Clinical Research - Clinical Research Informer

A REVIEW ON CLINICAL DATA MANAGEMENT : CURRENT STATUS IN CLINICAL RESEARCH

Pharma Tutor

MARCH 26, 2022

A REVIEW ON CLINICAL DATA MANAGEMENT : CURRENT STATUS IN CLINICAL RESEARCH. About Authors. MANISHA KOTADIYA*, JAYDEEP SAVALIYA. Shree Swaminarayan Sanskar Collage of Pharmacy Zundal, Gandhinagar, Gujarat, Email Id: manishakotadiya3@gmail.com, FTF Pharma Pvt. Ahmedabad, Email ID: jaydeepsavaliya27@gmail.com.

Clinical Research

Clinical Research Research Pharmacy

Grand Rounds October 21, 2022: Disinformation, Cyberthreat, and Choice: Protecting Patients and Clinical Research From the Digital Triple Threat (Eric Perakslis, PhD; Andrea Downing)

Rethinking Clinical Trials

OCTOBER 27, 2022

Duke Clinical Research Institute. Chief Research Technology Strategist. ePatient and Security Researcher. How do we maintain research access when health care access is limited in some of these states. ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ?. Speakers. Andrea Downing.

Clinical Research

Clinical Research Research Clinical Trials Clinical Trials

Grand Rounds October 28, 2022: The HERO (Healthcare Worker Exposure Response & Outcomes) Program: An Online Community to Support Observational Studies, Randomized Trials, and Long-Term Safety Surveillance (Emily O’Brien, PhD, FAHA; Russell Rothman, MD, MPP)

Rethinking Clinical Trials

NOVEMBER 1, 2022

Duke Clinical Research Institute. On March 21, 2020, in response to the COVID-19 pandemic, PCORI contacted leadership at Duke Clinical Research Institute and PCORnet and a decision was made to focus on the space of healthcare workers. Emily O’Brien, PhD, FAHA. Associate Professor. Duke University School of Medicine.

Trials

Trials Clinical Research Vaccination Vaccine

Grand Rounds February 23, 2024: Virtual Vigilance: Monitoring of Decentralized Clinical Trials (Adrian Hernandez, MD; Christopher J. Lindsell, PhD)

Rethinking Clinical Trials

FEBRUARY 28, 2024

Speakers Adrian Hernandez, MD Executive Director, Duke Clinical Research Institute Vice Dean, Duke University School of Medicine Christopher J. I hope we see further development of education programs that support the workforce with the skills needed.

Clinical Trials

Clinical Trials Clinical Trials Trials Clinical Research

Grand Rounds January 19, 2024: Why Are Imaging RCTs Different? Lessons From Chest Pain Evaluation Trials (Pamela S. Douglas, MD, MACC, FASE, FAHA)

Rethinking Clinical Trials

JANUARY 23, 2024

Tags #pctGR, @Collaboratory1 The post Grand Rounds January 19, 2024: Why Are Imaging RCTs Different? Douglas, MD, MACC, FASE, FAHA) appeared first on Rethinking Clinical Trials. Speaker Pamela S. The tests are so common in aggregate it is a big expense. – What is the sensitivity of portable AI ECHO devices?

Trials

Trials Cardiology Clinical Trials Clinical Trials

September 30, 2022: CTTI’s Digital Health Trials Hub Recommendations and Resources to Run Your Digital Health Trial (Marianne Chase, MGH, CTTI Team Lead, Jörg Goldhahn, ETH Zurich, CTTI Team Lead)

Rethinking Clinical Trials

OCTOBER 4, 2022

Senior Director Clinical Trial Operations. Neurological Clinical Research Institute. Clinical Trial Transformation Initiative (CTTI); Decentralized Clinical Trials (DCTs); Digital endpoints; Developing novel endpoints. . Speakers.

Trials

Trials Clinical Trials Clinical Trials Production

Grand Rounds October 20, 2023: A National Initiative to Eliminate Hepatitis C in the United States – Why This Matters to Clinical Trialists (Rachael L. Fleurence, PhD, MSc; Joshua M. Sharfstein, MD)

Rethinking Clinical Trials

OCTOBER 26, 2023

There are possible clinical research components that would include research on treatment during pregnancy, vaccine development, and implementation model research. with the rate of reported acute Hepatitis C cases increasing 400% during 2010-2020. Rates are the highest among 20-39-year-olds.

