Mobile & IoT

Mobile, Tablets, IoT, Sensors, Wearables and more

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.

Health 2.0 social media-based clinical trial (CT) enrollment management

How enrollment fits into the overall CT process

At the very highest levels, the following sequence occurs during a CT:

  1. First the Sponsoring organization designs the clinical trial (a.k.a. the Study Design)
  2. Once the Study Design is complete, the Sponsor (or CRO agent) will then proceed to enroll Subjects (a.k.a. Patients) who meet the design profile to participate in the CT
  3. Each patient that enrolls proceeds to follow the CT Protocol from start to finish (i.e., First Visit to Last Visit). The CT Protocol strictly determines the duration of this period (i.e., it cannot be accelerated, it can only be aborted).
  4. Once all the patients in the study have completed the Protocol, a key milestone called Last Patient-Last Visit (LPLV) is achieved. This kicks off a large sequence of biomedical and regulatory activities that ultimately lead to filing of an application for a new drug, biologic or medical device for approval by the FDA, EMEA and others.
Where Enrollment falls in the overall Clinical Trial life cycle
Where Enrollment falls in the overall Clinical Trial life cycle

Why focusing on CT enrollment is so important

Enrollment is a very costly and time-critical process. The sooner you can enroll patients who meet the Study Protocol Profile, the sooner you can begin to Conduct the Study. The sooner you can begin Study Conduct, the sooner you can Closeout, Analyze, Publish and Submit the results of the Study for regulatory approval. (This, in turn, drives how soon you can get regulatory approval and begin using the new drug, biologic or medical device to help patients and obtain a return on your R&D investment.)

Why social media is so helpful

CT Enrollment is a major part of the operation of a clinical trial where Pharmas, Biotechs and CROs cannot maintain full, internal control. During this process, they are dependent on how quickly Patients (and their Doctors) enroll in the Study.

Traditionally, Pharmas, Biotechs and CROs use a mixture of channels (clinic visits, advertising, direct mail, email, facsimiles, etc.) to locate and reach out to potential CT Subjects. Unfortunately, these channels are not optimal at preserving the context of information between exchanges. As a result, organizations require many information exchanges to find Subjects, inform them, review their Profiles and enroll them into the Study. Social Media, on the other hand, is excellent at preserving information context between exchanges. When applied correctly) is. As such, it makes an excellent channel to reach out to, inform, and enroll Patients.

How social media-bases CT enrollment outreach would work

After completing the Study Design, the organization managing the CT would create a web site that would let people explore, at a very top level, what the CT is about. This may sound exactly like the information that can be found on www.clinicaltrials.gov. However, this is just the start: now it is time to add the Social Media components.

When a person visiting the site is interested in finding out about the CT, he or she would register to join the network. The interested person would register by providing Personal Identifying and Profile Information. This creates a connection to share contextual exchanges between the prospective Subjects (i.e., Members) and the Organization managing the CT:

  • Members can explore information about the CT and its Principal Investigators
  • Members can directly submit Requests for Additional Information or even apply for Enrollment in the CT
  • Organizations can analyze Member profiles to find prospective subjects and reach out to them for enrollment using the contact information provided

Ultimately, these exchanges provide prospective Subjects easier access to information and enable Organizations to complete enrollment into Studies faster and more efficiently. Ultimately this can save millions of dollars per CT AND bring new treatments to markets faster (saving lives and accelerating revenue.)

How to achieve this using a low-risk approach

I know what you are thinking: doesn’t use of Social Media for CT enrollment open huge risks regarding HIPAA, ICH and 21-CFR compliance? It does not—because this service uses a hybrid social network model:

  • Member information is not shared outside the network – or even between networks (key for HIPAA compliance)
  • Members do not create open profiles with avatars that risk HIPAA Privacy non-compliance. Instead they complete drop down-based profile forms that ensure privacy and enable easy identification of members who could match the Study Protocol Profile
  • Members do not contribute free-form user-generated content (where they may inadvertently disclose data that trigger pharmacovigilance- or ICH-driven management and reporting requirements. Instead the use drop down-based forms to submit requests for additional information. Principal Investigators can then use traditional (compliant-proven) channels for follow-up
  • All activities are attributed to members who have authenticated themselves using verifiable identification data (key for 21-CFR compliance)

This is easy to achieve

This service does not require invention of new technology. It simply requires an understanding of how to apply Social Media to solve a problem facing every new CT today. It demonstrates how Social Media should be viewed as a valuable channel to transform the effectiveness of you connection with external stakeholders. (Instead of something uncontrolled that will turn your business inside-out.)