Clinical Trials Patients and the Pipeline

Clinical Trials patients and the process they go through is best described in relative detail through the following diagram/infographic. By the time a drug finishes clinical trials testing and goes to market to millions of people it has been tested with less than 25,000 people.

Infographic Supplementary Chart

The adherence problem is significant, and is a public health risk for clinical trials.

Even if we could get patients to agree to fork over their data and combine it with their prescription data like we intended to, it still wouldn’t be accurate as per the nature of people not taking their medicine on time, in the right dosage, or forgetting to take it almost completely.( aka The Medical Adherence Problem.) I admit the 290 Billion dollar figure in the article might not be accurate, but it’s one indicator that Adherely is swimming in the proximity of a meaningful problem. We found an unusual solution methodology which seems to come down to ‘talking the patient’ through adherence and coaching them. We prefer stronger verification specifically with healthcare payment structures changing to a system where everyone is paying for each others’ medicine.

86% adherence is achieved by combining prescriptions into one pill.

The following data set is from the UMPIRE study described in more detail here. The article and results of the study suggest that combining all the medicines in a pill increases adherence. They’ve aptly termed this technique as a ‘fixed dose combo.’ 86% from our perspective is still highly unacceptable considering these people are unhealthy, assuming their prescription has an effect on their outcomes, and that we might be paying for these medicines and furthermore complex procedures as a results of non-adherence symptoms.

Public Health Risk: more than 50% of clinical trial subjects don’t report missed doses.

Additionally we found a recent survey of old clinical trials that found the following:

Between 1997-1999, patient adherence was not monitored in 53% of clinical trials. Many of these drugs are still on the market.

Up to 30% of study patients do not take the full dose of the study drug.

Study patients cannot understand 35% – 94% of Informed Consent documents.

At least 50% of study patients do not tell the study team they missed doses.

It can be easily described as a public health risk. Articles like these add fire to the flames. HackerNews Thread here.

If we solve this problem, and combine prescription, patient, and adherence data, we get closer to a massive post FDA approval clinical trial with millions of participants. In a perfect world, a clinical trial would have millions of participants.

It’s an extremely risky and ambitious proposition: If we can fix medical adherence and bring it to 100%, we can ‘fix’ all patient and prescription data assuming we can obtain it in mass, and measure the efficiency of a drug. Insurance companies pay for drugs that don’t work and patients who don’t take their medicine. more often than we thought… The article links back to Ben Goldacre an avid scientist who explains his analysis and reveals bad science in action. Doctors and insurance companies don’t know about the drugs they prescribe.

How does drug development become potentially cheaper if you solve adherence?

Often times these set of compounds have positive and negative side effects outside the intended locus of control. In crude terms what we’re hinting at……Hypothetically, if you have AIDs+Cancer and your consumption of a cancer drug reveal that some elements and compounds of the drug could be used as an antiretroviral, one can potential reduce the research costs and queuing time for FDA clinical trials or so we theorize based on what we’ve found…..

Documenting the unintended consequences of drugs results in innovation and makes drug development cheaper as it speeds up identification of the right compounds.

The infographic below indicates the funnel for figuring out the right compounds….. If a compound is already ‘military grade’ and has passed the clinical trials process, it’s cheaper and easier to implement it in a new drug. This insightful TED video talksabout clinical trials, the patients behind them, and making drug development faster by looking at historical data.

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Bad UX/UI is Pervasive across Clinical Trials recruiting sites and Pharma News Sites

There are a number of companies that are centered solely around acquiring and building these patient pools that I’ve listed below. Their interfaces lag behind. There’s also a dire need for a diversity of clinical trials patients with less than 10% of clinical trials subjects being African American.

Subject A: Clinical Trials Recruiting Sites

The List:

All of these sites are great for finding patients, but suffer noticeable UX/UI issues. Filling a candidate pool of clinical trials patients is a point of traction for many pharma companies. Solving the clinical trials patient recruitment problem is another problem in this space that’s worth pursuing. By sourcing clinical trials patients faster, bottlenecks are reduced and clinical trials costs are driven down.

Subject B: Pharmaceutical News and Reporting Sites

Medical Adherence Solutions

We describe some of the consumer level adherence applications on our site in more detail.

Supplementary

Here’s a link to the HN thread. One of the most frustrating parts about researching this space is the total lack of access to online publications and research. RIP Aaron Schwartz.