Science37 Brings Clinical Trials into Your Home
While it seems like drug companies can’t develop drugs fast enough to meet demand these days, the Chinese sorted themselves out centuries ago. Most Americans probably don’t know much about Traditional Chinese Medicine or TCM. It’s a practice that is both complex and fascinating, dating back more than 2,500 years, and which is probably looked upon with a great deal of skepticism by your average Western person. There are literally 100s of ingredients that go into treatments, and here’s what an actual Chinese pharmacy looks like (you can bet there’s a cat hiding in that shop too):
With instructions that are usually written in Engrish, you’d be excused for thinking that TCM proposes some of the strangest sounding”medical treatments” imaginable, but the truth is that this stuff works. When you go to work in China and insurance companies ask you if your plan should be for TCM or “Western medicine”, you know that the almighty dollar has spoken and ascribed TCM with some real legitimacy. One reason why TCM became so effective over time was that it wasn’t subjected to the burden of the “FDA Drug Approval Process”. Nowadays, if you want to try and create a new medicine, it takes anywhere from 10-15 years for approval.
In a past article we looked at the drug approval process and remarked at how inefficient and drawn out the whole thing is. Only 5 in 5000 drugs make it through pre-clinical trials (animal testing) and on to human testing. Of those 5 drugs, only one will eventually be approved with a price tag of around $2.6 billion. Here’s a visual interpretation of the bureaucratic nightmare that encompasses “the FDA approval process”:
Now before you start wringing your garments, just be aware that one reason this process needs to be in place is because of the litigious society we live in where people expect life saving drugs with no detrimental effects otherwise it’s class action lawsuit time.
In the above diagram, you can see the “clinical trials” portion of the FDA drug approval process. This is where all the human testing takes place. You can only imagine how difficult the clinical trials process must be, something that we would imagine looks like the following:
- Find a diverse population of individuals who fit a (sometimes very narrow) criteria while taking into account everyone’s vastly differing medical history.
- Convince all these people and their doctors that they somehow stand to benefit from the trial by explaining in layman’s terms to the patient, just what you’re getting up to while building their trust and securing their commitment.
- Administer dosage of drug and placebos as a strict regimen to be followed, then worry that people aren’t following it.
- Gather every single iota of information collected. If a patient who is not on a placebo shows even the slightest ailment, you need to be all over that like a cheap suit.
- Deal with patients not cooperating, dropping out, or dropping dead.
If that’s what the drug developer has to deal with, you can only imagine that the patients have to undergo a fair amount of inconvenience as well. Traditionally, clinical trials have not been patient centered, are time consuming for the subjects involved, and inconvenient since some trials could require multiple visits to a testing center or site over a certain amount of days or in the same day. Recruitment can be challenging since geography affects what populations are enrolled. When researchers in the pharma and biotech space test a drug or therapy for efficacy, diversity of the population is imperative.
Just as challenging as recruitment is retention of participants. When you think clinical trials, you probably don’t think much of the “drop out” rate associated with them. A test subject has the right to withdraw from a study at any time but not without consequences such as compromised data, costly delays for the sponsors and inconclusive results. The percentage of “drop outs” is quite high and that is due to several reasons such as side effects, fear and anxiety, schedule conflicts and inconvenient locations just to name a few. Happy patients make for happy doctors, and that’s where startups like Science37 come into the picture.
Founded in 2014, Los Angeles startup Science37 has taken in $66.5 million in funding so far with just under half of that in the form of a Series C which closed in April of this year. With big name investors on board like Google, Amgen, and Sanofi, Science37 plans to use their recent funding for the continued development of their Network Oriented Research Assistant (aka NORA), which is a software platform that allows more populations to easily participate in clinical studies.
All the people on Medium who like to attribute success in tech to gender should take notes from co-founder and Chief Medical Officer, Belinda Tan, who is not only a UCLA trained doctor but also has a PhD in Immunology. (You don’t see too many PhDs on Medium because they’re all too busy working). Dr. Tan is the Chief Medical Officer at Science37 alongside CEO Noah Craft, another UCLA trained physician with extensive corporate leadership experience. The consistent addition of staff since the company was founded, in particular senior management, shows that they’re looking to scale their offering quickly.
The main problem with recruiting people for a clinical trial is the fact that you have to go looking for them in the first place. People with a particular disease who may be open to case studies shouldn’t have to go out there searching for them. This is the reason why Science37 is establishing “communities” around various conditions in the areas of cancer, internal medicine, neurology, and dermatology which can be seen below:
Once you’re a part of the community, you can then see information about your condition like news and frequently asked questions. You can learn more about the Science37 study team, and at some point in time a “compassionate and knowledgeable S37 research coordinator” will contact you by phone to discuss the research study and answer your questions. Once your primary care doctor gives approval, you sign an electronic consent form and then “go to your primary care doctor for an exam and various tests that may include blood tests, electrocardiogram, or other tests“. A decision is then made as to whether or not you can participate and if the answer is yes, this is where you begin engaging with their software platform, NORA:
With everything these days being improved by technology, drug companies can now provide a true patient-centered experience worldwide, allowing those recruited to participate in Phase 1 thru Phase IV testing right from their homes. So far they’ve seen patient participation greatly improve by as much as 60% and visits to the clinical study site are almost non existent. Necessary testing such as intravenous drug administration, blood draws and retrieval of complex data through mobile units that were once only on site are all performed by nurses trained in their specific field of research right in your own home. The added advantage is that clinical sites don’t need to worry about the logistics of planning for all the patients to visit, and consequently they now have the ability to recruit more patients without the burden on site.
The verdict is still out when it comes to whether or not going to an on site testing center is actually a negative. The thought is that participants thrive on the relationships established with the staff they encounter on site versus the “isolation” they are allowed to have if clinical trials are carried out at home. With that being said, drop out rates across all Science 37 trials combined is less than 5%, so patients must find it convenient. With home clinical trials, the patients are held to a higher degree of responsibility, continually checking in, and entering the days data collection without the positive reinforcement received on site by staff. One way that this burden could be eased is by using wearables. Interestingly enough, one of the pharma companies backing Science37, Sanofi, is teaming up with PAREXEL for a pilot study that looks at using wearables in clinical trials.
Science37 isn’t the only company to realize there’s a big old opportunity here. A San Franscico startup called goBalto has raised $38 million so far to build a software platform that develops cloud-based solutions for drug trial sponsors and clinical research organizations. Another UK company called Antidote is “transforming the way patients and researchers connect, so that breakthroughs happen faster“. Before their rebrand, the startup was called TrialReach. An article by Tech Crunch a few years ago highlighted a $13.5 million Series B round and talked about how they do most their business in the U.S. and how “three quarters of the top twenty pharmaceutical companies” are using their platform to support clinical trials.
In researching this article, we were quite amazed to see just how much interest there is in”paid clinical trials“. This was something we did not know was a thing. Apparently, there are plenty of companies that will pay you meaningful sums of money to be a human guinea pig. On the other hand, if you have a condition that isn’t seeing signs of improvement, then that should be motivation enough for you to participate in a study provided that you felt you were going to potentially benefit from doing so. That’s the educational hands-on element that Science37 provides so people don’t actually feel like guinea pigs for those big bad pharma companies. With ClincalTrials.gov currently listing 43,344 clinical trials that are actively enrolling, it’s fair to say that Science37 has their work cut out for them.
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