Let's Bring the Trial to the Subject!

July 1, 2005

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-07-01-2005, Volume 0, Issue 0

Following the model of the home health care industry might be the answer to high subject dropout rates in clinical trials.

How often have we heard the phrase "improved retention rates"? How about "increased compliance"? These catch phrases in our industry defy, mystify, and often stupefy us. They sound simple enough, but in practice, these issues can often signal the great black hole in a clinical trial. Compliance and retention issues can lead to loss of subjects, increased costs, and, invariably, extended timelines.

Tim Hynes

Who's to blame? More importantly, can drop- out rates be minimized and even avoided? A cold fact about subject attrition data shows that the typical drop out rate is about 20% in a given trial.

The typical response to recruitment and retention problems is to add more sites. Does adding sites work? We all know the answer. There is an old saying: "the definition of insanity is doing the same thing over and over again expecting different results." Perhaps we need to make a paradigm shift and try to think outside of the box.

Bring the trial to the subject!

Although rare in the industry, bringing the trial to the subject is effective and possible. We can take a lesson from the home health care industry. The most effective way to improve compliance and retention is to visit the subject in the comfort and privacy of the home. How often have subjects been lost to follow-up due to their debilitating disease state, or distance from the investigator site, or their hectic lifestyle, which adds increasing pressure on them to continually make their way to a physician's office for that trial they agreed to six-eight months earlier when life was less complicated?

Reliable homecare agencies exist throughout the United States. They can perform assessments and procedures typically done in the physician's office. Qualified agencies can administer investigational drugs, perform blood draws, check subject diaries, review concomitant medications, administer Quality of Life surveys, etc., all in the subject's home.

The key word is qualified. The agencies should be required to be national in scope in order to have the geographic reach required for the multicenter trial. Use the same measures you would in qualifying a CRO or central lab. Sponsors should also require that the agencies offer a coordinated training, one that has been reviewed and approved by the sponsor, long before the trial begins. Invite the homecare partner to the investigator meeting and ask them to explain their services. Give them the opportunity to answer questions that the investigators might have about homecare. This meeting will highlight to the investigator that homecare can increase their geographic reach, bringing new subjects to them that would literally be out of reach. Show that the use of homecare agencies will not replace visits to the site, but rather augment them. Review your protocol's Flowchart of Assessments. Could certain visits be performed in the home? How about that PK assessment? Perhaps your study requires an infusion of an investigational product. Who better than a qualified nurse to perform the infusion, observe the subject post-infusion.

Subjects benefit as well

These subjects receive one-on-one care for the entire visit by a trained health care professional. Typically, subjects are very appreciative of this type of individualized care and become more compliant.

National homecare agencies have SOPs requiring that the visiting clinical nurse complete source documentation while in the home. The documentation should mimic your CRF and be sent to the investigator site in a timely manner.

Rescue measures for ongoing studies

What about ongoing studies, ones that are seeing the dreaded attrition rates mentioned above? Why not use in-home visits as a "rescue" measure? Determine your problem sites and query them as to their interest in augmenting their services with in-home visits. Or utilize the in-home model for a select few subjects. In this way, the subject is retained in the study and the timelines for study completion are improved. Consider the case of snowbirds that will flock to warmer climates during the winter months and, as a result, miss visits or worse yet, decide not to enroll in a study in the first place. In-home visits performed by a qualified homecare agency can continue the visit sequence until these subjects return to their permanent residences. This not only keeps the subjects in the study, but compliant, too.

The key to appropriate in-home support for your clinical trial begins with proper due diligence. Do your homework. Does the homecare entity have the geographic reach needed for your study? Is it national in scope? Are its nurses experienced in the management of clinical trials and GCP/ICH guidelines? Do they have a pharmacy in their branch in the event that you need an investigational product stored, reconstituted, and delivered to the subject or investigator site? Most importantly, does the agency have a centralized project management model that assures procedures are being performed identically for both the snowbird in Florida and the subject living on Puget Sound? If the agency answers yes to these questions, than quite possibly, the fastest way to market is through the home!