Blogs Missing Data at the Clinical Trial Level? Completeness of Clinical Trial Reporting April 2nd, 2024 3 minute read Professor Sally Hollis, PHASTAR’s Head of Statistical Consultancy, was a panellist on an EFSPI/PSI webinar on D...
Blogs Reviewing and Updating the Statistical Analysis Plan and Creating Mock Shells as Part of the Phastar CARES Scheme February 19th, 2024 4 minute read Phastar is providing pro-bono support to Medicines Development for Global Health (MDGH) as part of its Phastar CARES ...
Blogs Season’s Greetings from Phastar’s 2023 SAS Art Competition Winner! December 14th, 2023 2 minute read Season’s Greetings from the Phastar team! Each year Phastar holds an internal competition among its programmers...
Blogs Phastar Celebrates Third Annual Sally Hollis Memorial Lecture November 2nd, 2023 5 minute read A great turnout of members from the Phastar family, together with guests from the wider community, gathered in Maccle...
Blogs Phastar is Now a B Corp™ – What, How, and Why? July 11th, 2023 5 minute read We are absolutely delighted that Phastar is now a certified B Corporation®, effective from June 2023. We are proud to...
Blogs AutoCRF: A Tool to Create a Mock eCRF Screen from Excel Data Specifications June 21st, 2023 4 minute read Case report forms (CRFs) are critical in clinical trials as they capture vital data related to patient safety, treatm...
Blogs Decoding the HTA Craze: A Closer Look at the Exciting World of Health Technology Assessment (HTA) at PSI 2023 June 10th, 2023 3 minute read There is always an excited buzz around one or two hot topics at statistics conferences, and PSI 2023 was no exception...
Blogs Addressing Data Sparsity in Clinical Trials — and Female Sparsity in Data Science May 11th, 2023 5 minute read Digital Health Technologies (DHTs) are democratizing data collection during clinical trials, while promising to make ...
Blogs Data Science Collaboration with Ishango.ai – Part Two December 14th, 2022 4 minute read Phastar embarked on a collaboration project with Ishango.ai to work on a data science project to automate the medical...
Blogs Data Science Collaboration with Ishango.ai – Part One November 25th, 2022 3 minute read Phastar recently embarked on a collaboration with Ishango.ai to host two aspiring data scientists to work on an innov...
Blogs Smart Signal Detection — Part Two November 10th, 2022 3 minute read In a previous blog post, we described how, as part of the Centre for Analytical Excellence, Phastar delivered a proje...
Blogs Smart Signal Detection — Part One November 2nd, 2022 5 minute read As part of the Centre for Analytical Excellence, we recently delivered a challenging yet enjoyable project looking at...
Blogs Phastar’s Approach to Digital Health August 25th, 2022 6 minute read Currently, there is no widely adopted definition of Digital Health. At Phastar, we take a broad view and refer to Dig...
Blogs The COVID Impact on Clinical Trials Requires New Approaches for Statisticians March 10th, 2022 10 minute read COVID-19 and its subsequent variants have provided challenges in many ways, not the least of which are in the conduct...
Blogs Missing Data Caused by the COVID-19 Pandemic on Clinical Trials – Overall Approach December 13th, 2021 5 minute read In our final blog of the series, we examine the impact of missing data caused by the COVID-19 pandemic on clinical tr...
Blogs The Effect of COVID-19 on the Estimands of Clinical Trials December 8th, 2021 4 minute read In our latest blog of the series, we examine the topic of estimands with respect to clinical trials affected by the C...
Blogs Assessing The Impact of COVID-19 on a Clinical Trial December 6th, 2021 5 minute read In this blog series, we examine the impact of COVID-19 on the conduct, analysis, and interpretation of ongoing clinic...
Blogs How the COVID-19 Pandemic has Affected Clinical Trials December 3rd, 2021 4 minute read Throughout this blog series, we will be discussing how the COVID-19 pandemic situation has affected clinical trials, ...
Blogs Delivering an Interim Analysis During a Pandemic from a Data Management perspective May 12th, 2021 6 minute read When the World Health Organisation (WHO) declared the COVID-19 pandemic on 11th March 2020, countries the world over ...
Blogs How FSP Can Increase Efficiency and Quality in Japan May 12th, 2021 4 minute read FSP (Functional Service Provision) is fairly common in the United States and Europe, where many of the world’s ...
Blogs A Programmer’s View on IDMCs May 12th, 2021 5 minute read Introduction An IDMC (sometimes known as a DMC/DMEC/DSMB) is an Independent Data Monitoring Committee, whose role it ...
Blogs The Application of AI in the Management of Data January 25th, 2021 3 minute read The crucial role of clinical data management (CDM) in a successful clinical trial is well understood, and central to ...
Blogs The Pros and Cons of FSP and Full-service August 18th, 2020 10 minute read Functional Service Provision (FSP) and Full- Service outsourcing models have been hotly debated topics over the past ...
Blogs Method Agreement Analysis – Common Pitfalls and a Review of Methodology February 25th, 2020 6 minute read A common question in clinical research is whether a new method of measurement is equivalent to an established one. As...
