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Gaea | Clinical Ltd
One Broadcarr Road
Macclesfield
SK11 0AQ
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Gaea Clinical Trial Services LLC
97343, Saint-Petersburg,
ul. Matrosa Zheleznyaka, 57A, 122N

Tel: +44 1625 413 900
Fax: +44 1452 798 222
Mobile: +49 151 51 11 19 31
Email: ngg@gaea.co.uk

Director's Hot Topics



24th November 2016:

Gaea works with Flex Databases

Flex Databases CTMS provides Gaea with a real-time online overview of all studies and activities. Partnering with Flex Databases is an important step in the digitalisation of Gaea. Implementation of the CTMS reduces time and efforts for keeping the overview of operational data on different levels. The system provides digital dashboard for all team members and supports the efficiency across operations. The Flex e-System reduces paper work and allows a more environmentally -friendly document management which has been a priority of Gaea Clinical. Flex Databases is a software solutions company that provides instant access to CTMS, LMS and EDC. Unlike traditional e-Systems developers, Flex Databases provides a combination of extraordinary flexibility, fair prices, go-the-extra-mile service and support with a constant focus on quality.


Flex Databases











13th January 2015:

Risk -adjusted monitoring - my view...

To my knowledge, so far no drug has gone through the full FDA approval process on the basis of risk-adjusted monitoring. So I have a nuanced view of risk -adjusted monitoring: If a drug is in the regulatory process - what if routine FDA audits of the high enrolling sites in the pivotal trial demonstrate significant findings as a result of this risk-adjusted monitoring? Then what? Will ECs in Europe, in particular, accept risk-adjusted monitoring in earlier phase trials where the safety profile is not yet defined? Some anomalies are easier to pick up remotely when looking at aggregate data. But does any e-CRF system flag up outlier data points relative to data in the database (as opposed to an outlier against a pre-defined set of criteria)?

The large CRO business model is tilted towards the "cash cow" of monitoring, and so if this is reduced in their estimates to look lower cost - in the harsh reality will it simply be made up later in their out of scope services? The old term is "use a small fish to catch a big fish"

By reducing CRA time at site, critical non-SDV functions are reduced, so what about site team training?

With reduced visibility of the CRA, will the site staff actually enrol as many into the trial as they would with the CRA being there to cajole and discuss screening in the face-to-face interactions?

Conduct very effective site feasibility!

The sponsors must be aware that the responsibility of oversight ultimately lies with them, and so if they agree to a risk-adjusted monitoring plan and the CRO messes up, the sponsor is still responsible. One of the simplest but yet most effective methods for saving costs is to conduct very effective feasibility in the start-up stage of the project. This is often not done well by large CROs that just use boilerplate templates and conduct it as simply as possible and then suggest additional sites later in the clinical programme. There are sites that also know how to play the game - offering large numbers and low cost and fast start-up times as they know this what the CRO wants to read. It�s also regrettable in terms of improving standards, that sponsors, fearful of offending "key opinion leaders" will go back to sites that produced significant management issues and offer new trials. Effective feasibility assessment of sites is the starting point, and stringent review of the information is required to ensure sites are only selected with as much knowledge as can be gained on their ability to perform well in the trial and generate high quality data. This step reduces risk.

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10th October 2014:

EANO- 20th meeting of the European Association of Neurooncology, October 2014...

eano2014-1
I attended the 20th meeting of EANO and I am now up to date on many issues in GBM. Outcome remains dismal and the need is for new treatment modalities, as the current modalities have reached their maximum. Issues on what, and how to combine modalities are of course, fundamental. Imaging remains complex. Gaea is the bespoke CRO on a phase 1 of an exciting new intratumoural approach in recurrent GBM, having taken over the trial for large CRO. We also offer patient recruitment expertise for poor performing sites in existing trials.

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22nd September 2014:

The Largest CRO homes in on small biotech co with new service offering...

"Emerging biotech companies have well-documented concerns about working with big CROs. Their scale, technology and expertise is all very alluring in the courtship stage, but when big pharma calls up the CRO, biotech fear they'll get saddled with a CRO C team"

Right! Standard Practice No 1 of large CRO- move out the A team from a small project and bring in the C team

Dubbed the Emerging Biopharma Solution, a big CRO's new model to seduce biotech: "guarantees real-time data access and senior-level sponsorship for every customer alongside all the scalable clinical know-how it offers to all of its clients"

Large CRO Standard Practice No 2.The word "scalable" is the big one, as that means what the biotech actually needs is going to cost plenty, as extra services.

