Scientific control

ChemoCentryx and VFMCRP Provide Topline Results from ACCOLADE Trial of Avacopan in C3 Glomerulopathy Including Improved Estimated Glomerular Filtration Rate (eGFR)

Retrieved on: 
Monday, December 21, 2020
Clinical research, Articles, Vifor Pharma, Scientific method, Placebo, Scientific control, Alternative medicine, Science

After the initial blinded treatment period, all patients receive avacopan as part of an open label extension for a further 26 weeks.

Key Points: 
  • After the initial blinded treatment period, all patients receive avacopan as part of an open label extension for a further 26 weeks.
  • The data from this well-controlled, blinded placebo comparison trial provides evidence that avacopan can improve kidney function in C3G.
  • We are pleased with the results of the ACCOLADE study, said Stefan Schulze, Chief Executive Officer of Vifor Pharma.
  • The study further consolidates the effectiveness of avacopan in proliferative glomerular diseases and provides more evidence for the safety profile of avacopan.

CalciMedica Announces IDMC Recommendation to Continue with Trial Evaluating Auxora™ in Patients with Severe COVID-19 Pneumonia

Retrieved on: 
Thursday, December 17, 2020
Clinical research, Health sciences, Design of experiments, Medical research, Health, Experiments, Clinical trials, Pharmaceutical industry, Placebo, Coronavirus disease, Randomized controlled trial, Scientific control

The IDMC recommendation that the trial continue is based on an unblinded analysis of safety data from over 50 patients.

Key Points: 
  • The IDMC recommendation that the trial continue is based on an unblinded analysis of safety data from over 50 patients.
  • We are encouraged by the IDMC recommendation to continue evaluating Auxora in patients with severe COVID-19, especially at this critical time when hospitalizations are rapidly rising and communities across the country continue to struggle to contain the pandemic, said Sudarshan Hebbar, M.D., chief medical officer of CalciMedica.
  • In May 2020, the FDA strongly recommended CalciMedica move to a blinded placebo-controlled trial with Auxora in patients with severe COVID-19 pneumonia.
  • The ongoing blinded, placebo-controlled clinical trial is enrolling up to 400 patients with severe COVID-19 pneumonia to assess Auxora plus standard of care compared to placebo plus standard of care alone.

cTAP Study Shows Real-World, Natural History Data Comparable To Placebo Data From Clinical Trials In Duchenne Muscular Dystrophy

Retrieved on: 
Tuesday, September 8, 2020
Clinical research, Health, Articles, Design of experiments, Medical research, Clinical trials, Scientific method, Pharmaceutical industry, Placebo, Scientific control

"This rigorous study establishes a strong foundation for using natural history data as a substitute for placebo control in clinical trials and as a comparator to determine the effectiveness of prescribed drug treatments versus standard of care treatment."

Key Points: 
  • "This rigorous study establishes a strong foundation for using natural history data as a substitute for placebo control in clinical trials and as a comparator to determine the effectiveness of prescribed drug treatments versus standard of care treatment."
  • This is the first study to demonstrate the comparability of disease progression in NH/RWD and placebo arms of clinical trials in DMD.
  • To date, the potential for bias in clinical trials versus clinical practice has limited the use of NH/RWD to supplement or replace placebo controls.
  • With its large and continually growing multi-national database of natural history and clinical trial data sources, cTAP enables therapy developers to conduct smarter trials and bring new therapies to patients sooner.

Kindred Biosciences Announces Positive Results from Pilot Field Efficacy Study of its IL-4/IL-13 SINK Molecule Being Developed for the Treatment of Atopic Dermatitis in Dogs

Retrieved on: 
Tuesday, March 24, 2020
RTT, Medical specialties, Atopic dermatitis, Type I hypersensitivity, Placebo-controlled study, Dermatitis, Medicine, Scientific control, Research methods

The study was a randomized, blinded, placebo-controlled pilot effectiveness study that enrolled 26 client-owned dogs diagnosed with atopic dermatitis to assess the efficacy, safety, and pharmacokinetic profile of KIND-025.

Key Points: 
  • The study was a randomized, blinded, placebo-controlled pilot effectiveness study that enrolled 26 client-owned dogs diagnosed with atopic dermatitis to assess the efficacy, safety, and pharmacokinetic profile of KIND-025.
  • Treatment success for individual dogs at each visit was defined as a 50% or higher reduction from baseline in CADESI-4 or PVAS scores.
  • Positive efficacy signals were also detected with other endpoints including 20mm or higher reduction from baseline in PVAS score.
  • "These positive results mark KindredBio's eighth positive pilot study in a row, half of which relate to canine dermatitis.

Tricida Announces Fourth Quarter and Full-Year 2019 Financial Results

Retrieved on: 
Thursday, February 27, 2020
Biotechnology, Pharmaceutical, Health, Clinical research, Health, Medical research, Design of experiments, Articles, Clinical trials, Placebo-controlled study, Placebo, Scientific control

Tricida announced positive results of the TRCA-301E trial, a placebo-controlled, blinded, 40-week extension trial.

