Rethinking Clinical Trials

OCTOBER 11, 2023

Moyer, PhD Statistician, NIH Office of Disease Prevention Slides Keywords Implementation; Study design; Hybrid; Clustered; DECIPHeR Key Points People often contest that hybrid designs are not as rigorous as they should be. One of the key features was that implementation measures were to be used as primary outcomes.

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VirTrial

DECEMBER 4, 2023

In the fast-paced world of clinical research, Randomization and Trial Supply Management (RTSM) systems play a pivotal role in ensuring the success of trials. Late integration of RTSM means it inherits decisions made upstream in the trial process.

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Pharmaceutical Technology

DECEMBER 27, 2022

Our response to the worldwide pandemic evolved over time, and so did the needs of the sector and the people relying on healthcare companies to deliver solutions. Along the way, mergers and acquisitions continued to happen, new drugs and devices got approved, and innovations in the clinical trial industry were introduced.

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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.

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Cloudbyz

SEPTEMBER 19, 2023

The process of building a clinical study can be both time-consuming and error-prone, as it involves extracting essential data from protocol documents and translating it into electronic data capture (EDC) systems like Cloudbyz EDC. This leads to higher data quality and more reliable clinical trials. GDPR, HIPAA) is paramount.

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Worldwide Clinical Trials

OCTOBER 19, 2022

Vice President of Scientific Solutions, Neuroscience, at Worldwide Clinical Trials. Of note, these programs differ significantly from conventional psychiatry trials. Just take heed of a few things first: Building a psychedelic protocol. Managing the ethics of psychedelic trials. One is cadence.

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ACRP blog

JANUARY 3, 2024

Historically, patient recruitment and retention have been pressing issues within the clinical trial space. Eighty-five percent of trials fail to recruit enough patients, while 80% are delayed due to other factors like participant dropouts.

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Worldwide Clinical Trials

SEPTEMBER 19, 2022

Researchers exploring psychedelic trials are faced with unique safety challenges for protecting patients and site staff because of the profound nature of the psychedelic experience and the requirements for psychotherapy that accompany psychedelic-assisted therapy treatment models. This patient sentiment is not uncommon in clinical research.

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Cloudbyz

APRIL 30, 2023

Clinical trials are complex and time-consuming endeavors, requiring efficient management and coordination between various stakeholders. Cloudbyz’s Unified Clinical Trial Management Solution, built on the Salesforce platform, offers a comprehensive, customizable, and secure platform for streamlining clinical trial operations.

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Camargo

JUNE 15, 2021

The sponsor’s product used a novel delivery platform technology designed to reduce the treatment burden for people with a rare chronic pituitary gland disorder. Camargo supported the sponsor with obtaining orphan drug designation for the product and then navigating the complex approval process. Background.

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ACRP blog

MARCH 19, 2024

Maintaining patient engagement and minimizing dropout rates in clinical trials is a persistent hurdle, with dropout rates soaring up to 30% in some studies. Traditional methods often fall short in addressing the needs and concerns of participants, leading to disengagement and, ultimately, withdrawal from the trial.

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Drug Discovery World

SEPTEMBER 6, 2023

million female patients, meaning 45% of data were collected from women. The new service harnesses data from Phesi, and uses Krystelis’ writing services to empower sponsors to improve diversity from the trial planning stage onwards. In a further 2023 analysis on a subset of data from 22.4 million patients, Phesi discovered only 10.2

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Cloudbyz

FEBRUARY 21, 2023

QMS define, document, and implement standard operating procedures and guidelines that ensure clinical trials comply with regulatory requirements and industry standards. QMS is a set of processes, policies, and procedures designed to ensure the quality and safety of products and services. What is Quality Management System (QMS)?

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WCG Clinical

JANUARY 12, 2024

Thus, an absence of process or lack of experience in one area can significantly affect others, leading to a cascade of problems that undermine recruitment and retention plans. Multitasking is a myth, and a potentially detrimental one when it comes to clinical trials and those volunteering to participate.

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ACRP blog

APRIL 25, 2024

Despite its noble objectives, the field faces numerous challenges to reduce the complexity of clinical trials notably due to an increasing demand for more data from regulatory and reimbursement stakeholders. Proponents of this approach claim it will improve the efficiency of recruitment efforts, reduce costs, and accelerate trial timelines.

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Clinical Trial Podcast

APRIL 23, 2023

In light of the EU Medical Device Regulation (MDR), medical device manufacturers are required to implement a Postmarket Surveillance (PMS) plan, which in turn may require them to conduct Postmarket Surveillance Studies. The post Postmarket Surveillance Studies with David Rutledge appeared first on Clinical Trial Podcast & Blog.

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WCG Clinical

JANUARY 4, 2024

Connecting people, data, insights, and technology for a better, more efficient clinical trial experience. While the industry continues to adjust in a post-COVID world, as of this publication we expect clinical trial starts in 2024 to be up slightly over 2023. Despite this improvement, disconnects remain.

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Clinical Trials Clinical Trials Trials Clinical Research 59

ACRP blog

FEBRUARY 29, 2024

Implementing trials at study sites is a process fraught with challenges. About 80% of clinical trials fail to achieve enrollment targets and timelines, with resulting delays costing up to $8 million per day in lost revenues for sponsors.{1}Contributing 1}Contributing factors include avoidable protocol amendments.

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XTalks

NOVEMBER 1, 2023

It has been confirmed by independent studies that integrating patient perspectives at the initial stages of clinical development can produce trials with endpoints that are more meaningful. Watch the free webinar for expert insights, and read on to learn three best practices to enhance patient engagement in clinical trials.

