Rethinking Clinical Trials

AUGUST 8, 2024

Speaking at the NIH Pragmatic Trials Collaboratory’s 2024 Annual Steering Committee Meeting in May, Commissioner of Food and Drugs Robert Califf and NIH Director Monica Bertagnolli discussed the intersection of pragmatic research and national health priorities. It is imperative to get a learning health system in progress,” she said.

Clinical Trials 173

Clinical Trials Clinical Trials Trials Doctors 173

Worldwide Clinical Trials

MARCH 20, 2024

One way to ensure customized disease management is to utilize pharmacogenomics (PGx) in your clinical trial. As the study of how an individual’s genes affect their response to drugs, pharmacogenomics is a critical factor in developing effective and safe drugs and dosages in clinical trials.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Genetics 130

AuroBlog - Aurous Healthcare Clinical Trials blog

APRIL 29, 2024

Clinical trial companies see immense relevance on US FDA Electronic Submission Safety Reports. The guidance provides instructions about how the individual case safety reports (ICSRs) from investigational new drug (IND) need to be supported with Adverse Event Reporting System (AERS).

Clinical Trials 170

Clinical Trials Clinical Trials Trials Drugs 170

Rethinking Clinical Trials

JULY 5, 2023

June 23-24, 2023 : The NIH Pragmatic Trials Collaboratory hosted a Pre-Conference Workshop, “Changing Trials for Changing Times: Essentials of Embedded Pragmatic Clinical Trials Workshop,” at the Health Care Systems Research Network 2023 Annual Conference.

Clinical Trials 130

Clinical Trials Clinical Trials Clinical Research Trials 130

AuroBlog - Aurous Healthcare Clinical Trials blog

JUNE 6, 2024

This according to multinational majors like Amgen, GSK, Eli Lily, Bayer, Mylan, AstraZeneca among others indicated that it underscores India’s importance in R&D and clinical trials. These GCCs in the lifesciences and healthcare segment are driving digital tech assignments, key business and corporate […]

Clinical Trials 151

Clinical Trials Clinical Trials Trials Clinical Research 151

Rethinking Clinical Trials

OCTOBER 22, 2023

What Are Pragmatic Clinical Trials? Description In this video, Dr. Lesley Curtis describes pragmatic clinical trials. The post What Are Pragmatic Clinical Trials? The post What Are Pragmatic Clinical Trials? appeared first on Rethinking Clinical Trials.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Clinical Research 130

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 6, 2024

Oncologists during clinical trials of paediatric cancer cases are seen to encounter parent reluctance. Since the trials involve a lot of government permissions as well and many healthcare facilities, hospitals under NDA […]

Clinical Trials 148

Clinical Trials Clinical Trials Trials Clinical Research 148

Worldwide Clinical Trials

FEBRUARY 26, 2024

With the necessary prioritization of various factors when designing your clinical trial, the patient experience can be overlooked or improperly addressed in study design. From a combined perspective, somewhere along the way, we tend to be able to land at what is the true design of clinical research,” says Perez.

Clinical Trials 147

Clinical Trials Clinical Trials Trials Clinical Research 147

Rethinking Clinical Trials

FEBRUARY 21, 2024

In this Friday’s PCT Grand Rounds, Adrian Hernandez and Christopher Lindsell of Duke University will present “Virtual Vigilance: Monitoring of Decentralized Clinical Trials.” He also serves as co-principal investigator of the NIH Pragmatic Trials Collaboratory Coordinating Center. Join the online meeting.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Bioinformatics 130

Cloudbyz

APRIL 23, 2024

The landscape of clinical trial management is marked by complexity, with organizations facing numerous challenges in effectively managing trial budgets while ensuring adherence to regulatory requirements and maintaining high standards of quality.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Regulation 98

Cloudbyz

APRIL 17, 2024

Decentralized clinical trial (DCT) platforms represent a paradigm shift in the way clinical research is conducted. By leveraging technology, DCTs aim to make clinical trials more accessible and convenient for patients, reduce costs and increase efficiency.