Clinical Research

Clinical Research Clinical Trials Clinical Trials Research

Grand Rounds April 14, 2023: RECOVER in Action – Status of Clinical Trial Protocols (Kanecia Zimmerman, PhD, MD, MPH)

Rethinking Clinical Trials

APRIL 18, 2023

Tags #pctGR, @Collaboratory1 The post Grand Rounds April 14, 2023: RECOVER in Action – Status of Clinical Trial Protocols (Kanecia Zimmerman, PhD, MD, MPH) appeared first on Rethinking Clinical Trials. It seems the most severely affected people came from the early waves of COVID.

Clinical Trials

Clinical Trials Clinical Trials Trials Immune Response

Grand Rounds March 24, 2023: From Observational Studies to Pragmatic Clinical Trials: (Almost) A Decade of Research in PCORnet® (Erin Holve, PhD, MPH, MPP; Russell Rothman, MD, MPP; Schuyler Jones, MD; Neha Pagidipati, MD, MPH)

Rethinking Clinical Trials

MARCH 28, 2023

It has grown to be a major force for supporting pragmatic research, both real-world evidence research and supporting observational research and pragmatic clinical trials. has 8 clinical research networks across the country. enabled research. Those are the areas we are looking at moving forward.

Clinical Trials

Clinical Trials Clinical Trials Trials Research

Grand Rounds December 15, 2023: Diversifying Clinical Trials: A Path Forward (Roxana Mehran, MD, FACC, FAHA, MSCAI, FESC)

Rethinking Clinical Trials

DECEMBER 20, 2023

Tags #pctGR, @Collaboratory1 The post Grand Rounds December 15, 2023: Diversifying Clinical Trials: A Path Forward (Roxana Mehran, MD, FACC, FAHA, MSCAI, FESC) appeared first on Rethinking Clinical Trials. With the current ability to become pregnant this can affect women up to the age of 50.

Clinical Trials

Clinical Trials Clinical Trials Trials Cardiology

Grand Rounds August 19, 2022: Inclusion and Diversity in Clinical Trials: Actionable Steps to Drive Lasting Change (Gerald Bloomfield, MD, MPH; Michelle Kelsey, MD)

Rethinking Clinical Trials

AUGUST 23, 2022

There is a national priority to increase diversity in clinical trials, from regulatory, funding agencies, industry, and others, so that the participant population reflects the U.S. The Duke Clinical Research Institute (DCRI) organized and sponsored a Think Tank to address diversity in clinical trial research.

Clinical Trials

Clinical Trials Clinical Trials Trials Medicine

Grand Rounds October 13, 2023: Incorporating Social Determinants of Health Into PCORnet (Keith Marsolo, PhD)

Rethinking Clinical Trials

OCTOBER 18, 2023

The PCORnet Common Data Model (CDM) includes data available from Clinical Research Networks. Some data, such as basic clinical data and demographics, are ready for research. First steps are getting the data in such a state that would allow us to learn about some of those social determinants of health.

Clinical Trials

Clinical Trials Clinical Trials Clinical Research Research

Grand Rounds January 12, 2024: Design and Implementation of a Weighted Lottery to Equitably Allocate Scarce Covid-19 Resources (Erin K. McCreary, PharmD, BCIDP)

Rethinking Clinical Trials

JANUARY 17, 2024

Tags #pctGR, @Collaboratory1 The post Grand Rounds January 12, 2024: Design and Implementation of a Weighted Lottery to Equitably Allocate Scarce Covid-19 Resources (Erin K. McCreary, PharmD, BCIDP) appeared first on Rethinking Clinical Trials. Speaker Erin K. Many patients did not answer the phone.

Clinical Trials

Clinical Trials Clinical Trials Antibody Trials

Grand Rounds July 22, 2022: ACTIV-6: 1-Year Later and Trial Results for Ivermectin-400 and Inhaled Fluticasone (Susanna Naggie, MD, MHS)

Rethinking Clinical Trials

JULY 27, 2022

Vice Dean for Clinical Research. The key clinical questions of the ACTIV-6 study are: how to help someone feel better faster with newly diagnosed mild-moderate COVID-19 and how to prevent hospitalizations or death in someone with newly diagnosed mild-moderate COVID-19? Susanna Naggie, MD, MHS. Professor of Medicine. Key Points.

Trials

Trials Pharmacy Medicine Clinical Trials

Grand Rounds May 19, 2023: Aspirin or Low-Molecular-Weight Heparin for Thromboprophylaxis After a Fracture (Robert O’Toole, MD)

Rethinking Clinical Trials

MAY 25, 2023

The research team did not run into institutional barriers in the trial, likely because of the opportunity of Aspirin to be a much lower cost option if proven safe and effective.

