All articles by Blatha
Blatha
Perfect harmony
The way clinical trials are conducted in the EU will experience a significant shift when Regulation (EU) no. 536/2014 (termed Clinical Trial Regulation) is implemented in 2019 and this has created a lot of uncertainty for member states. Louise Thomas discusses the key changes arising from this legislation and how clinical trials will be affected.
Through the keyhole
A number of strategies are being developed to help the UK compete in the global research market post-Brexit, including the creation of ‘high-throughput centres’ to accelerate phase-II and III trials. Jonathan Sheffield, chief executive of the NIHR Clinical Research Network, speaks to Louise Thomas about the potential of these centres to deliver efficient patient-focused clinical trials, thus increasing the speed of getting drugs to market.
Straight to the source
Choosing between full-service and functional-service outsourcing models isn’t a new debate in the pharmaceutical and biotech industries, but balancing the need for high-quality results, cost-effectiveness and time savings remains a challenge. Patrick Kingsland investigates the features of both models and looks at how to navigate complex outsourcing decisions.
Compare and contrast
Choosing comparators is often an onerous process that involves navigating a lot of different models. A key decision is choosing between global and local sourcing. David Callaghan discusses the advantages and risks of different options, and how to determine the right partner for a trial.
New direction
The growth of direct-to-patient (DtP) clinical trial strategies is expected to continue for the foreseeable future. Adopting a DtP approach has the potential to improve recruitment, retention and efficiencies, as well as reduce costs. However, legal and regularity barriers can hinder implementation. Emma Green considers the challenges.
Strong ties
Social media is a powerful tool for patient recruitment, providing a valuable addition to more traditional methods. It can be harnessed to build strong relationships between sponsors, site physicians and patients that begin before the trial and can last all the way through to the next. Wolfgang Eglmeier of Witten/Herdecke University talks to Emma Green about how to optimise social media strategies to foster these connections.
Ride the tidal wave of data
The variety and quantity of data available for clinical trials is greater than ever before. While this promises huge benefits in terms of monitoring subjects and measuring results, more information doesn’t always translate to more knowledge. Kumar Komuravelli, director of clinical data management at Mallinckrodt Pharmaceuticals, tells Grace Allen about the challenges facing clinical data management and how these developments can be capitalised upon.
Cool runnings
With the stakes being so high for cold chain, finding new ways to maximise efficiencies and prevent revenue losses is key. Digitisation is a cost-effective option with huge potential, but it remains underutilised within the industry. Abi Millar investigates how to successfully harness these technologies to optimise procedures.
A sea change
The last 25 years have seen a dramatic evolution in clinical trials and processes. The delivery of investigational medicinal products to clinical sites and patients is continually shifting, yet the need to supply patients and sponsors with safe, flexible packaging remains. Kerry Taylor-Smith speaks to Dr Wynand Smythe about the challenges involved and how to maximise efficiencies.
Blockchain: behind the buzzwords
As the hype around blockchain has exploded, its actual applications have become harder to discern. However, specific aspects of the technology have the potential to address the ongoing problem of reproducibility in clinical trials. Dr Steve Arlington and Dr Richard Shute of the Pistoia Alliance, and epidemiologist and blockchain specialist Dr Mehdi Benchoufi tell Tim Gunn what lies beyond the buzzwords.