scholarly journals Ethical rationale for better coordination of clinical research on COVID-19

2020 ◽  
Vol 16 (3-4) ◽  
pp. 1-10 ◽  
Author(s):  
Francois Bompart

Hundreds of clinical trials of potential treatments and vaccines for the “coronavirus 19 disease” (COVID-19) have been set up in record time. This is a remarkable reaction to the global pandemic, but the absence of a global coordination of clinical research efforts raises serious ethical concerns. Some COVID-19 patients might carry the burden of clinical trial involvement even though their trial cannot be completed as researchers are competing for patients. A shortage of medicines can occur when existing drugs are diverted for clinical trials. Research ethics committees are overburdened with multiple applications. A multitude of trials can also overstretch medical staff and risk neglecting non-COVID-19 patients. And finally, conflicting conclusions from a multitude of heterogeneous trials might lead to delays in public health decisions about life-saving issues. These challenges are made worse by the unpredictable evolution of epidemics, the active involvement of political decision-makers in scientific issues and the pressure of social media globally. While freedom to conduct research must be safeguarded, global health emergency situations would greatly benefit from effective international coordination mechanisms for clinical research.

2016 ◽  
Vol 1 ◽  
Author(s):  
R. Roy Chaudhury ◽  
D. Mehta

There has been a drop in clinical research in India following stringent conditions put in place by the Indian Supreme Court in 2013. The Court's orders came in the wake of irregularities highlighted in the conduct of clinical trials in the country. This paper highlights the steps taken by the Indian regulator, the Central Drugs Standard Control Organisation to comply with these directions. These are of three kinds: strengthening regulatory institutions, protecting participant safety and creating regulatory certainty for sponsors and investigators. Examples include the large-scale training of Ethics Committees, framing detailed guidelines on compensation and audiovisual recording of the informed consent process, as well as reducing the time taken to process applications. It is expected that these measures will inspire confidence for the much-needed resumption of clinical research.


2016 ◽  
Vol 101 (10) ◽  
pp. 980-983 ◽  
Author(s):  
Vic Larcher ◽  
Joe Brierley

Adolescents need safe effective drugs that have undergone ethically approved testing in clinical trials; such studies often require pregnancy testing in ‘women of childbearing age’ which includes children/adolescents. There is a lack of consistent standard operating procedures for pregnancy testing in these individuals, in either research or clinical (ie, both preprocedure and clinical emergency) settings. Some harmonisation between a selective or universal testing approach based on a risk analysis of the trial drug or procedure would seem sensible. The need for pregnancy testing and the reasons for the method chosen (universal or selective) should be clearly defined in the research protocol. Research ethics committees (RECs) need to satisfy themselves that the selection of subjects to be tested, the procedures for obtaining consent and the respecting of the young person's confidentiality are appropriate and that management of any positive tests are in accord with local safeguarding policies and procedures. Researchers should have core competencies necessary to manage sensitive questioning and child safeguarding training. Clinical trials of medicinal product (CTIMP) pregnancy testing in females 13–15 years of age requires parental consent and the child's active involvement in the decision-making process (‘assent’) the implications of a positive test should be discussed in advance. Children under 13 years should not normally be subject to pregnancy testing in CTIMPs, unless there are exceptional circumstances, for example, a trial of contraceptive agents of a high teratogenicity risk, as reviewed by a specialist paediatric REC. We analyse the ethical, legal and practical aspects of this issues and supply guidance to support those involved.


Author(s):  
Rachel M. Gilbert ◽  
Michael J. Donzanti ◽  
Daniel J. Minahan ◽  
Jasmine Shirazi ◽  
Christine L. Hatem ◽  
...  

