Global health trials

Increasing Demand for Vehicle Safety to Stimulate the Market Growth The increasing demand for safer automotive systems by consumers along with government initiatives is anticipated to augment the growth of the Integrated Vehicle Health Management Market during the forecast period.

The prognostics projected to grow at a significant CAGR in This is attributable to the development of vehicle health management from traditional to diagnostics and prognostics systems. On the basis of component segment, the market is bifurcated into software, and hardware. The software segment is anticipated to grow at substantial CAGR during the forecast period. On the basis of sales channel, the market is bifurcated into OEM, and personal care.

The OEM segment of integrated vehicle health management market is projected to dominate the global market owing to the pre-installation of vehicle health monitoring systems in the automobiles.

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Market Size in Thus, it might be acceptable for an initial vaccine trial to have a placebo-controlled arm, if there was no other vaccine candidate approved for this specific age.

However, when at a country level an emergency approval is granted, it becomes much harder to justify continuing with a placebo-controlled trial, particularly in the midst of the pandemic. As soon as a new vaccine is granted emergency approval in the country or region where the trial is being deployed, ethics committees should scrutinise proposed plans for unblinding the trial with a view to ensuring that participants in a placebo arm if applicable are not disadvantaged.

Vaccine trials generally involve large numbers of participants. In LMICs, children from marginalised and economically poorer communities must be included in trials to ensure that results are as relevant as possible to diverse parts of the population. This generates specific duties of ancillary care that will have to be factored into the ethical evaluations of the trials.

For example, children from lower-income groups may be more likely to present with conditions such as malaria, acute diarrhoea, acute respiratory tract infections, and other conditions related to poverty, and researchers have at least a partial obligation to consider those conditions.

Furthermore, children from low-income communities may not have eaten on the day of research—and perhaps their siblings have not either. This is a considerable challenge especially when the COVID pandemic has increased poverty among the most vulnerable. It would be important to assist such children without necessarily turning participation in the trial into an incentive to obtain other forms of assistance. What is important is that researchers need to carefully consider ancillary care obligations, and ethics committees need to assess whether the ancillary care offered during the trial is reasonable.

In the case of ethics committees, there is the need to draw on existing normative guidelines and to adapt them to the rapid evolution of the pandemic and response measures. As vaccines appear to be successful in reducing deaths and severe illness among adults, a major concern now is how to protect children from getting infected and transmitting the virus, and from falling ill themselves.

An important tool is the vaccination of children. Yet, this choice needs to be backed by science and ethics. This brief paper is an effort by a group of ethicists working within the COVID Research Coalition to share concerns and ideas with ethicists who are currently or will soon be reviewing protocols for vaccine trials among children.

CAA worked on the conceptualisation and the initial draft. CAA is guarantor of content of this paper. Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

Provenance and peer review Not commissioned; externally peer reviewed. You will be able to get a quick price and instant permission to reuse the content in many different ways.

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Article menu. COVID vaccine trials with children: ethics pointers. Abstract As healthcare authorities around the world strive to get as many citizens as possible vaccinated against the SAR-CoV-2 virus, many countries have begun including children in the population groups to be vaccinated. Data availability statement All data relevant to the study are included in the article.

This scheme is open to Principal Investigators who are employed by eligible research institutions based in LMICs where the work will take place and to Principal Investigators who are employed by an eligible UK institution.

Applicants based in China or India are not eligible to be the Principal Investigator of an application to this call but are welcomed as international Co-Investigators within proposals. Further detail can be found on the UKRI eligibility web page.

For researchers based in LMICs, eligible institutions include higher education institutions and non-profit research institutions.

If the application is submitted by an LMIC organisation, the primary headquarters of that organisation must be in one of the LMIC countries where the trial will take place. This means that the institution sponsoring a Principal Investigator must be legally registered in the UK or in a LMIC and the Principal Investigator must be employed by the institution that is hosting the research. Research Institutions based outside the UK will be asked to complete additional eligibility and financial checks before an award is offered, and awards will be dependent on satisfactory completion of those checks and on-going monitoring.

MRC units and institutes can apply to this call; usual rules for funding grants to MRC units and institutes will apply. If you are based at an MRC unit or institute, please contact your local MRC research support office for further information. It is not permitted for the same person to be a Principal Investigator on more than two proposals submitted to this call.

The nature of this scheme means that we would expect applicants to be predominantly based in LMICs. Funding for co-applicants and collaborators in other regions can be requested, but we would expect that the majority of funds would support the costs in the LMIC where the trial will be conducted. Investigators employed by an institution in China, India or a high-income country outside the UK cannot be a Principal Investigator on a proposal but can be a Co-Investigator and are expected to make a significant contribution to their own research costs, including covering their own overheads.

