Participant and Caregiver Perspectives on Clinical Research During Covid‐19 Pandemic

Padala, Prasad R.; Jendro, Ashlyn M; Gauss, C. Heath; Orr, L Casey; Dean, Kim T.; Wilson, Kerrie B; Parkes, C.; Padala, Kalpana P.

doi:10.1111/jgs.16500

Cited by 33 publications

(40 citation statements)

References 17 publications

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“…We drew on historical occupational health frameworks for infectious disease biosafety and risk assessment and the most recent peer reviewed and grey literature about infection dynamics, as well as staff experience, to build a framework to evaluate risk of exposure to SARS-CoV-2. [3,14,18,19] The intent was to develop criteria that were clear, simple and actionable for eld managers and staff to implement and recommend appropriate practices and materials, in accordance with the risk level of each procedure and perceived risk threshold.…”

Section: Methodsmentioning

confidence: 99%

“…Every day, we are gaining a greater understanding of the transmissibility of SARS-CoV-2, and this knowledge increases our ability to safely resume a wide variety of non-COVID-19 related research activities. [3,4] Where local law or institutional regulations allow activities to restart, investigators need to evaluate the risks and bene ts to both research staff and participants of resuming data collection. To safely conduct study activities, researchers need to develop standardized procedures that are based on realistic assessment of these risks, provide guidance on where and when they are manageable as well as how to minimize the risk with physical distance measures and appropriate personal protective equipment (PPE).…”

Section: Introductionmentioning

confidence: 99%

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A Risk Assessment Tool for Resumption of Research Activities During the COVID-19 Pandemic

Simkovich

Thompson

Clark

et al. 2020

Preprint

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Rationale: The spread of severe acute respiratory syndrome coronavirus-2 has suspended many non-COVID-19 related research activities. Where restarting research activities is permitted, investigators need to evaluate the risks and benefits of resuming data collection and adapt procedures to minimize risk. Objectives: In the context of the multicountry Household Air Pollution Intervention (HAPIN) trial, we developed a framework to assess the risk of each trial activity and to guide protective measures. Our goal is to maximize integrity of reseach aims while minimizing infection risk based on the latest understanding of the virus. Methods: We drew on a combination of expert consultations, risk assessment frameworks, institutional guidance and literature to develop our framework. We then systematically graded clinical, behavioral, laboratory and field environmental health research activities in four countries for both adult and child subjects using this framework. Results: Our framework assesses risk based on staff proximity to the participant, exposure time between staff and participants, and potential aerosolization while performing the activity. One of of four risk levels, from minimal to unacceptable, is assigned and guidance on protective measures is provided. Those activities which can potentially aerosolize the virus are deemed the highest risk. Conclusions: By applying a systematic, procedure-specific approach to risk assessment for each trial activity, we can compare trial activities using the same criteria. This approach allows us to protect our participants and research team and to uphold our ability to deliver on the research commitments we have made to our participants, local communities, and funders. The trial is registered with clinicaltrials.gov (NCT02944682).

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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

A Risk Assessment Tool for Resumption of Research Activities During the COVID-19 Pandemic

Simkovich

Thompson

Clark

et al. 2020

Preprint

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“…La pandémie en cours liée au SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2 ou coronavirus 2 du syndrome respiratoire aigu sévère) est présentée comme susceptible d'induire, au-delà de son impact physiologique potentiellement dramatique, des conséquences psychologiques lourdes, relevant notamment de l'état de « panique » et du trouble caractérisé relié à cet état [1][2][3][4][5]. Paradoxalement, les données évoquant concrètement ce lien entre la COVID-19 (coronavirus disease 2019 ou maladie à coronavirus 2019) et l'évolution du taux de trouble panique n'apparaît pas disponible à ce jour dans la littérature.…”

Section: Introductionunclassified

Panique et pandémie : revue de la littérature sur les liens entre le trouble panique et l’épidémie à SARS-CoV-2

