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!

No Makeup Selfie for Cancer Awareness!

All over Facebook and Twitter People have been stripping off their make-up and nominating someone to do the same to raise awareness for Cancer Research UK! When you post your picture you donate £3 to cancer research UK by texting BEAT to 70007. 

Kubo spoke to Cancer Research UK today about the buzz surrounding the No Make up Selfies and since yesterday they have received around 800,000 text donations and raised over £1m to help beat cancer sooner!

Carolan Davidge, director of communications at Cancer Research UK said, “The #nomakeupselfie Twitter trend isn’t something Cancer Research UK started – but it’s great to see so many people getting involved to help raise awareness of cancer amongst their friends and family. If people would like to choose to support our work to beat cancer sooner, they can visit www.cruk.org.”

Here at Kubo we thought we would get behind the No Makeup Selfie Challenge and post our own pictures! 

Lara Gill 

Recruitment Consultant

Andi Brown 

Recruitment Consultant 

The only person missing here is our boss! Head of Recruitment, Rachel Keay! Maybe if we get enough likes she will let us post her picture too!?!? 

Come on everyone get behind the campaign and lets see your No Make up Selfies! To donate to the cause text BEAT to 70007 and donate £3! 

Wow its March already!!

 

I just can’t believe how quickly this year is going, the daffodils are out and the sun is beginning to show its face a bit longer every day and before you know it, you will be dusting off the BBQ for summer! 

If you feel like you need a change or are looking to progress your career, have a look at some of the job roles Kubo are currently recruiting for!

Senior SAS Programmer- UK

The role is full-time permanent employment in the South East of England.

The candidate will be responsible for producing and validating statistical analysis using SAS. The Senior SAS Programmer has the overall responsibility of the reliability of output produced within a project and is in charge of training and supporting Statisticians and SAS Programmers on programming subjects. http://kuborecruitment.com/jobs/senior-sas-programmer-uk

Quality Assurance Manager - Switzerland

Our client is a rapidly expanding pharmaceutical group located in Switzerland, its strategy focuses on the development and registration of innovative pharmaceutical products. An exciting opportunity has arisen within the Research & Development Division for an experienced Quality Assurance Manager. http://kuborecruitment.com/jobs/quality-assurance-manager-switzerland

Director of Regulatory Affairs- UK & Europe

Are you looking for a dynamic new career opportunity?

To deliver the medical, regulatory and safety strategy for new products and ensure on-going compliance within the total UK/Ireland/Scanda region, leading to the growth of our UK/Ireland/Scanda business. http://kuborecruitment.com/jobs/director-of-regulatory-affairs

ADaM Statistical Expert – USA

Our client is looking for an ADaM statistical expert in the USA with 5+ years work experience in Data Management, Biostatistics or Programming in the Pharmaceutical or Biotech arena. Consultants should have practical experience implementing ADaM and the ability to assist the study teams to create analysis dataset specifications that conform to the ADaM standard (e.g. define dataset, variable, value and results level metadata) and have a strong background in statistics. http://kuborecruitment.com/jobs/adam-statistical-expert-usa

Statistician- Denmark

This is an urgent project. Candidates will be required on site initially for 2-3 months and after this time 50 % home based work is an available option.

The ideal candidate’s will be experienced Statistician’s with at least 2+ years knowledge and experience of the clinical research industry. The candidate’s will be responsible for the design, analysis and reporting of clinical trials and must have good SAS programming skills. http://kuborecruitment.com/jobs/statistician-denmark

Clinical Operations Manager – Switzerland

Our client is a rapidly expanding pharmaceutical group located in Switzerland, its strategy focuses on the development and registration of innovative pharmaceutical products. An exciting opportunity has arisen within the Research & Development Division for an experienced Clinical Operations Manager with 5+ years experience in a similar role and working knowledge of ancillary areas such as data management, statistics, regulatory affairs, etc.

 http://kuborecruitment.com/jobs/clinical-operations-manager-switzerland--3

Please visit www.kuborecruitment to see all our current jobs roles or email andi.brown@kuborecruitment for any further information. 

Does flexibility in the workplace have a big part to play in whether you take a job or not?

Giving employees the freedom to choose where and when they work, can keep them from looking elsewhere and save companies the considerable long-term costs of employee turnover.

 According to the sage journal survey conducted in America last year:

• 79% of candidates would pick the job with flexibility over one without

• 74% believe flexible working improves employee retention

• 71% think it makes employees more loyal

• 73% said flexible working lowers stress levels amongst staff

• 59% would turn down a job completely if it didn't offer flexible working

Flexible work options can reduce employee absences and turnover, both of which typically cost employers a hefty sum in lost productivity and extensive replacement costs. In fact, The Bureau of National Affairs estimates that over $11 billion is lost annually due to employee turnover.

 Would you turn down a promotion in favor of more flexible working?

Being offered a promotion is of course very flattering, but sometimes the lure of a shiny new title and more money just isn’t enough for some people. The thought of longer working hours, business travel and more stress means they would rather take a lower paid role if it means getting their work-life balance sorted.

Flexible working is more than just working from home, not only is it not an option for some job roles, but sometimes being flexible on working hours or using skype to have a meeting instead of traveling to the office can make you feel appreciated and much more willing to go that extra bit further for your employer because you know you are valued.  So its win, win. The employee is happier because they can be there for their child’s parents evening and the employer is happy because they are getting a dedicated employee who is giving 110%.

What are your thoughts? Is flexibility important to you?

check out our website for all the latest job offers www.kuborecruitment.com