JJ hospital dean asks panel to streamline clinical trials

The dean of Sir JJ Group of Hospitals has set up a committee to investigate clinical trials conducted at the institution involving a private firm and an honorary doctor. The committee is examining the trials carried out since 2018 and the role of the firm and doctor involved. It has found that some doctors were not paid and is investigating whether patients received their incentives. The committee is also reviewing the overall process of clinical trials and will examine the procedures followed by other medical colleges.

The dean of Sir JJ Group of Hospitals has directed a five-member committee to streamline the process of clinical trial at the institution after it was found that one of the honorary doctors was operating out of the pharmacology department where clinical drug trials involving 14 people, who were not employed by the administration, were being carried out.

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HT on June 30 reported that the dean, Dr Pallavi Saple, had set up a committee to investigate the clinical drug trials conducted since 2018 and the role of a private firm, Parshwa Life Sciences (PLS), and Dr Hemant Gupta, the honorary physician, in them. The panel is headed by Dr Ameeta Joshi, head of the microbiology department.

On Friday, the committee interviewed faculty members from all departments who had carried out clinical drug trials which were sponsored by pharma companies, and asked them to give in writing if the trials they had conducted from 2015 to date involved PLS, the total number of trials done, if there were any adverse drug effects etc.

The panel also called PLS officials for questioning. “It was found that in some cases JJ doctors who did the trials were not paid. The committee is checking if the patients involved in the trials got the incentives mentioned in the contract,” a senior official at the hospital said.

Preliminary enquiry revealed that PLS had in 2018 signed an MoU with Dr Mukund Tayade, the then dean, and it had been running a lab in the pharmacology department with 14 people and Dr Gupta, officials said. The lab was conducting stage 3 and stage 4 clinical drug trials involving branches of medicine, orthopaedic, ENT, dermatology, surgery, psychiatry, paediatric etc, they added.

“It has been found that the process of clinical trial is a mess that needs to be streamlined. It is observed that the ethics committee after giving permission for the trial has never checked if the patients have received incentives,” another official said, adding the committee will also examine the process followed by other medical colleges.

JJ Hospital has only one ethics committee. For a doctor to conduct a clinical drug trial, s/he needs to submit a proposal to the committee which also has a lawyer, a social worker, and a faculty member of another medical college on board. The proposal has details about the approvals of the drug, the money involved in the trial, and about the sponsor. A contract is signed before the trial begins. Since 2020, apart from the ethics committee, the state government’s permission is required.

“The five-member panel is checking if the clinical drug trials conducted after 2020 had the government permission and whether the same was checked by the ethics committee,” the official said.

Dr Sangeeta Rawat, dean of KEM Hospital and GS Medical College, said they have three ethics committees and one of them is dedicated to clinical drug trials. “We also have a dedicated ethics committee for research done by students and the research society.”

The institute is strict with the monetary part, she said. “The principal investigator does not get the money directly. The money is deposited either in the account of the research society or the department development fund which can be used only after a sanction by the dean. Even before it comes to the dean, the committee decides if the demand is justified. The patient gets travel allowance, and the drug is free of cost,” she pointed out, adding adverse effect, if any, is directly reported to the dean.