Biotech can think that big CROs give security and yes -they have thousands of resources - but the size makes it slow with extra service costs they will be relying on to make the project profitable. If a biotech co needs a 10,000 patients obesity CV risk trial - then it needs a huge CRO and needs to spend the $100 -150 million - but if a biotech co needs -200 patients in a phase 2 in prostate cancer then it's not the optimal solution.

For biotech co: what is an optimal solution?

As the start: place experienced, effective, resources inside your own company.

Go to a CRO that can show you direct experience in your disease and has enough resources to deliver your project.

Then your team must be rigorous in ensuring that the full scope of work is agreed and the project team including CRAs is identified to avoid the C- team switch that all CROs may try to do.

Effective site feasibility is essential - its false economy to choose a CRO to run a project because they offer to do this for free. Would we choose a builder to build a house that offers the foundations for free?

Gaea is sized to run phase I - II trials. You always have Gaea Director's significant pharma and CRO experience as Sharing our Experience means using our experience to deliver practical solutions to our clients: we want each study to meet its operational objectives to time and with quality data so that it can answer the protocol objectives and hopefully lead to progress in patient care. Every study matters to Gaea: would you say that of a big CRO?

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09th June 2014:

Congratulations to our Enormous Elephant Runner

Photo1
We are delighted to update you that Rebecca White, a Gaea Project Manager, ran the First UK Enormous Elephant Run on 7th June in support of the David Sheldrick Wildlife Trust (http://www.sheldrickwildlifetrust.org/).

The event was on Wimbledon Common with participants running in elephant onesies for either 5k or 10k. In true British fashion the run was the least of everyones worries when the rain turned the course into a mud-bath. Finishing the 5k in 35 minutes and raising just over £200 we are delighted to congratulate Rebecca on this achievement.

Photo2
Across Africa, 50,000 elephants are being killed a year for their tusks to become symbols of wealth in China. Elephant family life is destroyed as the poachers target the oldest female for her tusks and milk dependent calves die unless they are the lucky few to be rescued in Kenya by the David Sheldrick Wildlife Trust. Of course the tusker males are a huge target, other males witnessing these deaths become stressed to literal death - they attack all humans they come across and are usually killed as result. Extinction of elephants in 10 years is real, unless China can be convinced to close its ivory trade.

The First UK Enormous Elephant Run raised £27,000 has been raised for the David Sheldrick Wildlife Trust from the Enormous Elephant Run which is a huge accomplishment. This money will help the Trust to continue their work in the rescue and rehabilitation of elephants in Africa and continue to try and protect this iconic species.


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29th May 2014:

Soon Gaea's 20th Birthday and an update on my son: Jomo Goodman

My birthday (24th May) and Gaea's 20th birthday on the 15th June are great motivators to me:

To work even harder to introduce to potential clients that Gaea can deliver an exceptional service
As well as full service CRO and rescue CRO, Gaea works to fix issues at sites in other trials. I believe that outside of trials that search for de novo patients, enough cancer patients are in the right clinics to meet trial enrolment goals. The problem is that often the right clinic aren't chosen, or they have many ongoing and competing trials. When sites are not performing in a trial the Gaea national Trial Manager or Senior CRA in each country who is experienced in recruitment and trial procedures conducts a direct assessment with site staff to identify the issues that are blocking enrolment. From that, we develop a site specific resolution plan.
Examples - trials can have countries that have almost no activity while in others its active, or countries where there is a high pre-screening rate in obtaining tumour blocks but this is leading to low screening or a high screen-fail rate. Both situations point to problems that the CRO is not identifying, and these mean significant costs to the sponsor - bottom line: the longer it takes the more it costs. We have only the interest that trials finish fast with quality data to answer the clinical questions.

To keep funding conservation and education (see website tab: Social Enterprise) in Kenya and South Africa
The recent photo of Jomo Goodman, "my son" prompts me: in 2012 I purchased Jomo, a black rhino as he was set to be sent to be Asia to a bad life. Jomo Goodman has since been re-homed in a Rhino sanctuary in South Africa (I can't say
nigel1
where as poachers are always looking for information), free to live amongst his own kind and start to reproduce. So here is Jomo - looking magnificent. I was able to go almost nose to horn with Jomo in 2012 and I wish him a long life and many heirs. In 2013 in South Africa as example, over 1000 rhino were killed by poachers and at this current rate the threat of extinction is real, bringing to an end their 64 million years on earth.


