Phase IV Studies: What Clinicians Need to Know!

Phase IV trials, also known as postmarketing safety and efficacy studies and postmarketing surveillance (PMS) studies, occur after a drug or medical device has received regulatory approval and is available in the market. These trials are designed to collect additional information regarding the product's safety, efficacy, and prolonged effects in a larger and more diverse patient population. The foremost goal of phase IV trials is to detect any rare or long-term adverse effects that may not have been identified during the prior phases of clinical development.

A non-entropy-based optimal multilevel threshold selection technique for COVID-19 X-ray images using chance-based birds' intelligence.

Recently, image thresholding methods based on various entropy functions have been found popularity. Nonetheless, entropic-based methods depend on the spatial distribution of the grey level values in an image. Hence, the accuracy of these methods is limited due to the non-uniform distribution of the grey values.

Safety and efficacy of mycophenolate in COVID-19: a nonrandomised prospective study in western India.

Background: Antivirals and immunosuppressive agents are used with variable success in the treatment of COVID-19. Mycophenolate, an inhibitor of enzyme inosine monophosphate dehydrogenase, is an immunosuppressant used to prevent allograft rejection and other autoimmune diseases. Few laboratory studies have also reported antiviral properties of mycophenolate.

A novel minimum generalized cross entropy-based multilevel segmentation technique for the brain MRI/dermoscopic images.

Background: One of the challenging and the primary stages of medical image examination is the identification of the source of any disease, which may be the aberrant damage or change in tissue or organ caused by infections, injury, and a variety of other factors. Any such condition related to skin or brain sometimes advances in cancer and becomes a life-threatening disease. So, an efficient automatic image segmentation approach is required at the initial stage of medical image analysis.

A prospective, multicenter, clinical Study to evaluate the Safety, Pharmacokinetics, and Efficacy of Bleed Outcomes, with HemoRel-A® in severe Hemophilia A Patients.

Purpose: To evaluate efficacy for an on-demand treatment of acute bleeding events, pharmacokinetics, safety, and tolerability of HemoRel-A® in severe hemophilia A.

Methods: A total of 44 male subjects with severe hemophilia A with an annualized bleed rate of 12 while on-demand treatment with factor VIII (FVIII) were enrolled in the study and received HemoRel-A® for bleed treatment. The efficacy of HemoRel-A® was evaluated based on a four-point scale (excellent, good, moderate, or none).

Randomised, Double-blind, Comparative Clinical Study of New Ranibizumab Biosimilar in Neovascular (Wet) Age-Related Macular Degeneration.

Purpose: The study was undertaken for regulatory purposes to establish clinical biosimilarity and interchangeability of a ranibizumab biosimilar with reference product.

Patients And Methods: A total of 159 subjects with neovascular (wet) age-related macular degeneration (AMD) were dosed with ranibizumab. Initial double blind period of 16 weeks was followed by open-label phase till week 24.

Randomized Comparative Clinical Study of First Global Omalizumab Biosimilar with Innovator Product in Moderate to Severe Persistent Asthma.

Purpose Of Study: Omalizumab the first anti-IgE antibody is proven with several real-world studies and meta-analyses as important adjuvant in severe allergic asthma. This study was undertaken for the first omalizumab biosimilar to establish clinical biosimilarity and interchangeability with originator product.

Materials And Methods: In this randomized, double-blind comparative study 105 subjects (70 subjects in the study group and 35 subjects in the reference group) were dosed up to week 16 as double blind phase and responders entered open label phase till week 24.

A comparative phase III clinical study to evaluate efficacy and safety of TrastuRel™ (biosimilar trastuzumab) and innovator trastuzumab in patients with metastatic human epidermal growth factor receptor 2 (HER2)-overexpressing breast cancer.

Introduction: The present study for biosimilar trastuzumab was a multicentric, randomized, two-arm parallel-group, comparative phase III study in patients with metastatic breast cancer.

Materials And Methods: Stage I of the study was conducted among 42 participants with equal distribution in the study and reference arm. After a loading dose of 8 mg/kg trastuzumab was administered intravenously on day 1 of the first cycle; serum samples were obtained at 0, 1.

