Patients First!

Currently less than 1.3 per cent of clinical trials conducted in the world are in India. There is a need to ensure more drug development through clinical research to help introduce newer treatments to patients in India

There can be no better fulfillment than alleviating a patient’s suffering… it is not very often that one has an opportunity to have a meaningful impact on the lives of patients.

Clinical research, which is the cornerstone of drug delivery, provides just that opportunity. It is only through clinical research that we can develop new drugs to address the unmet medical needs of patients. Every single drug that we consume today has successfully passed through the rigor of clinical trials.

At the core of clinical research is a patient. All stakeholders – be it government, regulators, investigators, ethics committees, hospital staff, academic and teaching institutions, pharma companies or CROs – have patients in mind right from the stage of designing studies to conducting them and through to analysis and reporting.

In India, clinical research has been going on for a few decades. Over these decades, several progressive steps have been taken at various levels to build a robust infrastructure for facilitating research of new drugs through meaningful clinical research. Some of these are:

• Regulations have been considerably strengthened to help build an appropriate framework for facilitating good quality clinical trials in India
• Capacity and capability building for stakeholders, be they doctors, hospitals, ethics committees or the sponsors of clinical trials and CROs.

Sadly, over the last few years, clinical research has acquired a negative image because of alleged irregularities that were observed in some trials. This has led to the spread of incorrect information about clinical trials across the country and there seems a trust deficit amongst various stakeholders. Even in the patient’s mind, clinical trial seems to be a dreaded thing…

While we don’t condone any such wrongdoing, and necessary corrective and preventive actions should be taken on such incidents, we cannot paint every trial with the same brush. There is a strong need to spread the high quality of and the good done by clinical research for millions of the patients in our country who are currently being treated for their diseases. The need of the hour is to bridge the trust deficit amongst various stakeholders.

Today, India has 16 per cent of the world’s population and around a fifth of the global disease burden. While there exists a large prevalence of infectious diseases, the burden of non-communicable disease is rapidly increasing. It is imperative for India to have a drug development agenda for diseases that are prevalent in India. Having said this, currently less than 1.3 per cent of clinical trials conducted in the world are in India, pointing to a large gap that exists. Clearly, there is a need to ensure more drug development through clinical research in India which will help introduce newer treatments to patients in our country.

To make this happen, all stakeholders need to play a role as illustrated below:

Government and Regulators need to

• Ensure that the rules for clinical trials in India are such that they protect the rights, safety and well-being of the patients and at the same time, make it conducive for clinical researchers to conduct good quality clinical research.
• Facilitate large scale capacity and capability building across multiple stakeholders.

Pharma companies (sponsors) and CROs need to

• Ensure that they have robust processes and quality systems in place to ensure that trials conducted are of top quality and adhere to applicable guidelines and regulations without compromising on ethics and safety of patients.
• Support infrastructure development, and capacity building.

The hospitals where the trials are conducted, along with the doctors and the para-medical staff performing the trials, need to ensure

• Patient safety and well-being take precedence over everything else
• Clinical trials are conducted as per the approved protocol and applicable regulations and guidelines.

The Ethics Committee needs to

• Ensure that the rights, safety and well-being of the patients is protected at all times. Over the years, the Ethics Committees have been entrusted with increasing responsibilities. Their role is thus crucial in the entire clinical research process and they must ensure that this is performed as per existing regulations and guidelines.

Patients/Patient Advocacy Groups

• Have a very important role to play because the trials are for them and patients who may in the future benefit from new treatment if the drug proves to be safe and efficacious
• While participating in clinical trials, must be aware about their rights and responsibilities. They need to immediately report any inconvenience or adverse event that has occurred during the course of a clinical trial. They should follow instructions provided to them by the investigator and the site team as per the study protocol.

Media

• Media must play a constructive role in highlighting the good that clinical research has done as well as in highlighting any wrongdoing so that necessary corrective action can be taken by concerned stakeholders.

When we ensure and implement the above, it will provide confidence to all stakeholders and help recognise the due importance of clinical research in the entire drug development process. Ultimately, it is for our patients and hence patients should come first in all that we do!