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Clinical Investigators

Clinical Investigators are medical professionals who conduct research studies to evaluate new treatments, therapies, or interventions.
They play a crucial role in advancing medical knowledge and improving patient care.
These investigators design and implement clinical trials, collect and analyze data, and report their findings to the scientific community.
They must adhere to rigorous ethical and regulatory standards to ensure the safety and wellbeing of study participants.
Clinical Investigators utilize their expertise in fields such as medicine, nursing, pharmacology, and biostatistics to drive medical progress and enhance patient outcomes.
Their work is essential for the development of new drugs, devices, and healthcare strategies that can transform the lives of patients worldwide.

Most cited protocols related to «Clinical Investigators»

1
ClinGen Hearing Loss Knowledge Base
As a ClinGen Clinical Domain Working Group (CDWG), the Hearing Loss CDWG aims to create a comprehensive, standardized knowledge base of genes and variants relevant to syndromic and nonsyndromic HL. Members were identified and recruited based on their expertise in hearing loss, and are representative of diverse institutions worldwide, spanning Asia, Australia, Europe, and North America. Members include otolaryngologists, clinical geneticists, molecular geneticists, ClinGen biocurators, clinical researchers, and genetic counselors from over 15 institutions. The Hearing Loss CDWG has so far formed two major efforts defined by ClinGen as a Gene Curation Expert Panel, and a Variant Curation Expert Panel (HL-EP).
Oza A.M., DiStefano M.T., Hemphill S.E., Cushman B.J., Grant A.R., Siegert R.K., Shen J., Chapin A., Boczek N.J., Schimmenti L.A., Murry J.B., Hasadsri L., Nara K., Kenna M., Booth K.T., Azaiez H., Griffith A., Avraham K.B., Kremer H., Rehm H.L., Amr S.S, & Tayoun A.N. (2018). Expert Specification of the ACMG/AMP Variant Interpretation Guidelines for Genetic Hearing Loss. Human mutation, 39(11), 1593-1613.
Publication 2018
Clinical Investigators Counselors Genes Genes, vif Hearing Impairment Otolaryngologist Reproduction Syndrome
2
Developing SLE Classification Criteria
The purpose of Phase 1 was to test ANA as a potential entry criterion and identify candidate criteria that should be considered for SLE classification using both data- and expert-based methods, including the patient perspective. Phase 1a comprised a systematic literature review of Medline, Embase and the Cochrane databases with meta-regression to evaluate the operating characteristics of ANA testing for consideration as an entry criterion (12 (link)). Phase 1b consisted of a Delphi exercise of international SLE experts from the Americas, Europe and Asia (17 (link)). These experts included rheumatologists, dermatologists, nephrologists, pediatricians and non-clinical SLE researchers, providing a broad perspective. The Delphi participants were asked to nominate a broad set of items potentially useful in the classification of SLE (17 (link)). In round 2 and 3, participants rated the items from 1 (not at all appropriate) to 9 (completely appropriate) for classification of SLE. Criteria were retained if they reached a median rating of ≥6.5; i.e. at least 50% of the ratings in the high range (7, 8 or 9). Participants were also asked about the importance of ANA and histopathology for classification of SLE. Phase 1c established an international cohort of patients with early SLE or conditions mimicking SLE to identify criteria that may discriminate subjects with early (less than 12 months) disease (18 (link)). Phase 1d comprised a cross-sectional survey of SLE patients, administered via the quarterly journal of the German SLE patient organization, which asked about symptoms within one year before and after the patient’s diagnosis of SLE (19 (link)). While at a risk of recall bias and not necessarily representative of other regions worldwide, this survey was done to explicitly take a patient standpoint into account.
For phase 2 and 3, additional renowned European and North American SLE experts were nominated by the steering committee and invited to participate.
Aringer M., Costenbader K.H., Daikh D.I., Brinks R., Mosca M., Ramsey-Goldman R., Smolen J.S., Wofsy D., Boumpas D., Kamen D.L., Jayne D., Cervera R., Costedoat-Chalumeau N., Diamond B., Gladman D.D., Hahn B.H., Hiepe F., Jacobsen S., Khanna D., Lerstrøm K., Massarotti E., McCune W.J., Ruiz-Irastorza G., Sanchez-Guerrero J., Schneider M., Urowitz M.B., Bertsias G., Hoyer B.F., Leuchten N., Tani C., Tedeschi S.K., Touma Z., Schmajuk G., Anic B., Assan F., Chan D.T., Clarke A.E., Crow M.K., Czirják L., Doria A., Graninger W.B., Halda-Kiss B., Hasni S., Izmirly P., Jung M., Kumánovics G., Mariette X., Padjen I., Pego-Reigosa J.M., Romero-Díaz J., Fernández I.R., Seror R., Stummvoll G., Tanaka Y., Tektonidou M.G., Vasconcelos C., Vital E.M., Wallace D.J., Yavuz S., Meroni P.L., Fritzler M.J., Naden R.P., Dörner T, & Johnson S.R. (2019). 2019 EULAR/ACR Classification Criteria for Systemic Lupus Erythematosus. Arthritis & rheumatology (Hoboken, N.J.), 71(9), 1400-1412.
Publication 2019
Clinical Investigators Dermatologist Diagnosis Europeans Mental Recall Nephrologists North American People Patients Pediatricians Rheumatologist
3
Stillbirth Epidemiology: A Multisite Case-Control Study
The study was designed as a multi-site, population-based, case-control study, with prospective enrollment of stillbirths and live births at the time of delivery. Table 1 characterizes the catchment areas. To achieve the target number of stillbirths within a defined calendar period, clinical site investigators were required to establish catchment areas containing at least 6,000 births per year for urban areas. The one rural area (Brazoria and Galveston Counties in Texas) was required to contain at least 3,000 births per year. The boundaries selected were state and county lines and the areas included portions of 5 states - Rhode Island, Massachusetts, Georgia, Texas and Utah. The investigators selected 59 hospitals (detailed in the appendix) for enrollment to ensure access to at least 90% of all pregnancies ending in live birth or stillbirth to residents of their catchment areas.