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13th May 2014:

Nigel Goodman has written an article for the British Association of Pharmaceutical Physicians (BrAPP):

PERSONAL VIEW: Risk-adjusted monitoring in clinical research a new idea to reduce estimated trial costs, but will there really be any savings and if so, at what consequence?

Please download the PDF. He would be happy to have feedback:

BrAPP May 2014 volume 24 | No. 6



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10th February 2014:

One in Five Adult Cancer Clinical Trials Fails to Complete

ASCO recently reported that one in five oncology trials fails to complete following an analysis of 7,776 trials registered on http://eclinicaltrials.gov where 20% failed to complete due to reasons unrelated to efficacy or side-effects. The chosen trials were phase II and phase III adult cancer clinical trials registered between 2005 - 2011. Poor accrual was the most common cause of the failure, accounting for 40% of these failed trials across all cancer types. Interestingly, researchers found that trials conducted at single locations, those with industry sponsor and those with study locations only inside the United States were more likely to fail. We know from recent experience the difficulties of enrolment into oncology trials, with a predicted 5% of cancer patients ever entering a clinical trial the issues are clear. However, when analysing enrolment rates by region there is consistently higher enrolment rates in Europe and Russia compared to America. Gaea has experienced CRA and CPM resources throughout Europe and Russia, able to manage a trial from feasibility through database lock with excellent enrolment rates. Junior CRAs are often intimidated by Principal Investigators and are focused only on data churn; our experienced resources do not have this problem and have a proven success record. Another role of Gaea is enrolment improvement, using our team of experienced, national CRAs and Trial Managers to attend sites and assist with patient identification, protocol inclusion/exclusion training and 'problem solvers' alongside the sponsor-chosen CRO. Our most recent experience in this role demonstrated 40% enrolment improvement in our countries with just 3-months work.

http://ecancer.org/news/5155-asco-gu--approximately-one-in-five-adult-cancer-clinical-trials-fails-to-complete.php

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7th February 2014:

Medivation and Astellas Announce Final Results for PREVAIL (enzalutamide®)

Medivation Inc. and Astellas Pharma Inc. announced final results on primary and secondary efficacy endpoint for their phase III PREVAIL Trial on 28th January 2014. PREVAIL was set-up to analyse the efficacy of enzalutamide in patients with asymptomatic or minimally-symptomatic chemotherapy-naive metastatic prostate cancer who have previously failed androgen deprivation therapy. A statistically significant overall survival benefit was seen in patients treated with enzalutamide (reduced death rate of 29%) compared to placebo (HR=0.71; p<0.0001) and significantly reduced the risk of radiographic progression or death by 81% compared with placebo (HR=0.19; p<0.0001). Another benefit seen was the median tie to deterioration in a measure of prostate cancer-specific quality of life were 11.3 months for enzalutamide-treated patients and 5.6 months for placebo (HR=0.625; p<0.0001). Gaea is delighted to see such positive results for enzalutamide, having been involved in the Clinical Operations and Quality Management for this phase III PREVAIL Trial, working alongside the sponsor-chosen CRO to reduce premature patient discontinuations, all imaging management and additional CRO Training.

http://www.astellas.com/en/corporate/news/detail/medivation-and-astellas-announ-8.html


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25th January 2014:

Clinical trial evidence supporting FDA approvals varies widely

Downing NS.�JAMA. 2014;doi:10.1001/jama.2013.282034.

The quality and scope of clinical trial evidence utilised by the FDA as the grounds for drug approvals is highly variable across indications, with just more than one-third of indications approved on the strength of a single pivotal efficacy trial, according to new study findings, reported in JAMA.

For each of the new drugs evaluated, an investigator determined the pivotal efficacy trials used as grounds for approval. The trials were classified based on 1) randomisation and blinding, 2) primary endpoints ,3) type of comparator, 4) number of treated patients,5) trial duration and 6) completion rates.

