Design of experiments

New Technology to Help Increase Patient Diversity in Clinical Trials

Retrieved on:

Monday, July 19, 2021

Health sciences, Clinical research, Health, Pharmaceutical industry, Medical research, Food and Drug Administration, Clinical pharmacology, Clinical trial, Design of experiments

Both for patients themselves and for public confidence in the drug development process, we need to improve diversity in clinical trials."

Key Points:

Both for patients themselves and for public confidence in the drug development process, we need to improve diversity in clinical trials."
"We need diverse populations enrolled in clinical trials for proper evidence generation to help ensure that a therapy is effective for everyone it is intended to help.
To find new and improved ways to address the healthcare challenges facing today's socio-economic and geographically diverse patients, Rajasimha developed a technology platform to launch an effort to increase diversity in clinical trials .
"Clinical Trials Have Far Too Little Racial and Ethnic Diversity," Scientific American, September I, 2018, scientificamerican.com/article/clinical-trials-have-far-too-little-racial-and-ethnic-diversity/
2.Chino, Dr. Fumiko; "Minority Participation in Clinical Trials: A Call to Action"; 21 Aug 2019; Astro; astro.org/Blog/August-2019/Minority-Participation-in-Clinical-Trials-A-Call-t
3.Klane, Lindsey.

Global Germ Cell Tumors Clinical Trials Review - H1, 2021 - ResearchAndMarkets.com

Retrieved on:

Monday, July 19, 2021

Health, General Health, Health sciences, Health, Clinical research, Medical research, Pharmaceutical industry, Clinical pharmacology, Food and Drug Administration, Clinical trial, Design of experiments

Report provides top level data related to the clinical trials by Region, Country (G7 & E7), Trial Status, Trial Phase, Sponsor Type and End point status

Key Points:

Report provides top level data related to the clinical trials by Region, Country (G7 & E7), Trial Status, Trial Phase, Sponsor Type and End point status
The report reviews top companies involved and enlists all trials (Trial title, Phase, and Status) pertaining to the company
The report provides all the unaccomplished trials (Terminated, Suspended and Withdrawn) with reason for unaccomplishment
Aids in interpreting the success rates of clinical trials by providing a comparative scenario of completed and uncompleted (terminated, suspended or withdrawn) trials
Facilitates clinical trial assessment of the indication on a global, regional and country level

ImmVira Launches Pilot-scale Production Line to Expedite the Advancement of Next-generation OV Clinical Trials

Retrieved on:

Monday, July 19, 2021

Health sciences, Health, Clinical research, Drug discovery, Pharmaceutical industry, Design of experiments, Life sciences, Clinical trial

Leveraging a strategy of dual in-house manufacturing and CDMO, ImmVira can continue to innovate on CMC techniques while concurrently improve production efficiency with the aim to expedite the advancement of clinical trials for its pipelines.

Key Points:

Leveraging a strategy of dual in-house manufacturing and CDMO, ImmVira can continue to innovate on CMC techniques while concurrently improve production efficiency with the aim to expedite the advancement of clinical trials for its pipelines.
Pilot-scale production line encompasses comprehensive functionalities from cell culturing, virus replication, harvest, purification to filling and stoppering, fully supporting early-stage clinical trials of ImmVira's next-generation product candidates.
This production line is expected to provide sufficient product supply for Phase I/II clinical trials of several key new pipelines, thus enhancing clinical trial progress and novel candidates development.
ImmVira will continue to cooperate closely with Obio Technology (Shanghai) Corp., Ltd on clinical trials production for its lead products including MVR-T3011 (also known as T3011).

Global Thrombocytopenia Clinical Trials Review - H1, 2021 - ResearchAndMarkets.com

Retrieved on:

Friday, July 16, 2021

Pharmaceutical, Health, Clinical trials, Cardiology, Health sciences, Health, Clinical research, Medical research, Pharmaceutical industry, Clinical pharmacology, Food and Drug Administration, Clinical trial, Design of experiments

Report provides top level data related to the clinical trials by Region, Country (G7 & E7), Trial Status, Trial Phase, Sponsor Type and End point status

Key Points:

Report provides top level data related to the clinical trials by Region, Country (G7 & E7), Trial Status, Trial Phase, Sponsor Type and End point status
The report reviews top companies involved and enlists all trials (Trial title, Phase, and Status) pertaining to the company
The report provides all the unaccomplished trials (Terminated, Suspended and Withdrawn) with reason for unaccomplishment
Aids in interpreting the success rates of clinical trials by providing a comparative scenario of completed and uncompleted (terminated, suspended or withdrawn) trials
Facilitates clinical trial assessment of the indication on a global, regional and country level

Ocugen, Inc. Announces Initiation of Rolling Submission to Health Canada for COVAXIN™

Retrieved on:

Thursday, July 15, 2021

COVID-19 vaccines, Clinical trials, Health sciences, Health, Medicine, Covaxin, COVID-19 pandemic in India, Clinical research, Design of experiments, Bharat Biotech, COVID-19 vaccine, CoronaVac

This follows the release by Bharat Biotech of Phase 3 clinical trial results , which demonstrated efficacy and safety in nearly 25,800 adults.

Key Points:

This follows the release by Bharat Biotech of Phase 3 clinical trial results , which demonstrated efficacy and safety in nearly 25,800 adults.
Often referred to as a rolling review, this allows Health Canada to start its review right away, as information continues to come in, to accelerate the overall review process.
Ocugen initiated the rolling submission through its affiliate, Vaccigen, Ltd. Health Canada will make a decision upon review of the evidence submitted that supports its safety, efficacy and quality.
Based on the more than 30 million doses supplied in India and other countries, COVAXIN has an excellent safety record.

