Clinical Trials in India- Where are we going ! Take preventive actions

With the way things are going in the Indian Clinical Trial space is not only saddening but also coming in as a threat for most of the sponsor companies who have made India their homes. The Indian Government is not too happy with the way patients/subjects are treated during clinical trials and as a result of which are becoming victims to SDRs (Severe Drug Reactions) and SAEs (Severe Adverse Events).

With over 1500 subjects becoming victims to the wrath of illegal and unethical clinical trial practices over the past 28 months, it is very important for us, as experts to ensure the right norms and procedures and followed. Times of India quotes - "This blatant violation of norms and ethics while conducting clinical trials is largely because of lax rules and absence of provisions for effective monitoring during each stage of the trial."

"There is no mechanism to monitor clinical trials," says Dr C. M. Gulati, editor, Monthly Index of Medical Specialities.

What is the solution to this ? In principal we need to look at robust monitoring mechanisms and better patient monitoring that can best be provided using mobile technology. Mobile technology can play a pivotal role in getting the right information from patients, ensure that they are compliant to their medication and site visits. With a validated mobile based system, the ethics committees and other governing bodies can drill down using audit trails and monitor the complete system.

Patients' even today come from rural areas but there is a ray of hope - All patients are aware and use mobile devices. Mobile devices can be used as a convenient medium for reminding patients and get them to be more compliant to their clinical trial protocol.

It is very important to have our basics right. Lets drill down to see whats wrong. We all are aware where the problem lies - A couple of pointers are:
1. Ensuring the trials are ethical
2. Ensuring that the trials are valid with the right approvals
3. Patients are compliant to their trial protocol
4. Patients safety is taken very seriously by the organization that is conducting the trial
5. Getting the right information from the patients in terms of QOL and other assessments

I still think there are huge gaps in the way things are done. And this is my request to the officials that they must look ahead in time, make tighter regulations for trials to be conducted as per the guidelines and bring in more automation for better results.

The Information Technology Advantage in Life Sciences and Healthcare

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

· 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.

Treatment Adherence

Treatment Adherence refers to how closely a patient follows a prescribed treatment regimen. Different types of therapeutic areas need different treatment methodologies and schedules of the prescribed medication dosage. Treatment adherence plays an important role in clinical as well as behavioural treatment in patients. While in certain cases of illness adherence to a health condition may not be critical, some illnesses need extremely high adherence and compliance to the treatment regimen. Treatment adherence could imply on behavioral treatment such as adhering to an exercise routine or a particular diet plan whilst being critical in cases of terminal diseases, oncology (cancer), CVD (Cardio-Vascular Diseases) etc wherein the patient needs to take their medication at a particular time( under pre-defined circumstances). Ensuring that the patient has taken his/her medication on time and by acknowledging the intake, the clinical fraternity( Doctors/Physicians/Nurses/Caregivers) can monitor their patients in a better way. Keeping a track of their patients and their medication intake compliance, they can zero in on to various health conditions applying to the patient.

From a Patient's standpoint, there are several reasons for them to become non compliant or non adherent to their medication intake/treatment schedule such as forgetfulness, busy work schedules, multiple medication intake and schedules, ignorance, severe health conditions, age etc. As a result of which they are not able to do due diligence and are subject to prolonged illnesses. It therefore is mandatory for the patient to be sticking to his medication/treatment regimen for better and quicker recovery.

While for the patient it means better health, for a healthcare institution it means better point of care, treatment adherence initiatives, close monitoring of the patients.

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.