Adaptive and Pragmatic Approach to Clinical Research: The Silver Lining of a Global Pandemic

PURPOSE: The COVID-19 pandemic has led to profound changes in clinical research, including remote consent, telehealth, off-site procedures, shipment of therapy, and remote study monitoring. We assessed longitudinal perceptions of these adjustments among clinical research professionals. METHODS: We distributed an anonymous survey assessing experiences, perceptions, and recommendations regarding COVID-19–related clinical research adjustments to cancer clinical research office personnel in May 2020 and again in November 2020. Responses were compared using Fisher's exact and Mann-Whitney U tests. RESULTS: A total of 90 of 102 invited research personnel (88%) responded. Fifty-three (59%) reported participating in both initial and follow-up surveys. The proportion of respondents reporting personal experience with COVID-19–related adjustments increased over time, particularly for remote initial consent (29% v 4%), remote reconsent (24% v 9%), and remote study monitoring (36% v 22%). Perceived impact of COVID-19–related adjustments on data quality ( P = .02) and patient experience ( P = .002) improved significantly. However, perceived effect on patient safety ( P = .02) and respondent's experience ( P = .09) became less favorable. Individuals with personal experience with the adjustment were more likely to recommend continuing remote consent (62% v 38%; P = .04), remote monitoring (69% v 45%; P = .05), and therapy shipment (67% v 35%; P = .01) after the COVID-19 pandemic, with nonsignificant trends for off-site diagnostics (44% v 24%; P = .13) and telehealth visits (66% v 45%; P = .08). CONCLUSION: More than 6 months into the global pandemic, perceptions of COVID-19–related clinical research changes remain favorable. Experienced individuals are more likely to recommend that these changes continue in the future.

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SP2-3 The impact of the COVID-19 global pandemic on oncology drug development, clinical research and R&D in Japan

Annals of Oncology ◽

10.1016/j.annonc.2021.05.361 ◽

2021 ◽

Vol 32 ◽

pp. S229

Author(s):

Toshio Shimizu

Keyword(s):

Drug Development ◽

Clinical Research ◽

Oncology Drug ◽

Global Pandemic ◽

The Impact ◽

Oncology Drug Development

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A Standardized, Pragmatic Approach to Knee Ultrasound for Clinical Research in Osteoarthritis: The Johnston County Osteoarthritis Project

ACR Open Rheumatology ◽

10.1002/acr2.11159 ◽

2020 ◽

Vol 2 (7) ◽

pp. 438-448

Author(s):

Nadiya V. Yerich ◽

Carolina Alvarez ◽

Todd A. Schwartz ◽

Serena Savage‐Guin ◽

Jordan B. Renner ◽

...

Keyword(s):

Clinical Research ◽

Pragmatic Approach

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Bringing New Meaning to the Term “Adaptive Trial”: Challenges of Conducting Clinical Research During the Coronavirus Disease 2019 Pandemic and Implications for Implementation Science

Open Forum Infectious Diseases ◽

10.1093/ofid/ofaa490 ◽

2020 ◽

Vol 7 (11) ◽

Author(s):

Westyn Branch-Elliman ◽

A Rani Elwy ◽

Paul Monach

Keyword(s):

Clinical Research ◽

Implementation Science ◽

Clinical Care ◽

Time Frame ◽

Dissemination And Implementation ◽

Practice Trial ◽

Evidence Based Practices ◽

Global Pandemic ◽

Science Community ◽

Rapid Dissemination

Abstract Although implementation of evidence-based practices takes an average of 17 years, in the context of the global pandemic, coronavirus disease 2019 (COVID-19) interventions were adopted in a greatly compressed time frame. This rapid uptake creates major challenges for conducting COVID-19 clinical research studies, because quickly evolving standards make it difficult to adapt in real time. The rapid dissemination and implementation of COVID-19 interventions is the realization of goals long pursued by the implementation science community. However, the downside of the rapid implementation is that low-quality evidence with little to no scientific vetting may be quickly integrated into clinical care, resulting in lost opportunities to advance our scientific understanding about how to manage infected patients. In the future, novel adaptive designs embedded into electronic health records (Embedded Quantified, Integrated-into-Practice Trial [EQuIPT] designs) that allow for easier and better access to clinical trials may simultaneously improve care and advance healthcare innovations.

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A pragmatic approach and treatment of coronavirus disease 2019 (COVID-19) in intensive care unit

Revista da Associação Médica Brasileira ◽

10.1590/1806-9282.66.8.1157 ◽

2020 ◽

Vol 66 (8) ◽

pp. 1157-1163

Author(s):

Sergio Henrique Loss ◽

Diego Leite Nunes ◽

Oellen Stuani Franzosi ◽

Cassiano Teixeira

Keyword(s):

Computed Tomography ◽

Intensive Care Unit ◽

Intensive Care ◽

Ventilatory Support ◽

Pragmatic Approach ◽

Chest Computed Tomography ◽

X Ray ◽

Global Pandemic ◽

Chest X Ray ◽

Different Populations

SUMMARY There is a new global pandemic that emerged in China in 2019 that is threatening different populations with severe acute respiratory failure. The disease has enormous potential for transmissibility and requires drastic governmental measures, guided by social distancing and the use of protective devices (gloves, masks, and facial shields). Once the need for admission to the ICU is characterized, a set of essentially supportive therapies are adopted in order to offer multi-organic support and allow time for healing. Typically, patients who require ventilatory support have bilateral infiltrates in the chest X-ray and chest computed tomography showing ground-glass pulmonary opacities and subsegmental consolidations. Invasive ventilatory support should not be postponed in a scenario of intense ventilatory distress. The treatment is, in essence, supportive.

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

Research Ethics ◽

10.1177/1747016120931998 ◽

2020 ◽

Vol 16 (3-4) ◽

pp. 1-10 ◽

Cited By ~ 1

Author(s):

Francois Bompart

Keyword(s):

Clinical Trials ◽

Clinical Research ◽

Ethics Committees ◽

Active Involvement ◽

Emergency Situations ◽

Global Pandemic ◽

Life Saving ◽

Ethical Rationale ◽

Global Coordination ◽

Set Up

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.

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What are the effects of COVID-19 on the environment?

HAPSc Policy Briefs Series ◽

10.12681/hapscpbs.24975 ◽

2020 ◽

Vol 1 (1) ◽

pp. 251

Author(s):

Michail Melidis

Keyword(s):

Indirect Effects ◽

Fossil Fuel ◽

Ghg Emissions ◽

Medical Waste ◽

The Other ◽

International Level ◽

Positive Effects ◽

Global Pandemic ◽

Silver Lining ◽

Existing Data

Contrary to the socio-economic aspects of the coronavirus crisis, the environment has comparably attracted lesser attention. To the question, if there is a silver lining to the global pandemic, existing data and studies show that the environment is an unanticipated beneficiary that gives a glimmer of hope for the post-COVID-19 period. Acknowledging the difficulties in conducting in-depth evaluations over the environmental impacts as the pandemic still unfolds, some preliminary inferences can be drawn. The aim of this paper is to outline and analyse the indirect effects of COVID-19 on the environment for a better understanding and knowledge during the lockdown at the international level. Indicatively, some of the positive effects are met in the decrease of GHG emissions, the fall of fossil fuel consumption, the improved air and water quality, and the re-emergence of wildlife. On the other hand, key challenges lie in the significant increase in medical waste, waste management, and environmental pollution.

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