Clinical trials face increasing challenges

Bio Pharma Dive

The COVID-19 pandemic emerged at a time when the clinical trial landscape had reached a peak in complexity. Global trials are now commonplace as drug makers seek to establish efficacy in diverse populations

Practical approaches to operationalizing decentralized clinical trials

Bio Pharma Dive

When appropriate, DCTs can accelerate trial conduct, create a wealth of high-quality data and improve efficiency

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How to address patient privacy and data-security concerns in clinical trials

Clairnes

The post How to address patient privacy and data-security concerns in clinical trials appeared first on Clinical Trial Recruitment & Management Services.

Pfizer gene therapy research delayed by trial changes, safety questions

Bio Pharma Dive

Data readouts for Pfizer's hemophilia gene therapies are now expected later than previously forecast, while the company also works through modifying a trial of its Duchenne treatment

Clinical trial DTC? It may not be right for your drug candidate

World of DTC Marketing

SUMMARY: Over half of all clinical trial sites are outside the U.S. 87 % of all subjects in recent biologics trials were enrolled outside the U.S. DTC may or may not work for clinical trial enrollment it really depends on the condition and risk as judged by the patient.

How to leverage data to boost atopic dermatitis trial registrations

Clairnes

The post How to leverage data to boost atopic dermatitis trial registrations appeared first on Clinical Trial Recruitment & Management Services.

Accelerating virtual clinical trials

Bio Pharma Dive

Leveraging the guidance and support of trial virtualization professionals with experience in key areas of a trial's lifecycle will undoubtedly impact overall success

Breaking down the barriers to decentralized trials

Bio Pharma Dive

Decentralized trials are here to stay. Here's how technology has and will continue to pave the way

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New cancer drug clinical trials struggling

World of DTC Marketing

WHAT’S THIS ABOUT THEN : Researchers are rushing to launch clinical trials of experimental vaccines against the coronavirus, and treatments for COVID-19. Eli Lilly recently announced that it would halt enrolment in ongoing studies and delay the launch of new trials.

4 Benefits Of Clinical Trial Participation

Olympian Clinical Research

Clinical trials are research studies designed to evaluate or test a medical, surgical, or behavioral intervention. Most recently, clinical trials have gained recognition through the development and testing of Covid-19 vaccines.

Advanced breast cancer patients denied opportunities to join clinical trials

Scienmag

Clinicians and the wider research community involved in treating advanced breast cancer (ABC) need to do more to help and encourage patients to join clinical trials, according to a patient advocate who is leading a study that shows only 14% of ABC patients in the UK have been recruited to a trial.

eCOA clinical trials: A simple, cost-effective approach to study build

Bio Pharma Dive

This new data capture model gives clinical trial sponsors control over study build

Sarepta embarks on late-stage clinical trial of Duchenne gene therapy

Bio Pharma Dive

Initiation of the Phase 3 trial is an important milestone for the biotech after earlier setbacks, as well as for patients with the inherited muscle disease

Worrisome side effects lead Pfizer to narrow Duchenne gene therapy trial

Bio Pharma Dive

Outside trial data reviewers have attributed three cases of severe muscle weakness to Pfizer’s treatment, causing the company to change the design of its closely watched Phase 3 study

The Apple Watch in clinical trials: Current uses and future possibilities

Bio Pharma Dive

Why the Apple Watch will likely be one of the top choices for use by sponsors, CROs and clinical trial teams wishing to use wearables in their trials

Equal Parts Caregiver and Advocate: Clinical Trials from the Caregiver’s Point of View

Camargo

In this Q&A, Andrea discusses their experience, especially as it relates to the two clinical trials Tom participated in. We wanted to participate in a clinical trial. But our original doctor doesn’t work with clinical trials—it’s just not his thing.

How new digital methods can increase atopic dermatitis screener completions and enrolment

Clairnes

The post How new digital methods can increase atopic dermatitis screener completions and enrolment appeared first on Clinical Trial Recruitment & Management Services.

Roche cuts ties with Atea after COVID-19 pill's trial failure

Bio Pharma Dive

The Boston biotech, shares of which soared last year on hopes for the antiviral drug, said it has plenty of money to advance development on its own

Trials 212

Use of digital tools for clinical trials triples during pandemic; survey

Pharma Phorum

A new poll of clinical trial sponsors has found that around nine out of 10 of them are running decentralised trials with the help of digital technologies, a big increase on pre-COVID-19 levels. Digital News clinical trials data decentralised trials digital digital health Veeva

Adopting RBQM to ensure trial oversight in COVID and beyond

Bio Pharma Dive

Now more than ever, a firm grasp of RBQM is needed for the success of all clinical trials

Fourth trial volunteer dies in Astellas gene therapy study

Bio Pharma Dive

The study, which was suspended following three deaths last year, had been restarted in February after Astellas lowered the treatment dose used

Pfizer, Merck launch large new trials of oral COVID-19 drugs

Bio Pharma Dive

Both companies are racing to prove their oral antivirals as treatments for COVID-19. Key clinical results could come later this year

Trials 285

Oncotarget: Impact factor and citation metrics in phase III cancer trials

Scienmag

Oncotarget published “Impact factor and citation metrics in phase III cancer trials” which reported that a journal impact factor is often used to measure research quality and importance. Medicine & Health cancer citation factor III impact metrics Oncotarget Phase trials

Reducing lung transplant rejection aim of clinical trial funded with $22 million grant

Scienmag

Medicine & Health aim clinical funded grant lung million Reducing rejection transplant trialPhysicians at Washington University School of Medicine in St.

