Advarra

FEBRUARY 4, 2025

At a busy research site, a clinical trial is ready to launch but its stuck in limbo over a single paragraph in the informed consent form (ICF). While the trial waits for approval, patients who are eager for a new treatment face delay. Language relating to the potential cost of participation.

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Clinical Trials Trials Compliance Therapies 52

Conversations in Drug Development Trends

MARCH 12, 2024

Biomarkers provide a rapid way to inform many clinical oncology study development decisions, including study endpoints. They can inform intervention outcomes, serve as study endpoints, and are advantageous across the spectrum of cancer care. What are they, how do they work, and how can they benefit your oncology study?

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Clinical Trials Immune Response Trials Disease 72

PPD

OCTOBER 9, 2023

“Patient-centric” is used frequently to describe today’s clinical trial and health care landscape. The industry applauds that point of view and strives to include a patient-centric approach in all aspects of clinical trial designs. Patient centricity has become more than a key consideration.

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Clinical Trials Trials Compliance International 98

Drug Target Review

DECEMBER 13, 2024

2 Unmet needs in lung cancer treatment Recent decades have seen significant advancements in lung cancer treatment, especially with the introduction of targeted therapies and immunotherapies, which have notably improved survival rates. 15 Figure 1: A schematic illustrating a bispecific antibody-drug conjugate (ADC).

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Therapies Treatment Clinical Trials Drugs 98

Codon

NOVEMBER 3, 2024

In the 1924 novel, The Magic Mountain , Thomas Mann describes a sanatorium patient named Anton Ferge as he undergoes a painful tuberculosis (TB) treatment. A 1994 review of 14 prospective trials and 12 case-control studies revealed that the BCG vaccine reduced the risk of TB by 50 percent. million people every year.

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Vaccine Trials Therapies Clinical Trials 92

Drug Patent Watch

DECEMBER 12, 2024

Branded drugs, developed through extensive research and clinical trials, often enjoy patent protection for a limited period. Drugs that require extensive clinical trials for generic approval or fall under special regulatory pathways may have a lower risk of generic entry.

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Licensing Licensing Drugs Biosimilars 96

Conversations in Drug Development Trends

MARCH 1, 2024

These designs facilitate streamlined trial logistics and centralized governance and create higher-quality data. Master protocols allow a trial to perform multiple tests on diverse patient populations or diseases under a unified design. But how do they work, and when are they appropriate? What Are Master Protocols?

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Trials Disease Drug Development Clinical Trials 78

Conversations in Drug Development Trends

AUGUST 9, 2024

Authors: Matt Cooper, PhD, Executive Director, Therapeutic Strategy Lead, Oncology; Megan Morrison, Vice President, Asia Pacific Strategy Lead Adaptive trial designs have become essential in oncology, offering a flexible and efficient approach for conducting clinical trials.

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Trials Clinical Trials Regulations FDA 80

PPD

JANUARY 5, 2023

In our survey, patient recruitment and retention remain significant concerns cited by clinical trial sponsors across all therapies. Research by Global Data finds that more than one out of four rare disease clinical trials terminate due to low patient accrual rates. Expand access with decentralized clinical trials (DCTs).

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Disease Trials Clinical Trials Clinical Research 52

Conversations in Drug Development Trends

JANUARY 21, 2025

Regulatory bodies such as the FDA oversee clinical trials to ensure that studies’ design, conduction, analysis, and reporting are per established guidelines and laws. Any delays or missteps in bioanalysis during a Phase I trial can derail the trajectory of a promising drug.

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Clinical Trials Laboratories Trials Drug Development 78

Broad Institute

NOVEMBER 7, 2023

While RA therapies targeted to specific inflammatory pathways have emerged, only some patients’ symptoms improve with treatment, emphasizing the need for multiple treatment approaches tailored to different disease subtypes. They also found that patients’ CTAPs were dynamic and could change over time in response to treatment.

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Treatment RNA Hospitals Disease 96

Conversations in Drug Development Trends

AUGUST 14, 2024

By: Simran Padam, Medical Director, Medical Affairs Personalized treatment approaches have emerged as pivotal in improving outcomes for hematological cancers. Hematological cancer cells can also develop resistance to therapies over time, reducing treatment effectiveness.

