Invisible gorillas and detection of adverse events in medical device trials

Weekly Episode #1 - Patients and study monitors are both people.

What is easier to detect in your study – Slow-moving or fast moving deviations?

This post considers human frailty and strengths.

We recently performed a retrospective study of the efficacy of  Flaskdata.io automated study monitoring in orthopedic trials. An important consideration was the ability to monitor patients who had received an implant and were on a long term follow-up program. Conceptually, monitoring small numbers of slow-moving, high-risk events is almost impossible to do manually since we miss a lot of what goes on around us, and we have no idea that we are missing so much. See the invisible gorilla experiment for an example.

One of patients in the study had received a spinal implant and was on a 6 month follow-up program dived into a pool to swim a few laps and died by drowning despite being a strong swimmer. Apparently, the pain caused by movement of the insert resulted  in loss of control and a severe adverse event. The patient had disregarded instructions regarding strenuous physical activity and the results were disastrous. 

It seems to me that better communications with the patients in the medical device study could have improved their level of awareness of safety and risk and perhaps avoided an unnecessary and tragic event.

Subjects and study monitors are both  people.

This might be a trivial observation but I am going to say it anyhow, because there are lessons to be learned by framing patients and monitors as people instead of investigation subjects and process managers. 

People are the specialists in their personal experience, the clinical operations team are the specialists in the clinical trial protocol. Let’s not forget that subjects and study monitors are both  people.

Relating to patients in a blinded study as subjects without feelings or experience is problematic. We can relate to patients in a personal way without breaking the double blinding and improve their therapeutic experience and their safety. 

We should relate to study monitors in a personal way as well, by providing them with great tools for remote monitoring and enable them to prioritize their time on important areas such as dosing violations and sites that need more training. We can use analytics of online data from the EDC, ePRO and eSource and connected medical devices in order to enhance and better utilize clinical operations teams’ expertise in process and procedure.

A ‘patient-centered’ approach to medical device clinical trials

In conditions such as Parkinsons Disease, support group meetings and online sharing are used to stay on top of medication, side effects, falls and general feeling of the patient even though the decisions on the treatment plan need to be made by an expert neurologist / principal investigator and oversight of protocol violations and adverse events is performed by the clinical operations team. There are many medical conditions where patients can benefit by taking a more involved role in the study. One common example is carpal tunnel syndrome. 

According to the findings of an August 3rd, 2011 issue of the Journal of Bone and Joint Surgery (JBJS), patients receiving treatment for carpal tunnel syndrome (CTS) prefer to play a more collaborative role when it comes to making decisions about their medical or surgical care. 

Treatment of carpal-tunnel syndrome which is very common and also extremely dependent upon patient behavior and compliance is a great example of the effectiveness of “shared decision-making, or collaborative, model” in medicine, in which the physician and patient make the decision together and exchange medical and other information related to the patient’s health.

As the article in JBJS concludes:

“This study shows the majority of patients wanted to share decision-making with their physicians, and patients should feel comfortable asking questions and expressing their preferences regarding care. Patient-centered care emphasizes the incorporation of individual styles of decision making to provide a more patient-centered consultation,” Dr. Gong added. 

In a ‘patient-centered’ approach to medical device clinical trials, patients’ cultural traditions, personal preferences and values, family situations, social circumstances and lifestyles are considered in the decision-making process.

Automated patient compliance monitoring with tools such as Flaskdata.io are a great way to create a feedback loop of medical device clinical data collection,  risk signatures improvement, detection of critical signals and communications of information to patients. Conversely, automated real-time patient compliance monitoring is a a great way of enhancing clinical operations team expertise.

Patients and study monitors are both people. 

Important EDC features for medical device clinical trials

esource tp get smart to market

Medidata Rave and its CTMS companion product iMedidata are a far more comprehensive solution than OpenClinica but when you choose EDC software for medical device clinical trials, you enter a realm of unique requirements involving connectivity, security, privacy, API integration and specific interfaces to hardware.

Electronic data capture software (EDC software) systems have demonstrated that their value is manifest for clinical trial efficiency and cost savings. Soon, medical device clinical trials will no longer be dependent upon paper-based systems at all. Paper is great for passing notes in class, but how often does that even happen anymore? Kids in school are more likely to use Snapchat or simply text each other.

As someone said recently – “millenials are off Facebook, adults still use email”.

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Homeostasis and medical device clinical trials

medical device clinical trials

Danny talks about how to strike a good balance between people and technology for monitoring medical device clinical trials.

Are real-time alerts too much of a good thing for monitoring your study? Maybe real-time alerts for patient compliance in medtech studies is just a fad – a fad just like WhatsApp.

I had a conversation with my friend John who has worked for years in digital technologies in the public education space. With over a billion people on social media, John was concerned that the human element is getting trashed.

My answer to him was – “No way”. People, both individually and collectively after they go through a change (especially a big technology change) they tend to return to a state of homeostasis.

The homeostasis of information

Stop for a moment and consider how much of your data sharing and private messaging interaction is digital and how much is paper and then ask yourself why clinical trial compliance monitoring is still dependent upon paper interactions.