Trials

Trials Clinical Trials Clinical Trials Compliance

Grand Rounds June 16, 2023: BeatPain Utah: Partnering With Community Health Centers Within a Socio-Technical Framework (Julie Fritz, PT, PhD, FAPTA; Guilherme Del Fiol, MD, PhD)

Rethinking Clinical Trials

JULY 9, 2023

Clinical research can exacerbate disparities, because clinical trials typically are based in urban, academic medical centers, underrepresent diverse populations, and overlook community engagement strategies in trial planning and design.

Clinical Trials

Clinical Trials Clinical Trials Trials Research

Grand Rounds June 30, 2023: Decentralized Trials – From Guidance to Reality & What’s Left (Adrian Hernandez, MD, MHS; Pamela Tenaerts, MD, MPH; Craig Lipset, MPH)

Rethinking Clinical Trials

JULY 6, 2023

Tags #pctGR, @Collaboratory1 The post Grand Rounds June 30, 2023: Decentralized Trials – From Guidance to Reality & What’s Left (Adrian Hernandez, MD, MHS; Pamela Tenaerts, MD, MPH; Craig Lipset, MPH) appeared first on Rethinking Clinical Trials.

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Trials Clinical Trials Clinical Trials Licensing

Grand Rounds August 25, 2023: Pragmatic Trial of an EHR Application to Display Real-time PRO Data: Successes and Challenges (Gabriela Schmajuk, MD, MS)

Rethinking Clinical Trials

AUGUST 30, 2023

The hypothesis was that the RA PRO dashboard used during clinical encounters will increase patient engagement, foster shared decision making, and improve health outcomes for patients with RA. There were 4 clusters with 4-6 physicians each (a mix of attendings and fellows). 552 unique patient participated in the trial. .

Trials

Trials Clinical Research Coordinator Medicine Clinical Trials

Bluebird’s $2.8M Gene Therapy Zynteglo Wins Landmark FDA Approval for Beta Thalassemia

XTalks

AUGUST 19, 2022

Zynteglo’s hefty price tag of $2.8 In a press release , bluebird said the approval of Zynteglo is “the culmination of nearly ten years of clinical research of gene therapy in patients with transfusion-dependent beta-thalassemia.”. The cells are prepared outside of the body ( ex vivo ) and then infused into the patient.

Gene Therapy

Gene Therapy FDA Approval Gene Clinical Trials

Grand Rounds August 4, 2023: AI & ML: Want to Play a Game? (Eric Perakslis, PhD)

Rethinking Clinical Trials

AUGUST 10, 2023

Tags #pctGR, @Collaboratory1 The post Grand Rounds August 4, 2023: AI & ML: Want to Play a Game? Eric Perakslis, PhD) appeared first on Rethinking Clinical Trials. For people, there are some jobs that will inevitably be replaced by these new technologies. The important thing is to learn and adapt to the changes.

Clinical Trials

Clinical Trials Clinical Trials Trials Medicine

Grand Rounds February 17, 2023: The Heartline Trial: A New Paradigm in Conducting Virtual Clinical Trials (C. Michael Gibson, MS, MD)

Rethinking Clinical Trials

FEBRUARY 22, 2023

Tags #pctGR, @Collaboratory1 The post Grand Rounds February 17, 2023: The Heartline Trial: A New Paradigm in Conducting Virtual Clinical Trials (C. Michael Gibson, MS, MD) appeared first on Rethinking Clinical Trials. If you are doing biomarker work, patients will have to go to a brick and mortar for that.

Clinical Trials

Clinical Trials Clinical Trials Trials Nurses

Grand Rounds April 21, 2023: Personalised Cooler Dialysate for Patients Receiving Maintenance Haemodialysis (MyTEMP): A Pragmatic, Cluster-randomised Trial (Amit Garg, MD, MA, FRCPC, FACP, PhD; Stephanie N. Dixon, PhD MSc)

Rethinking Clinical Trials

APRIL 27, 2023

Tags #pctGR, @Collaboratory1 The post Grand Rounds April 21, 2023: Personalised Cooler Dialysate for Patients Receiving Maintenance Haemodialysis (MyTEMP): A Pragmatic, Cluster-randomised Trial (Amit Garg, MD, MA, FRCPC, FACP, PhD; Stephanie N.

