PHASTAR CASE STUDIES

PHASTAR has a leading reputation for providing quality statistics, programming, data management and data science support. Read from a selection of case studies below to find out more.

Integrated Summary of Safety

PHASTAR was contracted to assist a pharmaceutical company with the conversion of 16 Legacy studies to SDTM (2 SDTM “Like” phase II studies, 14 Legacy Phase I studies)

Image of A Large Respiratory CV Outcomes Study with Focus on Interim Analysis and DMC

Blinded outputs were programmed internally by a sponsor and we had an independent statistician who attended the meetings and gave statistical advice. The sponsor created blinded outputs outside of their standard reporting environment so that we could easily recreate outputs using a standalone SAS environment. We were supplied the DMC charter for review prior to finalization.

An image of a PHASE 1 and 2 ONCOLOGY STUDY

Phase I/II Oncology Study

PHASTAR were engaged to report a phase I/II oncology study in advanced NSCLC with an initial phase I escalation followed by a phase II...

Image of the production of an ISS / ISE Package

Production of ISS/ISE Package

PHASTAR was contracted to assist a global pharmaceutical company with their integrated summary of safety and efficacy for a regulat...

Preferred Partnership

PHASTAR started a relationship with a top ten pharmaceutical company carrying out statistical consultancy and were subsequently were asked...

Genetic Rare Disease Reporting and Regulatory Support

PHASTAR provided a team of statisticians and programmers to deliver the analysis...

Functional Service Provision

PHASTAR has a number of sponsor relationships where we provide teams of statisticians and statistical programmers (S&P) to augment the...

PHASE III Asthma Study

PHASTAR was engaged to rescue another CRO’s reporting of a large phase III study in mild asthmatics to evaluate the efficacy and safety of the experimental compound. With a primary objective to prove superiority in asthma control, analyses consisted of a complex primary endpoint and a broad range of secondary endpoints which are typically observed in respiratory.

Data Management Oversight

PHASTAR is currently conducting oversight of data management activities on behalf of one of our established clients, a large pharmaceutical company...

Event Prediction to Guide Clinical Study Design

Following the completion of an early phase clinical trial, the sponsor was planning a larger phase IIb study with the same compound but wanted to...

Image of a Sample size for a sepsis diagnostic study

Sample Size for a Diagnostic Study

Recently PHASTAR aided on design input and sample size calculations for a study using a new diagnostic test to detect sepsis in blood samples...

CRO Rescue

PHASTAR began a relationship with a top ten pharmaceutical company carrying out statistical consultancy and were subsequently asked to bid to be a partner in a traditional outsourcing model (i.e. the reporting of clinical trials is done independently by PHASTAR using PHASTAR systems and processes). An RFI/RFP process was undertaken, and we responded, giving details of how we would deliver the results of the clinical trials and related deliverables. We were then selected to be one of two strategic partners after agreeing processes, pricing and governance structure. A two-layer governance structure was established, with a quarterly executive review.

IDAC Support

PHASTAR was awarded as a preferred supplier to a top 20 pharmaceutical sponsor, supporting five new studies per year. Each study was several years in length, with IDMC meetings taking place every 3-6 months. PHASTAR worked with this pharmaceutical sponsor through two models for IDAC support; model one offering independent programming of the blinded and unblinded IDMC package, with model two utilising sponsor programming code to produce blinded and unblinded IDMC package.

Dose Escalation

A PHASTAR statistician was tasked to assist with the design of a modular protocol to assess safety, tolerability and pharmacokinetics in a novel oncology compound in an acute indication. The first module consisted of a dose escalation portion with the aim of defining the maximum tolerated dose (MTD).

Epilepsy

PHASTAR helped to design and analyse a placebo-controlled crossover trial using an anti-epileptic to assess cognitive function in children. The study had a large number of outcome measures, covering cognitive function but also seizure frequency, an ambulatory EEG assessment, IQ and a behavioural assessment using the Conners Rating Scales. The study was also attempting to determine the relationship between transient ischemic attacks and short-term impacts on cognitive function.

Failed studies, what went wrong? Bioequivalence

A new formulation under investigation was planned to be submitted for use in both the US and Europe. As the reference formulation in the US differs from that in Europe, two separate bioequivalence studies were needed to gain approval from the FDA and EMA. Study 1 was conducted for FDA approval and successfully demonstrated bioequivalence. Study 2 was conducted for EMA approval and whilst AUC was within the bioequivalence limits, Cmax was not, and bioequivalence could not formally be declared..

Bayesian network meta-analysis

Hepatitis B virus (HBV) infection is among the most common persistent viral infections in humans. Chronic infection of HBV (CHB) can lead to serious medical complications such as cirrhosis, hepatocellular carcinoma, and liver failure. Surrogate markers are often used to monitor the progression of the disease and patients are treated with antiviral agents to reduce the risk of developing complications.

Missing data in COVID adverse events

Much of the discussion around adverse events (AEs) and serious adverse events (SAEs) in clinical trials through the COVID-19 pandemic has been focussed AEs associated with new therapies and vaccines for COVID-19 itself. But what about other clinical trials that have been impacted by COVID-19? We have already explored the many ways in which the COVID-19 pandemic has affected the conduct, analysis, and interpretation of clinical trials with respect to efficacy data. We have discussed how global quarantines and travel restrictions have resulted in site closures and interruptions to investigational product supply, which have subsequently resulted in issues such as missed assessments and treatment interruptions. But how might these issues also affect safety data?

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