Clinical Trials 105

Clinical Trials Clinical Trials Trials Compliance 105

ACRP blog

AUGUST 14, 2024

Diversity in clinical research has become a hot topic in recent years, with heightened attention leading to dramatic changes in the regulatory framework, including U.S. legislation broadening the scope of diversity consideration in clinical trials. Hispanic/Latino representation in clinical trials is approximately 11.6%

Clinical Trials 59

Clinical Trials Clinical Trials Trials Clinical Research 59

AuroBlog - Aurous Healthcare Clinical Trials blog

NOVEMBER 10, 2022

More evidence of the link has arrived with a phase 2, double-blind trial involving 233 participants, the largest study on this subject carried out so far in terms of sample size. For some years now, scientists have been investigating how psilocybin, the psychedelic compound in magic mushrooms, can ease the symptoms of depression.

Trials 223

Trials Clinical Trials Clinical Trials Clinical Research 223

XTalks

JANUARY 8, 2024

Whether it’s for a treatment for a chronic ambulatory condition, precision medicine or cell and gene therapy, there is a massive uptick in clinical trial complexity. It’s important to make sure that with this increase in clinical trial complexity, we don’t make our trials overly burdensome to sites or patients,” says Markham.

Clinical Trials 105

Clinical Trials Clinical Trials Trials Gene Therapy 105

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 3, 2023

Pharmaceutical giant Eli Lilly said Thursday it will seek approval to add its diabetes drug to the buzzy US weight loss market after achieving promising results in a new clinical trial. Tirzepatide, currently approved to treat type 2 diabetes under the name Mounjaro, is taken once a week as an injection. Eli Lilly said its […]

Clinical Trials 184

Clinical Trials Clinical Trials Trials Drugs 184

Rethinking Clinical Trials

JUNE 28, 2023

In this Friday’s PCT Grand Rounds, Adrian Hernandez, Pamela Tenaerts, and Craig Lipset will present “Decentralized Trials – From Guidance to Reality & What’s Left.” Tenaerts is the chief scientific officer of Medable, a cloud computing platform for decentralized clinical trials. Join the online meeting.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Clinical Research 130

XTalks

JANUARY 15, 2024

The field of clinical research will witness significant advancements in 2024. Read on to learn about the top 10 clinical trial trends for 2024, and be sure to explore and join upcoming webinars about clinical trials at Xtalks. percent from 2023 to 2033.

Clinical Trials 105

Clinical Trials Clinical Trials Trials Clinical Research 105

Outsourcing Pharma

JUNE 13, 2024

To guide sponsors, investigators, CROs, and other parties in clinical research, the European Medicines Agency (EMA) has consolidated the contemporary requirements for using computerized systems and electronic data in clinical trials.

Clinical Trials 95

Clinical Trials Clinical Trials Trials Clinical Research 95

Rethinking Clinical Trials

JULY 31, 2023

Building a Study Team for a Pragmatic Clinical Trial Description NIH Collaboratory investigator Dr. Lesley Curtis shares tips for building effective study teams for pragmatic clinical trials.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Clinical Research 130

Cloudbyz

JUNE 9, 2024

In the realm of clinical trials, particularly in oncology and rare disease research, SDOH play a pivotal role in shaping patient participation, adherence, and overall outcomes. Integrating eClinical systems can help mitigate these disparities, enhancing the inclusivity and efficacy of clinical research.

Clinical Trials 105

Clinical Trials Clinical Trials Trials Clinical Research 105

Rethinking Clinical Trials

JUNE 27, 2022

A special series of articles addressing pragmatic and virtual trials appears this week in the journal Contemporary Clinical Trials and offers practical approaches to the many challenges clinical trials face. The special issue can be found on the Contemporary Clinical Trials website.

Clinical Trials 147

Clinical Trials Clinical Trials Trials Clinical Research 147

XTalks

MAY 21, 2024

Yesterday, on International Clinical Trials Day 2024, the global healthcare community came together to commemorate the significant advancements in clinical research and the vital role clinical trials play in improving patient care and outcomes.

