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PaDiSys Improving Oncology Trials and Treatment

Authored by Vikrant Patnaik Rashmi K Gurnani


The clinical research industry is growing by leaps and bounds and the tremendous growth is expected to continue the same trend in the coming decades. Several trials are being conducted in various therapeutic areas nationally and internationally and the ones gaining momentum are the multinational trials. Cancer is a leading cause of death worldwide and accounted for 7.6 million deaths (around 13% of all deaths) in 2008 (1). Cancer incidence in developed world is >300 per 100,000 per year (2). World Health Organization reports suggest that deaths from cancer worldwide are projected to rise to over 11 million in 2030 (3). These statistics clearly suggest that cancer of any form is responsible for several deaths every year and hence this area requires medication which can stop the situation from worsening. To achieve this goal, trials in this area are being conducted in large numbers the world over. According to recent studies, oncology is the therapeutic area in which maximum number of trials is being conducted. It is estimated that every one in three trials is an oncology trial i.e.; 30% of the trials which are being conducted fall in the oncology space. Oncology trials are complex and require a different approach than clinical trials in other areas. Also conducting oncology trials is an expensive affair.


Patient Reported Outcome (PRO) data is important to all stakeholders in oncology trials which include patients, families, health care providers, public and private players, regulatory authorities and standards setting organizations. Patient Reported Outcomes can provide key end points, especially in oncology trials where even a minor important discovery from the recorded end points may prove to be a huge achievement which can improve the quality of life of a cancer patient. In the year 2010, there were 2,704 industry sponsored oncology trials conducted of which 322 (12%) included Patient Reported Outcome (PRO) measure (4). The use and impact of PROs is a growing area of importance in oncology trials particularly as they relate to tumor types, biomarkers and various patient populations and cultures. Collection of PRO data can enhance the understanding of cancer burden and impact of intervention on patient lives. According to an Oncologists survey, 51% oncologists agree that patient reported outcomes had influenced their recommendations for treatment which gives us a clear picture in terms of the importance of patient data being collected. Also PRO data may

complement and enhance clinical efficacy and safety data which can be extremely beneficial to subjects enrolled in oncology trials and the general cancer patients.


Patient compliance to protocol:
It has been observed that participation of patients in oncology trials is less when compared to the trials conducted in other therapeutic areas due to various reasons such as fear of side effects etc. It is mostly the elderly and the financially deprived who enroll themselves into cancer trials as the cancer treatment medication is too expensive to be bought and trials serve as the best option for such patients. In such a scenario wherein there is reduced enrollment into trials and the patient population consists of the elderly, it becomes very important for the investigators and sponsors to ensure that the patients comply with the protocol and also their follow up becomes a very important aspect.

Loss to follow up:

There are several reasons due to which there may be patient dropouts or loss to follow up during clinical trials. Some of the reasons may be as follows: Inability of the patient to come to the clinic which may further be due to transportation problems or physical disability which is most commonly observed in oncology trials The patient may have migrated to a far off region due to which there may be loss to follow up Demise of the patient.

Medication intake adherence:

Cancer is a state where, patients become physically weak and stressed due to which they tend to suffer from inability to remember their treatment and visit schedules. Additionally the patient may be of a geriatric group wherein due to poor memory the patient may not consume his/her medication at the prescribed time or may forget their visit schedule. Also sometimes the protocol is so complex that it becomes difficult for the patient to remember about his/her next visit to the investigator or the time schedule of his next chemotherapy session. Research on treatment and treatment adherence for people suffering from cancer has been going on for many years and several measures have been adopted towards

improving patient care at different levels. Patient care and their treatment regimen are of utmost importance during the treatment of cancer. Until recent times technology only empowered physicians to monitor patients and their treatment regimen but today, we certainly can improve the same by allowing the patients to be performing a part of the doctors job and proactively manage their medication intake, be compliant to the treatment regimen, follow strict site visit schedules etc. Mobile technology in such cases proves to be a boon to the clinical research industry and appears to be a one stop solution to sponsors, CROs, trial staff and most importantly the cancer patients.


A clinical trial is largely dependent on the data provided by the subjects enrolled into the trial, who consume the drug under question. A drug for it to be launched in the market after extensive research takes anywhere around 15 to 20 years. Also millions of dollars are spent each year by Sponsors on clinical trials. With such a lot of effort, time and money going into trials, the success of the trial becomes very essential. This success can largely be achieved by the right data reported within the right frame of time by the patient. Till date most trials have this data (PRO) captured by using the paper based system wherein all the questionnaires are administered by means of paper. With the modernization of the world and tremendous development of technology, time has come where all the players of the clinical research industry should use the features of information technology for improved results. The ePRO(Electronic patient reported outcomes) and mPRO(Mobile Based Patient Reported Outcomes) provide an edge over the traditional paper based system allowing: Rapid data capture, Avoidance of data entry errors, Ability to trigger alerts/notifications for specific responses of concern Elimination of double data entry processes Real-time tracking of survey and compliance Reduction in missing information as compared to with paper administration

Increase in patients willingness to report sensitive information Secure data storage in a compliant environment Easy access and storage of data -it omits the problem of data archival which is a huge problem with data storage as the regulations require the data to be stored for a minimum of 15 years after the start of the trial and 3-5 years after the drug has obtained marketing approval.


