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Journal of Postgraduate Medicine, Vol. 56, No. 4, October-December, 2010, pp. 333-335 Letter Phase 1 clinical trial: Growing role of anesthetists in India SM Ghosh1, RK Ghosh2 1 Department of Anesthesiology, Lady Hardinge Medical College, New Delhi, India Correspondence Address: S M Ghosh, Department of Anesthesiology, Lady Hardinge Medical College, New Delhi, India, dr.raktimghosh@yahoo.co.in Code Number: jp10098 PMID: 20935414 DOI: 10.4103/0022-3859.70934 Sir, India has become a global hub for clinical trial-related activities. The majority of clinical trials conducted in India as on date are Phase 3 and Phase 4 studies. Current Indian guidelines permit the conduct of Phase 1 trials of only those molecules which have been discovered or developed in India. With an expected change in the current regulations, India is likely to soon emerge as a hub for Phase 1 clinical trials. [1] In Phase 1 clinical trials, new drug molecules are tested for the first time in healthy volunteers after admitting them in a special Phase 1 unit. Although the drug is administered in human subjects after extensive animal preclinical safety study, adverse drug reactions and medical emergencies during Phase 1 study always remain a prime concern. Most of the medical emergencies reported during Phase 1 trial have been syncope, hypotension, anaphylaxis and cardiopulmonary arrest and multi-organ failure. [2] In a recently reported incident, all six volunteers enrolled in a Phase 1 trial of the anti-CD28 monoclonal antibody (TGN1412) had to be admitted to an intensive care in a London hospital after they developed multi-organ failure. [3] In another reported mishap, tha volunteer participating in a study of eproxindine, an anti-arrhythmic agent, had sudden cardiorespiratory arrest and died. [4] There are certain investigational medical products which are more prone to development of serious life-threatening events like biologics, monoclonal antibodies and cancer chemotherapeutics. [5] Adverse drug reactions mostly occur during first-time administration of a drug but there are chances of mishap during dose escalation study, determination of maximum tolerated dose and study of drug-drug interactions. Presently there are no Indian guidelines mentioning qualification of investigators and requisite setup for conduct of Phase 1 clinical trial. The association of British Pharmaceutical Industry (ABPI Edition 2007) recommends that Phase 1 clinical trial is to be conducted after admitting patients to a hospital either in the intensive care unit (ICU) or in wards which are close to the ICU or emergency management facilities. [5] The investigator or the team of physicians conducting Phase 1 study should be well-equipped and qualified to handle any medical emergency during the trial. A qualified anesthetist should monitor the study volunteers round the clock. [5] The Phase 1 clinical trial investigators are expected to be well-trained in medical emergency and resuscitation management along with good knowledge about the clinical trial regulations and good clinical practice (GCP) guidelines. [1],[5] The trial site should be well-equipped with facilities like resuscitation equipments, multimodality monitor to check vital signs e.g. electrocardiograph heart rate, blood pressure, temperature and pulse oximetry and tools for processing biological samples and arterial blood gas analysis. [5],[6] Emergency resuscitation trolleys should be made ready with apparatus and medicines that can be moved quickly to where they are needed during medical emergency. Each trolley is to be equipped with standard facilities and essential items as per ABPI and Resuscitation Council (UK) guidelines for adult resuscitation [Table - 1]. [5],[6] India, in the near future, needs a large number of qualified GCP-trained anesthetists and intensivists for successful conduct of global standard Phase 1 clinical trials. Currently, the professional training in anesthesiology does not include any exposure to clinical trials. It is important that investigators participating in Phase 1 clinical trials across India should have the same basic qualification in order to maintain uniformity in patient management in all centers. They should preferably be Advanced Cardiac Life Support (ACLS)-certified to meet global standards in resuscitation management. The major disadvantages of the ACLS course conducted by the American Heart Association are the cost and short validity. The professional bodies of anesthesiologists and intensivists in India could start their own certified courses on ′Emergency care and resuscitation in Phase 1 clinical trial′ as an alternative to the expensive ACLS training. People certified by these professional bodies are expected to provide uniform basic patient resuscitation and management skills. Greater emphasis should be given on cardiopulmonary resuscitation training (CPR) in the postgraduate curriculum of anesthesiology. The postgraduate students also need to be sensitized about Standard Operating Procedures (SOPs), ICH-GCP guidelines (International Committee on Harmonization) and regulatory guidelines in India (Modified Schedule Y). The Indian authorities should also come up with its own guidelines specifying the qualification and background of the Phase 1 trial investigators. References
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