Taking Trials Home

Despite a variety of patient recruitment tactics, outreach programs and advertising campaigns, patient enrollment accounts for over 25% of the median cycle time for clinical studies (from study start-up to analysis and report writing). 94% of US trials experience delays in patient enrollment. Once patients are enrolled, compliance and retention present additional challenges. The average dropout rate for phase II/III studies is 30%.*

The use of in-home nursing services for selected protocol visits can significantly simplify the recruitment process as well as improve patient compliance and retention. Although homecare services have been available for commercial patients since the early 1900’s, the integration of centrally managed national homecare services in clinical trials is relatively new. Study visits requiring investigational product administration, blood draws and clinical assessments can be safely and effectively done in the convenience of the study patient’s home or workplace. These services can be particularly helpful in long-term studies or when frequent visits are required. These services can also facilitate situations when patients are unable or unwilling to travel to the investigator site due to distance to investigator site, debilitating disease state, lack of adequate transportation, vacation/relocation or just plain inconvenience.

Following is a model for centrally managed homecare services.

In this model, the study sponsor contracts with a national homecare management organization. Homecare services are made available to participating sites to use as needed for protocol visits. The physician orders are standardized as are the homecare source documents. Once a patient is enrolled in a study, the site completes the order for homecare services. The local homecare clinicians are selected based on where the study patients reside. The homecare management organization trains the local clinicians on study-specific and regulatory requirements. Once completed, the local homecare nurse contacts the study patient and schedules and conducts the ordered services. Source documents are completed by the homecare nurse at each visit and provided to the site. The homecare management company oversees the day-to-day homecare activities.

Centrally managed services offer a number of advantages over ad hoc locally contracted homecare services. Most importantly, the clinician training, documentation and reporting are standardized. Secondarily, these services free up the sites’ personnel time, so that they can focus on additional patient recruitment or other study priorities. While homecare clinicians are generally highly skilled, comprehensive training is essential to cover regulatory requirements and study-specific procedures.

Following are two case studies that effectively utilized homecare services.

Case Study #1
This was a phase II, safety and efficacy study of a cancer drug for the treatment of patients with glioblastoma. The dosing regimen required 1-hour infusions three times weekly for six months. Patient recruitment was significantly behind schedule after six months of enrollment. 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 the sites recruited patients from out of state.

Use of Homecare Services vs. Traditional Site Visits

Using Homecare Services
Projected if using traditional site visits

Case Study #2
Four phase II/III safety and efficacy studies of a small molecule were conducted for the treatment of a rare pulmonary disease. The treatment regimen required daily oral dosing for up to two years with frequent safety blood draws. Compliance with protocol lab draws, sometimes three times weekly, quickly became a major issue. Many patients resided several hundred miles from the sites. Local blood draws were inconsistent – both from the standpoint of the patient going to a local service center within the protocol visit window and from the transmission of the results to the sites in a timely manner. Homecare nursing services were instituted approximately one year into the study. Compliance with study required blood draws dramatically improved as did the retention rate. Patients not using homecare had a retention rate of only 27% versus a 97% retention rate in patients using homecare services.

The use of homecare services provided win-win benefits for all parties involved. Patients had the convenience and flexibility of scheduling visits at their home or work place. Investigators were able to recruit patients from broader geographic areas and focus their efforts on other protocol requirements. Lastly, the sponsor benefited from the overall times savings with better protocol compliance and retention.

In conclusion, partnering with a national homecare management organization can provide solutions for some of the most challenging drug development problems and substantially decrease development time.

*Source of statistics: CenterWatch 2003: Analysis of 25,855 Study Volunteers in US