Key Points: 
  • Tricida announced positive results of the TRCA-301E trial, a placebo-controlled, blinded, 40-week extension trial.
  • The Lancet published results from Tricidas successful TRCA-301 Phase 3 clinical trial in March 2019 and the successful TRCA-301E long-term extension trial in June 2019.
  • Tricida hired key executives and expanded its Medical Affairs and Commercial organizations to support disease awareness efforts and the potential launch of veverimer in the fourth quarter of 2020.
  • Tricida will host a conference call today at 4:30 pm Eastern Time to discuss its financial results and business progress.

fishbat Discusses How Facebook Groups Can Improve Patient Engagement for Clinical Trials

Retrieved on: 
Friday, September 27, 2019
Health, Pharmaceutical industry, Clinical research, Clinical trials, Medical research, Patient recruitment, Scientific control

However, it is of no use if a patient recruitment company for clinical trials does not utilize the resource properly.

Key Points: 
  • However, it is of no use if a patient recruitment company for clinical trials does not utilize the resource properly.
  • To help those in the clinical trial industry better interact with their clientele, fishbat discusses how Facebook groups can improve patient engagement.
  • Facebook groups first and foremost have the ability to not only indirectly promote your business in a controlled, positive space, but also build loyal followers.
  • With patient recruitment in clinical trials being the goal, patient retention is equally as important.

Phase III Study Results for HP-3070 (Asenapine) Transdermal Patch for the Treatment of Schizophrenia to be Presented at the Society of Biological Psychiatry 74th Annual Meeting

Retrieved on: 
Thursday, May 16, 2019
Health, Pharmaceutical, Psychiatry, Schizophrenia, Medicine, Clinical medicine, Clinical research, RTT, Management of schizophrenia, Placebo, Antipsychotic, Ondansetron, Positive and Negative Syndrome Scale, Scientific control

Schizophrenia is often difficult to treat, and having multiple treatment options for patients is crucial as individuals have unique needs.

Key Points: 
  • Schizophrenia is often difficult to treat, and having multiple treatment options for patients is crucial as individuals have unique needs.
  • If approved, HP-3070 will not only be a novel treatment option to add to the armamentarium, but would be the first and only transdermal antipsychotic for the treatment of schizophrenia.
  • This randomized, double-blind, placebo-controlled Phase III clinical trial evaluated the efficacy and safety of HP-3070 in 617 patients diagnosed with schizophrenia.
  • The study results showed that when compared to placebo, HP-3070 achieved statistically significant improvement from baseline in PANSS total score.

VALBIOTIS Will Present the Results of the International Phase IIA Clinical Study of VALEDIA® before 31 July 2019

Retrieved on: 
Tuesday, May 14, 2019
Health, Biotechnology, Clinical trials, Pharmaceutical, Other Health, Research, Other Science, Diabetes, Science, Clinical research, Health, Mind–body interventions, Clinical trials, Design of experiments, Scientific method, Articles, Research methods, Placebo-controlled study, Scientific control, Placebo

VALBIOTIS will present the results of this study before 31 July 2019.

Key Points: 
  • VALBIOTIS will present the results of this study before 31 July 2019.
  • "Announcing the results of the Phase IIA clinical trial represents a major development for VALBIOTIS.
  • The international Phase IIA, multicentric study was randomized, double-blind placebo-controlled, and included 66 prediabetic subjects1.
  • In addition to these prediabetes results, the study will evaluate other physiological parameters, including, for example, triglyceride regulation or intestinal microbiota composition.

Kindred Biosciences Announces Positive Results from Pilot Effectiveness Study of its Fully Caninized IL-31 Antibody for the Treatment of Atopic Dermatitis in Dogs and Issuance of U.S. Patent

Retrieved on: 
Tuesday, October 30, 2018
Clinical research, Medical research, Health, Design of experiments, Clinical trials, Medicine, Placebo-controlled study, Placebo, Scientific control

In addition, KindredBio announced that the U.S. Patent and Trademark Office has issued a patent (Patent No.

Key Points: 
  • In addition, KindredBio announced that the U.S. Patent and Trademark Office has issued a patent (Patent No.
  • The study was a randomized, blinded, placebo-controlled, pilot laboratory study that enrolled 32 dogs to assess the effectiveness of KIND-016 at three doses.
  • "We are very pleased with the unequivocally positive results from this study, as well as the recently-issued patent.
  • We believe our fully caninized, high-affinity, IL-31 antibody is well positioned to become an important therapeutic in the space.

Janssen Announces Results from MARINER and COMMANDER HF Studies

Retrieved on: 
Monday, August 27, 2018
Clinical research, Design of experiments, Anticoagulants, Experiments, Placebo-controlled study, Scientific control, Rivaroxaban, HF, Chemistry, Organic chemistry, Methodology

In COMMANDER HF, XARELTO did not impact overall mortality outcomes compared to standard of care.

Key Points: 
  • In COMMANDER HF, XARELTO did not impact overall mortality outcomes compared to standard of care.
  • The MARINER and COMMANDER HF studies are part of XARELTO's differentiated and industry-leading clinical development program EXPLORER, which evaluates the potential role of XARELTO in treating a wide range of critical medical needs.
  • Sponsored by Janssen, COMMANDER HF was an international, prospective, multi-center, randomized, double-blind, placebo-controlled, event-driven study.
  • MARINER and COMMANDER HF are both part of the EXPLORER clinical research program for XARELTO.