Thread by @thebetterindia

(1/15) The most tricky part for a clinical trial investigator is identifying & recruiting appropriate participants in the middle of a pandemic while ensuring benefits to them with minimum risks,” says Dr Srikanth Krishnamurthy.

@iscrindia

(2/15) MD Consultant Pulmonologist, Head-Dept. of Clinical Research, Hindusthan Hospital, Coimbatore and a member of the Indian Society for Clinical Research (ISCR).

(3/15) A clinical trial investigator supervises and leads a team to conduct a clinical trial in compliance with the study protocol and applicable regulations.

(4/15) Given that patient protection and safety is at the core of any clinical trial, an investigator is also responsible for protecting the rights, safety, and welfare of a study participant.

(5/15) In a career spanning 15 years, Dr Srikanth has been a part of around 60 trials, and is currently working towards building a treatment ecosystem to fight COVID-19. However, the pandemic is unlike anything he has ever seen, Dr Srikanth says.

(6/15) In the first wave, we were unaware and confused. I didn’t know if my team members would turn up the next day. If there’s one silver lining in the second wave, it is that we are more organised.

(7/15) Vaccination is helping us work without any fears. Additionally, the wave has unlocked digital intervention. We are largely conducting the trials virtually, including monitoring & consultation.

(8/15) Technology is going to play a key role in speeding up and making clinical trials more effective in the future,” he adds.

For every drug development and discovery process that Dr Srikanth has been a part of, he has dedicated hours of research.

(9/15) The entire process is done in four phases, with each having a different purpose.

In Phase I, we spend months trying to figure out side effects of the dose in humans.

(10/15) In Phase II, which is with a larger number of patients, we test if the drug works in that particular disease condition. Once it is shown that it works, you advance to larger testing in Phase III.

(11/15) Here the patient population could be 200-1000. Finally, you get regulatory approval at the end of Phase III. You then do studies called Phase IV studies or post-approval studies, Dr Srikanth explains.

(12/15) Before becoming involved in clinical research, physicians should have a thorough understanding of various local and international clinical trial regulations related to the role of the investigator.

(13/15) Those who want to conduct trials should know about Good Clinical Practice (GCP), says Dr Srikanth.

Over the last few years, clinical trials in India have undergone a massive transformation.

(14/15) In the wake of emerging digital technologies and innovations in artificial intelligence, they are becoming more efficient by the day.

(15/15) Experts in clinical research such as Dr Srikanth are using these opportunities and digital interventions to significantly improve patient outcomes.

#InternationalClinicalTrialsDay #ICTD2021 #PatientsFirst