Current Trends in the Clinical Research Industry Aiming to Improve Patient Experience and Satisfaction

What is the clinical research industry?

The clinical research industry includes individuals, firms, and facilities involved in testing the safety and efficacy of new investigational medicinal products. This is done through carefully designed clinical research studies, or clinical trials - a type of scientific research study that involves human volunteers as research subjects to gather data and study the effects of potential new treatments/drugs/devices.[¹],[²]

There are two primary types of clinical studies:

• Clinical trials
• Observational studies

In the former, the efficacy and safety of medical interventions (which could be new drugs, procedures, or devices) is assessed in human subjects who are assigned to receive the investigational therapy or a comparison/control treatment, under controlled experimental conditions. The latter involves identifying and analyzing patterns in medical data such as health outcomes or response to treatments that are given under routine care conditions - no intervention is administered in the trial, but participants are monitored (observed) to collect data about safety and/or efficacy of the product.[¹]

Is clinical research considered part of the pharmaceutical industry?

Clinical research is a crucial arm of pharmaceutical development as it is the vehicle for gathering scientific evidence on the safety and efficacy of new medications.[¹] New drugs must go through various phases of clinical research before they can be approved for marketing. That’s why clinical studies are often sponsored by pharmaceutical companies. [²]

Is clinical research considered healthcare?

Clinical research is different from the healthcare or medical treatment someone might receive from a doctor or other medical professional.

Clinical research intends to answer specific questions through research studies, in order to benefit the medical community and patients at large through bringing new therapies and drugs to market. On the other hand, healthcare is focused on addressing the medical needs of individual patients, to their direct and sole benefit.[³]

Who participates in clinical research?

Clinical research studies require volunteer participants to gather data and information about the safety and effectiveness of new medical products - these can be healthy volunteers as well as volunteers with the condition being studied in a given clinical trial. There are various reasons why someone may decide to participate in a clinical trial.

Let's explore how many people participate in clinical trials and what commonly motivates them to do so.

How many people participate in clinical trials?

The participation rate in clinical trials varies yearly. According to FDA's Global Clinical Trials Report, 105,808 global patients took part in pivotal clinical trials in 2015, and 25,941 people volunteered in 2016.[⁴]

What are common motivations for participating in a clinical trial?

People may choose to participate in clinical trials for various reasons, including:

• Access to new treatments not yet available to the public
• Failure of standard therapy or inability to tolerate specific side effects thereof
• The hope of finding an effective treatment or cure for a specific disease or disorder
• Contribution to the advancement of medical knowledge
• Curiosity and wanting to know more about the medical condition
• Receiving affordable or free treatment and additional attention from medical staff*
• Empowerment in making healthcare decisions and proactive engagement with their own health journey[⁷],[³]

*It should be noted that clinical trials should not generally be thought of as “medical treatment,” as we discussed above. Participants may receive personal benefit, but trials are designed to test efficacy and safety of novel, investigational (experimental) products.

What are the potential benefits of participating in a clinical trial?

Partaking in clinical trials does not guarantee improving health outcomes or finding a cure. Personal benefits from participating in a clinical trial are not guaranteed, as the treatment or procedure is still in the testing phase, and research is primarily designed to gather information rather than focusing on curing the patients.

With that said, participating in a clinical trial offers the following benefits:

• The satisfaction of actively contributing to the advancement of medical science and the possibility of finding a future cure for patients
• The possibility of the treatment being effective for your condition during (or even after) the study
• The eventual development of new treatments that might help future generations with the same condition
• The opportunity to take charge of your health and get more involved with your healthcare decisions, as well as to learn

Barriers to participation in clinical research

In a 2020 survey, 41% of U.S. citizens surveyed reported not knowing about clinical trials. Only 8.9% said they had been invited to partake in a clinical trial, of which less than half enrolled.[⁷][⁸] Part of the reason for this is that there are certain barriers to participation in clinical trials. These include:

Lack of education, awareness, and exposure to information about clinical trials

Complex or overly specific eligibility criteria

Limited access to trials (and medical facilities and healthcare in general) for certain communities or geographical regions such as rural areas

Physicians not proactively discussing clinical trials and opportunities with potentially eligible patients

Different treatment preferences[⁸]

3 Clinical research industry trends aiming to put patients first and improve patient engagement and satisfaction

In light of the challenges and barriers to participation faced in the clinical research industry, clinical research stakeholders are taking steps to make trials more patient-centric and friendly. Most of these trends have accelerated since the onset of the COVID-19 pandemic, and in tandem with technological advancements, enabling the transition to new models of clinical trials. Patient-centric trials aim to be more accessible to patients and hold strong potential for improving patient enrollment and engagement.

1. Putting the patient first and decreasing burden: Patient-centric trials

Patient centricity entails incorporating the patients' voices, personal experiences, and perspectives into the clinical trial design to make the trial more fulfilling and less burdensome for them.[⁸][⁷] In a patient-centric trial, the patient is held as a respected contributor to the research.