The accrual period was to be of sufficient duration to enroll 500 stillbirths with adequate pathology assessment. Pre-study estimates of stillbirth rates across sites, derived from clinical databases, ranged from 5.3 to 11.8 per 1000 births, suggesting that the study would be able to identify approximately 1000 stillbirths in two years, providing an estimated 700 enrollments and 500 post-mortem examinations.
Parker C.B., Hogue C.J., Koch M.A., Willinger M., Reddy U., Thorsten V.R., Dudley D.J., Silver R.M., Coustan D., Saade G.R., Conway D., Varner M.W., Stoll B., Pinar H., Bukowski R., Carpenter M, & Goldenberg R. (2011). Stillbirth Collaborative Research Network: Design, Methods and Recruitment Experience. Paediatric and perinatal epidemiology, 25(5), 425-435.
Publication 2011
Autopsy Clinical Investigators Obstetric Delivery Pregnancy
4
Defining Remission Criteria in Rheumatoid Arthritis
Our first goal in selecting candidate criteria for remission was to define for the core set measures what cut points might constitute remission. In a survey we asked committee members (experienced RA clinical researchers and patient experts) what level of residual activity in individual core set measures would constitute remission. For all measures except joint counts, we used a 0-10 scale. For CRP we used a scale in milligrams per deciliter (mg/dL). For initial analyses of joint counts, we used a 28-joint count and then examined its validity for remission (see below). We asked for the highest level of each core set measure that would be compatible with remission if it were the only measure assessed and also asked for the highest level of a particular core set measure compatible with remission if all other measures pointed to remission.
Felson D.T., Smolen J.S., Wells G., Zhang B., van Tuyl L.H., Funovits J., Aletaha D., Allaart R., Bathon J., Bombardieri S., Brooks P., Brown A., Matucci-Cerinic M., Choi H., Combe B., de Wit M., Dougados M., Emery P., Furst D., Gomez-Reino J., Hawker G., Keystone E., Khanna D., Kirwan J., Kvien T., Landewé R., Listing J., Michaud K., Mola E.M., Montie P., Pincus T., Richards P., Siegel J., Simon L., Sokka T., Strand V., Tugwell P., Tyndall A., van der Heijde D., Verstappen S., White B., Wolfe F., Zink A, & Boers M. (2011). American College of Rheumatology/European League against Rheumatism Preliminary Definition of Remission in Rheumatoid Arthritis for Clinical Trials. Arthritis and rheumatism, 63(3), 573-586.
Publication 2010
Clinical Investigators Committee Members Joints Patients
5
Standardized Causality Assessment for Drug-Induced Liver Injury
Because DILI is a clinical diagnosis of exclusion, a formal and standardized approach to causality assessment was established in the DILIN.[5 (link),20 (link),21 (link)] Causality is assessed with the widely used Roussel Uclaf Causality Assessment Method (RUCAM) as well as by ‘expert consensus’.[22 (link)] The RUCAM provides a semi-quantitative assessment of causality by assigning −3 to +3 points to each of six domains. A final summary score allows categorization of causality as highly probable (>8), probable (6–8), possible (3–5), unlikely (1–2) or excluded (<0). For expert consensus, a DILIN causality committee was established that consists of seven voting members including the five clinical site investigators (or their designees) and a representative from the DCC and the NIDDK. Three causality committee members (the clinical site principal investigator and two others) receive key clinical, laboratory and diagnostic data abstracted from the DILIN baseline visit and clinical narrative (table I). The three committee members each independently calculate a RUCAM score using forms developed for this purpose and also assign a DILIN causality score ranging from 1 (definite) to 5 (unlikely). To standardize terminology and attempt to make causality assessment by expert opinion more objective, definitions were developed for each causality level (table III). These definitions included three elements: (i) a percentage likelihood that the drug caused the liver injury (>95%, 75–95%, 50–74%, 25–49% and <25%); (ii) standard legal terms to help define the weight of the evidence for causality (i.e. ‘beyond a reasonable doubt’, ‘clear and convincing evidence’ and ‘the preponderance of evidence’); and (iii) a set of criteria describing the clinical features that match the known timing and pattern of injury. These definitions were developed during the initial years of the DILIN study in an attempt to provide guidance for the expert opinions.
In cases involving more than one implicated drug, an overall causality score for the DILI event is assigned as well as scores for up to three different medications. When the DILIN causality scores of the three assigned reviewers do not agree, the case is discussed by the entire committee on a teleconference wherein a final consensus score is assigned. Finally, the severity of the DILI episode is categorized on a scale of 1–5 as summarized in table IV.
Fontana R.J., Watkins P.B., Bonkovsky H.L., Chalasani N., Davern T., Serrano J, & Rochon J. (2009). Drug-Induced Liver Injury Network (DILIN) Prospective Study: Rationale, Design and Conduct. Drug safety : an international journal of medical toxicology and drug experience, 32(1), 55-68.
Publication 2009
Clinical Investigators Clinical Laboratory Services Committee Members Diagnosis Dilin Injuries Liver Pharmaceutical Preparations