Reimagining Clinical Trials: Why are Virtual Clinical Trials Becoming the New Normal?

Delveinsight

Clinical trials are an essential part of the drug development process. Worldwide, more than 2 million clinical trials are registered and the number is steadily increasing over the past several years. The conduct of trials was not possible due to the risk of catching coronavirus.

Allogene cell therapy trials halted by FDA after safety finding

Bio Pharma Dive

Researchers found evidence of a "chromosomal abnormality" in one patient treated with Allogene's CAR-T cell therapy, spurring the clinical hold and an investigation

Trials 246

Biogen says experimental pain drug helps neuropathy patients in mid-stage trial

Bio Pharma Dive

Mixed trial results, however, may make it challenging to design a larger study that can persuade regulators to approve the pain drug With Aduhelm approved but struggling to gain traction, Biogen is talking up its pipeline.

The Future is Now: Trends in Clinical Trials Brought to Reality

Crucial Data Soutions

A medical device sponsor is conducting a clinical trial on an innovative cardiac stent. The sponsor has chosen to take a hybrid approach to their study to decrease risk and increase patient safety, adhering to the FDA’s guidance on conducting clinical trials during the pandemic.

AstraZeneca immunotherapy combo extends survival in liver cancer trial

Bio Pharma Dive

The results are a rare positive result for AstraZeneca's experimental drug tremelimumab, which has come up short in a handful of other studies and cancer types

Trials 227

Project Management & Planning for Successful Clinical Trials

Forte Research Systems®

Efficient Clinical Trials Site ManagementFollow these project management and planning basics while conducting clinical research at your site.

Pfizer beats Sarepta to the start of first late-stage Duchenne gene therapy trial

Bio Pharma Dive

The first patient enrolled in a Phase 3 trial of Pfizer's treatment was given the experimental one-time therapy on Dec.

Chinese drugmaker Clover says vaccine prevents COVID-19 in large trial

Bio Pharma Dive

Positive results from Clover's Phase 3 study could mean another coronavirus vaccine option for the many countries still grappling with short supplies

Trials 240

Wearables for actigraphy measures in clinical trials

Bio Pharma Dive

It's now possible to gather far more data, more often, more objectively, and more easily than ever before, and, with the appropriate choice, broadly expedite clinical trials utilizing actigraphy measurements

4 insights on decentralized trials for biotechs

Bio Pharma Dive

Here are four things we have learned about DCTs that biotech companies can consider when designing a decentralized or hybrid trial

Trials 130

Penn study finds solid-tumor cancer patients ineligible for clinical trials receive immunotherapy at greater rates despite lack of benefits

Scienmag

Cancer benefits cancer clinical finds greater immunotherapy ineligible lack Patients Penn rates receive solidtumor study trials

COVID-19 Clinical Trial Updates

My Local Study

They go through a clinical trial process to determine a vaccine or treatment’s safety and effectiveness. Read more COVID-19 Clinical Trial Updates. The post COVID-19 Clinical Trial Updates appeared first on MyLocalStudy.com.

Six Benefits of Using a Mobile App in Clinical Trials

Crucial Data Soutions

A paradigm shift is occurring in the clinical trials industry surrounding mobile technology, or more specifically, mobile health (mHealth) following the COVID-19 pandemic. A mobile-forward approach to clinical trials affords many advantages that cannot be realized with other modalities.

Are Patients Still Seeking Clinical Trials During Covid-19?

Find Me Cure

At the beginning of the global lockdown, our team at FindMeCure had some assumptions, concerns and predictions about the impact of Covid-19 on clinical trials and more specifically – the patients seeking treatments. Remote/virtual trials are still a good idea.

Smartphone-powered trial backs J&J’s Invokana for heart failure

Pharma Phorum

Johnson & Johnson’s SGLT2 inhibitor Invokana has been shown to have a significant effect on heart failure symptoms in a clinical trial that relied entirely on remote monitoring of symptoms using a smartphone app.

The Future of Clinical Trials

Riverside Clinical Research

The efficacy of clinical trials can have a direct correlation to the use of innovative technology within them. There has been and continues to be a shift to decentralization in clinical trials. Another major player in our remote clinical trial connections is the wireless medical device.

Virtual village treats HIV-associated loneliness in novel UC San Diego health trial

Scienmag

Space & Planetary Science Diego health HIVassociated loneliness San treats trial village virtual

Decentralized Clinical Trials VS Conventional Clinical Trials: A Comparison

Cloudbyz

Co-authored by Reeshav Mittal(Clinical Trial Subject Matter Expert) COVID-19 changed a lot of things. In the clinical research world, one of the most exciting new developments is the accelerated rise of Decentralized Clinical Trials.

Novavax says vaccine 90% effective against COVID-19 in large trial

Bio Pharma Dive

Highly anticipated results from a Phase 3 study testing the biotech company's shot showed it to be strongly protective and safe, a potential boon for the world's vaccination efforts

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