Deep Dive Into Clinical Research Dynamics
Published: 2024-04-01 11:37:41

Every pill, vaccine, procedure or medical device that improves health undergoes clinical research trials before being released for public use. But that doesn't make the journey any simpler.
This special edition of Pharmaphorum's Deep Dive series explores the challenges facing clinical researchers in today's healthcare landscape. We consider how adopting a patient-centric approach may provide advantages to all.

Patient Centricity

As healthcare continues its shift toward patient-centricity, pharmaceutical companies, and other organizations must understand how this transition will impact clinical research. Patient centricity should not just be seen as a marketing buzzword - rather, it should be an integral component of development processes. Organizations that successfully implement patient-centricity into their work will gain a competitive edge over their counterparts.

Patient centricity refers to an approach that considers patients' needs, values, and preferences in every step of product development - from research and discovery through CMC development, clinical trial management, regulatory approval, and post-approval review processes. 

Each step provides opportunities for direct or indirect patient input that may be integrated into these areas (Figure 1).
Key to patient centricity is communicating effectively with patients so they understand the value and benefits of participating in trials. This can include providing clear, concise information that fosters transparency and trust with participants as well as respect. Translation services may also prove invaluable in enabling effective communication.

Integrating patient-centric design principles early in drug development may help optimize many aspects of its process, including improving adherence, minimizing discontinuation rates and shortening the trial length. Furthermore, employing such principles could reduce costly late-stage changes that require significant process modifications and comparability studies.

An approach tailored around patient needs can improve outcomes by both improving healthcare quality and increasing patient satisfaction. Telemedicine provides patients with access to their physicians and receives care without leaving the comfort of their own homes, thus helping reduce exposure to disease while also avoiding hospital visits, secondary consults, and readmissions.

As we move forward, it is paramount that patient centricity be integrated into every company's core business strategies. Many organizations have already begun adopting this practice and committed to making patient-centricity part of their operations - but the greatest challenge remains demonstrating there is an adequate return on investment for patient-centric models.
.
Digital Health

Digital health also referred to as e- and m-health, encompasses everything from patient records and remote monitoring systems, connected devices and digital therapeutics, new methods of data collection analysis and sharing using IT systems and artificial intelligence (AI), etc.

The digital health industry is rapidly expanding, with market estimates projecting an expected market size of US$84.9 billion by 2025 according to market research estimates. A great part of its expansion can be attributed to smartphones, remote monitoring solutions, and telemedicine technologies becoming increasingly adopted by patients.

As technological innovations emerge, it's crucial to assess their effects on clinical research and practice. Furthermore, digital health should not be viewed simply as an industry; rather it encompasses disciplines, tools, software applications, and platforms that enable patients to engage with healthcare providers as well as each other.

Digital health technologies can dramatically enhance quality care while decreasing costs and expanding access for both patients and physicians. Their use may revolutionize healthcare delivery systems by creating more patient-centric services with interlinked networks; however, face-to-face encounters with healthcare professionals will remain essential in providing optimal patient outcomes.

Research communities should take an approach centered on patient needs when it comes to incorporating digital health technologies and approaches into clinical trial design and execution, endpoint collection and definition, as well as digital tool and technology validation by both clinicians and patients alike so they can be integrated into standard practices and clinical protocols.

Patient Engagement

Patient engagement refers to the degree to which patients collaborate with clinicians on decisions regarding their healthcare. Patients engaged with their care tend to follow prescriptions, keep appointments, and engage in healthy behaviors more consistently - which increases their odds of avoiding emergency admissions and long-term hospital stays.

As medical [clinical trials](https://spinoslifescience.com/) expands, so has interest in engaging patients as part of clinical trial design and conduct. This can be accomplished via surveys, focus groups, and interviews - though how best to define and measure patient engagement remains contentious. Engaging patients may have significant benefits in several areas including:

Patient engagement in their care increases the odds that they'll take an active part in making decisions with lasting impact, such as sticking to treatment plans or preventing future disease. This also aids them to remain on course, which improves long-term health outcomes such as disease prevention.

Clinicians have long included patients in decision-making processes, yet this approach remains evolving. Decisions typically occur during an in-person visit - which works well when making major decisions with clear ramifications - while including patients in routine decisions occurring multiple times within a single office visit can be more complex.

Patient engagement has gained increased momentum since the US Institute of Medicine's Crossing the Quality Chasm report advocated for its importance, advocating a shift away from paternalistic models of care that dictate to patients what should be done to collaborative partnerships that help patients better understand their medical conditions and make decisions that reflect their values. Patients actively engaged with healthcare providers are more likely to report higher customer satisfaction ratings as proof.

Engaging and maintaining patient engagement has never been more essential, particularly with the advent of new technologies that enable communication outside a hospital or clinical setting. Organizations must use digital communication platforms to engage patients before and between appointments - sending text reminders for prenatal checkups or car seat fittings, emailing information about folic acid supplementation or car seat fittings, or calling to offer STD screenings as tools for success.

Marketing & Sales

At a time of globalization and pharmaceutical companies expanding into new markets, marketing and sales strategies are more crucial than ever. Although grants from the National Institutes of Health fund much academic laboratory research, it's often private organizations such as QuintilesIMS, INC Research, Parexel Covance PRA International that bear most of the financial responsibility for bringing new medical treatments to market - this burden being carried mainly by [clinical research organization](https://spinoslifescience.com/) (CROs).

Trial management is a complex and time-bound process with two interdependent sets of processes - clinical and managerial. Unfortunately, due to culture's cultural bias towards trials as clinical endeavors, they tend to be led by people with clinical skills rather than people who specialize in management - this could result in neglect of managerial aspects and lead to degraded trial performance.

Trial success requires many activities to be carried out simultaneously; recruitment being the cornerstone. Understanding which factors influence doctors' and patients' motivation to participate can have a substantial effect on recruitment rates - which is where our study comes into play.

Researchers conducted an in-depth analysis of data from one multi-site clinical trial to identify variables driving physician and patient decision-making related to trial participation. 

Furthermore, interviews were held with hospital personnel involved in recruitment to gain further insights into their motivations, while creating a model to guide future trials.

Researchers identified several key determinants of participants' decisions to participate in clinical trials as the main determining factors: awareness, significance, and benefits to be gained by participating; status/prestige associated with participating; financial incentives offered by companies; physician demographic parameters, etc. 

These factors could then be used to design targeted communication and outreach initiatives designed to increase recruitment rates in future trials; plus hypothesis testing on various promotional tools used to attract HCPs towards clinical trials.