Most recents protocols related to «Clinical Investigators»

1
Sarilumab for Severe COVID-19 Pneumonia

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Publication 2023
Adrenal Cortex Hormones Adult Antiviral Agents Clinical Investigators Communicable Diseases COVID 19 Ethics Committees Ethics Committees, Research Inpatient Patients Pneumonia Safety sarilumab
2
Sarilumab Intravenous Infusion for COVID-19

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Publication 2023
Adrenal Cortex Hormones Antiviral Agents Biological Evolution Chest Clinical Investigators Hematologic Tests Intravenous Infusion Nasopharynx Oxygen Patients Physical Examination remdesivir Respiratory Rate Safety sarilumab SARS-CoV-2 Secondary Infections Signs, Vital Therapeutics X-Ray Computed Tomography X-Rays, Diagnostic
3
Factors Affecting PROM and PREM Implementation in Pediatric Care
This study was based on combined semi-structured interview data from two sources: (1) secondary analysis of semi-structured interview data obtained in a previous mixed methods study [13 ]; and 2) semi-structured interview data collected as part of an environmental scan with the aim of preparing a strategy to integrate PROMs and PREMs into pediatric care across Alberta. Data from Study 1 contained more perspectives from academic clinical researchers while Study 2 included a greater proportion of system-level perspectives (i.e., evaluation specialists and administrators). Combining these two datasets allowed us to gain a more comprehensive overview of the factors that could affect successful implementation of PROMs and PREMs users in Alberta. A similar semi-structured interview guide was used for Study 1 and 2, with some modifications in Study 2 to target participant perspectives on facilitators and barriers to PROM and PREM use (see Additional file 1 and Additional file 2).
Study 1. See [blinded for peer review] for a detailed account of the study, however, briefly, data were collected between May 2021 and April 2022 from 14 individuals who were PROMs and PREMs users in Alberta (7 physicians, 1 psychologist, 6 academic researchers). The focus of the qualitative arm was to understand the uses, benefits, and challenges associated with PROMs and PREMs in pediatric settings.
Study 2. Participants were recruited through newsletters and emails of professional groups (e.g., health professional associations, primary care networks, pediatric research institutions). Potential participants were also identified through publicly available profiles and through snowball sampling. Those individuals were emailed directly with an invitation to participate. All participants were invited to complete a survey where they were asked about the specific PROM and PREM instruments they used, their uses (clinical care, evaluation, research), modes of administration and challenges associated with their use. At the end of the survey, participants were asked if they wished to be contacted for an interview where their experiences with PROMs and PREMs would be explored in more depth. Data from those interviews were used in this study. Interviews were conducted between April and July 2022. The interview was focused on understanding the participant’s experiences with PROMs and PREMs, with an emphasis on the barriers and facilitators to implementing PROMs and PREMs in pediatrics. Interviews were conducted virtually using Zoom software and lasted between 30 and 45 min. They were audio-recorded and transcribed verbatim. Verbal informed consent was obtained from each participant prior to the start of the interview.
McCabe E., Rabi S., Bele S., Zwicker J.D, & Santana M.J. (2023). Factors affecting implementation of patient-reported outcome and experience measures in a pediatric health system. Journal of Patient-Reported Outcomes, 7, 24.
Publication 2023
A-factor (Streptomyces) Administrators Clinical Investigators factor A Health Care Professionals Peer Review Physicians Primary Health Care Psychologist Radionuclide Imaging Specialists
4
Lived Experience Researchers Exploring Mental Health