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Treatment Therapies Disease Protein Expression 78

FDA Law Blog: Drug Discovery

MARCH 7, 2024

Clissold — The trio of CDER, CBER, and CDRH released a new draft guidance titled “ Use of Data Monitoring Committees in Clinical Trials ” that revises the 2006 guidance “Establishment and Operation of Clinical Trial Data Monitoring Committees” and, when final, will replace the 2006 guidance.

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Clinical Trials Trials FDA Regulations 105

Conversations in Drug Development Trends

AUGUST 23, 2023

Patients are the backbone of clinical trials, playing an essential role in the drug development process. This engagement is often less understood and is underutilized by sponsors, meaning a significant element of the trial and drug experience is missed during sponsor engagement with the FDA.

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Drug Target Review

JULY 12, 2023

Molecular-level biochemical assays like transcriptomics, genomics and proteomics have emerged as valuable tools for identifying potential targets in cancer treatment through deep cyclic inhibition (DCI). Importantly, transcriptomics information shows that certain aspects of a disease change the gene expression profile.

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Biochemical Assays Treatment Bioinformatics Disease 98

FDA Law Blog: Drug Discovery

MARCH 13, 2023

Who better than people living with a condition to inform drug companies, physicians, academics, and the FDA on what it is like to live with their condition, what symptoms most impact their lives, what goes into their decision about whether to participate in a clinical trial, and what kind of treatment effects would be most meaningful to them?

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Therapies Trials FDA Clinical Trials 98

SCIENMAG: Medicine & Health

AUGUST 1, 2023

Findings from the first-ever prospective trial including a randomized pathway comparing surgery to non-surgical treatment of malignant bowel obstruction (MBO) provide important evidence to help inform clinical decision-making in managing this frequent complication in patients with advanced cancer.

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Treatment Trials 54

Drug Target Review

JULY 4, 2023

These therapies have broadened treatment options for patients to expand beyond the more traditional small molecule drug alternatives. ADCs have the potential to redress the poor balance between safety and efficacy seen with traditional cancer treatment options. 3D rendering of Antibody Drug Conjugate Molecules.

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Small Molecule Drugs Clinical Pharmacology Trials 145

Broad Institute

NOVEMBER 25, 2024

Ladders to Cures (L2C) Accelerator By Maria Nemchuk November 25, 2024 Breadcrumb Home Ladders to Cures (L2C) Accelerator The Ladders to Cures (L2C) Accelerator aims to catalyze progress across the research ecosystem and accelerates advances leading to treatments and cures for patients with rare genetic diseases.

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Clinical Trials Disease Trials Therapies 52

Advarra

MARCH 6, 2025

For more than 35 years, Advarra has been committed to protecting the rights and welfare of clinical trial participants while helping to improve healthcare outcomes, advancing medical knowledge, and bringing innovative, life-extending treatments to market that benefit millions of patients worldwide.

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Clinical Research Research Clinical Trials Bioethics 52

Olympian Clinical Research

MARCH 19, 2024

Clinical trials are essential for advancing medical knowledge and developing new treatments that can improve patient care and outcomes. Participating in a clinical trial is a significant decision that can have profound benefits, not only for the individual participant but also for future patients and the broader medical community.

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Clinical Trials Trials Clinical Research Nurses 52

PPD

DECEMBER 16, 2024

Cost and complexity go hand-in-hand The rising costs and growing complexity in clinical trials are deeply linked, with patient recruitment, extended timelines and meeting regulatory demands emerging as some of the key drivers. Nearly half (49%) of clinical trial sponsors surveyed identified rising costs as their foremost concern in 2024.

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Drug Development Clinical Trials Compliance Trials 52

Broad Institute

DECEMBER 18, 2023

Brain disorders are difficult to study and many drug candidates have failed in clinical trials, causing pharmaceutical companies to reduce their investments or even exit the field entirely. But a new path for bringing treatments to patients is starting to emerge. We all recognize the vast, unmet medical need.

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Drug Development Clinical Trials Drugs Disease 130

Advarra

SEPTEMBER 29, 2022

Informed consent is one of the central protections the regulations provide to research subjects. This tip sheet outlines the regulatory requirements for research informed consent forms (ICFs). The regulatory requirements for informed consent will vary depending upon which regulations apply to the conduct of a particular study.

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Regulations FDA Research Treatment 52

SugarCone Biotech

MARCH 2, 2025

Our skepticism was based on our understanding of the biology of those pathways and informed by observations made by the Antonia lab, several Roche groups and others that TGF- expression is sufficient to prevent T cell activation. No chemotherapy regimen is used in the trial. The lead program here was bintrafusp alfa, now terminated.