ABSTRACTAs the current COVID-19 pandemic illustrates, not all hospitals and other facilities are equipped with enough personal protective equipment to meet the demand in a crisis. Healthcare workers around the world utilize N95 masks to protect themselves and their patients, yet during this global pandemic they are forced to re-wear what is intended to be single-use masks. This poses significant risk to these healthcare workers along with the populations they are trying to protect. Ultraviolet germicidal irradiation (UVGI) has been validated previously as a way to effectively sterilize these masks between use, however, not all facilities have access to the high cost commercial UV-C lamp sterilization equipment. However, UV-C bulbs are sitting idle in biosafety cabinets (BSCs) at universities and research facilities around the globe that have been shuttered to slow the spread of COVID-19. These bulbs may also be available in existing medical centers where infectious diseases are commonly treated. Therefore, we have developed a method to modify existing light fixtures, or create custom light fixtures compatible with new or existing common UV-C bulbs. This system is scalable and can be created for less than 50 US dollars, on site, at the point of need, and leverages resources that are currently untapped and sitting unused in public and private research facilities. The freely-accessible design can be easily modified for use around the world. Hospitals can obtain this potentially life-saving UVGI resource with minimal funds, via collaboration between research facilities to obtain the UV-C meters and limited availability UVGI bulbs. While mask reuse is not ideal, we must do what we can in emergency situations to protect our frontline healthcare workers and the communities they serve.


2019 ◽  
Vol 47 (5) ◽  
pp. 1868-1876
Author(s):  
Chikako Kane ◽  
Kenshi Takechi ◽  
Masayuki Chuma ◽  
Hiroshi Nokihara ◽  
Tomoko Takagai ◽  
...  

Objective In Japan, under the new Clinical Trials Act pertaining to investigator-initiated clinical trials that came into effect on 1 April 2018, review boards should review proposed clinical trials while considering written opinions from specialists. Additionally, involvement of non-specialists is mandatory, and attention is being placed on their effective contributions. This study was performed to determine representative key issues with which to promote these contributions. Methods This qualitative study was conducted in 2018 using a focus group interview of six non-specialists regarding perspectives on clinical research itself and research ethics committees. Results For perspectives on clinical research itself, 33 codes were established and sorted into 2 categories and 6 subcategories relating to ambivalence toward clinical research. For perspectives on research ethics committees, 54 codes were established and sorted into 3 categories and 10 subcategories relating to the theme “knowledge and an environment that promotes non-specialist members’ participation.” One notable result was the willingness of participants to obtain details about a study should they be selected. Conclusions The results suggest that detailed explanation of a particular study would encourage non-specialist members to participate in a clinical research review committee. Education aimed at non-specialist participation should therefore be considered in future studies.


2019 ◽  
Author(s):  
Allison Hirsch ◽  
Mahip Grewal ◽  
Anthony James Martorell ◽  
Brian Michael Iacoviello

BACKGROUND Digital Therapeutics (DTx) provide evidence based therapeutic health interventions that have been clinically validated to deliver therapeutic outcomes, such that the software is the treatment. Digital methodologies are increasingly adopted to conduct clinical trials due to advantages they provide including increases in efficiency and decreases in trial costs. Digital therapeutics are digital by design and can leverage the potential of digital and remote clinical trial methods. OBJECTIVE The principal purpose of this scoping review is to review the literature to determine whether digital technologies are being used in DTx clinical research, which type are being used and whether publications are noting any advantages to their use. As DTx development is an emerging field there are likely gaps in the knowledge base regarding DTx and clinical trials, and the purpose of this review is to illuminate those gaps. A secondary purpose is to consider questions which emerged during the review process including whether fully remote digital clinical research is appropriate for all health conditions and whether digital clinical trial methods are inline with the principles of Good Clinical Practice. METHODS 1,326 records were identified by searching research databases and 1,227 reviewed at the full-article level in order to determine if they were appropriate for inclusion. Confirmation of clinical trial status, use of digital clinical research methods and digital therapeutic status as well as inclusion and exclusion criteria were applied in order to determine relevant articles. Digital methods employed in DTx research were extracted from each article and these data were synthesized in order to determine which digital methods are currently used in clinical trial research. RESULTS After applying our criteria for scoping review inclusion, 11 articles were identified. All articles used at least one form of digital clinical research methodology enabling an element of remote research. The most commonly used digital methods are those related to recruitment, enrollment and the assessment of outcomes. A small number of articles reported using other methods such as online compensation (n = 3), or digital reminders for participants (n = 5). The majority of digital therapeutics clinical research using digital methods is conducted in the United States and increasing number of articles using digital methods are published each year. CONCLUSIONS Digital methods are used in clinical trial research evaluating DTx, though not frequently as evidenced by the low proportion of articles included in this review. Fully remote clinical trial research is not yet the standard, more frequently authors are using partially remote methods. Additionally, there is tremendous variability in the level of detail describing digital methods within the literature. As digital technologies continue to advance and the clinical research DTx literature matures, digital methods which facilitate remote research may be used more frequently.