Patient-centric trials bring patient feedback into the very design of the trial, making trials more attractive and fostering more-effective recruitment. Patient centricity leads to greater patient engagement and improved communication. Ultimately, a higher-quality and bigger data pool results in more reliable outcomes and more representative results.[⁸]

Here are some factors that make a trial patient-centric:

• Increased patient engagement through audio-visual and digital communication means and clear, effective communication from healthcare providers to facilitate understanding[⁸]
• Simple, easy-to-follow protocols aiming to minimize patient burden
• Remote visits, flexible scheduling, and the use of wearable devices and remote data entry, oftentimes meaning that you can input data without leaving your home
• Incorporation of patient feedback
• Encouraging data transparency and explaining the risks and benefits of participation
• Giving patients due compensation to diversify clinical research participation and encourage participants to see themselves as research partners rather than subjects.

In many cases, sponsors are consulting with patient advocacy groups to design trials that better address patient needs. In general, this means that more and more trials are prioritizing the first-hand experience of patients, and that trials are becoming increasingly simple to participate in (this does not apply to all trials, but the trend is going in this direction).

2. Integration of technological solutions and decentralization

Decentralization of clinical trials enables patients to attend trials virtually and remotely. This has the potential to tackle accessibility issues due to geographical barriers.[⁷] It can also decrease drop-out rates and increase study efficiency due to the ease of remote data entry and fewer study visits.

Decentralized trials use local or mobile service providers, telehealth services, remote data collection, and different drug delivery models to ensure participants don't have to travel repeatedly to the central study site. Today, clinical trials can be fully decentralized, or hybrid (with certain aspects made remote). Such trials offer many benefits to patients, including:

• Reduced travel burden
• Improved engagement through connected or wearable devices, surveys, interactive technologies, and increased communication with the study site
• Improved flexibility, making them easier to manage within busy schedules[⁸]

Technology plays a crucial role in decentralized trials. The FDA has published new guidelines regulating the use of remote consenting or eConsent (electronic consenting; giving your informed consent without needing to visit the site). Some other uses of technology that are becoming increasingly common include:

• Wearable and connected devices, such as smart watches, which can (passively or actively) send data directly to a central database to record data on your heart rate, blood pressure, etc.
• ePRO (electronic patient-reported outcomes) ask you to report on your health status, enabling study researchers to remain informed about your health status in real-time, through questionnaires you can fill out on a tablet, computer, or mobile device
• Telehealth and remote study visits, allowing you to speak with the study investigator through video calls or over the phone rather than having to visit the site
• Electronic data capture tools, which enable sponsors and researchers to aggregate and assess data from various sources seamlessly.[¹⁰]

It is expected that the trend will continue, and that sponsors will continue to integrate technology to expand their workflows and embrace operational efficiency, meanwhile making trials more accessible and manageable for all types of patients.[⁹]

3. Focusing on diversity and inclusivity in clinical trials

Diversity and inclusion in recruitment and retention lead to higher-quality, more generalizable results, and the capability to assess relative risks across diverse populations.[¹¹]

Despite healthcare advancements in recent years, U.S. minority groups have benefited less from them than their white counterparts. Improved inclusivity and diversity in clinical trials will lead to more holistic, robust data that better captures the understanding of ethnic and racial differences in treatment responses.[¹²]

Moreover, improving diversity in clinical trials will spread awareness about clinical research participation through communities who have classically had lower exposure due to social, geographical, or financial factors. Getting increased numbers of people from such communities involved in trials may improve clinical research perceptions and participation overall.

Sponsors can provide pragmatic strategies to site staff to effectively identify, enroll, engage with, and retain underrepresented populations via a site-focused diversity plan.[⁹] Sponsors should offer support to ensure each local site follows through with partnerships with patient advocacy groups, official organizations, and community-based organizations.

Diversifying the recruitment strategy might involve the following:

• Working on physician referrals as patients trust their healthcare professionals for information above anyone else[⁸]
• Collaborating with patient advocacy groups to focus on patient centricity[⁷]
• Increasing the use of online recruitment campaigns and clinical trial marketing using social media platforms such as Facebook, as well as search engine marketing
• Partnering with vendors offering specialized solutions focused on clinical trial recruitment and increasing accessibility to clinical trials through reputable platforms, such as Power
• Diversity in clinical trials has also been shown to improve in general when clinical trial sponsors:
• Explain research studies clearly
• Visibly prioritize and ensure patient safety
• Show appreciation for patient involvement
• Emphasize support that is available for patients[¹²]

Conclusion

Participation in clinical research can be rewarding, depending on the participant's motivation. If you are joining a trial for altruistic purposes, your contribution will almost surely benefit the advancement of science, at least to some degree. While a clinical trial does not guarantee a cure or effective treatment, either at the personal level or for the broader population, it represents an opportunity to learn more about your condition by partaking in a trial and engaging with your health journey.

In light of some long-standing negative perceptions of the pharmaceutical industry and clinical research, strong trends are emerging to address these issues and make the clinical trial industry more patient-centric. This is currently centered around increased use of technology, employing diversification strategies, and designing patient-centric trials that prioritize the satisfaction and comfort of trial participants.