This paper provides an overview to the use of mobility in the area of Oncology Trials. It brings out the benefits and the impact that disruptive mobile solutions can bring to the table and improve patient compliance and treatment adherence in clinical and behavioral studies.

1. Authored by
Rashmi K Gurnani
Vikrant Patnaik
PaDiSys – Improving Oncology
Trials and Treatment

2. 1 www.padisys.com
PaDiSys- IMPROVING ONCOLOGY TRIALS & TREATMENT
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.
IMPORTANCE OF PRO DATA:
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 PRO’s 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

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

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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, CRO’s, trial staff and most
importantly the cancer patients.
THE INFORMATION TECHNOLOGY ADVANTAGE
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

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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.
INTERNET vs. MOBILE
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 world’s population, which is three times that of the
internet users.
ADVANTAGES OF MOBILE SOLUTIONS IN ONCOLOGY TRIALS
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 patient’s 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.

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PaDiSys – NEXT GENERATION PATIENT DATA CAPTURING AND TRIAL
ADHERENCE MANGEMENT
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 patient’s 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 patient’s 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 environment-
REAL TIME. Real time data capture makes the task at the investigator/oncologist’s

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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.
Calendar Medication Reminder QuestionnaireAssessment Reminder
Copyright, NowPos M-Solutions

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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

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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.
THE COST EFFECT
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.
TAKING THIS FORWARD:
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.

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REFERENCES:
(1) http://globocan.iarc.fr/factsheets/populations/factsheet.asp?uno=900
(2) www.who.int/mediacentre/releases/2003/pr27/en/
(3) http://www.who.int/mediacentre/factsheets/fs297/en/index.html
(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: vikrant.patnaik@nowpos.com
Phone: +91 9948220071
Email: rashmi.gurnani@nowpos.com
Phone: +91 9985918461
USA:
Email: vikram.marla@nowpos.com
Phone: +1 818-453-1805