2020 ◽  
Author(s):  
Lida Feyz ◽  
Yale Wang ◽  
Atul Pathak ◽  
Manish Saxena ◽  
Felix Mahfoud ◽  
...  

BACKGROUND Great and costly efforts are required to recruit potential participants into clinical trials. Using social media may make the recruitment process more efficient. Merely 20% of clinical trials are completed on time, a finding mostly linked to challenges in patient recruitment [1]. Recruitment through social media is increasingly being recognized as a tool to efficiently identify eligible subjects at lower costs [2, 3]. One of the key reasons for its success is the strong adherence of users to specific social media platforms. Facebook for instance has over 2.38 billion active monthly users of which about 75% access the network on a daily basis [4]. As such, the platform and other like it offer great potential to quickly and affordably enroll patients into clinical trials and surveys [3, 5-7]. At present, little evidence is available on the efficacy of using social media to recruit patients into cardiovascular and hypertension trials [8]. The aim of the present study was to evaluate the efficacy of social media as an approach to recruit hypertensive patients into the RADIANCE-HTN SOLO trial. OBJECTIVE The aim of the present study was to evaluate the efficacy of social media as an approach to recruit hypertensive patients into the RADIANCE-HTN SOLO trial. METHODS The RADIANCE-HTN SOLO (NCT02649426) is a multicenter, randomised study that was designed to demonstrate the efficacy and safety of endovascular ultrasound renal denervation (RDN) to reduce ambulatory blood pressure at 2 months in patients with combined systolic–diastolic hypertension in the absence of medications. Between March 28, 2016, and Dec 28, 2017, 803 patients were screened for eligibility and 146 were randomised to undergo RDN (n=74) or a sham procedure (n=72) [9]. Key entry criteria included: age 18-75 years with essential hypertension using 0-2 antihypertensive drugs. Patients were recruited from 21 hospitals in the USA and 18 hospitals in Europe. The study was approved by local ethics committees or institutional review boards and was performed in accordance with the declaration of Helsinki. All participants provided written informed consent. All recruitment materials including social media campaigns was approved by local ethics committees of the involved sites. Recruitment strategies included social media (Facebook), conventional advertisements (ads) (magazine, brochure/poster, radio, newspaper), web search (the clinical website, craigslist and web-browsing), and physician referral. Both newspaper ads and posters contained brief information about study entry criteria. Newspapers were distributed at public transport places and posters were displayed in outpatient cardiology and hypertension clinics. Radio ads were run for 30 or 60 seconds providing a short summary of the study, entry criteria and contact information. Ads were run in major metropolitan areas on radio stations with large adult listener bases during popular days and times. Facebook ads were targeted towards subjects >45 years old within a certain distance from a recruitment site (range 20-50 miles). Criteria were modified over time in order to increase response rates [i.e. distance was increased or decreased, age was increased to >55 year]. Facebook ads referred to a dedicated study website translated into country specific languages. If interested, subjects could complete an anonymous online screening questionnaire which provided direct automatic feedback on study eligibility. Eligible subjects were asked to provide contact details (name and telephone number) to receive additional information, a process coordinated via a secure online portal (Galen Gateway Patient Recruitment Portal, Galen Patient Recruitment, Inc., Cumberland, RI). Study site were only able to contact potential candidates within their area. The study sponsor was not able to access any personal data. Trained local site personnel or contracted secondary screeners contacted candidates by phone to verify eligibility and answer potential questions. A subsequent outpatient clinic visit was scheduled during which the study was explained in greater detail and the informed consent form could be signed. Statistical analysis Categorical variables were expressed as percentages and counts. Continuous variables were described as mean  standard deviation (SD) when normally distributed, data was compared using an Independent-Samples or Paired-Samples T test to analyze the difference between recruitment methods. In case of non-normal distribution, median data was presented with the interquartile range [IQR]. All statistical tests are 2-tailed. A P-value <0.05 was considered statistically significant. Statistical analysis was performed using SPSS statistical analysis (version 24.0).   RESULTS Results Facebook ads were active during a 115-day recruitment period between August and November 2017. A total of 285 potential candidates were recruited by different recruitment strategies in this specific time period, of which 184 (65%) were consented through Facebook (Table 1). The average age of the subjects consented through Facebook was 59 ± 8 years and 51% were male (Table 2). Facebook reached 5.3 million people in 168 separate campaigns run in proximity to 19 sites in the US and 14 sites in Europe. The number of candidates per site was variable with a median of 23 [17 – 26] candidates per site that passed the questionnaire (Figure 1). A total of 27/184 subjects were eventually randomised. Total cost for the Facebook ads was $152,412; costing $907/campaign and $0.83/click. This resulted in a total cost of $828/consent. During the same recruitment period, 7-day radio spots were launched with a total cost of $2,870; resulting in 9 inquiries with eventually 5 potential candidates and 2 consents ($1,435/consent).   CONCLUSIONS Conclusion Targeted social media was a successful and efficient strategy to find potential candidates for a multicenter blood pressure clinical trial. Whether this approach can be replicated across other disease states or demographics remains to be studied.


