Use of Mobile Technology for treatment adherence in Cancer Treatment/Trials

Cancer, the mere term that can shake up a perfectly healthy person’s life, let alone of those who are diagnosed of it. Any type of carcinogenic disease detection changes the course of a person’s life and it becomes extremely important for us to make use of modern techniques to cure or prevent cancer from spreading, especially in the initial stages.

Estimations given by global research firms’ state that there are more than 9.0 Million people diagnosed with cancer and about 4.5 million people succumb to different types of cancer every year. According to a WHO report we are expecting these numbers to escalate to 27 Million and 17 Million respectively, by 2030. It is a concern and we have to take the right steps towards mitigation of this lethal physical condition.

Knowing cancer as it is, it becomes critically important not only to be diagnosed and treated on time but more importantly to be adherent to the medication and treatment for those who have been detected with malignant carcinogenic cells.

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 a part of the doctors’ job and proactively manage their medication intake, be compliant to the treatment regimen, follow strict site visit schedules etc.

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.

The mobile technology today give physicians an option to closely monitor their patients in treatment and trials by providing scheduled reminders and alerts for some of the key activities that the patient must perform at his end. Some of them are as follows:

1. Medication intake reminders
2. Follow ups
3. Site visit reminders and alerts
4. Interventional messages
5. Patient data capture – Mobile based electronic diaries
6. Alerts for caregivers
7. Patient recruitment (clinical trials)
8. Patient retention and monitoring (clinical trials)
9. Monitoring patient compliance
10. Reaching out to patients in their own language
11. AE and SAEs reporting using mobile technology
12. Audit trail maintenance for every action made/done by patients or clinical staff.

The presence and usage trends of mobile technology across the globe in different socio-economic strata, allows us to look at a larger spectrum of patient population now to be catered to. With easy to use dashboards and metrics for reporting, the clinical staff can closely monitor patients and keep track of their health status remotely and be assured that the patient is following the treatment regimen.

Taking this forward:

It is important that the industry experts understand this requirement and take action to implement such available technology services for treating patients suffering from chronic and terminal illnesses. Oncologists across the globe must take the initiative of using cost effective methods to monitor their patients.

Where is the foresight ! Why Sponsors must look beyond ePRO?

With the advent of technology and access to internet, there has been a plethora of changes happening across industries. The life sciences and clinical trials not an exception to it, have also been drastically affected by the features of the web and the applications that reside on it.

Until very recent times, patient information capture in the life sciences and clinical trials area was being done through paper (PRO) and the industry has kind of become used to the process of using paper to gather information, peruse it, comprehend and derive results. With risks of incomplete data, illegible handwriting, non compliance of medication intake and the parking lot syndrome, the whole idea of research was going for a toss. In addition to a whole lot of monetary outflow and inconsistent data, the tracking of patient’s medication regimen was getting severely affected. Although to the rescue came the electronic format of the PRO, better known as the ePRO - brining in radical changes in the quality and consistency of data, a major lacunae was seen in untimely medication intake by the patients. Sponsors, CROs and their vendors have been struggling to ensure that their patients are in the closest compliance with the guidelines of the trial to give the most optimum results. No doubts about the fact that the overall performance of the trials per say has got better with patients getting more and more techno-savvy and aware of technological development around them. All said and done – the ePRO and EDC have created magic for the clinical trials and medical research domain- but what now? Are we getting stagnant here? Is not any one looking ahead of time… Has not any one thought of the thing that you can't live with out anymore.. Your Cellphone or mobile phone !!

Mobility solutions for Life sciences and healthcare, better known as mHealth is going to be the next big thing... And some of us just know how big it is going to be

Institutions like that of DIA, FDA, mHealth Alliance and WHO must look ahead to make use of the vision and revolution that mobile technology for health care ( mHealth) or life sciences can bring in…

My indication here is towards the fast developing mobile technology and a foresight to take advantage of it in terms of:
1. The pace of mobile technology development
2. Modes of quick communication
3. To get better in terms of compliance, quality and research results
4. People across the globe keeping themselves abreast with the changing times and technology
5. The world getting smaller
6. The MOBILE REVOLUTION in Life Sciences and Medical Research
7. Mobile Healthcare -mHEALTH

Beyond paper based PRO and now.. even beyond ePRO

Why should a sponsor look beyond ePRO?