A team of Lived Experience Researchers, (LERs), drawing on their own experiential knowledge about living with mental health problems, and other researchers from the UKRI Loneliness and Social Isolation and Mental Health network and the National Institute for Health and Care Research Mental Health Policy Research Unit (MHPRU) planned and conducted the study. The team included clinical academics and non-clinical researchers from a range of backgrounds (including qualitative and mixed methods research, health policy, health economics, and the arts). The research team met weekly by Zoom video call [27 ] to plan the study and discuss progress. Most interviews were conducted by thirteen LERs involved in the study, except for eight telephone interviews conducted by MB, an experienced qualitative researcher and occupational therapist. Three LERs were employed in university research roles; others had honorary research contracts with University College London. Eleven of the LER interviewers were female and five were from minority ethnic backgrounds. The LERs received training on conducting face-to-face and online interviews and obtaining written and verbal informed consent. A weekly lived experience reflective space provided LERs with emotional support and space to discuss the research process and emotional impact, peer-facilitated by four experienced LERs.
Birken M., Chipp B., Shah P., Olive R.R., Nyikavaranda P., Hardy J., Chhapia A., Barber N., Lee S., Pearce E., Lloyd-Evans B., Perkins R., McDaid D., Stefanidou T., Shafran R., Pitman A, & Johnson S. (2023). Exploring the experiences of loneliness in adults with mental health problems: A participatory qualitative interview study. PLOS ONE, 18(3), e0280946.
Publication 2023
Clinical Investigators Emotions Ethnic Minorities Face Females Interviewers Mental Health Occupational Therapist
5
Applying AACTT Framework to P-PRO Study
For the interviews with P-PRO clinical investigators, we applied the Action, Actor, Context, Target, Time (AACTT) framework [18 (link)] to define the behaviour(s) of interest, inform sampling, and the design of the interview topic guide. Two individuals (1 paramedic and 1 consultant) contributed to a team discussion to gain appropriate contextual information pertaining to the P-PRO study and the AACTT components. See Additional file 1.
An AACTT analysis was not completed for the interviews with pre-hospital trial researchers because they were not conducted with a specific behaviour of interest in mind. As stated previously, they were more open to identify the scope of relevant behavioural influences across multiple pre-hospital trials.
Lawrie L., Duncan E.M., Lendrum R., Lebrec V, & Gillies K. (2023). Challenges and opportunities for conducting pre-hospital trauma trials: a behavioural investigation. Trials, 24, 157.
Publication 2023
Clinical Investigators Consultant Paramedical Personnel

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More about "Clinical Investigators"

Clinical Investigators, also known as medical researchers or clinical study investigators, are highly trained professionals who play a crucial role in advancing medical knowledge and improving patient care.
These individuals design, implement, and oversee clinical trials to evaluate new treatments, therapies, or interventions.
Their work is essential for the development of groundbreaking drugs, devices, and healthcare strategies that can transform the lives of patients worldwide.
Clinical Investigators utilize their expertise in fields such as medicine, nursing, pharmacology, and biostatistics to collect and analyze data, ensuring the safety and wellbeing of study participants.
These investigators must adhere to rigorous ethical and regulatory standards, such as those outlined in SAS 9.4, Stata 10.0 module Ralloc version 3.5.2, and SPSS Statistics version 22.
They leverage cutting-edge tools like Quantikine enzyme-linked immunosorbent assay (ELISA) kits and Sedline brain function monitors to enhance the accuracy and reproducibility of their research.
By reporting their findings to the scientific community, Clinical Investigators play a vital role in advancing medical knowledge and improving patient outcomes.
Their work is essential for the development of new drugs, devices, and healthcare strategies that can transform the lives of patients globally.
PubCompare.ai's AI-driven protocol optimization tools empower Clinical Investigators to effortlessly locate the best protocols from literature, pre-prints, and patents, ultimately enhancing the impact of their research.
With PubCompare.ai's cutting-edge technology, investigators can maximize the reproducibility and accuracy of their studies, driving medical progress and improving patient care.