Kubo are proud to sponsor Tom Carlon at MK lightning for the 2nd year running!

As we approach the upcoming new hockey season Kubo Recruitment are proud to sponsor Tom Carlon at MK Lighting following his success last year!

Last year Kubo Recruitment sponsored Forward Tom Carlon as he debuted after signing with MK Lighting in 2013




Last season saw Tom Carlon scoring crucial goals for the team and playing a major part in the team’s success placing them 4th in the premier league at the end of last season!







Kubo look forward to continuing to support the team next season and wish them every success for the start of September!

Guest writer Thomas Zwingers part II- Ask the Experts: Late Phase Oncology Trial Design

Prinicipal Biostatistician Thomas Zwingers hosted Part II of his German-language webinar "Statistical Considerations in Oncology". Part II focuses on statistical methods for early decisions in Phases II and III.

 

According to expert biostatistician Thomas Zwingers, how can adaptive trial design be a method for the future of cancer research? 

 

During Phase III development, efficacy of the drug should be confirmed. Many new products have to find a very specific mechanism of effectiveness, so therefore subpopulations are necessary. Flexible study designs that allow for early termination and the use of fewer patients can be a successful solution for determining clinical efficacy. In oncology trials, we need to take into consideration differentiating factors such as slow patient recruitment, the importance of patient genotype, the use of various treatment combinations and the fact that the primary endpoint is overall survival time or time to progression. 

 

Adaptive Designs in late phase cancer research offer the possibility to make modifications to a study while in progress on the basis of new information pulled from accumulated data. While it is well know that there is the possibility to re-estimate the number of patients needed for a study based on observational data in interim analysis, it is less known that design can allow objectives to be achieved in one study that would normally require the scheduling of two distinct studies, so called "seamless Phase II/III designs".

 

Seamless Phase II/III designs combine two sequential and separate studies into one study and allows the use of collected information in the first stage to adapt the design in the second stage. The advantages of in this design are a reduction in overall time in the development of a drug, fewer patients required, and the early availability of long-term safety data. 

 

Another interesting possibility of an adaptive design is to select the right target population for the drug. This is of special interest in the development of highly specific cancer drugs, which are only effective in selected patient populations - for example, monoclonal antibodies. An adaptive study in Phase II/III may allow for the selection of the most promising target population in the first stage for the second stage.

 

Based on CROS NT's experience in oncology trials, their expert biostatisticians recommend the following for late phase adaptive trials:

- Budget more time for planning of an adaptive design as compared to a standard design
- Interact with regulatory authorities in the planning phase especially for Phase II/III studies
- Use simulations to calculate the power of the sample size and the probability of success
- Evaluate whether or not to stop the recruitment of patients for the interim analyses
- Schedule frequent monitoring visits in order to provide as much data as possible for the interim analyses

About Thomas Zwingers

In Thomas' current role, he provides pharmaceutical, biotechnology and medical device companies with statistical methodology advice pertaining to trial design, conduct and reporting including regulatory submissions. Thomas has been working in the clinical trial environment since 1980 in project team management and statistical analysis. He has particular expertise in Adaptive Designs and Bayesian Framework, Meta-Analysis and Non-Inferiority trials with therapeutic expertise in Oncology, Respiratory and Dermatology.

How have our attitudes to life and work changed through the Generations?

I came across the above on Linkedin a couple of weeks ago and it got me thinking about how our expectations have changed through the generations. 

When you look at the attitude towards careers you can clearly see how much peoples views on work have changed and people are no longer loyal to one company. But why is that? is that because people feel they are worth more and want to work for a company that can see that or is that because loyalty isn't rewarded as much anymore by companies? Maybe we all strive for change and progression and we need a bit of variety in our lives? What ever the reason, it seems the days of people staying with a company for 30 years are a thing of the past. 

One thing that stood out to me was the communication preference (above). Generation Y which is the generation that is now entering the work place for the first time are more likely to send an email or text message then have a face to face meeting. You can't really grasp someones tone over an email and things can get misconstrued and problems can arise with how different people can take an email, which was not intended to cause offence, but does. There was that case years ago where someone took their boss to a tribunal over his use of capital letters in an email, but then with an email you do have an email thread so can keep a record of what was said and when, so i guess there are benefits to the old and new way of doing things. 

