Challenges in operationalising clinical trials in India during the COVID-19 pandemic

Bassi, Abhinav; Arfin, Sumaiya; Joshi, Rohina; Bathla, Nikita; Hammond, Naomi; Rajbhandari, Dorrilyn; Vijayaraghavan, Bharath Kumar Tirupakuzhi; Venkatesh, Balasubramanian; Jha, Vivekanand

doi:10.1016/s2214-109x(21)00546-5

Cited by 15 publications

(18 citation statements)

References 4 publications

(3 reference statements)

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Research nurses had to work as clinical nurses in labor, delivery, and postpartum units. The pressure of researching clinical staff was significantly reduced, allowing them to respond to the patient's needs 39 . The research staffs were concerned about the risk of COVID‐19.…”

Section: Resultsmentioning

confidence: 99%

See 1 more Smart Citation

Challenges and solutions in clinical research during the COVID‐19 pandemic: A narrative review

Nomali

Mehrdad

Heidari

et al. 2023

Health Science Reports

View full text Add to dashboard Cite

Background and AimsThe COVID‐19 pandemic has presented significant challenges to clinical research, necessitating the adoption of innovative and remote methods to conduct studies. This study aimed to investigate these challenges and propose solutions for conducting clinical research during the pandemic.MethodsA narrative review was conducted (approval ID: IR.AMS.REC.1401.029), utilizing keyword searches in PubMed and Web of Science (WOS) citation index expanded (SCI‐EXPANDED) from January 2020 to January 2023. Keywords included COVID‐19, clinical research, barriers, obstacles, facilitators and enablers.ResultsOut of 2508 records retrieved, 43 studies were reviewed, providing valuable insights into the challenges and corresponding solutions for conducting clinical research during the COVID‐19 pandemic. The identified challenges were categorized into four main groups: issues related to researchers or investigators, issues related to participants and ethical concerns, administrative issues, and issues related to research implementation. To address these challenges, multiple strategies were proposed, including remote monitoring through phone or video visits, online data collection and interviews to minimize in‐person contact, development of virtual platforms for participant interaction and questionnaire completion, consideration of financial incentives, adherence to essential criteria such as inclusion and exclusion parameters, participant compensation, and risk assessment for vulnerable patients.ConclusionThe COVID‐19 pandemic has significantly impacted clinical research, requiring the adaptation and enhancement of existing research structures. Although remote methods and electronic equipment have limitations, they hold promise as effective solutions during this challenging period.

show abstract

Section: Resultsmentioning

confidence: 99%

“…To ensure transparency and efficiency, modifications to pre‐study documents, consent forms, study entry reports, conflict of interest, sponsorship, and side effects had to be reported to the ethics committee. This allowed for transparency and ensures that changes are made appropriately 15,39 …”

Section: Resultsmentioning

confidence: 99%

Challenges and solutions in clinical research during the COVID‐19 pandemic: A narrative review

Nomali

Mehrdad

Heidari

et al. 2023

Health Science Reports

View full text Add to dashboard Cite

show abstract

“…Bassi et al made a similar observation that research studies in India are challenging due to reasons such as limited workforce, and scarce facilities leading to operational difficulties. 15 During Covid-19, this would have been magnified due to the pressure on the workforce that was not just working for the trial but was also involved in care for Covid-19 patients. More time may be given to individual participants in future studies as a greater investment in time leads to a better understanding in research participants.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of satisfaction and reasons for participation in a Covid-19 vaccine clinical trial: A single-centre, observational study

