Clinical Trial Budgeting and Technological Impact

The current clinical trial and drug regulatory process have lagged behind advances in scientific research. Regulatory approval is based on the evidence of efficacy and safety gathered from pivotal trials. Most experts agreed that traditional approach to drug development constitute a blunt tool where a more focused experiment could suffice instead of a one-size-fits-all approach which is ineffective and wasteful.

According to studies conducted by New England Journal of medicine, almost nine in ten clinical trials do not meet FDA requirement and thus do not reach the market. Project fails when they do not meet endpoints. Lack of efficacy and complex protocol are the major cause of failure. To reverse this trend, productivity must be directed towards the poor predictive capability of the current experimental model.

Clinic trial plays a major role in drug development and advancement in technologies such as drug positioning, therapeutic target, and drug efficacy prediction are helping researchers and pharmaceutical companies in drug development.

Traditional trials have fixed parameter that is determined in advance and remain constant throughout out the process. One promising approach to modernizing clinical trials and maximizing efficiency is by adaptive trials which allow for certain parameters such as sample size and treatment regimen to be modified or replace on interim results.

The major hurdle is that investment in clinical research is dwindling as government and stakeholders tightened their budgets. As major sponsors revenue stabilize and cost continue to rise, the clinical trial finds itself in a financial squeeze. Pharmaceutical and medical-device companies have been intent on trimming budgets. Lean contract negotiations are the norm these days, no sponsor is walking around with money burning hole in their budget and most are responding to mandate to save cost by requiring CROs to provide unrealistic competitive budgets which are disastrous. With tightened budget, short-sightedness has become the order of the day and as a result, both sponsors and CROs reputation suffered.

Cutting back drastically or unwillingness to adequately fund a project will produce a poor result. This simplistic strategy is unrealistic and unsustainable. It is important to note that focusing solely on short-term strategy will be detrimental in the long-term. If sustainable research climate is created, prosperity will definitely grow.

There has been increasing effort in utilizing technologies to streamline protocol and boost efficacy in clinical research. The use of technology is empowering research professionals by helping them to make a decision based on resulting data. With the aid of technology, organizations are reducing cost and speeding up evaluation process. Technology allows for accrual of data faster and that information can be disseminated in real time. This can lead to a better decision being made on protocol, patient recruitment, and trial sites.

Here is the list of technologies impacting clinical trials today

Risk Based Monitoring (RMB)

Companies use risk based monitoring to target and prioritize resources, identify risks relating to quality, safety of subjects and integrity of clinical trial data. Risk based monitoring (RMB) can incorporate targeted monitoring or triggered monitoring and reduced source document verification (SDV).

Traditionally, source data verification (SDV) were conducted 100% via on-site monitoring, a labor intensive approach. Reduced SDV limits the measure of SDV at the site, study and subject level.

The quest for more key ways to manage clinical trials has distinguished risk based monitoring which attempts to manage resources without compromising on clinical quality.
The variables of protocol compliance, data integrity, and patient safety etc. impact how assets are deployed.

The impact of technology in risk based monitoring is profound and currently in markets are clinical trial management systems (CTMS) and remote data capture (RDC) which can support risk based monitoring system. Some systems still support manual entering and reporting of clinical trial data, for this reason, there is a need to setup more robust systems for flagging and alerting data automatically, these alerts can be developed for notifying those who need to act when an issue arises.

According to Medidata, the cost of onsite monitoring is approximated at 28.7% of study budget and project management at 26.47%. In moving to RMB, monitors can spend their time more judiciously and reduce cost.

Electronic Trial Master File

In biopharma industry, every organization involved in clinical trial maintains a trial master file containing several thousand pages of regulatory documents needed for each clinical trial.

Using a paper-based or hybrid trial master file system to manage thousands of clinical documents, processes and tasks can be overwhelming and can cause errors or misread that can ruin clinical trial and put it at risk for noncompliance.

Organizations usually employed an Enterprise Content Management System (ECM) to manage clinical trial regulatory documents. The ECM based eTMF offers automated methods to index, archive, and report on documents and content.

To eliminate paper from a clinical trial study, electronic signing utilizing digital signatures from verified users is being employed. Globally, most countries including the US and many countries in EU are accepting digital signatures in place of wet signatures thereby eliminating the need for scanned documents.

An electronic trial master file (eTMF) offers a robust platform to document management which allows study team members to gain a quick insight necessary to efficiently manage clinical trials and speedup time to market. Electronic document management processes are being adopted at a steady pace as it becomes vital to business productivity, shortened biopharma product development timelines, and cost cutting.

eSource

In 2013, the FDA release its Guidance Document on Electronic Source Data in Clinical Investigations, since then sponsors and study sites have been adopting and employing eSource as a method of recording data in clinical trials.