The investigators noted the use of "surrogate" outcomes, defined as any endpoint using a biomarker to predict clinical utility.Researchers for the cross-sectional study evaluated publicly accessible FDA documents relating to all novel therapeutic agents approved between 2005 and 2012.

The researchers found that during the study period, the FDA approved 188 new drugs for 206 indications, on the strength of 448 pivotal efficacy trials. Although for each indication the median number of pivotal trials was two, 74 indications (36.8%) were approved on the grounds of a single pivotal trial. Most trials were randomized (89.3%; 95% CI, 86.4-92.2), double blind (79.5%; 95% CI, 75.7-83.2) and used either an active or inactive comparator (87.1%; 95% CI, 83.9-90.2). Among all pivotal trials, the median number of patients enrolled per indication was 760. The approval of 68 indications was backed by at least one pivotal trial with a duration of at least 6 months (33.8%; 95% CI, 27.2-40.4). For 91 indications, pivotal trials using surrogate endpoints as the primary outcome constituted the sole basis of approval (45.3%; 95% CI, 38.3-52.2). Trials using clinical outcomes and clinical scales served as the exclusive grounds for approval for 67 (33.3%; 95% CI, 26.8-39.9) and 36 indications (17.9%; 95% CI, 12.6-23.3), respectively. The features of the trials differed based on therapeutic and indication variables, including therapeutic area, anticipated duration of treatment, orphan status and accelerated approval.

The researchers said although the FDA's regulatory flexibility allows valuable customisation in approving new agents, it should be considered when making therapeutic decisions.

"This variation has important implications for patients and physicians as they make decisions about the use of newly approved therapeutic agents, and has the potential to inform current FDA regulatory approval standards and post market surveillance initiatives," the researchers wrote.


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09th October 2013:

Continued High Staff Churn Rate in Large CROs

The initial findings from the 15th annual CRO Industry Global Compensation and Turnover Survey show the employee turnover rate at US CROs remained high in 2012, with 18.6% of employees leaving their companies compared with 19.7% in 2011. The turnover rate among CROs outside of the U.S. increased from 17.8% in 2011 to nearly 22% in 2012.

To address this, CROs have begun offering employment incentives in order to attract and retain their talent, �88% of CROs reported using recruitment bonuses to find talent and 53% utilised retention bonuses to keep their employees, both are significantly higher figures than in previous years. The new pay incentives target all levels of the company hierarchy.

As Gaea is often involved with fixing issues at sites in trials run by large CRO we see the negative effect that a regularly changing CRA team can have at sites. High turnover in CRAs can result in poor follow up on identified issues and does nothing to convince site staff that the sponsor values the trial or the site.

Add this to the consequence of the more experienced CRAs leaving, to be replaced by junior CRAs and I remain curious why many small biotech continue to believe that their only solution to trial delivery is to just go to one of the largest CROs .

http://www.fiercecro.com/story/cro-turnover-rate-sky-high-according-survey/2013-04-01

http://www.fiercecro.com/story/study-cros-dishing-out-bonuses-halt-high-turnover/2013-08-26


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05th September 2013:

Is patient travel distance associated with survival in clinical trials in head and neck cancer?

The US study (click here for source) concludes that there is a positive association between patient travel distance to treatment versus survival in a sample of 110 patients with HNC. "Referral" patients defined as patients who travelled over 15 miles to the site for treatment, had "only one-third the hazard of death of those living closer (HR = 0.32, 95% CI = 0.12 to 0.84)" 1 (defined as "local"). Variables such as treatment regimen were standardised with few differences in disease factors between the local and the referral populations. The statistical analyses adjusted for potential individual differences in economic status, race, age, neighbourhood income, tumour stage, cancer site, smoking history etc.

Despite HPV, most HNC is still a disease of traditional risk factors such as pack years of tobacco, and alcohol usage and is usually associated with lower socioeconomic status. The study found that "with each $1000 increase in annual family income, the hazard of death decreased by 3.6%" 1 ". Those with higher income are often more highly educated and were in the referral population of this study, and this may be key, as the more educated the patients are with regard to the treatments available and the value of leading a healthier lifestyle, the higher the chance of survival. This conclusion is supported by the fact that, although the local population tended towards having cancer locations with a generally better prognosis, overall they still had a statistically lower chance of survival.

So, "travel distance" seems to be mediating socioeconomic factors, which are the only major differences between the two populations in the study.

