‘Mobile’ solutions

Mobile phones are 'always there always on', so why not use them to enhance patient compliance, trial effectiveness and reduce trial cost, asks Vikrant Patnaik, Senior Manager, Global Marketing and Communications NowPos M-Solution

Clinical trials and medical research is experiencing the fastest transition that it ever experienced. With continuous innovation in technology, drug research initiatives are getting tremendous support in terms of getting more compliant and secure processes in place, making the research more result oriented. We are aware that the cost to develop a drug and bring it to market costs pharmaceutical companies about a billion dollars and during this process compliance and adherence come in as essential components of the drug development process. Since the efficacy of a drug will ultimately be determined by patients participating in the trial, it is important that patients follow their medication intake regimen and are monitored constantly for compliance, non compliance of which only raises the bar for pharmaceutical companies in terms of revenue outflows. With rapid growth of mobile smart phones and discovery of remote diagnostics devices, there are enormous opportunities to use mobile technologies and integrated wireless devices during clinical trials to improve patient’s medication regimen, reduce drop-outs, reduce site visits, and improve clinical data all contributing to reduced clinical trial cost and improved compliance.

Because cell phones are ‘always there and always on’, there could be numerous opportunities to use them for Life Sciences Research and Healthcare management. It’s now the time for clinical studies to take advantage of these technologies and to benefit from it.

Patient Reported Outcome capture is a key component during any clinical or behavioral trial for the research teams to get clear indications on efficacy of the drug being developed. During clinical trials, medication intake and outcome compliance among patient population is less than 45 per cent. Archaic methods of recording outcomes contributes to high levels of non-compliance, compounded by a patient population that is elderly or have low literacy levels to understand the importance of medication intake schedules and reporting outcome needs. Drug efficacy is determined with data secured from such low levels of compliance. In a non-clinical medication regimen, the cost of non-adherence to the healthcare system is estimated to be in the excess of about $100 billion in the US alone.

It is evident from pharma companies and health care providers, that there are enormous opportunities for improving patient outcome. Additionally, with four billion phones globally, its usage is growing by leaps and bounds. Most illiterate patients living in remote areas of developing countries have access to mobile phones with the knowledge to maintain and use basic its functions.

PaDiSys – The Patient Diary System is a mobile based patient data capture solution that includes Medication Intake Adherence. We have taken the most common features of mobile phones to develop an application that will help patients stay disciplined in their medication intakes and help provide QOL feedback in patients’ regional language – both in textual and audio prompts. Investigators and pharma sponsors can now monitor outcomes and patient health more closely in between site visits. Mobile phone devices can be integrated with other wireless vital monitors to empower principal investigators make better decisions of patient outcomes.

Some of the key issues that the life sciences and the pharma industry is facing in their research initiatives are non-compliance in patients in their medication intake and filling up of QOL assessments, inconsistent patient related information, Multilingualism – catering to patient population coming from different regions, literacy levels of the patients, geographical distances between the research centres and patients, who in most cases are from rural areas, administration and logistics related to paper based information collection systems etc. Mobile phones can this way bring a revolutionary change in the way operations are managed, helping organisations to reduce overall costs, closely monitoring patients, walk away from a paper based approach that is a major cost factor, bringing multimedia and translation features for patients from rural areas to be as compliant to their trial protocol as patients from urban area are.

In most trials today adverse event reporting is a challenge with patients not able to record the A.E or an SAE or not reporting the same on time, which is of a grave concern to the research fraternity. With mobility solutions, patients or their caregivers can now alert the clinical staff by the click of a button on their mobile devices. With the ability of systems to maintain an audit trail of all actions performed on the device with time and date stamps, the research teams can zero in on to the exact time and date of the event. With the latest row in the industry and government with regards to the number of people being victims of drug side effects during clinical trials, mobile technology can help sponsor companies to be more proactive in taking decisions based on the alerts from the patient at the time of SAE/AE.

Security – Using mobile phones in clinical trials for patient data capture.

A major concern that has always been within the life sciences industry, especially drug development is the aspect of security of technology and the various technology supported tools. From a security standpoint, mobile phones used for patient data capture can come as a handy option for pharma companies to use it as it can be developed and controlled as per the requirements of the trial protocol, following global security and international standard guidelines.

Key features that can be implemented in clinical and behavioral trials using mobile phones:

• Medication reminders to improve medication adherence
• Real time information exchange to investigator and monitors
• Improved trial compliance due to reminders and monitoring tools
• Reduced chance of, patient drop-outs and inaccurate data capture from patients
• Use of regular mobile smart phones to capture data

The goal is to raise the compliance levels in clinical studies from the current levels to upwards of 95 per cent and reduce patient drop-outs, which put together should help pharma companies capture better data when determining drug efficacy and hastening their product launch faster in the market.

In cases of chronic treatment, having patients reminded of their medication should reduce re-hospitalisations and recurrence of an illness. Additionally, with better outcomes from patients, doctors can prescribe dosages more effectively or to justify their insurance reimbursements.

(The author can be contacted at vikrant.patnaik@nowpos.com)