Clinical trials are a very important step in any medical research to ensure the veracity of a medical product, such as a drug, a vaccine or a treatment, before it reaches the patient. It is essential that the product fulfill the conditions of the trial in a manner satisfactory to the regulatory body of the country in which the trial is conducted.
The subjects or patients in a trial are selected with care so that the data collected by the trial is adequate enough to test the medical product. In this scenario, it is of utmost importance that the patients adhere to the conditions of the trial. This could be the single-most factorthat decides the validity and outcome of the entire exercise.
Some of the behaviors expected of the patients would be:
- Following the recommended treatment regimen including dosage and timings
- Visiting regularly when required to
- Completing assessment and reporting activities on time and as expected
Too many cases of non-adherence in a trial can lead not just to increasing costs, but also inaccuracy in the data collected, thereby leading to erroneous conclusions.
HCL Tech has analyzed this need of the pharmaceutical industry and recommends that the pharmaceutical company partner with a Patient Enablement Program (PEP) provider from an early stage such as trial design. It would focus on the role of stakeholders to enable the successful completion of the trial. The main components of the PEP provided by HCL Tech are detailed below:
This must be one of the earliest planned components of the trial, as it would provide the framework to capture all the data once patients are on board the trial. This includes the results of lab tests and other monitoring information. The CRM system would also provide risk classification at different levels of the trial.
This application service layer would enable wireless transmissions of reminders for patient adherence, tracking of unexpected events and issuing of alerts, when necessary. Using eDiaries for tracking real-time information may also be integrated as a separate component.
A local language-enabled helpdesk would provide 24×7 support to patients, including reminders for medication. It could efficiently handle many different situations including adverse events such as an allergic reaction to medication, which might require a medical support team to be notified immediately.
This term refers to a core team of experts, who are amongst the most important stakeholders of the trial, especially when related to patient adherence. The team of doctors and statisticians are the ones working most closely with the patient compliance data of the trial.
Communication and Data Mechanisms
To enable reaching out to a diverse group of patients, all modes of communication such as voice, email, messaging and use of smartphones need to be incorporated as part of the PEP solution. The method of storage of all communications and other patient-related clinical trial data is also an important component that needs to be decided right from the beginning.
A lot of thought needs to go into a PEP solution; there is no doubt that this is an essential factor in clinical trials. To ensure patient adherence to enable your product to satisfy all requirements and get to the market when required, HCL Tech might have the ideal solution for you.
To know more about the topic please refer the whitepaper written by experts at HCL Technologies