Developments, news and strategies for drug development specific to phase I through Phase III global clinical trial management, execution, project management and outsourcing. Go→
News, articles and issues specific to clinical trial practice and implementation at the investigative site level. Go→
Strategies and innovations related to how clinical professionals are utilizing technology internal and external to their organizations to advance clinical trials. Go→
News, articles and issues specific to laboratories role in the clinical trial, including ECG, imaging, genotyping, tissue samples and more. Go→
News, developments and strategies for clinical trials conduct in relation to the FDA, EMEA and other global regulatory authorities overseeing the drug development industry. Go→
News, articles and strategies related to clinical trial design which impact postmarketing studies, therapeutic areas, adaptive trials, statistics, protocols and more. Go→
This post first appeared on our sister publication's site, Pharmaceutical Executive.
In late 2013 Amazon announced they are testing unmanned aircraft/drones for same day and possibly same hour package delivery to customers. These vehicles will someday have the potential to fly packages from local distribution centers providing lower costs to Amazon and increased satisfaction to customers by delivering the right product at the right time. The drones represent a very interesting and real example of Amazon building out its core value thesis of reducing the steps and layers between people and the products they want to buy which has generated billions in revenues and shareholder value over the last decade and continues to grow.
There is a similar trend in healthcare and clinical research: finding ways to better connect patients with the medical services and therapies they need at exactly the right time. For clinical research this falls under the patient-centric moniker which is cropping up in conferences and articles and is a focus for a number of life sciences companies. Every pharmaceutical company today is patient-centric and focused on patients but what does patient-centric really mean for the healthcare ecosystem and for drug developers?
Similar to Amazon’s mission of being “earth's most customer centric company, a place where people can come to find and discover anything they might want to buy online” there is a changing goal of drug developers to become the earth’s most patient-centric organizations discovering and making the medicines and therapies people need to stay healthy, treat disease and improve quality of life. Almost 20 years ago, Amazon was able to cut out the middleman between people and the products they want. Who is the middle man in medicine and clinical research? Is it the doctor, the pharmacy, the hospital or the payer? How will medicine - and with it, research - change in the coming decade with the advent of big data, personalized medicine and quantification of daily life to take cost out of the current system while improving outcomes? And who will be the winners?
I don’t know what the new models will be but I see the informed patient as the winner. Like any other customer, a patient needs a reason to “buy” – or participate in a clinical trial. They should have at the very least the same level of information, respect and sense of community similar to what is available for other types of products and services. In many cases the choice to take a given therapy or participate in a clinical trial may be one the most important choices a person ever makes. And yet unlike many other products, there is much less generally available information to help make that decision. When choosing a vacation destination, a school, a doctor or even a pair of shoes a simple Google search will produce numerous reviews written by others that have experienced or purchased the same product.
Of course the stakes are much higher in medicine and clinical research than in the purchase of retail products, vacations or even the choice of a service provider. The outcomes are not certain. In a drug trial you may get placebo. There is no ability to “return” anything although there is the potential upside of a better outcome and/or quality of life, which is the reason most commonly cited by patients as their motivation for participating in research according to a report by ECRI.org.
With drugs there is information but gaps that companies like PatientsLikeMe are filling to determine how drugs and alternative therapies work on people with similar profiles. When searching for data on smartphone users across the world I can search a Google database with breakdowns by demographics, region, and type of data plan for 40+ countries around the world. Wouldn’t it be helpful to search similar information clinical trials being run for a given therapy?
The data exists, but it is not made publicly available. Drug developers sensibly don’t want to reveal too much information on their billion-plus dollar research projects. They rely on a lengthy informed consent, which in describing the pros and cons of the research details the possible good and long list of bad things that could happen to patients, but of course they make no mention of alternatives. Physicians who are charged with helping patients and potential participants weigh the pros and cons of treatment options including participating in research more than likely do not have all the relevant data available to help make that decision.
There is an opportunity for sponsors to share a little bit more to change the incentives for patients and physicians to participate in research. People are already finding out the information through channels like YouTube, Facebook, LinkedIn and other social media. There are patient advocates and bloggers for almost every disease who are sharing information on their own experiences including research trials within their spheres of influence. That information is finding its way to broader disease communities. With the advent of the Bring Your Own Device (BYOD) models within corporations and now in clinical research sponsors can leverage patients’ own technology and data to offer a broader set of capabilities to it easier and more convenient to fully participate in research.
eClinical technology vendors are moving toward building patient suites for clinical trials. These are broader sets of offerings that work as standalone products to collect data and promote patient healthcare. On top of informed consent, new products can improve patient engagement, recruiting, medication monitoring, patient safety, and patient education. Sponsors can work with vendors to develop an app for every trial. Patients can download the app for visit reminders, the most recent trial news, a form to contact their site person, information sharing – whatever the sponsor can offer and patients can use. Imagine you’re a patient, you’re traveling, and you develop a symptom you’re worried about. You can click on the app and it will show you the nearest site participating in the trial.
To those who raise the privacy issue my response is that information sharing and privacy are not always mutually exclusive. In clinical trials sponsors can’t know who individual patients are, but they can have a conversation and think about what useful information they can provide to deliver greater value to those patients participating in research as well as the broader disease community. Whatever the outcome of the program there is value in the science, and getting the message out there, whether good or bad, benefits the community at large.
Drug research, medical care and therapies are changing. There is a general consensus that the day of the broad blockbuster drug are coming to an end. That may be true but there is also optimism and evidence that the industry is on the brink of a renaissance in drug development, and of finding amazing ways to treat disease on a global level for smaller populations much more effectively. What we had before in terms of efficacy and safety will look crude by comparison in 30 years. Patient centricity is crucial to this effort. We need to find the right people, let them know they are the right people, get them into the right research with the right doctors, and put the pieces together. Whoever figures this new world out first will be like amazon – a leader, an innovator and the generator of tremendous value.
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