In conclusion, although the interesting result finally doesn't favour long distance over local, it is key to the success of any trial - particularly involving many visits common with vaccines - that patients are reimbursed for the expenses. Site bureaucracy can causes delays in repayment, therefore large CRO are forced to be inflexible and may offer a credit card, but patients in Europe want to receive cash. An advantage of Gaea as a small and humanistic CRO is in managing site - by - site with great attention to individual site need, thereby motivating both enrolment and the critical continuation of therapy.

Article: Journal of the National Cancer Institute, Vol. 95, No. 18 September 17, 2003- Is Patient Travel Distance Associated With Survival on Phase II Clinical Trials in Oncology? p1370-1375 (Lamont et al. 2003).

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23rd August 2013:

Risk-Based Monitoring - A Riskier Strategy?

The FDA recently finalised guidance on remote monitoring and concluded that such a technique is more likely to ensure subject protection and overall study quality than a reliance on routine monitoring visits (FDA, 2013). As Sponsors sweat over the high costs of large CROs, will they push vendors to adopt this approach? How fast will it take off? The Routine site monitoring CRA visits are a core revenue stream in the CRO business model so if they get reduced, is the hope that the sponsor invests the savings into new trials? How will they allocate CRA resources? CROs will want to know how the FDA will review filings from trials using risk-based monitoring: who will be the first to test it?

Data collection is an integral part of any clinical trial. With less on-site monitoring, I have the concern that it will become even more difficult to remotely identify inconsistencies in the inputted data. Data quality is our key and we will have all felt the pressure from inadequate monitoring or poor data management. Is it really a less risky and easier strategy to think more about the key data points and reduce source data verification from its common 100%? While CRO may invest in more technology to conduct more remote monitoring and "pick up trends" we all know that it’s only the CRA that is the key to finding out what really goes on at each site.

The EMA has not yet published any guidance and, although Gaea believes that a certain percentage of monitoring can be conducted remotely, it is vital that CRAs are on-site for data quality and also to encourage a good relationship with sites and increase enthusiasm for the study, to ensure better enrolment. I feel that the adoption of this approach, which will significantly reduce contact at some sites, may result in site teams forgetting the study as it’s no longer visible to them. So although it reduces monitoring visit costs, it will increase timelines – and in turn costs - from slower enrolment, or in the worst case scenario, from the need to re-monitor.

Source: U.S. Department of Health and Human Services Food and Drug Administration (August 2013) - Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Approach (p5).

Click here to link to the PDF on the FDA website.

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25th July 2013:

The Problem with Clinical Trials

While faster and more adaptive trial designs like the I-SPY trial are one important approach to the problem, they can address only some of the limitations. A fundamental issue continues to be that only 3 -5 % of adult cancer patients participate in clinical trials. The reliance of biotech companies with potential innovations on large CRO that then use junior CRAs, who are slaves to billable hours, compounds the routine lack of involvement of PI into any trial. Signing off on documents is not involvement. I believe that motivated PIs are a key driver of patient inclusion, and this was confirmed by the survey in the BJC (Jenkins V, Farewell V, Farewell D et al Drivers and barriers to patient participation in RCTs. British Journal of Cancer. 108 (108), 1402-1407 ) that confirmed the doctor having a positive attitude is a very important driver of patient consent. However, a point to also note is that the results of this survey suggested that the more complex a trial design, the less likely that health care professional explaining the trial would show enthusiasm about the research.

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24th May 2013:

The (Claimed) Benefits for Small to Mid-sized Biotech Partnering with Global CRO

More biotech companies are entering into strategic partnerships with global CROs. The partnerships are claimed by the CROs to be mutually beneficial: the biotech gainining resource efficiencies in CRO management of between 25-30% compared to conventional out-sourcing. CROs also claim that the knowledge of both the biotech and the CRO creates a partnership of expertise management, producing more effective clinical trial protocols and associated management plans that can accelerate cycle times, and reduce the costs and delays which both sides are usually accustomed to as 'standard outsourcing practice'. The most recent deal is that of Quintiles and Merck Serono, which gives Quintiles the keys to the Merck portfolio from phase I.

In prior times we had "preferred partnerships", with the same claimed benefits. They became less popular as the benefits didn't materialise for the biotech - if the CRO had such skilled resources in place why weren't they providing them already to such biotech without a preferred provider deal? In fact, CROs were tempted to count these clients as 'in the bag' and so reduce the skill set on the project and use the best resources with the biggest pharma.