The definition of electronic source (eSource) is a clear concept — to capture or process source data electronically, this data exclude the source data that was captured on paper and transcribed into an electronic database. In eSource, the source data element itself must be electronic.

The benefit of eSource is apparent and the FDA endorsed it because it will be useful in: facilitating real-time entering of electronic source data during subject visits, removes the need to duplicate data, allows for accuracy and completeness of data by using electronic prompts for inconsistent and missing data and lessens the chance for transcription errors.

The need to modernize and streamline the way data is collected are evolving, as a result, much of the exploratory done thus far by several pharmaceutical companies have been mostly to build internal competency. In moving forward, it is critical that standards and interoperability within different eSource modalities come together to help create systems that provide accurate data in clinical research.

Using Clinical Data Repository (CDR) to drive optimization

The ability to effective manage, report and analyze data is of paramount importance in clinical trials. The major hurdle is that data from clinical trials are frequently entered by clinicians electronically or manually across multiple channels including EDC, LIMS, CDMS and IVRS and other systems each with unique underpinning needs. This approach causes data to end up in different databases making it complex and time-consuming to leverage and synchronize the data.

There is confusion as to what constitute or defines CDR as distinct from a clinical data warehouse (CDW). CDR can be thought of as consolidated storage and transfer of data for clinical trials including security, workflow, and systems for performing daily task all under one umbrella.

Centralization of the storage and management of data results are the purpose of CDR and to provide a steadfast and reliable infrastructure that supports clinical data analysis and management, facilitate standardization and secure transfer of data, allow for analytics and cross-trial analysis and to leverage data from trials across the pipeline.

Why I Quit The Gym & You Probably Should Too

Around new year 2017 I made a pledge: To quit the gym and get fit.

I know this sounds like a slightly odd inverted new years resolution, but for around 5 years I had been a committed gymphile (not sure that’s a word but there you go). My physique hadn’t changed radically except for slightly better arm definition and on occasion slightly better pecs. But for the effort I was putting in, not to mention the money, it wasn’t really worth the return on investment.

And what’s happened since I’ve quit the gym? Well, I’ve drunk a lot of beer, eaten a lot of cheese and done some very half assed exercise regimes.

The result. I’m about the same as I was when I was going to the gym.

The response from many gym go-ers will undoubtedly be, well you weren’t putting enough effort in at the gym or else you’ve been quite good with your self motivation.

Neither of those statements are true.

I used to go to the gym three times a week and put in an hour at a time – working hard on each set and making sure every minute in there was put to good use. I walked out of the gym dripping with sweat every time I went. Literally. Every. Time.

So my self motivation post gym has been good? Well. I used to run home from work on a weekly basis (about a 5 mile run). Aside from that and some runs around the park. That’s it.

So why do I think you should quit the gym?

First of all, if you’re one of those people who does about 2 hours, 4 times a week in the gym and posts selfies on Instagram of you in gym gear – this does not apply.

If you’re one of those people who goes for the social and seems to know everyone in the place and is full of tips and stuff… Probably doesn’t apply to you either.

I’m talking to the other 90% of the population – the people who go because they feel like they should. The people who when they get to the gym just go through the motions and do a few sets of this or that, or worse still just SIT on an exercise bike.

You’ve probably been sat at a desk all day eating cake and you’re watching the calories tick up on the digital display, waiting til it gets to the same number as that Krispy Kreme so you can go home.

Or, you’ve got to lose a stone so you can go on that beach holiday/get in that wedding dress/eat more cake on your birthday.

Or you saw a photo of Kate Middleton in a bikini on holiday somewhere glamorous again and decided you hate your flabby body and you really should do something about it.

Don’t get me wrong these are all noble reasons to get exercising – and exercise you definitely should. But in the gym? Not necessarily.

The gym is made for those body sculptors – the people who have actual fitness regimes and programs and have an end goal. And they will get to that end goal because, well, that’s what they really really want. When they’re not in the gym they’re planning their next visit to the gym and ACTUALLY LOOKING FORWARD TO IT.

Is that you? If it isn’t do yourself a favour and cancel your gym membership now.

What do I do now then?

Cancelled it? Saving yourself £60 a month already? Go you! Have a doughnut.

I’m joking don’t have a doughnut, that’s a terrible idea.

