Clinical Research Looks Beyond Electronic Solutions-Mobile Technology for Patient reported Outcomes, Data Capture, and Treatment Adherence Solutions
Clinical Research is a prime component of the healthcare sector that bridges the gap between drug development in the laboratory and sale in the market. The Clinical and Medical Research industry has evolved rapidly over the last decade, and is expected to expand more horizons in the years to come. Clinical research is that aspect of the healthcare industry comprising trials in diverse therapeutic areas including even those that are conducted for testing the efficacy of toothpaste on whitening of teeth!! In view of the fact that hefty amounts of money is spent on conducting these trials worldwide, Sponsors are often on the lookout for cost-effective solutions without compromising on the safety and well-being of trial participants. Since the costs for conducting a trial may soar up to hundreds of millions of dollars, Sponsors have now opened up their avenues and have started implementing electronic systems in their trials. These time-saving and cost-effective electronic methods ensure that data captured is of the highest quality with minimum deviations and as accurate as that reported by the patient. Trial Sponsors now employ electronic mediums such as the Internet and electronic case report forms (e-CRFs) for data transfer and data capture, respectively. Most often, Sponsors are largely benefited by the cost-effective electronic technologies that help them procure quality data. Despite the ever-increasing use of these technologies for data capture and transfer, several issues pertaining to clinical trials are yet to be addressed. Some of the challenges of conducting a trial are monitoring patient progress, compliance to drug consumption, and protocol adherence. A novel approach that can address these challenges is the use of “mobile technology in clinical trials.” In today’s world, every individual is well acquainted and knowledgeable about the usage and reach of mobile phones. Be it an illiterate person, or a poor man with slumping financials, or the richest man with over-flowing resources, every individual knows to use a mobile phone. In recent times, mobile phones have been used to serve various purposes, including bill payments, shopping, advertising, etc. The humble mobile phone, which facilitates such complex activities, can be effectively manipulated to serve the clinical trials and healthcare industry. Application of mobile solutions in clinical trials: Mobile technology can be applied to various segments of clinical research:
- Patient recruitment: Most often, a trial is negatively affected or delayed due to impediments in patient recruitment. Each day lost to poor patient enrollment can burden the Sponsor with costs rising up to millions of dollars. Furthermore, trials have always had to consider an average of patients to cater to the screening and drop outs in the trial. Mobile solutions are a very effective tool to enhance patient recruitments and reduce patient dropouts in clinical trials. Pertinent protocol-specific patients can be identified and tracked on an appropriate basis ensuring timely closeout of a trial. When a trial is initiated, the details regarding the nature and therapeutic area of the trial can be sent to a patient’s mobile phone via an SMS. A patient interested in taking part in the trial may respond to the SMS, and subsequently be contacted by the clinical staff.
- Patient screening: A series of questions pertaining to a trial’s inclusion/exclusion criteria may be sent to a patient’s mobile phone. Based on the response and feedback from the patient, he/she may be considered for further screening, lab tests, or recruitment.
- Patient compliance to protocol: In addition to specifying Do’s and Don’ts, the protocol also advises trial participants to exercise caution. It is imperative for patients to follow the instructions specified in the protocol (For instance, going for a 15 min walk as per protocol specifications) as reiterated by the trial Investigator. Protocol adherence can be ensured by sending out SMS reminders to the patient enlisting all protocol-specific activities to be undertaken, which can further be acknowledged by the patient.
- Patient follow-up: During a trial, a sponsor may incur heavy losses if patients are lost to follow-up. The loss to follow-up may be attributed to several factors including transportation problems for clinic/hospital visits, physical disability, patient migration, or even lethargy. Such patients can be routinely monitored and followed-up by downloading and installing a mobile phone application on the patient’s mobile that can enable sending queries and receiving responses.
- Treatment adherence: Apart from achieving the objective of obtaining quality data from a trial, awareness about the health and well-being of trial participants is of paramount significance. A patient is more likely to fall prey to a serious adverse event (SAE) on omitting a drug dose. It may further decrease the quality of the data generated leading to inaccurate results. The key to ascertain that a subject consumes medication on time is to send SMS reminders/alerts a few hours/minutes prior to scheduled medication intake time.
- Lab/Clinic visits and biochemistry test reminders: Patients can be reminded regarding their routine visits to the Investigator for regular checkups as well as the laboratory for biochemistry tests by sending SMS alerts/messages to the patient’s mobile phone. Mobile applications/softwares on the patient’s phone may also facilitate this effort.
- Patient Reported Outcomes (PRO) data capture: Many trials such as behavioral studies, observational studies, trials comprising quality of life (QOL) assessments, etc., necessitate data capture of patient reported outcomes in order to evaluate the patient’s response towards a particular drug. The data obtained from the patients is exceptionally vital for achieving protocol endpoints. A vast majority of trials employ questionnaires to obtain responses/feedback from patients. Patients are required to make site visits in order to accomplish this, and trial patients can be inconvenienced due to repeated site visits for filling a questionnaire. A one-stop solution for this would be to provide trial patients with a phone having an inbuilt application that will have pre-fed questionnaires. This would be beneficial to the patient since all they would be expected to do is complete the questionnaires and submit them at the click of a button at the convenience of their homes!
The data transferred and submitted using the mobile phone is saved on a secure server/database that is compliant to all applicable regulatory guidelines. Using this tool, the Sponsor is assured of the security and validity of data, which can simply be accessed by an authorized person using easy-to-use dashboards. Right from the outset, we have observed that a vast majority of teams, including Sponsors, CROs, Investigators, Site Staff, and Data Managers, are immensely benefited with the use of mobile solutions in clinical trials.
- Sponsors are benefited as they can ensure study completion in a faster, better, and cost-effective manner.
- Clinical Research Organizations can ascertain improved monitoring of patient progress, protocol adherence, and compliance to timely medication intake.
- Investigators are assured of the safety and well-being of trial patients, improved patient monitoring, as well as rapid easy reporting of adverse drug reaction.
- Trial staff and Data managers are benefited by easy and immediate access to the database that is stored on a secure and regulations-compliant server.
NowPos M-Solutions has developed a turnkey mobile solution called PaDiSys – the “Patient Diary system” that can be used to record PRO data capture, patient treatment adherence, and patient protocol adherence. PaDiSys presents itself in two modules: the PaDiSys mPRO (mobile Patient Reported outcomes data capture) system and the PaDiSys mTA (mobile treatment/trial adherence) system. PaDiSys mPRO is a solution used for data capture from trial patients wherein NowPos provides the mobile phones, and secure server farms store the data submitted by the patients. PaDiSys mTA is a solution wherein reminder messages and alerts are sent on the patient’s own mobile phone. The PaDiSys solution has been developed to cater to global clinical and research studies in different therapeutic areas.
About the Company: NowPos M-solutions is a mobile technology development company based in Hyderabad, India with an office also in California, USA. NowPos specializes in developing mobility solutions for the Clinical Research, Life Sciences, and Healthcare sectors.
Authored By: Rashmi Gurnani – Techno Clinical Marketer
Vikrant Patnaik – Sr. Manager, Global Marketing and Communications
Phone: (IN) 91 40 23300577,
Telephone: (US) 1 818 453 1805