals amongst others. Results: More than 3/4th of the trial applications in the two study periods were for new chemical entities and nearly 90% were pharmaceutical industry sponsored studies. Comparing the period before and after implementation of mandatory trial registration, description of clearly defined trial outcomes improved from nearly 42% to 80% (p<0.001), sample size justifications increased from 38% to 70% (p<0.001) and use of allocation concealment improved from 24% to 49% (p=0.001). Marked improvement was also noted for blinding, description of statistical methods and handling of withdrawals and dropouts. Remaining characteristics did not change significantly between the two study periods. The mean cumulative scores for the study protocols improved significantly from 7± 0.296 in the first period to 8.93± 0.346 (p<0.001) in the second period. Conclusions: Our study found a significant improvement in the methodological quality characteristics of the protocols particularly in elements related to minimization of bias and statistical methods, which could be attributed to mandatory trial registration. Overall, the significant improvement was limited to global clinical trials, and room for improvement was noted for two quality characteristics – proportion of randomized studies and trials adequately describing the generation of allocation sequence.

scholarly journals Reporting guidelines for clinical trial reports for interventions involving artificial intelligence: the CONSORT-AI Extension

BMJ ◽  
2020 ◽  
pp. m3164 ◽  
Author(s):  
Xiaoxuan Liu ◽  
Samantha Cruz Rivera ◽  
David Moher ◽  
Melanie J Calvert ◽  
Alastair K Denniston
Keyword(s):  
Artificial Intelligence ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Trial Design ◽  
Trial Protocols ◽  
General Readership ◽  
Peer Reviewers ◽  
Multi Stakeholder ◽  
Analysis Of Error

Abstract The CONSORT 2010 (Consolidated Standards of Reporting Trials) statement provides minimum guidelines for reporting randomised trials. Its widespread use has been instrumental in ensuring transparency when evaluating new interventions. More recently, there has been a growing recognition that interventions involving artificial intelligence (AI) need to undergo rigorous, prospective evaluation to demonstrate impact on health outcomes. The CONSORT-AI extension is a new reporting guideline for clinical trials evaluating interventions with an AI component. It was developed in parallel with its companion statement for clinical trial protocols: SPIRIT-AI. Both guidelines were developed through a staged consensus process, involving a literature review and expert consultation to generate 29 candidate items, which were assessed by an international multi-stakeholder group in a two-stage Delphi survey (103 stakeholders), agreed on in a two-day consensus meeting (31 stakeholders) and refined through a checklist pilot (34 participants). The CONSORT-AI extension includes 14 new items, which were considered sufficiently important for AI interventions, that they should be routinely reported in addition to the core CONSORT 2010 items. CONSORT-AI recommends that investigators provide clear descriptions of the AI intervention, including instructions and skills required for use, the setting in which the AI intervention is integrated, the handling of inputs and outputs of the AI intervention, the human-AI interaction and providing analysis of error cases. CONSORT-AI will help promote transparency and completeness in reporting clinical trials for AI interventions. It will assist editors and peer-reviewers, as well as the general readership, to understand, interpret and critically appraise the quality of clinical trial design and risk of bias in the reported outcomes.

Interventional pain treatment – overview of available procedures

Ból ◽  
2019 ◽  
Vol 19 (3) ◽  
pp. 1-14
Author(s):  
Michał But ◽  
Andrzej Król ◽  
Teodor Goroszeniuk ◽  
Elwira Góraj ◽  
Kamil Starczewski ◽  
...  
Keyword(s):  
Subjective Experience ◽  
Pain Treatment ◽  
Hospital Setting ◽  
Anatomical Location ◽  
Heavy Burden ◽  
The Right ◽  
Fee Schedule ◽  
Interventional Pain Treatment ◽  
Based Medicine

Chronic pain has become dominant problem in recent years affecting not only patient quality of life but having economic impact and heavy burden on the health systems. The first line in pain management would be patient education, physical rehabilitation and pharmacotherapy. Unfortunately aforementioned treatment often appears incomplete and specialised, targeted pain interventions are warranted. With significant progress in pain medicine, the number of available and effective interventional procedures and techniques have increased. In this manuscript authors have carried out an up to date review of modern interventional techniques with emphasize of anatomy, level of advancement and complexity. Authors classified procedures according to anatomical location: head and neck, spine, upper and lower limb, trunk as well as pathophysiology: interventions in neuropathic pain, cancer pain including neuromodulation techniques. Whenever possible authors relied on evidence based medicine (EBM) but with emphasize of its limitation, especially in assessment of pain relief which remains patient subjective experience. In summary, reimbursement of up to date pain procedures, in the outpatient and hospital setting has been shown. It hopefully guide pain specialists to choose the right intervention and facilitate renumeration within NFZ fee schedule.

Clinical trial feasibility assessment and start-up tool (CTFAST).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e14089-e14089
Author(s):  
Amanda Tice ◽  
Richard Dima ◽  
Wasif M. Saif ◽  
Melissa Panzo ◽  
Sarah R. Vaiselbuh
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Patient Population ◽  
Feasibility Analysis ◽  
Pharmacokinetic Studies ◽  
Research Experience ◽  
Team Members ◽  
Feasibility Assessment ◽  
Start Up ◽  
The Right

e14089 Background: Selecting the right clinical trials for patients remains a challenging job. The better the match between a clinical trial and the target patient population before conducting a study, the more likely the study will successfully reach the target goal of recruitment. We developed a feasibility assessment scoring system based on our vast clinical research experience, managing multiple sites across a large health system, applicable to oncology as well. Methods: Our feasibility team (FT) is responsible for identifying clinical trials and determining if they are an appropriate match for our institution and unique patient population. Once a potential trial is identified, FT performs a feasibility assessment of the research protocol to determine the resources required to conduct the trial. We developed a Clinical Trial Feasibility Assessment & Start-up Tool (CTFAST) to help sites streamline their feasibility assessments and track their trial through the start-up phase. With CTFAST a feasibility score is generated based on the cumulative value assigned to several items such as: sponsor, study type, pharmacokinetic studies, trial phase, etc. A feasibility scale is assigned as follows: > 25 – Accepted; 15-25 – On Hold; < 15- Rejected. Accepted studies are assigned a color coded priority track (fast, intermediate, routine), that allows team members to prioritize their studies accordingly. Once a study is accepted, the study is processed for enrollment. Results: CTFAST has increased productivity and clinical trial revenues by 40%. CTFAST allows for early identification of bottlenecks in workflow, thereby improving outcomes. By appropriately matching of clinical trials to our site, enrollments increased by 50% with an expanded clinical trial portfolio across 9 different departments. Study start-up times have been reduced to a minimum of 21 days and the use of time & effort has been optimized. Conclusions: CTFAST is replicable across all clinical trial sites and provides an expansive and critical feasibility analysis that is not attainable by traditional querying of investigators and questionnaires. It is an excellent work flow improvement tool as it critically analyzes all aspects of a study, prior to enrollment. When conducting an effective feasibility analysis the clinical trial site can optimize clinical trial outcomes.

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