I think one thing that you can take from this when you look at our "Aspirations" (above) is that whether its in bricks and mortar or careers, our home life and the feeling of security is still the most important thing to us. 

www.kuborecuitment.com

Introduction to Adaptive Trials in Oncology: What makes oncology different from other areas

Adaptive Designs have been increasingly gaining attention during the past years. These designs provide greater flexibility for Investigators/pharmaceutical companies by using an iterative process of:

- Collecting Data
- Analyzing the collected data
- Making decisions on the study design parameters according to the outcome of the analysis; and then
- Collecting additional data

More and more, Investigators and pharmaceutical companies use the advantages of adaptive designs over traditional, fixed designs in order to:

- Decrease the necessary sample size in trials
- Increase the probability of success in each trial
- Shorten the development process time of a new drug

The application of adaptive designs in oncology trials can prove challenging which is due to the nature of this medical field and its unique characteristics which makes it different from other therapeutic areas. It is not a single characteristic which makes oncology different, but rather the simultaneous occurrence of the following items:

- Long timelines to reach clinical endpoints. The ultimate endpoint for registration of a new drug is still the "Overall Survival Time". Surrogate endpoints like "response rates" or "time to progression" are often used but mostly as secondary endpoints or in earlier phases of the development process.

- The use of treatment combinations. Many oncology indications are treated using a combination of either surgery or radiotherapy and chemotherapy where most chemotherapy treatments are composed of various drug combinations, e.g in leukemia up to 8 different drugs are used.

- The number of partially related diseases. Although all cancers share the common trait of "abnormal growing cells", the heterogeneity of histological and immunological features of each disease is extensive.

- The importance of disease sub-types and/or genotypes. Even within each disease entity, different genotypes of immunologic surface makers can determine or rule out treatment success.

- Regimen modifications during treatment. As anti-cancer drugs are highly toxic, treatment modifications due to adverse reactions is very common and make it difficult to create a population of homogenously treated patients. This also has an impact on the interpretation of the clinical outcome.

- The high impact of the disease on patient life.

- The high costs of treatment. The average cost of cancer treatments range from approximately $5,000 USD per year to over $100,000 USD per year for patients with brain tumors.

- Slow Recruitment. Except for the most common tumor types - breast cancer, colorectal cancer and lung cancer - in most other indications, the number of patients is usually low within each center, thus resulting in slow recruitment of trials with a multitude of centers. 

In this highly diversified area of drug development, adaptive designs offer features which enable Investigators to find effective drugs more quickly for the benefit of the patients.

This blog was guest written for Kubo Recruitment by Thomas Zwingers, Senior Director for Consultancy Services and Senior Biostatistician for CROS NT.

About Thomas Zwingers

In Thomas' current role, he provides pharmaceutical, biotechnology and medical device companies with statistical methodology advice pertaining to trial design, conduct and reporting including regulatory submissions. Thomas has been working in the clinical trial environment since 1980 in project team management and statistical analysis. He has particular expertise in Adaptive Designs and Bayesian Framework, Meta-Analysis and Non-Inferiority trials with therapeutic expertise in Oncology, Respiratory and Dermatology.

Tribunal rules commission must be included in holiday pay

Workers whose total pay package relies heavily on commission will have this reflected in their holiday pay, following a ruling in favour of an employee in a tribunal.

In the case of Lock vs. British Gas Ltd. and others, the Court of Justice for the European Union (CJEU) ruled that the employer must take into account Mr Lock's full remuneration package, including commission, when calculating holiday pay. 

Lock was represented by Unison in the case against British Gas. Unison general secretary Dave Prentis hailed the ruling as "extremely important".

"This will assist workers across the European Union to argue that they should be entitled to their normal pay, including any commission payments they normally receive, for periods of annual leave," he said. 

Ben Gorner, employment partner at DLA Piper said the ruling could put companies under serious financial pressures, especially SMEs. "People can backdate their claims, in some instances by up to 10 years," he said. "For a small company with several employees who have worked on commission for some time, this could spell serious trouble."

Brief details of the case

Mr Lock is a sales consultant for British Gas receiving a basic salary and variable commission on a monthly basis. His commission makes up about 60% of his pay. The amount of commission varies depending on the number and type of sales he achieves, paid at the time the sales contract is entered into and not when Mr Lock actually carries out the work to achieve the sale.
Mr Lock took holiday from 19 December 2011 to 3 January 2012 during which time he was paid basic pay and the commission he had earned on sales contracts entered into in the previous weeks. However, as he did no work during his holiday, he did not generate any sales and therefore his salary was lower in the months following him taking holiday as he received no commission, and therefore he "lost" income by taking his holiday. Mr Lock brought a claim for his "lost" holiday pay in the Employment Tribunal. The question of whether commission should be included in holiday pay and, if so, how this should be calculated, was referred to the Court of Justice of the European Union ("CJEU") by the Employment Tribunal.
The CJEU has now confirmed that the holiday pay required under the Directive is to enable a worker to actually take the leave to which he is entitled, and that commission such as that received by Mr Lock should be included in the calculation of holiday pay, since it is directly linked to the work he normally carries out. Although the amount of Mr Lock's commission varies on a monthly basis, it is nevertheless permanent enough to be regarded as part of his normal monthly pay. However, the Court has left it to Member States to decide on how that holiday pay should be calculated.