Trials

Trials Clinical Trials Clinical Trials Medicine

Grand Rounds March 17, 2023: Remote Symptom Monitoring with Electronic Patient-Reported Outcomes (ePROs) in Oncology (Ethan Basch, MD, MSc)

Rethinking Clinical Trials

MARCH 21, 2023

Patient self-reporting improves symptom monitoring and outcomes in routine cancer care and clinical research by expanding our understanding of the patient experience and engaging patients. From a health services research perspective, it demonstrates how hard it is to change a simple process, even if it makes a lot of intuitive sense.

Clinical Trials

Clinical Trials Clinical Trials Trials Research

Grand Rounds February 24, 2023: S2302 Pragmatica-Lung: New Directions for Decreasing Burden and Increasing Inclusion in NCTN Clinical Trials (Konstantin Dragnev, MD; Karen Reckamp, MD, MS)

Rethinking Clinical Trials

MARCH 1, 2023

We kept coming back to the one thing we want to know, which is the overall survival.

Clinical Trials

Clinical Trials Clinical Trials Trials Packaging

Grand Rounds July 21, 2023: Implementing New Care Pathways for Low Back Pain in Academic Healthcare Systems: Early Lessons from IMPACt-LBP (Christine Goertz, DC, PhD; Adam Goode, DPT, PhD)

Rethinking Clinical Trials

AUGUST 28, 2023

Tags #pctGR, @Collaboratory1 The post Grand Rounds July 21, 2023: Implementing New Care Pathways for Low Back Pain in Academic Healthcare Systems: Early Lessons from IMPACt-LBP (Christine Goertz, DC, PhD; Adam Goode, DPT, PhD) appeared first on Rethinking Clinical Trials.

Trials

Trials Research Medicine Doctors

After a slow start for expensive CAR-T therapies, drug developers revisit oral therapies for blood cancer

pharmaphorum

DECEMBER 23, 2022

price tag of $475,000 when it was first launched in 2017 – and it becomes apparent that these may not be desirable treatment options for every patient and in every setting. He continued: “Taken together, these findings provide clear encouragement for the further clinical development of this first-in-class drug.”.

Development

Development Drugs Clinical Development Antibody

Life Sciences 2022 Year in Review

XTalks

DECEMBER 21, 2022

The multi-million-dollar price tags are largely attributable to the high R&D and manufacturing costs associated with making a gene therapy, as the raw materials for producing the therapy can be expensive. These technologies are enabling a broader shift towards the digitalization of healthcare including clinical research.

Life Science

Life Science Gene Therapy Gene Clinical Trials

New Rare Disease Drugs and Research Advancements

XTalks

FEBRUARY 27, 2024

Despite high price tags of a couple of million dollars, gene therapy makers say they are working to ensure patients are able to access the treatments through patient assistance programs developed in conjunction with the support of governments. Sarepta hopes to clarify Elvidys’ effectiveness in older children in a confirmatory trial.

Research

Research Drugs Gene Therapy Clinical Trials

Spatial Genomics, Transcriptomics and Proteomics Solutions – An Amelioration of Tissue Analytics

Roots Analysis

AUGUST 28, 2022

Furthermore, several live cell imaging and non-destructive fluorescence histological methods measure limited number of biomarkers at a time and the tags introduced may interfere with the natural function of genes and proteins. 70+ spatial Genomics solutions are developed by industry and non-industry players.

Genome

Genome Genomics RNA Genome Project

Viagra ‘should be tested as Alzheimer’s therapy’

pharmaphorum

DECEMBER 7, 2021

That finding could provide some comfort to Biogen and Eisai, whose recently-approved amyloid-targeting drug Aduhelm (aducanumab) is struggling to gain traction in the market on the back of unconvincing efficacy data, safety concerns and a high price tag.

Drugs

Drugs Clinical Trials Clinical Trials Scientist

Clinical Research Informer

A REVIEW ON CLINICAL DATA MANAGEMENT : CURRENT STATUS IN CLINICAL RESEARCH

Grand Rounds October 21, 2022: Disinformation, Cyberthreat, and Choice: Protecting Patients and Clinical Research From the Digital Triple Threat (Eric Perakslis, PhD; Andrea Downing)

Trending Sources

Grand Rounds October 28, 2022: The HERO (Healthcare Worker Exposure Response & Outcomes) Program: An Online Community to Support Observational Studies, Randomized Trials, and Long-Term Safety Surveillance (Emily O’Brien, PhD, FAHA; Russell Rothman, MD, MPP)

Grand Rounds February 23, 2024: Virtual Vigilance: Monitoring of Decentralized Clinical Trials (Adrian Hernandez, MD; Christopher J. Lindsell, PhD)