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Therapies Clinical Trials Trials Clinical Development 69

PPD

JULY 29, 2024

In today’s data-driven world, AI has become valuable and indispensable, enabling organizations to extract valuable insights from vast amounts of data, make informed decisions and drive innovation across different sectors — including drug development.

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Clinical Research Clinical Trials Research Trials 98

DrugBank

JULY 8, 2024

Revolutionizing Treatment Through the Skin with Transdermal Drug Delivery Systems The human skin, often perceived as a passive barrier to the external environment, holds potential as a route for drug administration. These fluctuations can lead to unwanted side effects or compromise the effectiveness of the treatment.

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Treatment Drugs Clinical Trials Engineering 78

PPD

SEPTEMBER 16, 2024

This can be converted to a clinical trial simulator, which can model a clinical trial before the trial design is finalized and initiated. It identifies cases in instances where diagnosis codes and other information available in each database are too non-specific to do so.

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Clinical Development Clinical Trials Clinical Research Trials 98

Drug Hunter

JUNE 26, 2023

III trial ( NCT05099640 ; n=98, 7.5-60mg/kg Of note, sepiapterin might be a treatment option for patients who don’t typically respond to BioMarin’s sapropterin (Kuvan), as a phenylalanine reduction of 69% was seen in patients with classic phenylketonuria. Get ahead now by requesting a trial. already a member?

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Small Molecule RNA Trials Treatment 130

H1 Blog

MARCH 3, 2025

Now that we have more of a breadth of data where we can look at claims data and bibliometric data such as publications, claims, and trials, its really enabled us to uncover people that we might not have known in our territories. These valuable insights have allowed J&J to rethink its educational focus and make informed decisions.

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Nurses Trials Clinical Trials Treatment 52

Alta Sciences

SEPTEMBER 13, 2023

Four Pain Models Altasciences Uses to Assess Treatments During Clinical Trials pmjackson Wed, 09/13/2023 - 17:01 September is pain awareness month, and the importance of pain management and continued research into effective analgesics is integral to helping patients suffering from various pain conditions.

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Clinical Trials Treatment Trials Drug Development 52

Vial

JUNE 24, 2024

Contract research organizations (CROs) and pharmaceutical companies can leverage these cutting-edge technologies to streamline clinical trials and introduce automation in drug discovery. As clinical trials grow in complexity, the volume of data being gathered and utilized for these studies is expanding.

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Clinical Trials Trials Clinical Research Treatment 52

On Medicine

MAY 17, 2023

When health research is published, we tend to focus our minds on the findings and consider the implications for future treatments. Yet, what about those who took part in the trial? In recent years there has been an increasing call to let trial participants know the results of trials in which they have taken part.

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Clinical Trials Trials Research Hospitals 52

H1 Blog

DECEMBER 4, 2023

As the pharmaceutical and biotech industries continue to push for faster drug development, the importance of equity and diversity in clinical trial recruitment cannot be overlooked. With the rise of digital health and data, there are endless possibilities for reaching vulnerable populations and improving access to treatment.

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Clinical Trials Trials Pharmaceutical Companies Drug Development 59

H1 Blog

SEPTEMBER 26, 2023

Breaking Down Barriers to International Clinical Trials Global Disruptions, Health Equity & Data Sharing As the U.S. Breaking Down Barriers to International Clinical Trials Global Disruptions, Health Equity & Data Sharing As the U.S. Additionally, clinical trials are no longer confined to one country or region.

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Trials Clinical Trials International Regulations 59

Conversations in Drug Development Trends

JULY 8, 2024

By: Lisle Kingery, PhD, Therapeutic Strategy Lead, Neuroscience With depression rates at an all-time high and limited new treatments available, depression clinical trials are more important than ever. Treatment Treatment can take various forms, including therapy, medication, a combination of both, or a clinical trial.

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Clinical Trials Trials Treatment Therapies 52

Drug Target Review

FEBRUARY 21, 2024

This is a time when several promising treatments – including mRNA vaccines, BiTE therapies and CAR-T cell therapy, are essentially in competition with each other – they all have a common goal of treating the same disease, but they are approaching the objective from different angles.

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Therapies Treatment Vaccine FDA Approval 65