Will this make a big difference to how you take time off? Will it make it easier for you to take annual leave knowing you are not going to be financially worse off the following months? Kubo would love to know your thoughts on this!

UK Salaries on hold as job opportunities continue to rise!

• First quarter salaries show no growth on previous quarter

•  2014 salaries remain at the same level as Q1 2013

•  Number of new jobs available grows 10% during first quarter and is up 30% year-on-year

UK salaries continue to stutter, with zero growth during the first quarter of 2014, whilst the number of new jobs available is still rising, according to new figures release by reed.co.uk

 Renewed economic confidence has continued to prompt growth in new vacancies, but rates of pay remain flat. In the first quarter of 2014, the number of new vacancies being advertised grew by nearly 10% compared to the last quarter of 2013 and by more than 30% annually. There are now nearly twice the number of jobs on offer as there were in March 2010.

March: Top 5 sectors year-on-year

• 1. Legal +78.9%
• 2. Transport & Logistics +73.1%
• 3. Construction & Property +67.4%
• 4. Strategy & Consultancy +55.7%
• 5. Motoring & Automotive 54.1%

March: Top 5 regions year-on-year

• 1. Wales +44.7%
• 2. Yorkshire & Humberside +34.9%
• 3. North West 33.1%
• 4. London 31.7%
• 5. East Anglia +31.5%

For all Kubo Recruitment's latest roles please visit www.kuborecruitment.com

Statistical information from reed.co.uk

#Nomakeupselfie raises £8 million and funds 10 new Clinical Trials for Cancer Research!

WOW!  Due to the phenomenon that swept across the social networking sites Cancer Research UK's #nomakeupselfie phenomenon raised an amazing sum of more than £8 million to fund life-changing research!

Here's what Cancer Research UK had to say to some of the questions put to them!

Where is the money going?
It’s going towards funding our clinical trials research – these are studies involving people, testing kinder and more effective treatments and tests for cancer. So far this will enable us to completely fund 10 clinical trials, some of which we were previously unable to fully fund or couldn't afford to fund at all.  Nine of these are trials testing new treatments for cancer, and the other is collecting and analysing tumour samples from patients. Any remaining money will be put towards more of our research.

Which trials is it funding?

These trials will look at new treatments for sarcoma, acute myeloid leukaemia, neuroblastoma, liver, head and neck, breast, prostate, bladder and oesophageal cancers. The trials cover a range of treatment approaches including chemotherapy, hormone therapy and radiotherapy, as well as sample collection for a study looking at how a person’s genetic makeup affects their response to radiotherapy.

£8 million sounds like a lot of money for just 10 trials. Why do they cost so much?
Because these donations have been unexpected, we’re still working out the best way to spend all the money. So far we know that we can definitely support these 10 trials, but it’s likely that we will be able to support a lot more vital research from this money too. We can’t magic research projects out of the air overnight, but we’ll be doing our best to spend it in a way that will bring the most benefits to cancer patients.
Clinical trials run over many years and can involve hundreds of patients. The costs include paying to run the trial and collect data from patients, as well as analysing it to see if the new treatment works. The costs per year can range from around £30,000 per year to £100,000 depending on the particular study and the longer a trial runs, the higher the costs.  The money raised from the selfies will support these 10 trials over their entire duration. The shortest of the trials is two years while the longest is 10, and in total it all adds up to more than 50 years of research time.

Last month was also an amazing month for Cancer Research UK  because last week marked the 50th anniversary of the discovery of Epstein-Barr virus and it's links to cancer. Their researchers revealed that a vaccine against EBV has the potential to prevent an additional 200,000 new cancer cases worldwide each year. Cancer Research UK launched a new clinical trial to test a vaccine that could be used to treat some forms of cancer caused by EBV.


Kubo Recruitment continues to support the amazing work that Cancer Research UK is doing because everyone of us has been effected by cancer in someway, whether it's directly or through  friends or relatives!