Tag Archives: pharma

Blockchain: A Single, Immutable, Serialized Source of Truth

Last week MHL (Material Handling & Logistics) magazine publish a piece I wrote on the use of blockchain technology to provide high-value business benefits in supply chain management. Some of these include:

  • Creation of an immutable, portable record of all hand-offs between parties that is not held hostage by any one vendor or party
  • Complete, portable chain-of-custody useful for every from regulatory compliance to management of product recalls
  • (My favorite): Use of Smart Contracts to create distributed automated intelligence to do things like automatically triggering notifications and invoicing on milestone achievements (CFOs would love that). This could be accelerated even faster by using smart sensors.

My focus was on ideas that can truly be implement today, integrating with existing systems for milestone management and payment processing (easing adoption and integration). Please visit the MHL magazine to read the full article. You can also download the infographic they have hosted with the article here.

BTW, these same concepts can be applied anywhere serialization is needed: digital media sales, regulated product delivery, clinical trials, etc.

Fun fact: You can likely guess when I originally wrote the article based on the BTC price quoted for the music download. BTC has appreciated quite a bit since then. 😉

Health 2.0 clinical trial subject alert and reminder service

A few weeks ago, I began a blog series on low-risk, high value applications of social media to improve health care. As I mentioned, in my last post in this series, clinical trial (CT) management is an ideal place to start, as managers of CTs routinely need to reach out to and coordinate with a wide variety of external stakeholders, from Principal Investigators (PIs) and Subjects to Institutional Review Board (IRB) members and Regulators. This post will continue this thread, outlining the use of mobile social networks to reach out to CT Subjects to remind them clinic visits or alert them to special updates of interest.

A view of a CT from the outside: The subject’s perspective

Participation by a Subject (a.k.a. Patient) in a CT (clinical trial) requires many interactions:

  • After applying to participate in a CT, Subjects first need to visit a clinician for review of their vitals and medical history to determine if they meet the criteria for participation in the Study (as per the CT Protocol).
  • If they meet the Study criteria, they need to commit to participation in the Study for its entire duration. The first step of this is review and signature of an Informed Consent Form (ICF), indicating acceptance of the medical risks associated with the trial.
  • The next is scheduling and participation of many Patient Visits to the clinic. These visits must follow a schedule—in alignment of the CT Protocol, from First Visit (FV) to Last (LV). Some visits will be to receive care, others to check on progress on vital signs.
  • In addition, Subjects often will have to perform actions on their own, outside of the clinic (e.g., taking pills at regular intervals).

However, these are just the basic set of interactions. Extenuating situations may occur that require additional interactions:

  • If preliminary results of the Study may require amendment of the CT Protocol and/or ICF, requiring the Subject to return to the clinic for review and signature.
  • In addition the Study sponsor or manager may discover Adverse Events (AEs) that they must immediately communicate to Subjects (usually requiring additional clinic visits).

These interactions can take place over months or years throughout the Conduct of a Clinical Trial Study

clinical-trial-conduct-phase

The business case for this service

The logistics required to manage all the interactions between Study Sponsors, PIs and Subjects are complex and time-intensive—especially given that Subjects and Study Sites (Clinics) can routinely be spread across hundreds of locations and a dozen time zones. As a result—

  • Clinical Trial Sponsors routinely pay Study Managers tens of thousands of dollars per Subject to coordinate all of these interactions
  • Clinical Trial Sponsors can spend up to several million dollars (USD) to manage the update (amendment and re-signing) of an ICF by all CT Subjects
  • Subjects routinely drop out of studies because it is simply too much work (and too hard) to remember to do everything required. (This requires initial enrollment of higher numbers of Subjects, a costly endeavor.)

Clinics routinely manage coordination of these interactions through classic communications channels: the telephone, facsimile and direct mail. These are costly, work-intensive channels with low response rates.

Any service that could make this coordination simpler and more convenient would save billions of dollars of cost (ultimately making healthcare more cost effective for us all). For a typical 1,000-Subject CT Study:

Each 3% reduction in either the cost to manage Subject coordination or the Subject dropout rate would save as much as USD $1 million per individual Study

Multiply these benefits by dozens of studies across hundreds of organizations and you will get some very large savings.

Why use mobile social networks for this

As of 2009, the mobile telephone is now the most ubiquitous communication device in the world. People who own them rarely go anywhere without them.

In addition, many CT Subjects are located in hard-to-reach places. The most cost effective way to communicate with remote places is through use of mobile networks (avoiding cost of hard-line infrastructure and power-hungry devices like PCs).

These two factors make use of a Mobile Social Network (MSN) to communicate and coordinate with CT Subjects an ideal, cost-effective and low-risk choice.

How this service would work

This service would leverage approaches already proven in marketing campaign-based Mobile Social Network management:

  1. Subjects enrolling in a CT Study provide their mobile telephone numbers. These numbers are registered into a closed MSN. The MSN sends a Double Opt-in Message to each Subject both to confirm correctness of the contact number and confirm with Mobile Marketing Association guidelines
  2. Each CT subject is entered into a messaging campaign based on First Visit Cohorts. This enables the CT Manager to send text alerts to the subjects based on time- (and protocol-) based milestones: such as reminders to take medication or arrive for a clinic appointment. This makes if far easier for Subjects to remember what they have to do (and when they have to do it.)
  3. Each text message is part of a campaign requiring the subject to confirm receipt (but not action, as this would create a clinical trial data point). Using MSN reporting results, the Clinic or Study Manager can follow-up through other channels (e.g., direct mobile phone call) to Subjects who do not confirm receipt. This approach provides easy, less-invasive reminders to Subject without violating regulations for control of CT data.
  4. In the event of a special circumstance, e.g., need to sign a new ICF or visit a clinic in response to a newly-discovered AE, the CT Manager will send a text message to all recipients asking them to immediately call their clinic. (In smart phone this can be performed conveniently from the message itself.) Using MSN reporting results, the Clinic or Study Manager can directly call Subjects who do not acknowledge the text message and/or call back in a specified period of time.

This is easy to execute (at low risk)

This use of mobile social networks does not replace normal, accepted CT communications—it simply makes performing them more efficient and convenient for all. In addition, because this network does not communicate patient or safety data (or capture electronic signature) it provides cost and time savings at very low risk.