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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.)

Low-risk, high-value Health 2.0 ideas: An introduction

Adoption of social media for health care has been understandably slow

Over the past three years, use of social networking to transform business (i.e., Enterprise 2.0) and government (i.e., Gov 2.0) has been very hot. However, use of these same technologies to transform health care (i.e., Health 2.0) has been decidedly slower.

The reason is simple: all members of the health care industry – regardless of whether they are public, private and not-for-profit – are bound by a much wider set of regulations regarding the control and access of information than nearly any other industry sector. (Click here to see my prior blog post for a deeper discussion of these.) These regulations are not bad; rather, they are paramount. They assure scientific integrity, safety and privacy—things no one wants to do without.

regbodies

The way is to avoid the largest risks: Manage the flow of information

Health care is an incredibly collaborative sector. As such, use of social networking to foster information exchange presents enormous opportunities to improve both global health and a huge part of the industrialized world’s economy.

risk_180pxThe key to success is to use social networking in ways that taps collaboration and creatively while avoiding risks of data contamination or disclosure of everything from private health information to unverified or even false information. This can be done by strictly controlling the flow of information:

  • Separate patient, clinical trial subject and pharmacovigilance data from social networks. Instead leverage social networks to share only structured documents (e.g., Protocols and Informed Consent Forms) or operational data (e.g., clinic visit scheduling)
  • Wherever possible, replace unstructured with structured interaction to eliminate opportunities to share patient- and subject-specific data where it is not appropriate. Also limit the types of interactions available—especially on networks that include patients or clinical trial subjects.
  • When unstructured interaction is absolutely required, combine Access Controls and Pre-Publication Moderation to guard against inappropriate disclosure of privacy or safety data. Also ensure you employ strong authentication and audit trails to ensure even moderated user-generated content is regulatory compliant.

Four high-value ideas that do this

At this point, you may be asking if social networking can create value while adhering to the above risk avoidance approaches. It can. Here are four examples for BioPharma Social Networking business services that I put together in collaboration with experts from four different health care industry organizations:

  1. Clinical Trial enrollment and participation service
  2. Clinical Trial subject alert and reminder service
  3. Principal Investigator update and notification service
  4. Therapeutic area-based Key Opinion Leader (KOL) networks

In the coming months, I will post an entry outlining both the drivers for each of these services and a top-level overview as to how each could work.