It is a known fact that it take huge amount of capital, usually in billions of dollars to conduct and finally launch a dug into the market. It is also known that there are several studies that are either terminated or stopped half way due to several reasons technical and non-technical associated with it resulting in wastage of time and money both. Patient related data capture during a clinical trial plays an important role in the making of a drug. Through out the different phases of clinical trials information from patients are taken for efficacy, BA, BE measurements and make a considerable part of the trials or study. A lot of sponsors have been using ePRO to collect patient reported outcome, still makes only 30-40 % of studies being conducted using EDC and further less using ePRO.

It is time that sponsors look at more cost effective ways to gather PRO from subjects under trials and keep abreast with the pace of developing technologies. The next big wave in capturing PRO for clinical trials is the use of mobile phones and I am sure there are many a company that are working on it. Mobile phones are going to be the next computers that would enable users to manage all their communication and information transfer over mobile phones.

What can a sponsor look at from a mobile phone based PRO?

Well there are quite a few things for a Sponsor or for that matter a CRO to be looking at, when it comes to mobile based PRO system.

1. Faster reported outcome
2. Compliant to international regulatory bodies
3. Cost effective
4. Patient safety
5. Logistically simpler
6. Less erroneous data
7. Data integrity and security
8. New and improved features
9. An information management system that allows sponsors CROs to have instant access and action at different stages of the trial.

Clinical Trials - Yet another part of mHEALTH

Clinical Trials may be defined as voluntary research studies, conducted in people, that are designed to answer specific questions about the safety and/or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments. (Courtesy: FDA). Clinical trials have been existent since eleventh century wherein the learned lot of those times tried, tested and laid regulations for experimental use and testing of drugs and other related substances. Today in the 21st century, we have a whole population across the globe working on prevention and cure of diseases with latest technologies and science in a regulated environment put down by governing authorities and bodies like FDA, HIPPA, CDISC and others.

Clinical Trials can be classified into:
1. Observational Study
2. Interventional Study

There are different types of Clinical Trials specified by US NIH (National Institute of Health) as:

1. Prevention trials: look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vitamins, vaccines, minerals, or lifestyle changes.
2. Screening trials: test the best way to detect certain diseases or health conditions.
3. Diagnostic trials: conducted to find better tests or procedures for diagnosing a particular disease or condition.
4. Treatment trials: test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
5. Quality of life trials: explore ways to improve comfort and the quality of life for individuals with a chronic illness (a.k.a. Supportive Care trials).
6. Compassionate use trials: provide experimental therapeutics prior to final FDA approval to patients whose options with other remedies have been unsuccessful. Usually, case by case approval must be granted by the FDA for such exceptions.

The clinical trials process may be categorized into four major phases namely:
1. Phase I - Phase I trials are the first stage of testing in human subjects.
2. Phase II- Once the initial safety of the study drug has been confirmed in Phase I trials, Phase II trials are performed on larger groups (20-300) and are designed to assess how well the drug works, as well as to continue Phase I safety assessments in a larger group of volunteers and patients. When the development process for a new drug fails, this usually occurs during Phase II trials when the drug is discovered not to work as planned, or to have toxic effects.
3. Phase III -Here studies are randomized controlled multicenter trials on large patient groups (300–3,000 or more depending upon the disease/medical condition studied) and are aimed at being the definitive assessment of how effective the drug is.
4. Phase IV - Phase IV trial is also known as Post Marketing Surveillance Trial. Phase IV trials involve the safety surveillance (pharmacovigilance) and ongoing technical support of a drug after it receives permission to be sold.

Well, this is just a brief overview of what can be a Clinical Trial. It would come as an astonishing fact to those who are looking at it for the first time... This industry is typically conservative and a lot of people do not know what actually goes behind the scenes while making a drug. This industry is regulated by major regulatory and compliance authorities. There are a lot of other interesting things that make this a booming sector - EDC - Electronic Data Capture, ePRO- Electronic PRO, mPRO- Mobile PRO, about which I shall discuss in my forthcoming blogs.

Happy reading !! :)