Author(s):  
Michael Tansey

Clinical research is heavily regulated and involves coordination of numerous pharmaceutical-related disciplines. Each individual trial involves contractual, regulatory, and ethics approval at each site and in each country. Clinical trials have become so complex and government requirements so stringent that researchers often approach trials too cautiously, convinced that the process is bound to be insurmountably complicated and riddled with roadblocks. A step back is needed, an objective examination of the drug development process as a whole, and recommendations made for streamlining the process at all stages. With Intelligent Drug Development, Michael Tansey systematically addresses the key elements that affect the quality, timeliness, and cost-effectiveness of the drug-development process, and identifies steps that can be adjusted and made more efficient. Tansey uses his own experiences conducting clinical trials to create a guide that provides flexible, adaptable ways of implementing the necessary processes of development. Moreover, the processes described in the book are not dependent either on a particular company structure or on any specific technology; thus, Tansey's approach can be implemented at any company, regardless of size. The book includes specific examples that illustrate some of the ways in which the principles can be applied, as well as suggestions for providing a better context in which the changes can be implemented. The protocols for drug development and clinical research have grown increasingly complex in recent years, making Intelligent Drug Development a needed examination of the pharmaceutical process.


Author(s):  
Elizabeth Biswell R ◽  
Michael Clark ◽  
Michela Tinelli ◽  
Gillian Manthorpe ◽  
Joanne Neale ◽  
...  

2021 ◽  
Author(s):  
Diego A Vicente ◽  
Obinna Ugochukwu ◽  
Michael G Johnston ◽  
Chad Craft ◽  
Virginia Damin ◽  
...  

ABSTRACT Introduction Navy Medicine's Role 2 Light Maneuver (R2LM) Emergency Resuscitative Surgical Systems (ERSS) are austere surgical teams manned, trained, and equipped to provide life-saving damage control resuscitation and surgery in any environment on land or sea. Given the restrictions related to the COVID-19 pandemic, the previously established pre-deployment training pipeline for was modified to prepare a new R2LM team augmenting a Role 1 shipboard medical department. Methods The modified curriculum created in response to COVID-19 related restriction is compared and contrasted to the established pre-deployment R2LM ERSS curriculum. Subject Matter Experts and currently deployed R2LM members critically evaluate the two curricula. Results Both curricula included the team R2LM platform training and exposure to cadaver based team trauma skills training. The modified curriculum included didactics on shipboard resuscitation, anesthesia and surgery, shipboard COVID-19 management, and prolonged field care in austere maritime environments. Conclusions We describe Navy Medicines R2LM ERSS capability and compare and contrast the standard R2LM pre-COVID-19 curriculum to the modified curriculum. Central to both curricula, the standard R2LM platform training is important for developing and honing team dynamics, communication skills and fluid leadership; important for the successful function austere surgical teams. Several opportunities for improvement in the pre-deployment training were identified for R2LM teams augmenting shipboard Role 1 medical departments.


Sign in / Sign up

Export Citation Format

Share Document