The Local Touch

Lagging patient recruitment and high dropout rates continue to be among the most challenging aspects of a clinical trial. Increasing protocol complexity and a growing number of required procedures per patient are some of the factors that have complicated trials and contributed to these challenges. To facilitate clinical studies, an emerging model to conduct study visits at home has been gaining traction across the industry. This patient-centric approach has proven to accelerate patient recruitment and enrollment, improve patient compliance, and increase retention rates.

The concept started for the author over 20 years ago when a sponsor was trying to conduct a clinical study requiring weekly safety labs for patients with schizophrenia. To address the sponsor's challenge, the decision was made to conduct the study visit at the patient's home, leveraging the resources from a national home infusion company. It was found that by taking selected study visits to the patients, more patients were willing and able to participate. In addition, having a nurse go to the patient's home, or alternate location, was more reliable than hoping the patient would return to the site within the visit window. Home visits resulted in higher patient compliance and retention rates. This formed the basis of the service model, which continued to be refined over the years, as the author created and ran wholly owned subsidiaries of three national home infusion companies before starting an independent domestic company in 2004 and ultimately a global service provider company, GlobalCare Clinical Trials, Ltd, in 2010.

Global needs

In the past couple of years, the majority of clinical trials have migrated to locations outside of the United States. This has been due mainly to easier access to patients, especially treatment naïve patients, and lower costs in other countries versus the high cost and competition in the United States. In addition, some countries have offered incentives to attract the pharmaceutical industry to conduct trials. While the geography is shifting, so are some of the inherent challenges for the study patients themselves. Patient compliance and retention can be problematic for patients who live distant to investigator sites, have debilitating diseases, have family or work obligations, or may have difficulty with transportation. Long-term studies or studies with frequent visits can be especially challenging for study subjects.

The at-home service model has been gaining recognition and popularity over the past five years with new players offering local, regional, or global services. These organizations have ranged from small wholly-owned companies to franchised or subcontracted establishments. An important factor in any structure is to ensure standardization and compliance with applicable regulations. To ensure quality, the management platform for global providers should consist of experienced regional and global project managers who centrally manage a network of GCP/ICH certified, multi-lingual country coordinators, and thousands of local ambulant healthcare service providers. Each of the country coordinators, at least one per country, should have in-depth knowledge of not only clinical trial regulations, but also local medical practices, and local customs and culture. The country coordinators should communicate and train the ambulant care service providers in the local language to ensure comprehensive understanding of study requirements. The country coordinators should be medical doctors or research nurses. The local ambulant care service providers should be high-skilled nurses, but may also include physicians, depending on the country and services required.

Service offerings

The at-home services generally offered include study drug administration, blood draws, biologic sampling, clinical assessments, patient training and education, study compliance checks at home, completion of patient questionnaires, and visit documentation. Drug administration can include topical applications, injections, or infusions, including the provision and management of infusion devices and other administration and pharmacy supplies. Some companies also provide weekend and after hours visits and 24/7 on-call services for device management. Blood draw services are available for safety or specialty testing such as pharmacokinetics. Samples are generally processed in the patient's home and sent to local or central labs for analysis and reporting to the sponsor or sites. Also, as ambulant care service providers are in the patient's home, they can conduct a variety of assessments such as vital signs, ECGs, changes in concomitant medications or signs, and symptoms. They can also monitor compliance if subjects are completing their diaries or storing and taking medications properly.

Some organizations may also provide central pharmacy services to properly store, compound, and dispense investigational products in coordination with the home visits. Shipments can be conducted overnight following cold chain logistics. These services are used for products having at least a 24-hour stability and can significantly simplify logistics for multi-center trials. At-home services have been coordinated with local pharmacies for products with shorter stability.

Future predictions

With the staggering and rising cost of bringing a new drug to market capping $1 billion, the use of at-home services has helped to reduce costs associated with non-compliance or drop-outs and reduce overall development timelines by months and years over conventional studies. The author predicts that the use of home visits will continue to increase globally. The most obvious benefits are faster patient enrollment, better patient compliance, and higher retention rates. Sponsors are able to realize a return on investment utilizing at-home visits by enrolling fewer but more productive sites and completing trials quicker, and more importantly, getting life-enhancing products to consumers sooner.

Gail Adinamis is the Founder and CEO of GlobalCare Clinical Trials, Ltd, 2201 Waukengan Road, Suite 180, Bannockburn, IL, e-mail: gadinamis@globalcarect.com.