Specialized Nursing: From Clinical Trials to Launch

Specialized nursing home care organizations have emerged to provide and coordinate clinical care that is specific to brand-new therapies and help communicate the value of these new drugs.

The process of a successful new biological product development and launch can be one of the most complex tasks a pharmaceutical company undertakes. Biotech companies face big risks in getting their products to market. With limited resources, mistakes become costly. While investing heavily in marketing the approved drugs, biotech companies also need to employ the same marketing expertise when it comes to targeting, positioning, and communicating the value of the actual drug delivery.

This may turn into an unexpected cost barrier if the drug requires specialized nursing expertise to administer, educate, and/or train the patient in the home setting. Drugs can literally be left sitting on the shelf indefinitely until nursing is secured. Start of care may depend on the drug administration protocol, geographical location of patient, and nursing Standards of Practice (SOP).

Expertise in Biologics

Traditional home care organizations are relatively isolated from academic health centers or centers of health services research that have advanced the knowledge base and expertise in the launching of new biological products from clinical trials. Traditional home care organizations, SOP often do not include “first dosing,” or “administration of biologics” in the home setting. They rarely employ nurses with specialized expertise in biologics. These challenges play an important role in the delay in start of care for a patient.

To meet the need of new biological products launching from clinical trials, specialized nursing homecare organizations have emerged, providing and coordinating clinical care specific for these therapies and patients. These organizations consist of home health care agencies, staffing agencies, and nurse registries employing nurses with expertise in specific disease states.

The nurses engage with all members of the care team to provide optimal management of the patient’s care and are attuned to their special needs. Their professional practice requires detailed knowledge of the biologics through research, continuing education, and advanced education. By engaging the services of a specialized home care organization, the biotech company decreases the delay in start of care and increases the utilization of drug.

Clinical Trials

With the exponential growth in biotechnology product development, there is also a corresponding increase in the demand for experience and expertise in nursing during the clinical trial phase. Two of the detailed common perceived barriers with regard to clinical trial participation noted by The National Cancer Institute include lack of access to clinical trials and personal obstacles. The reality or the perception that there are no trials nearby deters many potential participants.

In addition, seeking care at a distant trial site presents time and travel barriers. Practical or personal obstacles such as costs of being away from work and family may be deterrents for some people. Others may not wish to leave the care of their own physician. Depending on where they live or access to transportation, people may have difficulty getting to a clinic. Some may find it difficult to take time off from work or find appropriate childcare.

Achieving clinical trial research participant enrollment is essential to conducting a successful trial. Partnerships between specialized nursing homecare organizations and qualified contract research organizations (CROs) have provided a solution to barriers in addition to offering a strategic benefit— they increase enrollment and shorten total study duration, thus saving sponsor time and money.

CRO’s utilization of a specialized nursing homecare organization offers an extension of the research site and nurse to the rural areas. The specialized homecare nurses adhere to the principle of Good Clinical Practices and have a central role in assuring patient safety, accuracy of data collection, data recording, and follow-up.

Challenges are greater than ever for biotech companies seeking to market new therapies and drugs. The introduction of specialized nursing’s seamless transition from clinical research trials to drug launch can contribute significantly to the efficiency and success of a new biological drug launch.

SPT

About the Author

Cherylann Gregory, RN, BSN, is founder and president of the Specialty Pharmacy Nursing Network (SPNN) and has more than 30 years of experience as an oncology/infusion nurse. SPNN provides a nationwide network of 1000 qualified nurses for specialty pharmacies and biotech manufacturers. Services include coordination of care, drug administration, first dosing, education, clinical outcome data collection and reporting, and on-call coverage for specialty therapies. Visit www.spnninc.org.