KUDYAR¹,

SONI²,

Gogtay³

2023

NMJI

View full text Add to dashboard Cite

Background In May 2020, WHO recognized the role of extensive immunization for interrupting the transmission of the SARS-CoV-2 virus. The development of such vaccines in clinical trials relies upon participants who are expected to be vested in the research process. Assessment of participant factors such as motivation and satisfaction are hence important to gauge perspective and ensure successful conduct and completion of these trials. Methods We administered a validated three-domain questionnaire to and documented the binary categorical responses (yes/no) of participants (after informed consent) who had taken both doses of COVOVAX™ in a phase 3 trial at our institute. Association of the dependent variables (participant responses) with the independent variables (participant demographics and socioeconomic strata) was computed using Chi-square test at 5% significance. In case of a significant association, Bonferroni post-hoc test was applied for multiple comparisons. Results Of the 78 participants who were administered the questionnaire, two-thirds were highly satisfied with their experience at our site. Gaining access to a new vaccine was a primary motivation overall (74%) and also in graduates (p=0.03) and middle-class population (p=0.002), whereas the lower-middle class population (p<0.0001) and those educated till secondary school (p=0.003) took part due to the long wait for government-approved vaccines. Conclusion Participants in a Covid-19 vaccine trial at Mumbai were largely satisfied with the care given to them though altruism did not feature as a primary reason for participation.

show abstract

“…2 ESM , http://links.lww.com/CCM/H419). CQRs contribute to overcoming common barriers to research through the streamlining of regulatory processes, implementing a centralized institutional research agenda, developing a core dataset, and enhancing access to low-cost technology (61, 62). Academic mentoring facilitated by CQRs networks can foster transnational collaborations and PhD tracks leveraging site-, country-, or multinational platform data.…”

Section: Evidence Generated To Understand Case-mix and Outcomes Of Ic...mentioning

confidence: 99%

National ICU Registries as Enablers of Clinical Research and Quality Improvement

Salluh,

Quintairos,

Dongelmans

et al. 2023

Critical Care Medicine

View full text Add to dashboard Cite

Objectives: Clinical quality registries (CQRs) have been implemented worldwide by several medical specialties aiming to generate a better characterization of epidemiology, treatments, and outcomes of patients. National ICU registries were created almost 3 decades ago to improve the understanding of case-mix, resource use, and outcomes of critically ill patients. This narrative review describes the challenges, proposed solutions, and evidence generated by National ICU registries as facilitators for research and quality improvement. Data Sources: English language articles were identified in PubMed using phrases related to ICU registries, CQRs, outcomes, and case-mix. Study Selection: Original research, review articles, letters, and commentaries, were considered. Data Extraction: Data from relevant literature were identified, reviewed, and integrated into a concise narrative review. Data Synthesis: CQRs have been implemented worldwide by several medical specialties aiming to generate a better characterization of epidemiology, treatments, and outcomes of patients. National ICU registries were created almost 3 decades ago to improve the understanding of case-mix, resource use, and outcomes of critically ill patients. The initial experience in European countries and in Oceania ensured that through locally generated data, ICUs could assess their performances by using risk-adjusted measures and compare their results through fair and validated benchmarking metrics with other ICUs contributing to the CQR. The accomplishment of these initiatives, coupled with the increasing adoption of information technology, resulted in a broad geographic expansion of CQRs as well as their use in quality improvement studies, clinical trials as well as international comparisons, and benchmarking for ICUs. Conclusions: ICU registries have provided increased knowledge of case-mix and outcomes of ICU patients based on real-world data and contributed to improve care delivery through quality improvement initiatives and trials. Recent increases in adoption of new technologies (i.e., cloud-based structures, artificial intelligence, machine learning) will ensure a broader and better use of data for epidemiology, healthcare policies, quality improvement, and clinical trials.

show abstract

Challenges in operationalising clinical trials in India during the COVID-19 pandemic

Cited by 15 publications

References 4 publications

Challenges and solutions in clinical research during the COVID‐19 pandemic: A narrative review

Challenges and solutions in clinical research during the COVID‐19 pandemic: A narrative review

Evaluation of satisfaction and reasons for participation in a Covid-19 vaccine clinical trial: A single-centre, observational study

National ICU Registries as Enablers of Clinical Research and Quality Improvement

Contact Info

Product

Resources

About