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Protocol for Human Drug Trials at KKCTH

  •  Name of the Principal Investigator – designation, experience in the specialty (Short C V)
  •  Name of the product – drug / vaccine / procedure / investigation / therapy.
  •  Type of study – prospective – retrospective analysis (data base or renewal of investigation involving withdrawal of blood, serum or tissue) Randomized, double blind, clinically controlled, fixed dose – ranging study to assess safety, tolerability and efficacy.

Duration of the Research Projects

As the projects are called for every year, the foundation prefers every project to end within one or two years. As the minimal number of patients to be evaluated is only 30, the medical officers are able to complete the projects within 2 yrs. When applied research is out with other research institutions, permission may be given for another 12 months.

Status reports are to be submitted every 6 months. For this, the investigator must submit the findings of the work to the research committee and give a preliminary report on the expenses incurred thus far. Submitting such a report has two advantages. On one hand, they may need excess of funding, which can be sanctioned after a preliminary assessment by the committee. Secondly if no progress has happened in the research, the committee can find out the reasons from the medical officer and rectify any problem. The foundation insists on certain important documents for this purpose, and strict guidelines are given to the researchers.

Special Type of Projects

  • Vaccine Trials – phase I, II, III, and IV level trials are available. But, we do only multicultural trials and phase III and IV trials, which are usually post marketing surveys. The policy of the hospital is not to permit phase I and II trials.
  • Drug Trials – Govt. of India permits us to do only phase III and IV trials, particularly in vaccines. Indigenous drugs alone can be tried out after the DCs clearance. Usually if a drug is routinely given, then no clearance from (DGCD)-Delhi is necessary. If the drug is manufactured in India, then under supervision phase II trial can be done. But our foundation prefers only FDA approved drugs. Hence the foundation gives liberty to researchers to carryout drug and vaccine trials. But always approval of the ethics committee is needed prior to starting the work.
  • Property rights of the work done by the participants of the research – The foundation has laid down the rule that any article published by the worker with the patients of K.K.C.T.H. shall be sole right of the institution. The institution and co-workers have to be acknowledged. Transferring any data from such work to any other institution or periodical without permission would be considered illegal.