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.