Support is conditional on the host institution being able to demonstrate that they are able to conduct the trial to the standards set out in the MRC Guidelines for Management of Global Health Trials. Under this scheme it is expected that the host institute will be the sponsor of the trial. There is a need for methodological research in LMICs to ensure that relevant issues are identified and communicated to healthcare workers in these regions so that they might optimise future designs for trials.

The aim of the study was to identify the top priorities for methodological research according to researchers and methodologists working in LMIC trials. A two-round online survey was conducted from December to April , targeting researchers who had designed, conducted or analysed trials in LMICs.

An invitation letter, describing the scope of the study and providing a hyperlink to the survey, was circulated amongst members of the Global Health Network, the European and Developing countries Clinical Trials Partnership EDCTP and other networks identified via the authors. The registry ClinicalTrials. Researchers involved in these trials who had provided an email address were contacted. The survey was conducted in English and translations of the invitation letter in French, Spanish and Chinese were also disseminated in order to help the targeted participants understand the scope of the study.

These translations were either back-translated or checked by a second individual to ensure that no information was lost or changed during the translation process. In round 1, an initial eligibility question identified health professionals and methodologists who had clinical trial experience in LMIC settings.

Participants were asked about their professional background, current country of residence and invited to provide between three and six topics that they believed should be priorities for trials methodology research in LMICs.

Trials methodology research was defined as research investigating the methods, practices and procedures that are used for the design, conduct, analysis, interpretation and reporting of clinical trials. Topics were categorised and reviewed by the Steering Committee, and those deemed not applicable or beyond the scope of the survey were excluded. A primary list of topics identified by four or more respondents was created in order to decrease participant burden in the second round thereby increasing the likely response rate, and the remaining topics were included in a secondary list.

In order to aid comparison between the UK and LMIC priorities, topics in the primary list for the UK survey which were not suggested in the current survey were also added to the secondary list. The hyperlink to round 2 of the survey was circulated to those who provided an email address in round 1. These first-round participants were sent weekly reminders to complete the survey via email to maximise the response rate. Round-2 participants were again required to provide information about their professional backgrounds and then to assign the topics in each list a score, using the GRADE guidelines scale [ 6 ] in order to identify the more important research topics.

Scores of 1 to 3 indicated that the topic was not important, 4 to 6 important but not critical, and 7 to 9 critically important. So as to reduce participant burden, assigning of grades to topics in the primary list was compulsory for completion but optional for topics in the secondary list. As an incentive, those who completed both rounds of the survey were included in a prize draw to win travel to, and accommodation at, the joint International Clinical Trials Methodology Conference and Society of Clinical Trials Conference in Liverpool, UK.

Completion of the survey was deemed consent to participate. Table 1 shows the demographic and professional characteristics of the completers of round 1 of the survey. The number of years of experience working in clinical trials for those who completed round 1 ranged from 1 to 45 years, with a mean standard deviation of 7.

The participants who gave information about their professional backgrounds but did not complete the survey were similar to those who completed the survey Additional file 1 : Table S1. The characteristics of the subgroup that completed round 2 were similar to those of the whole group Table 1. The remaining topics were categorised and divided into two lists. The primary list was limited to the 27 topics suggested by four or more participants Fig.

The secondary list comprised the 55 remaining topics suggested and two identified as a priority from the previous UK study but not identified in the current study, giving a total of 57 topics Fig. The top priority for further methodological research for trials in LMICs is appropriate choice of outcomes to measure.

Some examples of topics falling within choosing appropriate outcomes to measure, given by respondents, were: developing the correct objectives for the study, standardising outcome sets and identifying patient-focussed endpoints. The second top priority is methods related to training of research staff; for example, finding cost-effective and purposeful methods to train research staff and the use of blended learning incorporating new technologies.

Choice of appropriate outcomes to measure, methods for the conduct of pragmatic trials and calculating sample size all appeared in the top 10 most important items in both the LMIC and UK priority lists [ 2 ]. Many of the topics deemed most important to LMIC researchers were related to trial conduct as opposed to trial design or analysis. This could stem from resource issues and may indeed highlight the requirement for capacity development, stressing the need for cost and time-effective methods.

The priority most commonly graded as critically important, choosing appropriate outcomes to measure, was also a priority identified in the UK study and there is ongoing work on this through the Core Outcome Measures in Effectiveness Trials COMET Initiative [ 7 ].