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Cloudbyz

APRIL 9, 2023

Accelerating clinical site activation is crucial to ensure timely initiation of clinical trials and efficient resource utilization. Consider conducting a feasibility assessment to ensure that the chosen sites meet the trial’s requirements and can achieve enrollment targets.

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pharmaphorum

JUNE 30, 2022

As an industry, we recognise patients as partners in the development process, but if we aim to enhance the patient experience in clinical trials and ultimately, improve patients’ lives, we need to continue to consider how we keep the patient front and centre in drug development. Patient access.

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XTalks

NOVEMBER 20, 2023

Xtalks’ recent discussion with Rebekah Angove, PhD, Executive VP of Research and Evaluation at the Patient Advocate Foundation (PAF), offers a deeper understanding of incorporating patient narratives into clinical trials. To bridge this gap, PAF not only educates patients about available clinical trials but also assists in navigating them.

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Cloudbyz

MARCH 1, 2023

Clinical trials are a critical component of drug development in the life sciences industry. Conducting clinical trials requires significant investments of time and resources, including the management of budgets and payments. Historically, the management of budgets and payments in clinical trials has been a paper-based process.

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Clinical Trials Clinical Trials Trials Compliance 94

Cloudbyz

MARCH 18, 2023

Contract Research Organizations (CROs) play a crucial role in helping biotech companies conduct clinical trials and bring drugs to market. Build expertise: CROs should build expertise in specific therapeutic areas or types of clinical trials. CROs can better serve their clients by being flexible and adaptable in their approach.

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Clinical Trials Clinical Trials Trials Compliance 52

Cloudbyz

APRIL 6, 2023

Clinical trials are essential for the development of new therapies and treatments, and they require the coordination of multiple stakeholders, including study sponsors, investigators, patients, and regulatory agencies. However, these eClinical platforms come with unique challenges that impact clinical trial operations.

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ACRP blog

FEBRUARY 15, 2023

As we mark Black History Month, what are your thoughts on overall efforts to improve diversity within the clinical trials ecosystem? I am encouraged by how focused we are as an industry on addressing the serious underrepresentation of diverse populations in clinical trials. Although I was quite happy that the U.S. This is a good thing.

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pharmaphorum

FEBRUARY 7, 2022

The last three years in pharma have seen a growing awareness of and dissatisfaction with a trend that has plagued the industry for its whole life: Nondiverse and unrepresentative clinical trials, which lead to incomplete data and compounded health disparity for minority populations.

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XTalks

DECEMBER 5, 2023

Central labs ensure consistency in test methodologies, equipment and reporting standards, which is vital for the integrity of clinical trials. Accurate and reliable lab data play a crucial role in any clinical trial. There’s an entire ecosystem in the central lab and in a clinical trial that you need to be aware of,” he says.

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Cloudbyz

MARCH 13, 2023

Clinical trial data management involves collecting, processing, analyzing, and reporting data from clinical trials in a systematic and efficient manner. Effective data management is critical for ensuring the safety and efficacy of the tested intervention and maintaining the integrity of the trial results.

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Cloudbyz

FEBRUARY 23, 2023

Clinical trials are complex and resource-intensive endeavors, and as such, there is an increasing need to streamline clinical trial operations and increase operational efficiency. A unified platform that integrates multiple clinical trial management systems can be a game-changer in improving operational efficiency in clinical trials.

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VirTrial

NOVEMBER 30, 2020

VirTrial software offers trial-tested solutions for remote-based patient and site visits . By adding the capabilities of VirTrial, Signant Health now expands its software stack to further digitally enhance trial sites and offer sponsors superior evidence generation across traditional, decentralized, and hybrid trial models.

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Camargo

NOVEMBER 20, 2020

The next step is understanding why these studies are required and how they should be designed. Drug development programs use safety data generated from adult clinical trials, which are supported by nonclinical studies in adult animals. How Are Juvenile Animal Toxicity Studies Designed?

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Cloudbyz

JUNE 11, 2023

This transformation has permeated the domain of clinical trials, which is now embracing the concept of decentralized clinical trials (DCTs). This paper delves deep into the universe of DCTs, their distinctiveness from conventional trials, their inherent benefits, existing hurdles, and measures to bolster their adoption.

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WCG Clinical

JULY 17, 2023

Sponsors and provider organizations understand that patient- and site-centricity are critical for a robust clinical trial industry. Most sponsors design their protocol, to some degree, on feedback from investigators and participants. However, they typically turn to those already familiar with the clinical trial industry.

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Cloudbyz

NOVEMBER 20, 2021

This article is the third part of a Cloudbyz article series about Recruitment & Retention in clinical trials. The second part of this series highlighted some of the most common challenges in recruitment & retention for clinical trials. And shall then address these solutions from a future perspective.

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Cloudbyz

MARCH 30, 2023

However, the development and delivery of cell and gene therapies present significant operational challenges that must be navigated carefully to ensure successful clinical trials. Cost: Manufacturing cell and gene therapies can be expensive, especially for small patient populations, which can impact the overall viability of a trial.

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Cloudbyz

MARCH 8, 2023

However, getting these devices to market requires extensive clinical trials to ensure their safety and efficacy. The clinical trial process can be time-consuming, with various stakeholders involved, including investigators, sponsors, CROs, and regulatory authorities. What is a Unified Clinical Trial Management Platform?

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