Blogs Technology, AI and Real World Evidence February 25th, 2020 3 minute read Real world evidence (RWE) in medicine is the clinical evidence regarding the use and potential benefits or risks of a...
Blogs How can we Compare Medicines from Different Clinical Trials? February 24th, 2020 3 minute read At a conference, the results of a clinical trial demonstrate that a new medicine is efficacious and safe for a partic...
Blogs From Practical Maths to Superstar Stats – Zoe’s Story February 14th, 2020 5 minute read I started out my university experience by going to Dundee to study mathematics, this was mainly a theoretical degree ...
Blogs A Quantitative Framework to Inform Extrapolation Decisions in Children February 13th, 2020 6 minute read When developing a new medicine for children, the potential to extrapolate from adult efficacy data is well recognised...
Blogs What About the Smell? – Challenges of Clinical Trial Design and Maintaining Blinding January 15th, 2020 5 minute read When designing a clinical trial, one of the biggest factors that needs to be thought about is blinding. In clinical t...
Blogs Phastar Graduate Programme – Lisa’s story January 10th, 2020 6 minute read Starting a career in industry can be a daunting experience at any time of life, but especially when it is your first ...
Blogs Phastar Graduate Programme – One Year In! December 10th, 2019 6 minute read I am now one year into my graduate role at Phastar, and it has been one of the quickest years of my life. I joined Ph...
Blogs Data Science: Making Sense of Data November 1st, 2019 4 minute read The volume of digital data in healthcare is projected to increase more rapidly in the coming years than any other sec...
Blogs The Opportunities and Challenges of Basket Studies November 1st, 2019 4 minute read There has been a growing emergence in the utilisation of basket studies and it’s not difficult to see why. Progress i...
Blogs Data Management of Adaptive Trial Designs November 1st, 2019 3 minute read Traditionally, studies have been run with a process of study design, study conduct, study report. Whilst this is more...
Blogs Beyond the Hype: AI and Machine Learning in Clinical Trials and Healthcare August 19th, 2019 7 minute read There is considerable hype surrounding Machine learning (ML) and Artificial Intelligence (AI) yet despite that, these...
Blogs Meta-analysis in Clinical Trials August 19th, 2019 4 minute read In medical research, information on the outcomes of a treatment may be available from a number of clinical studies wi...
Blogs Data Integration for ISS/ISE August 19th, 2019 5 minute read Integration of data from a number of clinical trials for an Integrated Summary of Safety (ISS) and Efficacy (ISE) req...
Blogs Phastar’s Approach to Risk-Based Monitoring May 24th, 2019 4 minute read Data quality and integrity are key aspects of Good Clinical Practice (GCP) and sponsors are expected by regulators to...
Blogs Data Visualisation: Customised Graphics and Combining Outputs May 24th, 2019 3 minute read It has become easier to produce customised graphics in SAS and to produce reports that combine outputs from several d...
Blogs Data Science at Phastar May 14th, 2019 3 minute read Understandably, there is considerable excitement around the field of data science particularly in relation to healthc...
Blogs Adaptive Trial Design: A Programmer’s View February 15th, 2019 4 minute read The FDA defines an adaptive design as …an adaptive design is defined as a clinical trial design that allows for prosp...
Blogs Adaptive Designs for Dose Escalation Early Phase Studies February 15th, 2019 5 minute read A key objective of Phase I dose escalation trials is to establish a recommended dose and/or schedule for an experimen...
Blogs Multiplicity August 28th, 2018 4 minute read Recently, an FDA industry guidance draft on “Multiple Endpoints in Clinical Trials”1 provided an overview of multipli...
Blogs Estimands – What’s All the Fuss About? August 28th, 2018 3 minute read The public consultation period for the ICH E9 (R1) addendum on estimands and sensitivity analyses to the guideline on...
Blogs Rare Diseases: Treatment and Controls August 28th, 2018 7 minute read A rare disease is defined by the European Union as one that affects less than 5 in 10,000 of the general population a...
Blogs Data Quality and CDASH January 3rd, 2018 3 minute read How do you define the importance of data quality in clinical trials? An accurate reflection of a subject’s experience...
Blogs Quality Deliverables – Phastar’s Programming Perspective January 3rd, 2018 3 minute read Quality is paramount to all programming work carried out at Phastar to ensure accurate reporting and analysis of clin...
Blogs Missing Data: Management and Prevention August 9th, 2017 3 minute read Data managers strive to produce high quality, reliable and intact data for analysis. Integral to this quality standar...
Blogs Interim Locks and DSMBs April 12th, 2017 3 minute read Special consideration needs to be given to providing data for interim locks and DSMBs during the course of a study. I...
Blogs Statistical Issues in Oncology Trials August 30th, 2016 4 minute read A key issue in assessing the efficacy of new drugs in oncology is getting the balance right between choosing a hard e...
Blogs Programming Issues in Oncology Trials August 30th, 2016 3 minute read Oncology trials are complex and require a different approach to trials compared with many other therapeutic areas and...
