The barriers between IT industries and the clinical research industry is quickly blurring. Now the software tools are sorting the most difficult management tasks in clinical trials. One of such challenging tasks in clinical trials is patient management. The patient management software very well manages and executes all patient-related tasks effortlessly.
While conducting clinical trials, traditionally, researchers used paper-based documentation and would track clinical trial participants manually. It would lead to many human errors and ensure results. Also, it would be a burden for regulators during the review. So now, the regulators are recommending researchers and sponsors utilize software tools to manage these tasks. Some regulators are also offering special guidance documents for such software use.
Patient-related tasks during the clinical trial
While conducting a clinical trial, researchers require to perform patient-related tasks such as
- Schedule, track and notify study visits.
- Ensure timely medications and documentation.
- Need to perform study-related regular activities such as diaries, PRO completion, etc.
- Motivate patients and retain study participants.
- Educate patients on various aspects during the clinical trial.
Effective patient recruitment and retention are the key factors in delivering a successful clinical trial. Unfortunately, patient recruitment and retention are not only expensive tasks but also very challenging to achieve for any clinical trial.
The patient experience landscape in clinical trials is evolving from traditional methods to digital platforms, wearable devices, and virtual clinical trials. Using electronic consent (eConsent), electronic clinical assessment outcomes (eCAO), etc., is becoming more feasible for all the stakeholders involved in clinical trials. Along with improved patient experience, these platforms are making clinical patient engagement and management very easy at the fingertip.
Patient engagement & patient management in clinical trials
A persistent patient-focused clinical trial can positively influence crucial health-related outcomes in clinical trials. For a sponsor, better patient engagement would obviously give better study outcomes. In many cases, patients are successfully enrolled in clinical trials but often drop out during the study. It may be due to poor communication, study-related understanding, and management.
Patient engagement and management are of utmost importance in clinical trials. Traditionally researchers use paper documents to track and manage clinical trial participants, schedule visits, create patient education data, motivate patients, etc. But now, things have changed and are managed using digital platforms. Decentralized clinical trials, sensors, wearables, and advanced data and insights have bought new wings to clinical research. One can access these from anywhere on the globe.
Conducting a clinical trial right from designing a treatment, clinical trial, or other health solution centered around the patient to the trial end is known as patient-centric trials. It helps the sponsors and patients efficiently conduct a clinical trial and bring out value endpoints. Patient management is very crucial in patient-centric trials. Omnichannel communication, timely scheduling of site visits, patient education, and motivation are some aspects of patient management.
- Patient-centric trials helps patients to be more aware of their condition, and treatment stage, and understand the purpose of the trial more closely using digital platforms.
- Trial participants are educated through digital platforms. It reduces the number of patient visits and provides immediate response to patient queries.
- In virtual trials the clinical trial data is entirely captured with this real-time data. Stakeholders can learn more about the participant’s lifestyle and implement the patient-centric approach. It drastically reduces manual errors usually seen in conventional trials.
- Strong communication between stakeholders and the trial participants benefits both. It reduces the patient dropout problems, helps in better collaborations, and conducts an effective clinical trial process.
Virtual site platforms
A virtual clinical trial refers to digitally empowered clinical trial processes. A virtual clinical trial is also known as a remote or decentralized clinical trial. Simply, virtual trials means the use of advanced applications, electronic devices, online social engagement platforms, artificial intelligence, robotic process automation, and machine learning while conducting a clinical trial.
How Virtual/Decentralized Clinical Trials Different From the Conventional Trials?
Virtual clinical trials or decentralized trials are well known for cost-effectiveness. Virtual clinical trials help in patient recruitment campaigns, safety monitoring, patient education, pre-screening, and data verifications. Using digital technologies in clinical trials helps widen the pool of patients, extend patient retention, and obtain quality data.
Top three tasks that you need to manage for better patient engagement
Patients visit tracking
Visit tracking is one of the crucial factors for patient engagement. It becomes more prominent in cases where patients have to travel long distances, participants over all time allotment, and the number of study visits.
Managing it manually is challenging, and many cause inconsistency. Using software technology helps reduce these burdens by easily tracking patient visits. It also reduces inconsistencies in data capture during visits.
Medication adherence is one of the biggest healthcare challenges for Investigational Medicinal Products (IMPs) in clinical trials. According to research, medication adherence rates drop by 40% within a year of clinical trial commencement, and is same with all therapeutic areas. Incorrect medication or dose could lead to a medical error which is evil in clinical by following some practices as below.
- Using software tools to track medications
- Sending medication alerts to patients timely
- Regular interaction and communication with a patient who takes trial doses on their own and
- Educating and training patients in administering medications
Adverse events alert
Generally, AEs in clinical trials are identified during scheduled visits or when participants inform investigators of unscheduled visits to the emergency department or clinic. Unscheduled visits are sometimes detected during the review of patients’ electronic health records. Delayed awareness of AEs among study personnel may jeopardize patient safety, so the prompt detection of unscheduled visits is important during clinical trials.
Adverse events also influence changes in the protocols and informed consent documents along with guiding dose administration regimens for clinical trial designs.
Here comes the necessity of building a software tool that alerts and documents AE. AE management software shall include detection, processing, and reporting.
Tracking and monitoring adverse events that occur during a clinical trial is a fundamental component of any clinical trial. Software tools to manage and monitor adverse events (AEs) in clinical trials, particularly in multi-site clinical protocols. These software tools must comply with regulatory guidelines and be easily adaptable for site staff.
These alert systems inform stakeholders, such as sponsors, institutional review boards (IRBs), or regulatory bodies about unusual and unscheduled visits of participants to hospitals and emergencies. These systems are integrated with CTMS and CRF. In conclusion these alert systems can effectively improve safety reporting timelines.
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