The internet certainly has played a very important role in giving a new dimension to the way things were and how they are today, however, with the advent and prevalence of mobile phones, there is a new dimension that can be explored and benefited from. Today we can achieve higher compliance ratios, better treatment follow up and intervention especially in Cancer treatment and trials using mobile technology. Global statistics show that there are more than 4 billion mobile phone users across the globe which constitutes of 2/3 rd of the worlds population, which is three times that of the internet users.


As stated above, there are various reasons for a cancer patient to be non compliant to the protocol or it may become difficult to track the patients progress after completion of the treatment regimen as per the protocol. A patients compliance to a protocol and his treatment adherence can be greatly improved by using the mobile technology and mobile based solutions. In any cancer trial the most important aspect is to make sure that the patient enrolled in the trial consumes medication on time, eats food at the prescribed times as per the protocol, visits the clinic for chemotherapy and radiation on time, provides the required data to the investigator for their own betterment and a successful completion of the trial. All these aspects can be taken care of with ease, using a mobile solution.

PaDiSys is the abbreviated form of Patient Diary System that allows patients enrolling in clinical trials to use smart phone devices to report their clinical outcomes electronically. PaDiSys is a mobile technology platform built from a ground up approach, complying with international regulatory and compliance guidelines such as CFR 21 Part 11, FDA, EMEA etc. The PaDiSys System has two major configurations, namely; 1. PaDiSys mPRO Mobile Based Patient Reported Outcome Capturing Solution 2. PaDiSys mTA Mobile Based Patient Trial Adherence Solution The aforementioned mobile solutions can be used across therapeutic areas; however, find extensive utility in Oncology trials and treatments.

Improved efficiency of patient reported outcomes in oncology trials using PaDiSys:

PaDiSys mPRO comes with a feature of capturing patient data at source- as per the clinical trial protocol or the treatment regimen. The mPRO configuration allows the patient to fill up assessments/questionnaires to monitor patients health status as per the requirement of study protocol or the treatment being administered to the patient. With such a solution the patient or in critical cases the patients caregiver fills up questionnaires that appear on a mobile phone device at the convenience of their homes/sites/care centers, without having to go to the site visit to submit the same.

Understanding the need to capture and collect valid information, the system allows the information and data transfer to happen over secure and compliant environmentREAL TIME. Real time data capture makes the task at the investigator/oncologists

end much simpler and quicker with them able to take further actions and for making amendments to the treatment faster. The system allows investigators to manage multiple patient groups and send specific group related information or customized individual alerts and instructional messages. In case of Oncology trials a huge emphasis is laid on the quality of life of patients. Any drug which improves the quality of life of patients by even a minor percentage is viewed as a potential discovery by sponsors and Oncologists. To know the levels of stress, pain etc and the quality of life of the subjects in the trial, several questionnaires are to be filled up by the patients. The same holds true for measuring the quality of life of subjects in an oncology trial for which Quality Of Life (QOL) questionnaires need to be filled by the subjects. To fill up these questionnaires, the patient will have to visit the clinic several times. This stress to the patient can be avoided by allowing patients to complete such assessments via the mobile phone using the PaDiSys mPRO solution. All the responses provided by the patient reside on a secure database and also the data is captured real time. Hence the information provided by the patient can be viewed by the investigator immediately. Immediate visibility to information can help the investigator know if the drug is effective on a patient and incase the investigator decides based on his experience that the drug may cause side effects to the patient or if the drug is already causing some side effect to the patient, the medication can be immediately discontinued without waiting for the patients next visit to the clinic and hence stopping the situation from worsening. This is especially essential in case of oncology trials, where even a small change in drug dosage causes severe side effects. Any side effects experienced by the subject can be immediately reported to the investigator using the PaDiSys mPRO. In case of severe visible side effects, a picture can be immediately taken by the patient and sent to the trial staff. With the usage of such a system, there are reduced chances of inaccurate data capture from patients.
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Medication Reminder