Clinical Trials 64

Clinical Trials Clinical Trials Trials Clinical Research 64

Drug Discovery World

AUGUST 25, 2023

Educational campaign, Clinical Trials For All, has been launched to drive greater understanding, participation and diversity in clinical trials. Clinical research isn’t what many people think it is,” said Cinda Orr, Founder of SCORR Marketing, the company that is leading this initiative. “Low

Clinical Trials 52

Clinical Trials Clinical Trials Clinical Research Trials 52

XTalks

AUGUST 22, 2023

Recruiting participants is perhaps the most challenging aspect of any clinical trial, regardless of the therapeutic area. Yet this one piece is also the most vital, with a trial’s ability to enroll and retain participants being a key predictor of a study’s future success. What is Clinical Trials For All?

Clinical Trials 97

Clinical Trials Clinical Trials Trials Clinical Research 97

pharmaphorum

MARCH 11, 2024

Enhancing clinical trial outcomes through algorithmic prespecification in subgroup analysis can provide valuable insights for the FDA and medical community. Learn more about this practice and its importance in clinical research.

Clinical Trials 110

Clinical Trials Clinical Trials Trials Clinical Research 110

XTalks

MAY 30, 2024

At the forefront of transforming clinical studies is the Clinical Trials Transformation Initiative (CTTI) , which has been instrumental in shaping the future of clinical trials to be more efficient, inclusive and patient-centered.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 52

Cloudbyz

AUGUST 9, 2024

Over the past few decades, the landscape of clinical trials has undergone a dramatic transformation, largely driven by advancements in technology and data management practices. Today, over 80% of clinical research utilizes EDC solutions. What are EDC Systems?

Clinical Trials 52

Clinical Trials Clinical Trials Trials Compliance 52

XTalks

AUGUST 16, 2024

The effectiveness of clinical trials often depends on the quality and depth of the data utilized. This rich data resource has significant potential to innovate clinical trials, providing real-world, timely insights that can enhance success and streamline trial processes.

Clinical Trials 59

Clinical Trials Clinical Trials Trials Clinical Research 59

Cloudbyz

MAY 17, 2024

This Act is poised to significantly change the clinical trials landscape within the life sciences sector. As AI increasingly becomes a cornerstone in clinical research and drug development, it is crucial for industry stakeholders to grasp the extensive implications of this regulation.

Life Science 102

Life Science Clinical Trials Clinical Trials Trials 102

Antidote

SEPTEMBER 22, 2023

Connecting patients with clinical research opportunities is our mission here at Antidote, but often, we find that misconceptions can serve as barriers to achieving this goal. It’s important to carefully weigh the pros and cons of participating in a clinical trial but to do this effectively, it’s critical to have accurate information.

Clinical Trials 122

Clinical Trials Clinical Trials Trials Clinical Research 122

XTalks

MAY 9, 2023

Clinical trial manager jobs are vital for the development and execution of clinical trials, which are essential for developing new treatments for diseases. In this article, we discuss the job duties, education and experience requirements, outlook and salary expectations for clinical trial managers.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Clinical Research 98

Clairnes

JUNE 9, 2022

The post Decentralized Clinical Trials: the next step towards digitalization of clinical research appeared first on Clinical Trial Recruitment & Management Services.

Clinical Trials 76

Clinical Trials Clinical Trials Clinical Research Trials 76

Imperical Blog

FEBRUARY 27, 2024

With more than 65,000 clinical studies currently recruiting, our industry is constantly working hard to enroll participants and meet study timelines. Unfortunately, public skepticism in clinical trials can get in the way of those efforts.

Clinical Trials 59

Clinical Trials Clinical Trials Trials Clinical Research 59

XTalks

JANUARY 17, 2024

Given this hotbed of activity, innovation in the space to drive faster decisions and more efficient trials is intense. They discussed the top new trends in oncology trial design that sponsors are either incorporating into clinical trials or need to start planning to include.

Clinical Trials 124

Clinical Trials Clinical Trials Trials Gene Therapy 124