Clinical trials as the first line of treatment: Empowering patients to decide

Gene S Lysko

Medical Writer

We know that clinical trials are the cornerstone of new-drug marketing approvals. But there’s more to it than that. For a considerable number of patients with advanced cancer or rare disease, clinical trials represent a potential lifesaver—or at least their chance for the highest currently available standard of care—offering hope to patients who may not have another treatment option.

It’s in these instances that a clinical trial may not only be considered as first-line treatment, but in some cases, treatment guidelines specifically recommend a clinical trial as a patient’s best option for potentially effective therapy. When a clinical trial is recommended (whether by treatment guidelines or by a patient’s doctor or nurse), it’s important for the patient to understand and truly appreciate the possible benefits and risks of participating.

It’s here that education plays a key role. Education can help to:

•  Dispel myths—“no one’s experimenting on me” and “I might only get a sugar pill”

•  Empower patients by explaining in plain words the benefits and the potential risks

• Break down barriers to recruitment and retention

• Show patients that clinical trials help all of us (appeal to altruism) 

Artcraft Health Clinical Trials (www.artcrafthealthed.com/clinical-trials/) optimizes the use of health education to create a unique path to meeting recruitment and retention goals, which increases the strength of your clinical trials. Visit our corporate Web site at http://www.artcrafthealthed.com/ to learn how we can help you.

Outsourced Clinical Development

Tom Savonick

Since its beginning in the 1970s, outsourced clinical development has moved from one-stop shopping to an approach offering a greater range of options.

The industry began with the contract research organization (CRO). By the 1990s, full-service CROs provided sponsors with all services and expertise needed to move a new drug or device from conception to marketing approval, without the sponsor having to maintain a staff for those services. One shortcoming of a CRO is that it may not provide a consistent level of service across every function that it performs. 

Another model of outsourced clinical development, the functional service provider (FSP) model, addresses that shortcoming. The FSP model supports selection of individual services rather than the “one-stop shopping” provided by a CRO. This enables sponsors to select the a service provider from each discipline rather than focusing on one provider to perform all services. 

The latest trend in outsourced clinical development is the niche service provider, which provides a high level of expertise for a specialized service. Artcraft Health Clinical Trials (AHCT) provides sponsors with an array of high-expertise services in 7 key areas:

•    Recruitment

•    Eligibility

•     Retention

•     Consent

•     Compliance

•      Education

•     Communication

AHCT’s customized services provide clinical trial sites with tools and solutions to help them meet recruitment timelines, enroll qualified participants, educate them about the study and the importance of compliance to protocol, and retain them throughout the study duration.

Low compliance and high dropout rates are 2 of the most daunting challenges facing sponsors. Recent studies have shown that participants’ compliance and retention are strongly affected by how well they understood the study when they opted to enroll. A poor understanding of the study can lead to poor compliance and even dropout. AHCT ensures that participants thoroughly understand their role in the study through customized informed consent documents and study guides that lower the literacy level by:

•         Replacing legal and medical jargon

•         Using plain language

•         Including phonetic pronunciation guides

•         Adding pictures, icons, and other visual elements

•         Using plenty of white space

•         Providing participants with clear, ease-to-follow schedules and calendars

These steps ensure that participants thoroughly understand the study and what is expected of them. By eliminating the surprises faced by participants, sponsors can ensure maximal compliance and minimal dropout rates. Like all niche service providers, AHCT can employ its services regardless of how you choose to source your study.