Frequently Asked Questions (FAQs):

How do Clinicians use the Prescribing Support Tool?

In the hands of experienced Clinicians, the Prescribing Support Tool is a decision support framework to assess combinational drug treatments for stratified patient groups with chronic pain.

Clinician interaction with the Tool enables the prescriber to exercise their judgment, to fine-tune drug combination treatments along a spectrum that trades off desired analgesic effects versus undesirable side effects for better patient results and heightened satisfaction, based on individual patient characteristics and preferences specified in the Tool by the Clinician.

Describe In Silico Biosciences’ modeling methodology.

The company employs Quantitative Systems pharmacology (QSP). QSP involves a complex mathematical computer model of firing activity in neuronal circuits. Based on formalized domain expertise in the neurosciences, ISB assembles existing and new computational models into a system that:

Simulates the biological processes and neuronal circuits underlying pain relief.
Represents the central nervous system networks which produce pain-induced adverse effects and adverse effects induced by drugs.
Includes the four major types of pain: nociceptive, inflammatory, neuropathic, and functional pain.
Models the central processes underlying pain modulation and why individual responses to the same painful stimulus might differ.

The computational QSP platform predicts the optimal combination of existing drugs for individual patient groups, integrating four models into the Prescribing Support Tool:

Central Nervous System PB/PK Models
Drug-target Interactions Models
Cellular Signal Transduction Models
Neural Circuit Models

What is the Clinical Utility Index and how is it used?

The Prescribing Support Tool aggregates patient characteristics (age, sex/gender, and genotypes) and clinician-patient goals for analgesia and side effects (sedation, cognitive impairment, and drug abuse liability). The output of the In Silico Biosciences modeling presents data as an optimal set of drug combination treatments for “utility” – the balance between analgesia and side effects. Clinical Utility Indexes are displayed showing a range of optimally effective combination drug treatments and doses, as well as treatments to be avoided for a particular set of patient characteristics and preferences.

What are the meanings of the indications that are displayed on the “Prescribe for Patient” outcome chart?

Top-level meanings of indications:

For analgesia, lower numbers (i.e. more negative values) indicate greater pain relief.
For drug abuse liability, greater values (over 50) indicate greater susceptibility to drug misuse.
For cognitive impairment, lower values indicate greater working memory problems.
For sedation, higher scores reflect greater sedation risk.

More in-depth meanings of indications:

For each drug combination reported, the models predict the average response for the patient with the specified characteristics for each of the four indications:

analgesia: the change in pain intensity as measured by a visual analog scale (0-10); more negative values indicate greater decreases in pain intensity.
drug abuse liability: the drug liking by the patient on a scale of 1-100 with a value of 50 indicating indifference; values greater than 50 represent greater drug liking while values less than 50 represent drug disliking.
cognitive impairment: the percent correct in a 2-back working memory test; lower values indicate greater cognitive problems.
sedation: the outcome of the Epworth Sleepiness Scale (0-24); greater values indicate greater sedative outcomes.

What are examples of determining weights when entering “Treatment Plan Factor Importance” for New Patients?

Examples of determining weights:

A patient who wants pain relief no matter what the side effect consequences would use values of analgesia = 100, drug abuse liability = 1, cognitive impairment = 1, and sedation = 1.
A patient who is worried about drug misuse more so than analgesic efficacy might use values of analgesia = 50, drug abuse liability = 100, cognitive impairment = 1, and sedation = 1.
A patient who is worried about all side effects equally as well as analgesic efficacy would use equal weights such as analgesia = 10, drug abuse liability = 10, cognitive impairment = 10, and sedation = 10.
A patient who is more worried about side effects than analgesic efficacy might use values of analgesia = 10, drug abuse liability = 30, cognitive impairment = 30, and sedation = 30.
A patient for which cognitive impairment and sedation are a little more important than analgesia, and who does not have a history of drug abuse in their family might consider values of analgesia = 70, drug abuse liability = 1, cognitive impairment = 80, sedation = 80.

What security measures are provided to ensure patient and physician confidentiality?

All data on the databases are encrypted. The code that does the encryption is also encrypted as an additional security measure.

Clinician-entered data is encrypted in the database. In addition, each Clinician’s inputs are uniquely encrypted with specific keys for each Clinician. Therefore, only the Clinician who entered his or her patients’ data can view their patients’ data.

How do you maintain the security of Clinicians’ login information?

The Prescribing Support Tool uses 2-factor authentication for logins. Clinicians may set the system to recognize their computer or handheld, requiring a 2-factor authentication only every two months, once a successful 2-factor login has been accomplished.