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.

4 Impossibly Simple Dental Hygiene Tips for Everyday

Everyone wants to have that fantastic toothpaste-model smile. Did you know that getting such a smile is not all that difficult? Sometimes all that is needed is to maintain high levels of oral hygiene. All dental problems- at least a majority of them- are as a result of poor dental care. These issues could be anything from gum disease, bone loss, heart disease and so much more. Checkups and proper hygiene can prevent these issues. Here are some simple dental hygiene tips that you can employ to ensure that you keep your teeth healthy for years to come. They are exactly what you know:

1. Brushing

This is one of the simplest ways of maintaining oral hygiene. If you are brushing your teeth, you need to place your brush at an angle of 45 degrees close the gum line. The gum line and tooth surface must be in contact with the bristles. On the outer surface of the teeth using a backward -forward, up-and -down motion, making sure to be done gently to evade bleeding.

In order to clean the inside surfaces of the teeth and gums, place the bristles at a 45-degree angle and repeat the backward forward, up-and-down motion. Finally, the brush surfaces of your tongue and the roof of your mouth to remove bacteria, which may lead to bad breath. Brushing your teeth twice a day helps you to curb buildup of bacteria. If you cannot do this, rinse your mouth with water after eating to reduce the amount of food that would serve as the home for the bacteria.

2. Flossing your teeth.

Flossing can help you remove food particles and other damaging substances that regular brushing of teeth cannot. It enables one to reach between the teeth where toothbrush bristles cannot reach or mouthwash can’t wash away. It is recommended that you floss your teeth once in a day.

3. Reduce tobacco intake

This will help your teeth a lot. First, it will save you from oral cancer and periodontal diseases. Second, it will put away all the many horrible side effects caused by agents used to mask the smell of tobacco. For instance, when you smoke a cigarette, you are highly likely to use candy, tea or coffee to mask the smoky breath and odor from getting out. This increases the harm created.

4. Use mouth wash apart from brushing and flossing

They are not important and not all are effective. They contain Listerine and carbon dioxide is very helpful because they help exterminate and preserve the bacteria in your mouth. Mouth wash can help sustain well-built teeth. However, mouth wash goes hand in hand with brushing, flossing, visiting the dentist and eating well, it is just the thing that will improve your dental strength and make it grand.

Remove Unwanted Facial And Body Hair Using Laser Treatment

Removing unwanted hair is time-consuming and repetitive no matter what your preferred hair removal technique is, and whether you shave, pluck, wax, thread or use depilatory creams, the hair will always grow back. You’ll find the skin on your face is sensitive, and constantly using harsh hair removal treatments can cause a great deal of skin irritation.

All women have hair on the face, usually it’s fair and fine and is difficult to see, but those with darker hair are not so lucky. You will find that most of your female friends have the same issues when it comes to unwanted facial hair. The hair on the upper lip, chin, cheeks and sideburns can all be very embarrassing and cause you a great deal of insecurity. It seems that every time you think you’ve disposed of unwanted hair, you’ll find more of it sprouting up somewhere else, and even after you get rid of the hairs, they just grow back.

You can cover up your excess hair in areas that aren’t constantly exposed, but the hair on your face is always on display, and it can seem as though everyone is always looking at the hairs on your upper lip, chin or sideburns. A good way to get rid of unwanted hair is with laser hair removal.

Benefits of laser hair removal:

It permanently reduces hair safely
It’s a fast treatment time
The results will boost your self-confidence
Prevents razor bumps and irritation
Laser treatment causes only minimal discomfort

Laser energy gets absorbed by the pigment in the hair follicle, and this laser energy is then converted to heat, causing thermal damage to the follicle without harming the surrounding skin. This results in hair growth being stopped in the damaged follicle.

Generally for white skin you’ll need around 6 treatments, spaced 4-6 weeks apart, and this usually results in 80% of hair removal. Darker or black skin may need around 8 treatments, resulting again in 80% of hair removed.

Most clients experience minimal discomfort; some may experience a minor stinging or pinching sensation on the skin as we deliver the laser pulses, but we can offer topical anaesthetic cream to make treatments more comfortable.

Although we can perform laser hair removal treatment on white or black skin, lasers only work on hair which has pigment, because it absorbs the laser light and allows the heat to build up and diffuse throughout the follicle to destroy it. Therefore it’s not possible to treat white, grey, and blond hair by laser.

If you need help choosing a cosmetic procedure, we provide an extensive range of cosmetic procedures for the face and body: Botox, Vaser Lipo, Lip Augmentation, Dermal Fillers and many more treatments, to help create a younger, slimmer, more youthful looking you!