A virtual clinical trial (a remote or decentralized clinical trial) refers to clinical trial procedures supported by technology. Because it is a relatively new model of clinical trials in terms of acceptance, this clinical research method needs to be more utilized.
Virtual clinical trials can potentially drive significant digital changes in clinical research methodologies to improve the patient-centric ecosystem. These solutions consider the countless advantages of technology, cutting-edge applications, gadgets, online social networking sites, robotic process automation, machine learning, and others.
Virtual clinical trials use telehealth/digital technology to conduct secure and superior clinical trial research by incorporating virtual patient monitoring, wearable medical devices, remote SDV, etc. These virtual trials are convenient, affordable, and patient-focused.
Virtual trials use a web-based platform to virtually coordinate all requirements, bringing the clinical trial experience to the patient's home. Patients can plan their operations to reduce the stress of going to a clinical center and spending hours there. Direct-to-patient studies are most successful for severe conditions and uncommon disorders when patients are housebound.
The patient's home is sent with all the necessary supplies, including equipment and pharmaceuticals, for a visit. Study doctors and pharmacists offer assistance via videoconferencing at the same time. In clinical trials, telehealth and mobile health applications transmit remote real-time data directly to the leading study site and collect medical information from patients.
Before the COVID-19 pandemic, few CROs (Contract Research Organisations) provided clients with a full range of virtual clinical trial services. However, the trend toward trials was well underway. Since the pandemic began, Contract Research Organisations have been involved in this field, especially by forming alliances with and purchasing companies that offer home healthcare services, eClinical software, and remote patient monitoring (RPM) services to improve their capacity for conducting virtual trials.
Although patient retention rates are still an issue, trial recruitment rates are improving, with many participants leaving their studies before they are finished. Making trials more patient-centric is the key to enhancing the entire trial experience and increasing retention rates.
To ensure that the patient's voice is heard, patient-centric research should be designed and executed with the requirements of participants at its center to do standard clinical research. It has been demonstrated that including patients in creating the study protocol improves the caliber of the study, patient outcomes, and participant relevance, improving enrollment, adherence, and retention.
Trials without trial sites are becoming more popular as technology develops and is integrated into the clinical development sector. These facilities are the testing grounds for various therapies, medical equipment, and human medications. Patients who collect all of their data electronically are participating in planned trials. Trials that are designed have been shown to:
Planning trial site visits can be expensive, stressful, and confusing. Patients won't have to deal with the cost and inconvenience of traveling to the trials, thanks to eliminating the need to visit the sites. Additionally, since this is done around the clock and adverse events are evaluated and treated as soon as possible, patients do not need to keep track of any symptoms they may have encountered.
Sponsors can fill trials much more quickly than they can with traditional trials by screening and recruiting participants through online social media channels. Virtual trials are much more accessible to participants, making it much simpler for patients to participate.
Virtual trials appeal because traveling to trial sites takes less time and money. They offer greater access to care, are more comfortable and convenient, and are especially beneficial for people with mobility problems. Patients can participate in virtual trials at home, ensuring willing participation. Additionally, more patients are accessible to more doctors and trial staff.
With the advancement of tracking technology, life sciences companies can now gather more data remotely than they could through a series of office visits. Virtual trials are anticipated to grow into novel and potent data collection methods. The study benefits data collection by successfully and efficiently meeting deadlines with better safety reviews for new endpoints and measures.
Despite the advantages, virtual clinical trials may have some drawbacks, such as:
Study protocols requiring time-consuming procedures like biopsies and expensive imaging equipment like MRIs cannot be carried out as virtual trials because they demand provider involvement.
Patients' privacy concerns arise from the potential risk of sharing their sensitive health information online. In the case of continuous monitoring, some patients might feel uncomfortable wearing wearables or other devices all day.
Ailments and discrepancies compared to the medical sites may result from trials conducted in an unsterile environment. Lower levels of medical literacy and familiarity with technology and medical supplies could cause an aberration in the results.
The market for virtual clinical trials is driven by the healthcare industry's increasing digitization, increased R&D activities, and the adoption of telehealth. The market is expected to expand due to technological developments such as web-based clinical trials, partnerships between clinical research companies, biotechnology companies, pharmaceuticals, and government support programs. Clinical trials give you free access to treatments and medications that are currently unavailable.