Assessment Reminder


Believing that patient information capturing during clinical trials and especially an oncology trial is crucial, getting the right data at the right time is seldom possible. - The protocol of oncology trials is a complex one when compared to the protocols of trials of other therapeutic areas. It becomes difficult for the patients, research coordinators and the investigators to remember the schedule of every assessment and visit. To make things easier, the PaDiSys mPRO is provided with a patient calendar where the patient can view his medication, assessment and site visit schedules in advance. This is a boon also to the investigators and the coordinators as they need not remind the patient of their visits and also the patient will adhere to the protocol. - In case of oncology trials patient follow up is extremely valuable to gather safety and efficacy end point information which is essential to the study as well as the life of the trial subject. It is observed in clinical trials that several patients are lost to follow up or become dropouts, especially in oncology trials, which can prove to be very expensive In addition it also extends the trial duration which again proves to be costing the sponsors hugely. The loss to follow up may be due to inability of the patient to visit the clinic often. This problem is taken care of by PaDiSys mPRO as the patient can fill his vital information using a simple cellular smart phone while he/she is at home. Another reason of loss to follow up or patient dropout is the migration of patients to far off regions, in the case of which the patient is not able to visit the clinic. This aspect of follow up also is easily taken care of by PaDiSys mPRO as these products are portable, light and handy. - A cancer patient suffers from not only physical health deterioration but also undergoes a lot of mental trauma. In such cases apart from the medication, palliative care also becomes very important. At every point in the trial it becomes imperative to check the levels of stress, depression, pain and various other parameters essential and important in oncology trials.

Features of the PaDiSys mTA that can be used in oncology trials:

PaDiSys mTA, is a scaled down version of the PaDiSys mPRO solution, essentially focused towards improving trial/treatment compliance in trials which not necessarily, need patient data capture. In this system, text messages or mobile alerts are generated for the trial patients regarding the consumption of medication, their next visit to the doctor, the dates of radiation therapy or their visit

to the site for chemotherapy incase the medication is to be administered by the intravenous route. Such features are extremely useful in case of cancer trials as the patient is off the burden of remembering too many things which is particularly difficult for any cancer patient. These reminders can also be helpful in sending interventional messages which indicate the type of food and the timing of food (i.e.; before taking the medication or after taking the medication) to be had. Hence treatment adherence, which is the most important aspect for any clinical trial is well taken care of. Due to effective treatment adherence, patient compliance and close monitoring of the treatment or study, the data and results obtained will be much more accurate and validated.


A huge investment is made to conduct Oncology trials. Every aspect of oncology trials beginning from the selection of the site, compensation to trial subjects to final regulatory submissions takes investment, time and resources. If any inaccurate data is recorded during the trial, it ultimately results in further losses to the sponsor as the required safety and efficacy end points which are essential to the study will not be obtained. The drugs tested in every oncology trial as well the concomitant medication is extremely expensive when compared to the drugs used in other trials. Every patient lost to follow up is a loss to the study. Also it results in a delay in the completion of the study. In clinical trials, especially oncology trials, each day lost is thousands of dollars lost in added expenses and opportunities. The PaDiSys mPRO and PaDiSys mTA are low cost solutions that ensure patient compliance to protocol, treatment adherence, regular and timely visit to the clinic/investigator and most importantly accurate data capture. It is estimated that in the long run the trial/treatment cost for an oncology study or treatment would be reduced by a very large extent using technology. All this in turn result in timely submissions to the regulatory authorities and above all appropriate trial results which can prove to be useful to cancer patients worldwide.


It is important that the industry experts both in the Life Sciences and healthcare spheres understand this requirement and take action to implement such available technology services for treating patients suffering from chronic and terminal illnesses. Oncologists and sponsors across the globe must take the initiative of using cost effective methods to monitor their patients and provide better point of care.

(1) (2) (3) (4) Current Status of Patient-Reported Outcomes in Industry-Sponsored Oncology Clinical Trials
and Product Labels -Kathleen Gondek, Pierre-Philippe Sagnier, Kim Gilchrist, J. Michael Woolley From the Bayer Corporation, West Haven, CT; AstraZeneca Pharmaceuticals, Wilmington, DE; Amgen Inc, Thousand Oaks, CA; and Bayer Pharmaceuticals, Puteaux, France

About the Authors: Rashmi K Gurnani: Techno-Clinical Marketing Intern Vikrant Patnaik: Sr. Manager Marketing and Comm. About the Company: NowPos M-Solutions is a Mobile Technology Development and Services Organization specializing in Life Sciences and Healthcare. In the past years the organization has gained significant expertise in the mobile and web domain with several mobile based products. NowPos is primarily focusing on developing end to end mobile solutions for capturing Patient Related Outcomes in the Clinical Trials Domain of the Bio-pharma and Life Sciences Industry. Working in a completely secure environment and adhering to international compliance guidelines and following the GAMP 4/5 development methodology, NowPos as an organization believes in bringing a paradigm shift in the way things were being done earlier. As an initiative to cater to the fast growing mobile applications and technologies, the NowPos Technology Services Group offers custom mobile application development on upcoming mobile technologies. The Technology Services Group also offers consulting services for development on iPhone, Android and Symbian applications. Contact: India: Email: Phone: +91 9948220071 Email: Phone: +91 9985918461 USA: Email: Phone: +1 818-453-1805