Comparative pharmacokinetics, efficacy, and safety of bevacizumab biosimilar to reference bevacizumab in patients with metastatic colorectal cancer.

Objective: To establish clinical biosimilarity of BevaciRel™ bevacizumab biosimilar (study bevacizumab) with the reference innovator bevacizumab in terms of pharmacokinetics, efficacy, and safety in metastatic colorectal cancer (mCRC).

Materials And Methods: A total of 119 patients with mCRC were enrolled across 20 centers and randomized to receive study and reference bevacizumab in this Phase III clinical study. Of these, 116 patients were administered bevacizumab 5 mg/kg intravenously every 2 weeks with folinic acid, fluorouracil, and irinotecan regimen.

An Open Label, Prospective, Single Centre Study to Evaluate the Efficacy and Safety of Fixed Dose Combination of Rabeprazole (Enteric-Coated, EC) 20 mg + Domperidone (Sustained Release, SR) 30 mg Capsule in Treatment of Patients with Laryngopharyngeal Reflux Disease.

Objective: To evaluate the efficacy, safety and tolerability of fixed dose combination of Rabeprazole (enteric-coated, EC) 20 mg + Domperidone (sustained release, SR) 30 mg for treatment of laryngopharyngeal reflux disease (LPRD).

Design: A prospective, single centre, open-label, non-comparative, observational study

Setting: The study was conducted at an otolaryngology clinic in India between May 2012 and November 2012.

Patients: Patients (>18 yrs) with suspicious LPR-related symptoms, reflux symptom index (RSI) score >13 and reflux finding score (RFS) >7, willing to undergo rigid laryngoscopy and requiring fixed dose combination of Rabeprazole (enteric-coated, EC) 20 mg + Domperidone (sustained release, SR) 30 mg capsule treatment according to the investigator's discretion were eligible for enrolment in the study.

Efficacy and safety profile of combination of tramadol-diclofenac versus tramadol-paracetamol in patients with acute musculoskeletal conditions, postoperative pain, and acute flare of osteoarthritis and rheumatoid arthritis: a Phase III, 5-day open-label study.

Objective: We aimed to evaluate the safety and efficacy of a fixed-dose combination (FDC) of tramadol and diclofenac versus a standard approved FDC of tramadol and paracetamol, in patients with acute moderate to severe pain.

Methods: A total of 204 patients with moderate to severe pain due to acute musculoskeletal conditions (n=52), acute flare of osteoarthritis (n=52), acute flare of rheumatoid arthritis (n=50), or postoperative pain (n=50) were enrolled in the study at baseline. Each disease category was then randomized to receive either of two treatments for 5 days: group A received an FDC of immediate-release tramadol hydrochloride (50 mg) and sustained-release diclofenac sodium (75 mg) (one tablet, twice daily), and group B received an FDC of tramadol hydrochloride (37.

Efficacy and safety of methylcobalamin, alpha lipoic acid and pregabalin combination versus pregabalin monotherapy in improving pain and nerve conduction velocity in type 2 diabetes associated impaired peripheral neuropathic condition. [MAINTAIN]: Results of a pilot study.

Background And Objective: To assess whether methylcobalamin and alpha lipoic acid (ALA) added to pregabalin provide additional benefit compared to pregabalin alone in type 2 diabetes mellitus associated peripheral neuropathy.

Setting And Design: An open label, randomized, controlled parallel-group pilot study.

Materials And Methods: Thirty adult patients with type 2 diabetes mellitus with symptoms of peripheral neuropathy for ≥6 months were randomized to receive pregabalin 75 mg, methylcobalamin 750 μg, and ALA 100 mg (PMA, n = 15); or pregabalin 75 mg (PG, n = 15) for 12 weeks.

A Hall effect angle detector for solid-state NMR.

We describe a new method for independent monitoring of the angle between the spinning axis and the magnetic field in solid-state NMR. A Hall effect magnetic flux sensor is fixed to the spinning housing, so that a change in the stator orientation leads to a change in the angle between the Hall plane and the static magnetic field. This leads to a change in the Hall voltage generated by the sensor when an electric current is passed through it.