Such relationships give an allusion of partnership or may arise from panic - as perhaps in the case of Merck as their oncology portfolio has failed to deliver. My experience is that such relationships are more one sided than 50:50 and the CRO gains more with both: access, removal of competitors and a secure revenue steam. Once tied in, a biotech cannot then untie the knots as easily.

What is an alternative to such an agreement?

A biotech with smart personnel should still be able to conduct all the activities and still retain independence from any CRO. As an example - to know about a disease: form a well-prepared advisory team of clinical experts who still are still active in in clinical trials. Listen to the advice! Don't be fooled by the glitz of big CRO management systems, as in fact such systems are designed for large global studies and so do not work so well in the small biotech arena.

Gaea has a long history of assisting biotech in establishing and executing a clinical plan. Starting with the conduct of key market research, to the organisation of a clinical advisory meeting in an indication, through the implementation of the project in a cost effective manner. We work with the PIs who know what is happening in their disease area. We favour direct contacts with sites' staff as our experience is that feet on the floor in the feasibility and trial set up is what matters, as site staff are (still) human.

Source: Josh Schultz (Parexel) 2013. CRO Strategic Partnerships; Benefits for small- and mid-sized biopharma Available: Click here. Last accessed 18th May 2013.

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10th May 2013:

What Impacts Recruitment into Oncology Trials?

Globally, it's shocking that only about 3% of cancer patients enrol into a trial.

The authors of the recent paper published in the British Journal of Cancer used questionnaires to define what motivates patients to take part in a clinical trial, and what discourages their involvement.

Altruistic motivations were the main reason for patients wanting to be a part of clinical research that could benefit others in the future (40%). Reasons for declining were "automatic randomization" - patients don't understand what randomization means and want their doctor to decide which they receive (54%), and - critically - the amount of trust they have in the doctor.

The results also showed a trend in what kind of treatment patients were more likely to accept: if the trial was combining a standard treatment with a novel IMP then patients were far more inclined to participate (45%), compared with a novel IMP alone.

Reasons for consenting to participate in a trial were irrespective of disease stage, gender, age group and the site of the cancer.

So the doctor having a positive attitude is a very important driver of consent. However the data suggest the more complex a trial design, the less likely that health care professional explaining the trial would show enthusiasm about the research.

This confirms that the PI is a key driver to enrolment, in giving the patients all the options, in explain randomisation and in showing enthusiasm for the research. In our experience the typical start up meeting is driven by detail in limited time and is not about PI motivation. Gaea is brought in to fix enrolment issues late, often when the site team is defensive. To my mind it would be much more effective that we came in early as MSL and, for example, worked alongside the CRO at the start-up meeting to ensure that the PI is fully engaged on the trial and motivated as the PI is the key.

Source: Jenkins V, Farewell V, Farewell D et al. (2013). Drivers and barriers to patient participation in RCTs. British Journal of Cancer. 108 (108), 1402-1407

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26th April 2013:

Zytiga® Vs. Xtandi® - who will win?

Prostate cancer treatment has seen a number of progressive changes. The introduction of Cougar Biotech's (now JnJ) Zytiga® (abiraterone acetate) and Medivation/Astellas' Xtandi® (enzalutamide) have at last provided options for the post-chemo CRPC population; Zytiga's expanded approval now provides a treatment in pre-chemo CRPC. Xtandi® will soon join the pre-chemo market, but the question is, which will be found to be superior? Zytiga at a (US) cost of c $66,000 a year but with the added requirement of prednisone, or Xtandi at c $85,000 a year and no prednisone? Or finally, in Europe, will the payers push back?

My team is delighted to have been involved with both drugs: we worked for three years in the two phase III studies for abiraterone acetate, representing Cougar in Europe with all aspects of their trials. This was repeated for one year with enzalutamide in PREVAIL, with Gaea working as clinical consultancy to deal with site issues in Eastern Europe.

The high level of unmet need, premium pricing and aging population make the CRPC market a very attractive proposition for drug developers. Gaea would be happy to discuss how we can share our experience from the three phase III, to help your product's clinical programme in Europe, in Russia (with huge potential for enrolment) and now the USA.

Click here for further information on the sales figures of Zytiga Versus Xtandi.

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