Researchers agree that 100% virtual trials will not work for all types of research activities, but by 2025 all trials may have some virtual component which will give flexibility for trials subjects and make clinical studies more appealing and accessible to community. Patients participation in clinical study plays an important role in clinical development, including the development and designing of research protocols, collection of outcomes and endpoints, development of strategies for patient retention & recruitment, and Publication and dissemination of clinical results.
Some subject think of clinical studies as something of a custodian amenity. “It’s above & beyond what they’re receiving in hospital, and they like the fostering, visit hospital, get infusion & have human interaction.” While Other participants get the expediency of being able to enroll in clinical trials without leaving hometown, particularly during the epidemic.
“Once you replace negative thoughts with positive ones, you’ll start having positive results”.
First, consider the causes of the patient’s retention problems. Yes, this usually happens in two main ways:
- Patients and caregivers are forgotten after recruitment is finished
- Study protocol and design are not subject or caregiver centric
As professionals, patients and caregivers should be given respect and value as they dedicate their valuable time to clinical studies. We need to pay close attention to the individual interests and needs of each person. Design clinical studies in accordance with the need of patients and caregivers. When we started it, we started raising patient retention, which increased the patient participation in clinical studies.
Patient approaches, such as those participating in clinical studies using telemedicine visits, were more satisfied with the clinical trials than conventional trials. Telemedicine is the most popular method, with more than 80 percent of the 50 top medical company surveyed using their experiments because “they are quick and easy. Thirty percent of respondents visit homes for testing and procedures & just over twenty percent ship studies supplies unswervingly to subjects.
One of the problems preventing patients from participation is that they are afraid of the technology sponsor use in virtual clinical trials, but this technology has not diminished their participation in some experiments. However, there is not much interest in the type of research offered by some experiments. But this is not the reason for the COVID-19 drug test.
Pandemic has caused the various stakeholders — investigators, clinical trial sites, patient groups, CROs and pharmaceutical companies — “to appreciate and attain a level of flexibility in how we treatment our subjects in hospitals.
There may be some tests that do not require FDA approval, at least a Level 4 or specific certification, and this information can serve as an “example” of incorporating this patient monitoring technique. Later they went to conduct some regulated trials. Principal investigators should include the patient in enrollment and registration early. Effective and simple testing can be aimed at reducing costs and increasing patient safety and minimized exposure.
- Manage hospital relationship procedures with “early rendezvous with site managers” to set up a communal confidential disclosure agreement (CDA) in order to simplify the drift of clinical information.
- Decide to high-level procedures such as how the sponsor/CRO will pursue a site’s involvement, how the hospital will be a preferred option for the sponsor & how escalation process will be dealt.
- Promote communication between sponsor and CROs through regular meetings and messages.
- Deliver site assistances with all groups, planning together to evade any shocks amid clinical operations.
- Engage Principal Investigator to Seek medical advice for patient well-being and participate in learning about current events and determining the right time to share information.
- Communicate and set clear objectives related to the goal.
- Say “thank you” – cultivate a sense of gratitude from the site staff and distribute thank you cards.
- Focus on how patient and caregiver respond to their research experience.
- Timely share updated clinical information to patient and caregivers.
- Reduction in the number of invasive procedures amid trials is also beneficial and site retention also increases.
- Replan your clinical study design & decentralize it for patient benefit. Travel reimbursement is also helpful and should be paid well on time for smooth conducting of clinical trials.