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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.
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.
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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.
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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.
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
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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.
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Calendar
Medication Reminder
Assessment Reminder
Questionnaire
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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.
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.
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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
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