BOSTON, May 27, 2020 /PRNewswire/ --While COVID-19 has severely affected many industries, scientific pursuit for a host of medical conditions is also threatened by sharply negative effects of the pandemic on clinical research for non-COVID-19-related pursuits. This is evidenced by an industry-reported 65 percent decline in new patient study enrollment in March 2020 relative to March 2019. The industry is adapting by borrowing from the zealous approach associated with COVID-19 research by deploying extraordinary collaboration and patient-centric services to achieve timelines for as many studies as possible.
"Although phase 1 trials involving healthy adults leery of virus infection are the most affected, even trials related to life-threatening conditions are seeing significant reductions, with oncology trial enrollment down by 48 percent. Coupled with the need for a response to this pandemic is the need to ensure the continuity of existing trials and the start of new research," says Rob Laurens, principal, quality assurance, BBK Worldwide. "At BBK, we're making a difference by deploying any reasonable means to support patients already enrolled in important studies relevant to them and the rest of the world."
The application of innovative solutions that break down barriers to enrollment has a positive effect on study completion timelines, meaning treatment options are available for those in need on a more efficient basis. BBK's analysis of responses from more than 19 countries, 400 sites, and 800 patients demonstrates that baseline support to participants—such as immediate reimbursement for study-related out-of-pocket expenses and arranged travel itineraries for visits combined with high-quality provisioned ground transportation—increases compliance and retention. The "Patient Voice" research conducted on an ongoing basis at BBK reveals that patient withdrawal percentages were 60 percent lower at study sites that used RSG® Card (BBK's reimbursement program) and global patient withdrawal percentages were 58 percent lower at sites that used RSG® Arrive (BBK's travel assistance service) than at those study sites that did not embrace these programs.
Direct-to-patient technologies and patient visit support services, such as those cited above and others that have suffered from slow industry adoption in the past, are now being more eagerly embraced to combat the social distancing challenges that are disrupting participation. "Since announcing BBK's COVID-19 Support Package, we have received more than 500 requests from a wide range of pharmaceutical and biotech companies looking for information on technological solutions and patient support services separate from our traditional media and recruitment efforts to safely maintain current research initiatives—that's more requests in two weeks for virtual and direct-to-patient engagement services than we have seen in the last 12 months," says Aaron Fleishman, director, market development, BBK Worldwide.
Consider the following practices initiated by BBK:
Instead of visits solely devoted to patients picking up their next course of an investigational drug, clinical trial sponsors are opting to deliver medications directly to the participants' homes. BBK arranges for global delivery services with drivers who must adhere to COVID-19 guidelines issued by the U.S. Centers for Disease Control and Prevention and the World Health Organization, including wearing masks and gloves, practicing social distancing, and deploying web-based interfaces that allow for individuals to confirm delivery without having to use a shared device for sign-off.
To avoid public transportation, sponsors are using BBK's RSG Arrive program to supply patients with ground transportation alternatives that eliminate close contact, use vehicles that are sanitized after each passenger trip, and are operated by professionals who adhere to hygiene standards.
BBK has been working with study sites directly to re-assign patients from closed trial study sites to sites that remain open solely for the purpose of their research participants. Coordinating the logistics involved in changing a participant's study site location can be relatively simple, but more often than not, it requires complex considerations such as governmental documentation, medical record translation, and extended family involvement.
COVID-19 cross-border travel restrictions mean that many globally recruited clinical trial participants find themselves quarantined in foreign countries. Most affected are those volunteers and their families enrolled in rare disease and pediatric studies who must receive care from select experts, at a few sites, in limited locations around the world. BBK deploys its RSG Arrive Plus program to coordinate long-term housing, interpreters, child care, and other assimilation support services necessary to help ensure participant and family safety and study visit compliance.
As federally-funded and commercial insurance companies integrate telehealth as a reimbursable visit, accelerating physician adoption, principal investigators and study coordinators are replacing in-clinic visits required by the protocol with telehealth and regulatory bodies are assisting by approving such techniques. Study visits are also moving toward in-home interactions and the use of wearables and other mobile technologies for physician-to-patient communication, and automated health data collection has had a tremendous adoption boost.
"Never before has there been this degree of altruistic and determined interest in clinical research by the general public. This peak awareness is a moment in time that scientific pursuit should capitalize on," says Joan F. Bachenheimer, founding principal and CEO, BBK Worldwide. "The COVID-19 pandemic may in fact create a more informed consumer demanding study designs that better incorporate their needs and remove barriers to participation. Patient-centric support necessary to manage study-life balance should be the new norm."
COVID-19 has instilled research flexibility, response, and adaptation and is a common thread across revised regulatory policy. Regulatory agencies have declared themselves to be open to reasonable adaptation in the conduct of clinical trials. Most notably, guidelines for conducting clinical trials during the pandemic were issued in mid-March by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) and then updated several times by the end of April 2020. Sponsors are encouraged to work with research ethics committees to ensure that any such adaptations are supported by long-standing clinical research norms regarding patient protection and validity of results.
Numerous guidance documents have been issued by the FDA and other government offices with leading roles in clinical research, such as the Cancer Therapeutics and Evaluation Program of NCI (CTEP), the National Institutes of Health (NIH), and the Office for Human Research Protections (OHRP). "The COVID-19 pandemic has seen the rise of a cooperative partnership among public, private, and government resources as we all participate in the shared urgent drive to find ways to prevent, treat, and diagnose this disease," says Michele Russell-Einhorn, chief compliance officer and institutional official, Advarra.
"Starting now, and continuing long after the dust settles, we need to pick up lost time for non-COVID-19-related research initiatives," says Bachenheimer. "The sustained realization from this pandemic is that our clinical trial volunteers stand side-by-side with researchers and regulators in the pursuit of the cure. Beyond COVID-19, BBK believes that by investing in this partnership, we have the best chance to get discovery back on course for all in need of scientific advancement."
About BBK Worldwide (BBKworldwide.com) BBK Worldwide (BBK) is committed to enhancing the clinical trial patient experience through a combination of services and technology-driven solutions that educate consumers, engage participants, unburden sites, and support sponsors. BBK has driven the development of the patient recruitment and engagement industry for more than 35 years, spearheading disease-related public education campaigns that have changed the course of clinical trial care on a global scale. Notable efforts include a collaborative research initiative examining global motivations to participate in clinical research; an award-winning public education initiative recognized by the Centers for Disease Control for legitimizing migraine as a medical condition; a "Come out Fighting" breast cancer campaign that empowered women to fight back with information about all treatment options, including clinical study participation; and supporting advancements for rare diseases—including instrumental involvement in successfully enrolling rare disease studies that have few, or no, treatment options. Headquartered near Boston, Massachusetts, BBK has partners and offices across Europe and the Asia-Pacific region.