Navigators assist patients in locating clinical trials they may qualify for and have proven successful at increasing cancer clinical trial enrollment among medically underserved populations, including racial/ethnic minorities.
This mixed-methods survey study targeted current students and alumni enrolled in a clinical research graduate program at a large university. Invitations were sent via e-mail for participation.
Goods
Clinical research requires both physical and intangible goods for its success. Physical goods include equipment, tools, and supplies needed for conducting trials; while intangible services provided by staff members enable trial schedules to proceed as scheduled. Without this support from both sides, research could become significantly harder than it already is.
To meet these challenges, the Research Excellence Consortium has devised a set of best practices to be utilized by all members of the research community, such as guidelines on training and education requirements for various roles within an enterprise. These best practices serve as a response to an ever-increasing need for professionals with clinical research expertise as well as keeping pace with technological innovation in healthcare settings.
Core competencies have helped spark academic programs and career pathways for clinical researchers. Unfortunately, research indicates high staff turnover within this industry due to numerous factors; including unclear professional development plans and role progression pathways.
By using an open-ended approach, the survey asked participants for their personal insights regarding clinical research as a career choice, how they obtained their first job in this field, and advice they would offer novices trying to break into it. Results from this survey indicated that beginners can break into clinical research if they start at entry-level positions and quickly advance; networking and referrals can be also be effective tools when looking for their initial job in this industry.
Other key themes revealed from the survey included the importance of providing employees with a supportive working environment and networking for new opportunities; both factors can help mitigate burnout among clinical research employees who have reported this as an issue in the past. It is also critical to communicate clearly with staff about goals and expectations of research enterprises to ensure everyone knows exactly what their role in these enterprises should be.
Access to Resources
By enrolling in clinical trials, patients have an opportunity to help scientists better understand their condition or disease and may even receive new treatments before it hits general availability. Furthermore, participation can give people more of a say in their medical care and give a sense of personal accomplishment by contributing research efforts. Plus, participation helps doctors learn more about how certain drugs or treatments affect patients.
Navigators play an invaluable role in helping patients locate and join clinical trials that best suit them. By providing information about trials and assisting them through complex patient requirements, navigators help individuals make more informed decisions regarding their treatment options. Furthermore, navigators can reduce some of the burden from physicians by informing them about different therapies available; oftentimes former patients or survivors themselves can understand a patient’s fears regarding participating in a clinical trial.
As one of the primary concerns among patients is being exposed to placebo medication, it’s essential that they know any treatment given during a clinical trial is at least as effective as standard care.
One common concern of patients enrolled in studies is not being able to meet its time requirements. While this is understandable, navigators can help by scheduling appointments with doctors and nurses for you, providing transportation to research appointments as necessary and working around your work or school schedule as appropriate.
Navigators can assist with the application process as well, which can be an arduous one due to all of the forms required and intricate queries from study teams. Navigators can assist in filling out these forms as well as provide language help when discussing the study in more detail.
Navigators not only directly affect enrollment rates; they can also influence the culture and conduct of clinical research in general. Studies have revealed that improving communication about the purpose and benefits of clinical trials is capable of increasing enrollment rates by 95% [12].
Service Actions
Researchers depend on people to participate in clinical trials, and researchers owe it to these participants to protect their welfare and safety through informed consent procedures. An investigator must inform potential participants of the nature of the trial itself as well as risks, benefits and alternatives they should consider prior to signing informed consent forms; additionally they must allow time for them to ask any pertinent questions they might have. Besides this procedure, researchers must also ensure their studies adhere to any federal or state regulations and rules applicable during conduct of studies.
Many individuals may be reluctant to participate in medical research due to concerns over confidentiality, opting out, and how their participation might impact their healthcare. Studies have demonstrated that most participants who undergo clinical research find their experience rewarding and worthwhile; studies into disease causes, prevention techniques, diagnostic approaches, and novel approaches for treatment have improved life expectancies, reduced infant mortality rates, limited infectious disease spread rates, and improved overall quality of healthcare delivery systems for many.
Although participation rates for racial minorities in cancer clinical trials tend to be much lower than for white Americans, various strategies exist that may increase willingness of racial minority individuals to join research studies. One such strategy is patient navigation which has been found effective at increasing enrollment into therapeutic cancer trials; those enrolled via patient navigation often receive ongoing support throughout their trials with monthly phone calls from their navigator and referrals to resources for unmet needs or concerns.
Education and outreach can also increase participation rates in research studies. Publications or education campaigns that stress the positive outcomes of medical research while simultaneously emphasizing participants’ privacy rights should also increase willingness for participation. Outreach should focus on incomplete data as an issue for scientific inquiry as well as encourage individuals to participate with IRB or Privacy Board supervision or through waiver of patient consent or authorization agreements.
Intangibles
As part of valuing a business, intangible assets can present unique valuation challenges. Since these assets cannot be touched or held directly, valuation professionals must rely on other means for estimating their worth – this might involve measuring brands, goodwill and intellectual property for instance. While intangibles may be possible to measure and value independently, many companies shy away from doing so due to being difficult to measure and manipulate.
Value of intangible assets, like brands, is determined by how willing shareholders are to pay for future cash flows expected from them. A brand’s worth can fluctuate greatly based on consumer perceptions about quality and reputation of products they own; for this reason, brand values may often surpass physical assets owned by businesses.
So it is not surprising that investors tend to be wary when dealing with businesses with significant intangible value, making acquisition of businesses difficult. This is particularly the case for healthcare-based service companies which may possess considerable intangible assets that go well beyond what can be measured with physical assets.
Clinical researchers increasingly value intangible elements in clinical research. Empirical studies in low and middle income countries (LMICs) have highlighted how various ideas, norms, values and issues related to power or trust influence attitudes and behavior within health systems – which in turn thwart efforts made to improve them [3].
Studies have demonstrated the power of patient navigation programs to significantly boost enrollment rates for clinical trials, with some studies reporting up to 95% patient recruitment through interventions that focus on communicating about the purpose and risks of clinical research participation as well as financial feasibility, timing of trial information delivery and who is responsible for providing this data.
Tech can also be leveraged to streamline a variety of processes and significantly lower costs and speed up trials, increasing efficiency while decreasing duration timeframes. By switching from paper data capture to electronic capture technology, CROs such as Vial can accelerate trial start-up by decreasing documents and meetings required, while streamlining regulatory submissions, monitoring processes and TSDV/eCOA processes more quickly.