Grand Rounds January 19, 2024: Why Are Imaging RCTs Different? Lessons From Chest Pain Evaluation Trials (Pamela S. Douglas, MD, MACC, FASE, FAHA)

September 30, 2022: CTTI’s Digital Health Trials Hub Recommendations and Resources to Run Your Digital Health Trial (Marianne Chase, MGH, CTTI Team Lead, Jörg Goldhahn, ETH Zurich, CTTI Team Lead)

Grand Rounds October 20, 2023: A National Initiative to Eliminate Hepatitis C in the United States – Why This Matters to Clinical Trialists (Rachael L. Fleurence, PhD, MSc; Joshua M. Sharfstein, MD)

Grand Rounds April 14, 2023: RECOVER in Action – Status of Clinical Trial Protocols (Kanecia Zimmerman, PhD, MD, MPH)

Grand Rounds March 24, 2023: From Observational Studies to Pragmatic Clinical Trials: (Almost) A Decade of Research in PCORnet® (Erin Holve, PhD, MPH, MPP; Russell Rothman, MD, MPP; Schuyler Jones, MD; Neha Pagidipati, MD, MPH)

Grand Rounds December 15, 2023: Diversifying Clinical Trials: A Path Forward (Roxana Mehran, MD, FACC, FAHA, MSCAI, FESC)

Grand Rounds August 19, 2022: Inclusion and Diversity in Clinical Trials: Actionable Steps to Drive Lasting Change (Gerald Bloomfield, MD, MPH; Michelle Kelsey, MD)

Grand Rounds October 13, 2023: Incorporating Social Determinants of Health Into PCORnet (Keith Marsolo, PhD)

Grand Rounds January 12, 2024: Design and Implementation of a Weighted Lottery to Equitably Allocate Scarce Covid-19 Resources (Erin K. McCreary, PharmD, BCIDP)

Grand Rounds July 22, 2022: ACTIV-6: 1-Year Later and Trial Results for Ivermectin-400 and Inhaled Fluticasone (Susanna Naggie, MD, MHS)

Grand Rounds May 19, 2023: Aspirin or Low-Molecular-Weight Heparin for Thromboprophylaxis After a Fracture (Robert O’Toole, MD)

Grand Rounds June 16, 2023: BeatPain Utah: Partnering With Community Health Centers Within a Socio-Technical Framework (Julie Fritz, PT, PhD, FAPTA; Guilherme Del Fiol, MD, PhD)

Grand Rounds June 30, 2023: Decentralized Trials – From Guidance to Reality & What’s Left (Adrian Hernandez, MD, MHS; Pamela Tenaerts, MD, MPH; Craig Lipset, MPH)

Grand Rounds August 25, 2023: Pragmatic Trial of an EHR Application to Display Real-time PRO Data: Successes and Challenges (Gabriela Schmajuk, MD, MS)

Bluebird’s $2.8M Gene Therapy Zynteglo Wins Landmark FDA Approval for Beta Thalassemia

Grand Rounds August 4, 2023: AI & ML: Want to Play a Game? (Eric Perakslis, PhD)

Grand Rounds February 17, 2023: The Heartline Trial: A New Paradigm in Conducting Virtual Clinical Trials (C. Michael Gibson, MS, MD)

Grand Rounds April 21, 2023: Personalised Cooler Dialysate for Patients Receiving Maintenance Haemodialysis (MyTEMP): A Pragmatic, Cluster-randomised Trial (Amit Garg, MD, MA, FRCPC, FACP, PhD; Stephanie N. Dixon, PhD MSc)

Grand Rounds March 17, 2023: Remote Symptom Monitoring with Electronic Patient-Reported Outcomes (ePROs) in Oncology (Ethan Basch, MD, MSc)

Grand Rounds February 24, 2023: S2302 Pragmatica-Lung: New Directions for Decreasing Burden and Increasing Inclusion in NCTN Clinical Trials (Konstantin Dragnev, MD; Karen Reckamp, MD, MS)

Grand Rounds July 21, 2023: Implementing New Care Pathways for Low Back Pain in Academic Healthcare Systems: Early Lessons from IMPACt-LBP (Christine Goertz, DC, PhD; Adam Goode, DPT, PhD)

After a slow start for expensive CAR-T therapies, drug developers revisit oral therapies for blood cancer

Life Sciences 2022 Year in Review

New Rare Disease Drugs and Research Advancements

Spatial Genomics, Transcriptomics and Proteomics Solutions – An Amelioration of Tissue Analytics

Viagra ‘should be tested as Alzheimer’s therapy’

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