Clinical Trial Mobilization

Mobile nursing for a clinical trial is performed by a qualified nurse at an alternate location (home, office, vacation) requiring the same data quality and subject safety as on-site visits.

By offering mobile visits for clinical trials, the site can see improvement in patient recruitment, patient retention and compliance, expanded geographic reach, and increased subject convenience. For sponsors or CROs, the use of mobile nursing visits for a clinical trial potentially reduces the number of patients needed, accelerating the clinical trial and reducing the overall cost.

How can mobile nursing visits help improve the success of a clinical trial?

Many common trial challenges can be addressed through the use of mobile nursing visits. For example, when a long distance between the site and subject prohibits travel back and forth; the subject population depends on someone else for transportation (i.e., elderly and pediatrics); the subject is home bound due to their medical condition; or frequent visits to the site are required, home visits can benefit the trial. Mobile nursing visits for a clinical trial can also help by offering subject convenience as a recruiting tool and can be contributed to an improvement in compliance and retention.

What can be done on a mobile nursing visit?

Services provided on a home clinical trial visit can be anything within the scope of practice of an RN or LPN with portable equipment including:

• Protocol defined assessment

• Assessment of adverse events

• Recording of concomitant medication history

• Administration of investigational product (IV, injection, oral, topical, etc.)

• Accurate source documentation

• Blood draws, processing, and shipping

• Collection and shipment of specimens

• Protocol and procedural training for sites and subjects

• Customized services per sponsor/protocol

What kind of clinical trials should consider using mobile nursing visits?

All phases and therapeutic areas can benefit from mobile nursing visits.

How can mobile nursing visits be incorporated into a clinical trial?

Mobile nursing visits can be initiated either during the development of the protocol or later on as a "rescue" tactic to improve patient recruitment and/or retention for a clinical trial. The sites will place the provider on their 1572 as a vendor and then each nurse will sign a Delegation of Authority with the site they are servicing. Trial specific documents and training is normally developed and delivered by the provider to the nurses in the field with approval from the sponsor. Source documentation is completed by the nurse in the field and then originals are sent to the investigator site.

How does the mobile nurse work with site personnel?

The mobile nurse works cooperatively with the investigator and site coordinator to make sure that the subject visit meets the target date and is completed with the same quality as an on-site visit. If requested, the mobile nurse can go to the site for an introduction or additional training and in many instances the mobile nurse is required to go to the site to pick up investigational product, lab kits, or supplies. Some mobile nurses can also be available for site augmentation services if a site is short handed and needs assistance with site visits.

What about central lab and pharmacy coordination?

Many of the mobile nursing companies coordinate with a central lab and provide central pharmacy services. Pre-made lab kits are normally sent to the nurse from the central lab with return packaging to send back collected and processed samples. When investigational product administration is part of the home visit, the nurse coordinates with a central or local pharmacy to have the product shipped within the required perimeters of the drug (i.e., stability, temperature controlled, limited access, etc.) to be administered to the subject within the targeted time frame.

What does the typical service model for mobile nursing visits look like in the industry?

The most typical model consists of a central coordination company that sub-contracts with local home healthcare agencies in close proximity to the site or subject to provide nurses to visit the subjects in their homes. For the most part, these small home healthcare agencies do not have standard operating procedures for clinical trial home visits or training in GCP. Their employment screening practices vary and they commonly have no experience in clinical research. This potentially creates an extra layer of administration and risk in the quality of the delivery of home visits and the accuracy in the completion of source documentation.

What are some other service models for the industry and why are they superior?

Contracting with a clinical trial home visit company who hires, screens, trains, and manages their own nurses increases the quality of service and lowers the risk. With this model, employees are interviewed and screened by the company through the FDA, GSA, OIG/HHS, NURSYS, and state licensing boards. All credentials and health records are kept up to date and in compliance with industry standards. The company has their own standard operating procedures that all nurses provide services under. Each nurse is trained in the principles of clinical trial research, GCP, SOPs, and IATA. The mobile nurse has clinical support through RN supervisors who train the nurse in the trial specific protocol and support the nurse in the field through monthly study team calls and one-on-one coaching. The mobile nurse works directly with the company's trial manager to confirm scheduled visits and insure complete and accurate source documentation is submitted to the site in a timely manner.

Julie Church-Thomas, is Vice President, PCM TRIALS, 500 E. 8th Ave, Denver, CO, e-mail: julie.churchthomas@pcmtrials.com.