Drug Discovery World

AUGUST 15, 2022

She is a Senior Enterprise Fellow at the University of Southampton and coordinates the AI 4 Scientific Discovery Network and the Future Blood Testing Network, in addition to running an Ethics working group.

Drugs 52

Drugs Research 52

Rethinking Clinical Trials

APRIL 27, 2023

Cluster randomized trials of hemodialysis center-wide policies raise complex ethical issues. 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 130

Trials Clinical Trials Clinical Trials Medicine 130

Rethinking Clinical Trials

FEBRUARY 14, 2024

There was a lot of work that went into startup, making sure incentives were aligned across the VA system, meetings with primary care, cardiology, the VA ethics office, and ultimately with the central IRB. The actual startup was about 18 months.

Clinical Trials 152

Clinical Trials Clinical Trials Cardiology Trials 152

Rethinking Clinical Trials

OCTOBER 13, 2022

We planned this trial with three centers and then the third center did not get the approval by the ethics committee, so we had to include 12 centers. . – What didn’t go as you expected and what were some of the lessons that you learned that would inform a follow-on trial to this trial? pctGR, @Collaboratory1.

Trials 130

Trials Clinical Trials Clinical Trials Nurses 130

Rethinking Clinical Trials

JULY 6, 2023

As IRBs and ethics committees review of DCTs, they can use newly developed recommendations for what should be submitted and discussions that should occur once the appropriate documents are submitted. All trials are different, but it’s important to ask the right questions and be clear in the protocol.

Trials 130

Trials Clinical Trials Clinical Trials Licensing 130

Drug Discovery World

OCTOBER 31, 2023

The UK Medicines and Healthcare Products Regulatory Agency (MHRA), Research Ethics Committee (REC), and Health Research Authority (HRA) have all approved the clinical trial application that was submitted by The University of Manchester in August 2022.

Gene Therapy 52

Gene Therapy Gene Trials Clinical Trials 52

Rethinking Clinical Trials

AUGUST 28, 2023

The principles aim to promote good science and ethics, be clear and concise, be inclusively developed and be progressive and durable. Annex-2 of E6(R3) will include additional considerations of GCP principles focused on decentralized elements, pragmatic elements and real-world data sources. The guidance should not remove the need to think.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Development 130

Rethinking Clinical Trials

AUGUST 28, 2023

The principles aim to promote good science and ethics, be clear and concise, be inclusively developed and be progressive and durable. Annex-2 of E6(R3) will include additional considerations of GCP principles focused on decentralized elements, pragmatic elements and real-world data sources. The guidance should not remove the need to think.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Development 130

pharmaphorum

AUGUST 17, 2020

In this article Joanna Carlish, managing director of financial services at Tag Americas , and Robb DeFilippis, Tag Americas’ managing director, life sciences, go head-to-head to discuss marketing within a regulated industry. Joanna Carlish, managing director, financial services, Tag Americas. Virtual connections.

Regulation 84

Regulation Marketing Sales Branding 84

XTalks

AUGUST 25, 2021

Pre-pandemic, Daniel Maloney could be found working sample booths at food markets around New York City, telling consumers about the brand’s rich history and commitment to ethical farming. But without food sampling, consumers may not be able to justify the $6 price tag, let alone be aware of the brand. .

Branding 98

Branding Marketing Nurses Production 98

pharmaphorum

SEPTEMBER 29, 2021

Because we spend so much time on it, using email appropriately and purposefully can help enterprises conduct business in a responsible manner obeying applicable laws, guidelines and ethical standards. Don’t engage in conversations that may conflict with your professional responsibilities, laws or ethics. Reduce your readership.

Life Science 116

Life Science Containment Sales Marketing 116

Drug Discovery World

JANUARY 30, 2024

Other Challenges: Limited insurance coverage: Many insurance companies are hesitant to cover CGTs due to their high price tags and limited long-term data. Patient access and equity: High costs disproportionately impact access for low-income patients, creating ethical and equity concerns.

Gene Therapy 71

Gene Therapy Manufacturing Gene Clinical Trials 71

XTalks

AUGUST 23, 2021

Are Placebo Arms Still Ethical in Alzheimer’s Clinical Trials? While a placebo-controlled trial is considered to be the most robust study design possible, there are ethical questions about whether it’s appropriate to withhold an approved drug from patients who have the potential to benefit from it.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Drugs 52

Drug Discovery World

OCTOBER 3, 2022

She coordinates the AI 4 Scientific Discovery Network and the Future Blood Testing Network, in addition to running an ethics working group.

Drugs 52

Drugs Scientist Bioinformatics Medicine 52

Rethinking Clinical Trials

OCTOBER 19, 2022

Ethics, IRB, FM-TIPS. Due to the low referral rates of fibromyalgia patents to PT (~30%), FM-TIPS had an emergent ethic issue related to patient recruitment and whether the study team could include the American College of Rheumatology criteria to screening to increase eligibility. Wilson Family Chair in Medicine. Key Points.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Medicine 130

Intouch Solutions

AUGUST 25, 2021

In this POV, we evaluate the potential impact to the email channel and opportunities to continue to deliver ethical, quality email experiences and personalization for pharma customers, including healthcare providers (HCPs) and patients. In terms of scale, there are 113 million iPhone users in the United States alone. ©Intouch Group 2021.

Marketing 52

Marketing Regulation Engineer Branding 52

Rethinking Clinical Trials

FEBRUARY 2, 2023

We had to develop an ethical framework for this for our institution. Tags #pctGR, @Collaboratory1 The post Grand Rounds January 27, 2023: The PREPARE II Trial: Embedding a Pragmatic Trial Into Clinical Care During an Emergency Procedure (Derek W. At Vanderbilt, we did not have any contact internally with the IRB.

Trials 130

Trials Clinical Trials Clinical Trials Medicine 130

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 59

Research Drugs Gene Therapy Clinical Trials 59

Rethinking Clinical Trials

AUGUST 4, 2022

-Were any concerns raised on ethics of keeping a placebo arm in this population? For the countries we are working in this has not been an issue because of the drugs that were available during the time of the study. Immunosuppressed patients might be a subgroup that would particularly benefit from this type of treatment.

Trials 130

Trials Vaccination Vaccine Clinical Trials 130

XTalks

FEBRUARY 11, 2021

They conducted two experiments, one with radioactive phosphorous to label DNA, and one with radioactive sulfur to tag protein (DNA does not contain sulfur and protein does not contain phosphate groups). Through the radioactive labels, they were able to track which of the two, DNA or protein, was injected into the bacteria.

Genetics 119

Genetics DNA Genome Genomics 119