Theratechnologies Reports Financial Results for the Second Quarter of Fiscal 2021 and Provides Update on Its Planned Phase 3 Clinical Trial in NASH

Retrieved on:

Thursday, July 15, 2021

Health sciences, Clinical research, Health, Pharmaceutical industry, Life sciences, Drug discovery, Design of experiments, Food and Drug Administration, Clinical trial

In NASH, we concluded regulatory discussions in the U.S. and EU and now have a ready-to-proceed Phase 3 clinical trial design, said Paul Lvesque, President and Chief Executive Officer, Theratechnologies.

Key Points:

In NASH, we concluded regulatory discussions in the U.S. and EU and now have a ready-to-proceed Phase 3 clinical trial design, said Paul Lvesque, President and Chief Executive Officer, Theratechnologies.
Based on regulatory discussions, the final Phase 3 clinical trial design will result in higher costs than what the Company had previously estimated.
Partner identification and negotiations will alter the initiation of the Phase 3 clinical trial that was previously expected to begin in the third quarter of calendar year 2021.
As such, Adjusted EBITDA provides improved continuity with respect to the comparison of our operating results over a period of time.

Global Peanut Allergy Disease Clinical Trials Review - H1, 2021 - ResearchAndMarkets.com

Retrieved on:

Wednesday, July 14, 2021

Health, Clinical trials, Health sciences, Health, Clinical research, Medical research, Pharmaceutical industry, Clinical pharmacology, Food and Drug Administration, Clinical trial, Design of experiments

Report provides top level data related to the clinical trials by Region, Country (G7 & E7), Trial Status, Trial Phase, Sponsor Type and End point status

Key Points:

Report provides top level data related to the clinical trials by Region, Country (G7 & E7), Trial Status, Trial Phase, Sponsor Type and End point status
The report reviews top companies involved and enlists all trials (Trial title, Phase, and Status) pertaining to the company
The report provides all the unaccomplished trials (Terminated, Suspended and Withdrawn) with reason for unaccomplishment
Aids in interpreting the success rates of clinical trials by providing a comparative scenario of completed and uncompleted (terminated, suspended or withdrawn) trials
Facilitates clinical trial assessment of the indication on a global, regional and country level

RegeneRx JV Updates RGN-259 Regulatory Progress for Dry Eye Syndrome

Retrieved on:

Wednesday, July 14, 2021

Health sciences, Health, Food and Drug Administration, Clinical research, Design of experiments, Keratopathy, Clinical trial

As previously reported, ReGenTree is working with a 3rd party FDA consulting firm to complete a regulatory gap analysis and explore the prospects of a pre-BLA meeting.

Key Points:

As previously reported, ReGenTree is working with a 3rd party FDA consulting firm to complete a regulatory gap analysis and explore the prospects of a pre-BLA meeting.
This includes a review of clinical studies, non-clinical studies, CMC requirements and previous meeting minutes between ReGenTree and FDA.
Thus far, ReGenTree has sponsored three Phase 3 studies in the U.S. for dry eye, which are ARISE-1 (Phase 2b/3), ARISE-2 (Phase 3), and the recently completed ARISE-3 (Phase 3) for dry eye.
In addition to dry eye, the Company completed a Phase 3 study (SEER-1) for neurotrophic keratopathy (NK), an orphan indication in ophthalmology.

SMi Trial™ "Closes the Loop" by Confronting One of the Biggest Problems in Clinical Trials

Retrieved on:

Wednesday, July 14, 2021

Health sciences, Health, Clinical research, Medical research, Clinical pharmacology, Design of experiments, Pharmaceutical industry, Clinical trials

SAN DIEGO, July 14, 2021 /PRNewswire/ --ScienceMedia announces that SMi Trial's fully mobile, fully compatible, just-in-time solution closes the loop in clinical trials.

Key Points:

SAN DIEGO, July 14, 2021 /PRNewswire/ --ScienceMedia announces that SMi Trial's fully mobile, fully compatible, just-in-time solution closes the loop in clinical trials.
Clinical trials are embedded in a clinical process of humans caring for humans.
SMi Trial for site-based trials, and SMi TrialD for decentralized or hybrid trials, mitigate clinical risk and decrease trial cost by optimizing study compliance throughout the lifetime of your clinical trial.
For ongoing insight aboutproven clinical trial performance solutions for decentralized and hybrid trials, followScienceMediavia LinkedIn or our blog .

Castor Raises $45M Series B to Modernize the Clinical Trial Process and Maximize the Impact of Research Data on Patient Lives

Retrieved on:

Wednesday, July 14, 2021

Castor was created with the mission to help researchers globally conduct more effective clinical trials while improving the patient experience, said Derk Arts, M.D., CEO & Founder of Castor.

Key Points:

Castor was created with the mission to help researchers globally conduct more effective clinical trials while improving the patient experience, said Derk Arts, M.D., CEO & Founder of Castor.
Prioritizing the patient and site user experience is particularly important today, when COVID-19 has fundamentally changed the nature of clinical trials.
Castor offers a modern, self-service clinical research platform, which enables every researcher worldwide to design studies and integrate data from any source in real-time.
Castor is bringing human-centered design to the clinical trial process, from recruitment to analysis, and improving the quality, security and reusability of data for researchers worldwide.