Clinical trials involve measurement of vital parameters at regular intervals of time. Vital parameters include measurement of respiratory rate, blood pressure, pulse and blood oxygen saturation whenever required.
Importance of vital parameters are as follows:
- This helps in understanding any significant improvement or deterioration of health.
- It can help in the early diagnosis of an acute medical illness.
- They are also important markers in chronic disease states.
With traditional clinical trial setup following are the drawbacks:
- For recording these parameters patients must visit the hospital at a regular interval of time which is time and cost consuming.
- It is difficult to arrange for the equipment and time for each patient in hospitals with large numbers of patients.
- There are possibilities of missing earlier variabilities as the patient’s visit to the hospital occurs only at a stipulated period.
- With emerging emergencies like pandemic situations, it is tough to get the parameters on time which can risk a patient’s life.
Artificial intelligence’s role in the measurement of vital signs:
AI based remote vital sign monitoring devices are emerging into the market.
The advantages of such devices are as follows:
- The number of visits to the hospital can be reduced as patients can monitor their vital signs at home without visiting the hospitals.
- As the number of points of measurement increases, the chances of early detection of end-point can be obtained.
- Due to the early detection of the end-point, the trial can be completed much earlier.
- Due to the continuous monitoring of vital signs, the deterioration in patient health condition can be detected at a much earlier stage and can help in better treatment.
- The continuous monitoring and increased number of readings can also help in understanding the disease condition in a better angle leading to development of more efficient treatment.
Another such improvement in clinical trials from a patient’s perspective is AI enabled Patient dairy.
Patient dairy is the record where the patient enters the daily routine of intake of medications and any health conditions experienced by the patients during the treatment period.
Hence patient dairy plays an important source record in any clinical trial. It is the basis of any adverse events that occur in a clinical trial.
By making the patient dairy AI enabled, following are the advantages:
- In a few trials compliance of patients administering the medication is crucial. There are many instances, where in patient participating might not abide by the timelines to administer the medicaments. Some of the reasons are:
- Due to forgetting the dose timings.
- Sometimes patients come across other people who influence in not taking the trial medications, hence might forge in such situations.
In such cases, If the patient dairy is technology based, it can provide daily reminders for intake of medication.
It can be live video linked, where in the administration of daily dosage of the patients can be monitored in live time.
- The direct capture of data entry inpatient dairy into eCRF would further reduce manual errors, time consumption and resource consumption. This would reduce the cost.
- The Clinical trial team can be updated in live timings regarding any discrepancies before the patient updates during future visits. This would help in capturing any significant variations and provide better treatment to the patients.
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