There were numerous articles in June 2017 that covered a wide range of topical issues. Here are five of the best stories you might have missed... (click the headline to finish reading the story)
The U.K. Government triggered the formal procedure to exit the European Union on March 29, 2017. The U.K. and the EU institutions are now determining the arrangements for the orderly withdrawal of the U.K. Unless an extension is agreed, this process must be completed by March 29, 2019, and so while negotiations on the terms of the U.K.’s departure have not yet officially begun, EU institutions and government departments in the U.K. have started their planning activities.
Unsurprisingly, the nature of the U.K.’s departure and its relationship with the EU once it ceases to be a Member State has attracted a great deal of speculation. There is considerable uncertainty surrounding how Brexit will actually work, not least because no Member State has left the EU in its current form.
To conduct a clinical trial requires meticulous planning from establishing a budget all the way through to picking the right site. Once the site has been picked, sponsors have to hire the right people to carry out the trial itself. So what should companies consider when hiring personnel for a clinical trial? Below are four tips companies should consider when hiring new staff.
1) Set your strategy
So you’re looking to hire a team of clinical research associates for a new study. To get things moving, first ask yourself, what do you want your team to look like? The team you put together should be a reflection on yourself as the manager and your management philosophy. Then consider whether you want to hire from within your organization, or hire people from outside who will bring fresh ideas and impetus. More crucially, assess whether you want to mould and develop new personnel or if you want to hire for immediate impact. Hiring new personnel can be an arduous process at the best of times, so companies must set a strategy that weighs up what skills, competencies, and attitudes you will hire for.
While the extent of clinical research today is in many ways astounding – clinicaltrials.gov lists 242,358 studies with locations in all 50 states, and 198 countries as of February 2017 – it is informative to step back and look briefly at the origin of the somewhat rigorous processes we all follow today. Probably the earliest description of a rudimentary trial was that conducted by King Nebuchadnezzar of Babylon sometime shortly after 600 BC, wherein he examined the difference in health outcomes between a group of individuals who sustained themselves on a diet of legumes compared to those who consumed only meat and wine. While not exactly a placebo-controlled double blind randomized study, there was a clear difference between the two groups. This has been described as the initial observation where a medical test guided a decision about public health.
Clinical trials are notoriously expensive. The more credible the trial design and trial managers, the easier it will be to find and maintain funding. More successful approvals on the resumes of the trial managers are comforting to investors. But even first timers can get this done.
There are some typical approaches, but nothing beats good planning and execution. This is helped tremendously by having at least a core experienced design team, and operations team. Good design and execution will improve the use of funds.
Attracting resources for a small company has parallels with resourcing a project within a larger company. All successful projects have a champion, who needs to be particularly effective. The champion must secure and maintain enthusiasm from the funding source (investors or company), to keep them informed of progress, and of course to set and continue good inertia throughout the trial execution.
Development of inhaler devices is a complex process and any development needs to address a number of issues. Firstly, does the inhaler confuse the patients? Can patients recall the correct handling of each inhaler they use? How large is the risk that different inhaler devices pose to public health? In order to address these questions, human factors studies are conducted.
Human factors (HF) studies examine the interaction of people and technology ensuring the safety and effectiveness of that interaction in order to improve human/device compatibility. That includes the user interface, instructions, and training programs to avoid use error. Use errors can occur when the device is not being used as intended or the design features are less than optimal.
PHOTO CREDIT: Rob Nguyen