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.
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. With a fact that the cost to develop a drug and bring it to market costs pharmaceutical companies about a billion dollars, which is largely based on the efficacy of the drug towards a particular therapeutic area. 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 in different industry verticals. With mobile technology penetrating deeper into the lives of the citizenry and across the socio economic strata, the clinical trials and drug development industry is no exception to it. With patients or subject populations from different levels of society using and familiar with such technologies, mobile technology can see multifarious use in clinical trials and research studies such as: improve patient’s compliance towards their 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%. 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.
While patient data capture comes in as an important factor to determine the efficacy of an experimental drug, treatment adherence is another major component of the research and study. There are various reasons for which patients can be non-adherent to their medication intake regimen and other interventional activities as specified in the clinical trial protocol and thus it becomes imperative for clinicians to take additional steps such as reminding, alerting and following up with them.
It is evident from pharmaceutical companies and health care providers, that there are enormous opportunities for improving patient outcome and treatment adherence. Additionally, with 4 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 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 pharmaceutical 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. The PaDiSys System allows the clinical staff to track and monitor patients in terms of their adherence to the protocol and also to the assessments (PRO questionnaires). With standard and custom reports the clinical staff can analyze patient information as required and thus take critical decisions at appropriate times, without wasting time and resources.
Some of the key issues that the Life Sciences and the Pharmaceutical 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 organizations 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.
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.
In cases of chronic treatment, having patients reminded of their medication should reduce re-hospitalizations and recurrence of an illness. Additionally, with better outcomes from patients, doctors can prescribe dosages more effectively or to justify their insurance re-imbursements.
Several other areas in the Life Sciences and Healthcare sectors can benefit from mobile technology, some of which are widely known but less used. We, from the PaDiSys Team, want to go a step further and spread more awareness on such forward looking technologies to the Clinical and public research industries, helping them enhance their results and improving patient monitoring by assisting them with our mobile competencies. It would be our primary motto and consistent effort to keep the clinical trials fraternity educated and execute such advancements and initiatives towards making the patient’s health better.
Vikram Marla has 20+ year experience in pharmaceutical drug development technology solutions and an extensive knowledge of the clinical trial processes. Mr. Marla developed Clinicopia –a clinical supply management system that is used by many of large global Pharma companies to manage their clinical trials. For the past 12 months, Mr. Marla is heading a company based in Hyderabad that has developed the most innovative clinical patient data capture and treatment adherence system using mobile phones.