Proof Positive Results

Clinical Resource Network takes protocol visits to the patient to accelerate patient recruitment and significantly lower dropout rates.

Insanity: doing the same thing over and over again and expecting different results: Albert Einstein. Have we been conducting clinical studies the same way over and over again, expecting different results?

Patient recruitment problems
Timely patient recruitment is the Achilles heel of the clinical trial process. Even with the most efficient site selection processes, sophisticated trial designs, outreach programs and advertising campaigns, patient recruitment accounts for over 25% of the median cycle time for clinical trials. Making matters worse, approximately 20-30% of patients drop out from phase II/III trials resulting in 90 percent of studies missing targeted completion dates.

The hassle factor
Everyone reading this article has probably directed, managed, reviewed or analyzed a clinical trial…but have you ever been a patient involved in a trial? If so, you know firsthand about the ‘hassle factor’ of clinical trial participation:

• Scheduling challenges
• Distance to the PI’s location
• Challenges due to disease state
• Disruption from school schedules, work responsibilities, travel plans, etc.
• Caregiver burden
    
Every potential patient, considering whether or not to enroll in a trial, thinks about many of these issues when making the clinical trial enrollment decision. Once the trial begins, patients will drop out if the hassle factor caused by trial participation becomes overly burdensome. So what can be done differently?

Taking visits to the patient
Clinical Resource Network’s service model is based upon a ‘patient-centric’ approach to implementing clinical trials. Rather than requiring patients to go to the investigator’s site for protocol visits, CRN takes selected visits to the patient – at home, at work or on vacation. Since 2003, CRN has been offering access to their mobile clinical network of over 15,000 highly skilled nurses, pharmacists and clinicians, supporting hundreds of studies in multiple therapeutic areas and in all age groups and phases of development. How it works:
 
• Study sponsors contract with CRN, a national homecare management organization; homecare services are made available to participating sites to use as needed for protocol visits.
• Physician orders and homecare source documents are standardized; the site completes the order for homecare services once a patient is enrolled in a study.
• Local CRN homecare clinicians are selected based on where the study patients reside, clinicians are trained by CRN on GCP’s and study-specific and regulatory requirements.
• Local clinicians contact the study patients and schedule and conduct the ordered services; source documents are completed by the local clinicians at each visit and provided to the site, CRN oversees the day-to-day homecare activities.

Case study: accelerated patient enrollment
Making study participation convenient for patients through NDA compliant in-home or alternate-site protocol visits, has proven results.

This was a phase II, safety and efficacy study of a cancer drug for the treatment of patients with glioblastoma. The dosing regimen required one-hour infusions three times weekly for six months. Patient recruitment was significantly behind schedule after six months of enrollment. Study-specific nursing and pharmacy homecare services were implemented for the administration of study drug and safety blood draws. As a result, enrollment nearly tripled over the next six months and was completed.  Seven of 10 sites recruited patients from out of state.

Conclusion and summary
CRN’s innovative and proven trial model is available for patients, sponsors, CROs and clinical sites and can provide an important alternative to the traditional study logistics. More patients are willing and able to participate in trials via this model. Additionally, more patients are retained resulting in decreased development time.

Gail Adinamis is president and CEO of Clinical Resource Network, LLC, a diversity company specializing in the provision of in-home nursing and pharmacy services to facilitate all phases of clinical trials throughout the US, Canada, UK, Europe and Israel. Ms. Adinamis has 29 years of comprehensive clinical trials experience, including over 12 years of global clinical trials management at Abbott Laboratories and Astellas Pharma US. She also established the clinical trials divisions for three national homecare companies and served as president of those wholly-owned subsidiaries.