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Dr. B. S. Ajaikumar

India needs more investigator-initiated clinical trials & Phase I studies particularly in oncology: Dr. B S Ajaikumar

  • Date: 2024-02-06 10:07:08
  • Author: Dr. BS Ajaikumar
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India needs more investigator-initiated clinical trials & Phase I studies particularly in oncology: Dr. B S Ajaikumar

India needs more investigator-initiated clinical trials particularly in oncology. It also requires to equally be engaged in conducting Phase I studies, said Dr. B S Ajaikumar, Executive Chairman, HealthCare Global Enterprises.

The country has a vast clinical repository in terms of knowledge, experience, and competence, as also in terms of the critical infrastructure needed to conduct oncology clinical trials on a consistent basis. Unfortunately, an unwelcome synthesis of restrictions, constraints, and misconceptions are preventing us from making steadfast progress on this crucial path of clinical trials, he added.

In the past, clinical trials from India were looked down upon by authorities, primarily the drug controllers. Consequently, clinical trials were not encouraged for all the wrong reasons. Now, a country that does not encourage its clinicians to do more trials cannot make significant progress. Both types of trials: One that is supported by drug manufacturers to test the efficacy of cancer drugs and second the investigator-initiated trials are imperative to explore, substantiate and put into practice any form of research outcome that ultimately propels a breakthrough in discoveries, Dr Ajaikumar told Pharmabiz.

Clinical trials are in four phases. Here Phase I seeks to establish whether the cancer therapy or drug is safe and effective on a small group of patients. Phases II and III probe deeper into the efficacy on an expanded group of patients. Phase 4 identifies the long-term pros and cons on a fairly larger number of patients. Now Phase I is fundamental. But somehow, in India, we do not see many such trials happening which is a major drawback that has kept us behind the West, he said.

The United States is doing commendable work on this front and the revenues generated for some of the hospitals is enormous. Even US drug companies do not mind sharing their findings, largely because the quicker such reports are exchanged, the faster it becomes to get USFDA approval, said Dr Ajaikumar.

As for the non-sponsored investigator-initiated clinical trials, there are very few Indian companies engaged in it. HCG is encouraging of investigator-initiated trials and at least 61 trials are ready to be launched in due course. We are right now in the process of funding them and obtaining ethics committee approvals, he said.

India will do well to take a cue from the US. It is imperative to get rid of some sticky misconceptions that cloud our imagination and block our needful thought and actions. Patients side-effects ensuing from such studies are a common apprehension that stalls many a clinical trial in India, he said,.

Dr Ajaikumar as a former US practicing oncologist also pointed out patients there are more than willing to undergo a clinical trial, not only for their own sake but also to serve the larger cause of humanity. “We hope that authorities in India will permit healthcare stakeholders the commensurate autonomy to conduct more sponsored and investigator-initiated clinical trials.”

The future clearly belongs to a conducive era where more investigator-initiated trials are conducted, and many of them also seamlessly merge into each other midway. Once a drug company realises the measurable value and impact of an investigator-initiated trial, it may be inclined to sponsor it to help expedite the whole process. We hope that the coming years will usher in a paradigm shift for India’s clinical trials which help to win the war against cancer, said Dr Ajaikumar.