Food

First things first – it’s your diet. Hate to break it to you but that’s probably why you’re a bit flabby around the edges. If it comes in a packet and has ingredients that you don’t really understand – avoid it. If it claims boldly on the cover to be packed full of minerals and vitamins and to make you at least 6 times more attractive to the opposite sex – avoid it. Those ‘healthy’ breakfast bars and cereals or those low fat thingumyjigs. Swerve it.

So what to eat? Eat natural food. And not loads of it either.

Also drink water. Don’t go crazy, 2 litres is the recommended amount – about 4 pints of water.

But, you know when you’re thirsty? Have some water.

Exercise

When you’re taking in decent fuel for your body and not pumping it full of additives, you won’t have to work so hard to process it. This makes the exercise bit relatively easy.

My routine was this.

Every day I’d walk to the nearest tube station, which is about a fifteen minute walk away. I’d then get to my very sedentary work, get to lunch and then on my 45 minute lunch break I would walk as much as possible. Some days that was 5 or 10 minutes. Other days it was my whole lunch break. And then when I got home I’d either walk back home or I’d go for a run.

Total active time daily was around 1 hour 30 or more.

To amp up any exercise regime it is often a good idea to have fun while you’re doing it.

I’ve recently discovered parkour. Yes, parkour is famous for the people doing backflips and jumping across roofs but at it’s foundations it is simply a way to get from a to b in a slightly more interesting way. I’ll be honest, I’m not backflipping or rolling yet, but what I am doing is jumping onto things, pulling myself up walls or trees or doing press ups and sit ups in the park.

Basically, I’m doing resistance exercise. Trying to use my body for the things it was meant to be used for – climbing, jumping, lifting. But… Without paying a hefty monthly fee to do so.

Ways to get free exercise

There are plenty of ways you can exercise and not pay a penny. Parkour, for me, is a good one as it literally involves running outside and when I get to a bench I jump on and off it for a bit. Or if I see a tree or a fence I climb or vault it.

If you live in the country – or a smaller city nearer the country – good for you. You can probably run up hills, climb trees, swim in the sea or a river and so all kinds of free things.

In the big city it can be harder.

Running is a good start but some people find this can impact on their joints, especially without proper warm ups.

The simplest one is walking. Just walk as much as possible, as fast as possible and do it every day. Supplement it with some exercise outdoors and if you can do maybe ten or twenty sit ups and press ups too, you’ll find some good results.

Taking up a sport is probably the best way to stay in shape. Football, volleyball, dodgeball, cycling, tennis, yoga, pilates, swimming, gymnastics, hide the sausage… OK maybe not hide the sausage, but basically anything that keeps you moving and having fun.

Actually yeah maybe hide the sausage.

However you do it, get some exercise and crucially, don’t do it at the gym. Unless you NEED a weights rack to sculpt those tight buns of yours, you’re only wasting your money.

What We Eat Mentally Affects Our Physical Body

With the onslaught of globalisation and instant communication people are absorbing the evils of the world at a greater rate than ever before. Where once there was time to think about what we took in mentally it is now almost unnoticeable as it can happen in a second or less. Television, the Internet, and smart phones are occupying our time while flashes of information pass before our eyes as sparks in the universe.

Every spark has the potential to start a fire in the compost of our dreams. They can outweigh emotions and send us on a tangent that is completely different to the path we were on. Unless we are strong enough mentally to ward them off we will fall victim to the aim of their makers.

This is what the world has become. It is ruled by an insanity of dreams, conflicts, make-believe, and their consequences. It is governed by the things designed to pull us apart mentally and test our resolve to reconnect with our roots.

What am I talking about? The best explanation concerns my reincarnation and link to the Universal Spirit. It fills all of space and is in each one of us driving and guiding us to our end. Not one has independent thought or actions but we are a collecting body of the forces of creation.

Some have been chosen and are led in a different manner because of their link to the Spirit. They neither lie nor can accept lies. They ward off the sparks of make-believe and earthly ideals like water from a duck’s back. They are content and peaceful enough in their ways that only the Almighty can stir them into action.

Others, however, are like pins on a bowling alley Anything that strikes them will be a hit. They take in the filth of the world and they absorb the sparks to warm their cockles. They treat others as fodder and many will destroy in a pitch for greatness.

The question is, therefore, why has God made humans to be so diverse in nature, character, and behaviour. The answer lies in the plan laid down from the start to bring some to the glory of spiritual power and they are growing in a garden of weeds, prickles, and rocks to test them.

“For they prophesy a lie unto you, to remove you far from your land, and that I should drive you out, and ye should perish.” Jeremiah 27:10

This is what has happened to the world. Lies, make-believe, and sparks of unsubstantiated lights are driving people away from reality. Only those strong enough to withstand them are growing with strength and will be there are the harvest.