Javelot

Weiner²

2020

L'Encéphale

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r é s u m é L'état de panique associé à la pandémie liée au SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) incite à s'interroger sur les troubles anxieux que cette situation pourrait générer ou aggraver. Si la littérature a déjà fourni des projections généralistes en la matière, les données concrètes concernent à ce stage davantage le trouble de stress post-traumatique et le trouble obsessionnel compulsif, tandis que quelques évaluations s'intéressent au cadre nosographie du trouble anxieux généralisé. Le trouble panique ne se voit que peu ou pas cité et l'évocation de la « panique », au sens social, la supplante largement. Bien que d'une légitimité clinique encore débattue, le trouble panique qualifié de « respiratoire » pourrait se voir augmenter en nombre et/ou être intensifié chez les patients qui en présentent déjà. D'éventuelles situations co-morbides entre un tel trouble et la COVID-19 (coronavirus disease 2019) doivent inciter à certaines précautions en matière de prescriptions médicamenteuses, notamment en lien avec les traitements ou situations, sources d'hypokaliémie : (i) le salbutamol, source potentielle de surconsommation, notamment chez les patients anxieux ; (ii) l'infection par le SARS-CoV-2 et plus encore en cas de diarrhées et/ou vomissements. L'hypokaliémie est associée à un risque accru de torsade de pointe, il convient donc également d'être prudent en matière de prescription de psychotropes à risque : comme avec le citalopram et l'escitalopram, des antidépresseurs indiqués dans le trouble panique ou encore l'hydroxyzine, à visée anxiolytique. Ces données sont de nature à resituer l'importance de la prise en considération du trouble panique dans le cadre de la pandémie en cours.

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“…Clinical trials may need to focus more on the essential and less on the aspirational for the near future. Third, the research community needs to consider the impact of COVID‐19 on patients’ willingness to participate in clinical trials ( 11 ) with efforts made to assure participants that their safety has been and remains a primary focus. Indeed, COVID‐19 may provide an opportunity to highlight the role of clinical research in health care advances.…”

Section: Investigational Product Clinical and Device Trialsmentioning

confidence: 99%

Clinical Research in Hepatology in the COVID‐19 Pandemic and Post‐Pandemic Era: Challenges and the Need for Innovation

Verna

Serper

Chu³

et al. 2020

Hepatology

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The severe acute respiratory syndrome coronavirus 2 pandemic has drastically altered all facets of clinical care and research. Clinical research in hepatology has had a rich tradition in several domains, including the discovery and therapeutic development for diseases such as hepatitis B and C and studying the natural history of many forms of chronic liver disease. National Institutes of Health, foundation, and industry funding have provided important opportunities to advance the academic careers of young investigators while they strived to make contributions to the field. Instantaneously, however, all nonessential research activities were halted when the pandemic started, forcing those involved in clinical research to rethink their research strategy, including a shift to coronavirus disease 2019 research while endeavoring to maintain their preexisting agenda. Strategies to maintain the integrity of ongoing studies, including patient follow‐up, safety assessments, and continuation of investigational products, have included a shift to telemedicine, remote safety laboratory monitoring, and shipping of investigational products to study subjects. As a revamp of research is being planned, unique issues that face the research community include maintenance of infrastructure, funding, completion of studies in the predetermined time frame, and the need to reprogram career path timelines. Real‐world databases, biomarker and long‐term follow up studies, and research involving special groups (children, the homeless, and other marginalized populations) are likely to face unique challenges. The implementation of telemedicine has been dramatically accelerated and will serve as a backbone for the future of clinical research. As we move forward, innovation in clinical trial design will be essential for conducting optimized clinical research.

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Participant and Caregiver Perspectives on Clinical Research During Covid‐19 Pandemic

Cited by 33 publications

References 17 publications

A Risk Assessment Tool for Resumption of Research Activities During the COVID-19 Pandemic

A Risk Assessment Tool for Resumption of Research Activities During the COVID-19 Pandemic

Panique et pandémie : revue de la littérature sur les liens entre le trouble panique et l’épidémie à SARS-CoV-2

Clinical Research in Hepatology in the COVID‐19 Pandemic and Post‐Pandemic Era: Challenges and the Need for Innovation

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