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

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 !! :)