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Why medical device studies need business controls

patient compliance in medical clinical device trials

There are some interesting analogies between cyber security and medical device clinical trials from a risk management perspective. Both areas are complex, vulnerable to human exploits and may result in loss of data.

Medical device trials are not exempt from unexpected human behavior.

Despite this concern, I find it significant that guidance for remote-risk-based monitoring of global multi-center clinical trials does not consider business controls for human resources, internal audit, and information security.

In this post, we consider the importance of study monitoring from a non-regulatory perspective of business risk.

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10 ways to reduce clinical trial risk and they are all free

Are the lights on but no one home in your medical device clinical trial?

Collecting low-quality data means that your trial is likely to fail. You will not be able to prove or disprove the scientific hypothesis of your medical device clinical trial. You will have wasted your time.

You cannot outsource quality, you have to build it into the trial design

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How to overcome 5 eSource implementation challenges

Jenya wrote a piece about the challenges of clinical trials operations change management for regulatory people who have to work with medical technology developers and I just had to write my own intro.

Frankly, its easier to talk about change for other people than for yourself. A lot easier.  I have written here, here and here about the gaps between the stakeholders in medical device clinical trials – security, IT, engineering, product marketing ,regulatory affairs and medical device security to name a few.

Overlook change management at your own risk

Change management is a topic usually overlooked when medtech companies implement cloud EDC, and introduce medical IoT for collecting data from patients directly and use electronic source documents for their connected device/mobile medical app or device clinical trial.

In this post, Jenya talks about how to manage change during the transition from traditional medical device clinical trial data management to cloud technologies, remote monitoring, medical IoT and electronic source data.

So enjoy.

Danny

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Cost effective EDC for medical device clinical trials

clinical data management

There is a saying in American English dating back to the 1940’s – “Call me when you have a nickel in your pocket”. With limited budgets, small, innovative medical device vendors will be looking at the nickel in their pocket and thinking that they cannot afford a cloud EDC offering for clinical data management and opt for the paper default or the DIY option for monitoring. None of which are a particular good idea.

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The key is not first to eSource, the key is smart to market

This post is not for the Pfizers, Novartis, Merck and GSK giants of the life science industry.

Its for the innovators, the smaller, creative life science companies that are challenged by the costs, the regulatory load and complexity of executing a clinical trial.

This post is dedicated to the startup entrepreneurs of the world.

Building an EDC system for your clinical trial requires executing a plan in order to successfully recruit patients, collect high quality data, sustain patient safety and produce your statistical report in a timely fashion. You can potentially embark on an EDC journey without a plan, without a simple, well-designed protocol, and without appropriate clinical monitoring. This will guarantee you a long trek of pain, burning cash while you resolve issues and clean data.

The pivotal question to any clinical decision maker is this: Do you want to start building an ECRF (electronic case report form) now and pay in pain and cash later, or plan now and own the process?

Simple concept, but important message.

It doesn’t matter if your business is a one-person startup or a “Big Five” bio-technology company. If you develop medical devices, medtech, biotech or drugs on a daily basis, you are faced with an increasing stable of competitors, and barriers to success that can frustrate you as a business manager or a startup entrepreneur trying to make payroll.

Being an entrepreneur like you, I’ve constantly been exposed to walls that have continuously tried to prevent me from success. In this post, you will learn how to plan and execute EDC quickly, efficiently and successfully and break through the business, clinical and regulatory barriers that stand in your way. In a world where competition erodes market share, depresses product pricing, and where large company branding and marketing tramples the innovative medtech startup, the key is not first to eCRF the key is smart to market.

So – here are 2 factors to consider to help get you faster to the finish line.

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Assuring patient compliance to the study protocol-spending smart on monitoring

patient compliance in medical clinical device trials

Today I want to go beyond having compelling ideas, a team and a great market opportunity and talk about what you need to successfully execute a clinical trial on your way to FDA approval.

Sometimes there is nothing more powerful than the passion and vision of an entrepreneur.

But passion and vision are just not enough. You need execution. You need to be able to accept the pain.

Execution for an early stage biomed startup means successful execution of clinical trials, from pilot through double-blind Phase I to Phase II and Phase IIB validating the efficacy and safety of your product.

Are you overly optimistic about the time it will take to get results from your study?

In our experience, even experienced entrepreneurs do not factor in the amount of time it really takes to collect data in the clinical trial and monitor and assure patient compliance.

Patient compliance to your protocol is by far the most important success factor for interventional trials. It is the basis for everything and the key to your time and money.

There are 2 schools of thought on the topic of assuring protocol compliance.

The first school of thought likes outsourcing everything to a CRO.

This is often an expensive proposition which does not assure optimising time to market for a very good reason: the CRO business model is not success-based.

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Dates: the silent death in medical device clinical trials

Bad Dates: Assessing and assuring high quality dates in clinical trials

Introduction

Clinical trials are based on collections of time-based clinical data. If the dates and time-stamps in the data set are low quality, everything else will be low quality: measurement of study progress, enforcement of visit protocols and study schedules, measurement of site progress and any clinical parameter that is a function of time, such as cumulative dosing, pregnancy and hundreds of other time-based use cases.

Jenya talks about bad dates and how really bad quality dates that can spell disaster for your clinical trial – and suggests what do to about it.

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