How It Works
MedVector uses FDA-compliant logistics and telemedicine to enable patient participation from alternative locations. We know clinical trial candidates are not medical mysteries, they typically have an existing diagnosis and a relationship with a treating physician. Due to this fact, the best place to find study candidates is at alternate locations such as long-term care facilities, local clinics, and local providers.
How It Works
We know clinical trial candidates are not medical mysteries, they typically have an existing diagnosis and a relationship with a treating physician. Due to this fact, the best place to find study candidates is at alternate locations such as long-term care facilities, local clinics, and local providers.
Aligning physicians & investigators
The answer is a resounding, “YES!”
Are sponsors missing opportunities by misinterpreting FDA guidance?
In short, yes. Jonathan Helfgott, Former FDA Associate Office Director states, “Sponsors tend to be overly conservative while the FDA is open to new technologies that make it easier for patients to participate in clinical research, whether it be from their home, a local clinic, or a provider’s office. Simply using technology to connect a patient from an alternate location to the PI’s site does not trigger any new clinical sites or clinical investigators.” (Helfgott, 2022)
Most studies have the ability to utilize MedVector. Examples of visits that can be completed using MedVector include
- Screening Visit / Informed Consent
- Blood Draws with Central Labs
- Study Questionnaires
- Basic Physicals
- Specialist Driven Evaluations (Neuro, Rheumatology, Cardio, etc.)
The more visits that can be facilitated at alternate locations, the more likely the alternate locations are willing to share patients. MedVector will take the lead and validate if your study has appointments that fit.
What Studies are a Fit?
Most studies have study visits that are a fit for MedVector. Because of this, we focus on Study Visits rather than full protocols. The more study visits using MedVector, the more patient referrals from treating physicians.
Because some protocol events MUST be performed at the clinical trial site, each protocol requires MedVector to analyze which study visits can utilize MedVector, which events require additional logistics, and which visits are not eligible. Fortunately, there is no cost for MedVector analysis, and you might be surprised which protocol events are eligible.
Don’t try and be the expert, ask MedVector if your study has appointments that fit.
Getting Started
MedVector is the expert at what works and what doesn’t, so it’s best to let us identify eligible visits within your current protocols (We already have NDAs with most of the major Pharma companies, but please confirm before sending us yours). After submitting protocols, you might be surprised that we are already working on one of yours, which means the appropriate approvals could already exist at the sponsor level, and you could begin using MedVector very quickly.
Sponsors can start slow
How is data entered?
So, because the participant is in the room with the investigator team (just like a walk-in participant), data is still entered at the clinical trial site, by the investigator team, the same as other participants that travel to the clinical trial site physically.
Who handles the logistics and training?
- MedVector works with sponsors to identify which study visits are eligible.
- MedVector works with clinical trial sites to identify referring physicians.
- MedVector meets with referring physicians to onboard them as alternative locations.
- MedVector coordinates all logistics between the clinical trial site and alternative locations.
- MedVector provides all training at clinical trial sites (no training is required at alternative locations).
What study visits are compatible?
Examples of compatible study visits are:
- Screening Visit / Informed Consent
- Blood Draws with Central Labs
- Study Questionnaires
- Basic Physicals
- Specialist-Driven Evaluations (Neuro, Rheumatology, Cardio, etc.)
Is this compliant with FDA?
Yes! Using a utility like MedVector does not require any protocol amendments. However, we take compliance very seriously, so we get all the appropriate approvals and verify compliance before we begin connecting patients. We want everyone to be comfortable.
“Sponsors tend to be overly conservative while the FDA is open to new technologies that make it easier for patients to participate in clinical research, whether it be from their home, a local clinic, or a provider’s office. Simply using technology to connect a patient from an alternate location to the PI’s site does not trigger any new clinical sites or clinical investigators.” (Helfgott, 2022)
– Jonathan Helfgott, Former FDA Associate Office Director, and author of FDA eSource Guidance
How are the referring physicians identified?
Ask any investigator team, “Is there a local specialist that should be referring patients, but isn’t?” The answer is a resounding, “YES!” MedVector meets with these local providers to onboard them as an alternative location for your study.
Questions regarding source data?
When engaging a participant at an alternate location using telemedicine, there are sometimes questions regarding the source data location. When basic measurements are taken by a local nurse (e.g., blood pressure, weight, temperature, pill count, etc.) and entered directly into the EDC by an authorized originator, the source is the clinical trial site and not the participant location.
FDA Guidance for Industry (September 2013)
Electronic Source Data in Clinical Investigations
Source Data Capture: 2 a https://www.fda.gov/media/85183/download
“Many data elements (e.g., blood pressure, weight, temperature, pill count, resolution of a symptom or sign) in a clinical investigation can be obtained at a study visit and can be entered directly into the eCRF by an authorized data originator. This direct entry of data can eliminate errors by not using a paper transcription step before entry into the eCRF. For these data elements, the eCRF is the source.”
In conclusion, existing protocols (not just DCT focused) can utilize MedVector to enable participation from alternate locations. The FDA has established, when a participant is virtually present at the clinical trial site the source data remains unchanged. This means for select study visits, there is no difference between a participant who is physically present versus a participant who is virtually present.