In Autumn 1990 Fisons contracted with Data Analysis and Research (DAR) Limited, of Cambridge, to undertake a multicentre clinical trial entitled "An open crossover study to compare the acceptability and efficacy of Tilade Mint (4 mg qds) delivered by the Autohaler with Tilade Mint (4mg qds) delivered by the standard metered dose inhaler".
Fisons suggested to DAR that, amongst others, Dr RB Gonsai, a single-handed general practitioner in Plaistow, London, E13, might have an interest in this trial. DAR wrote to him enquiring as to whether he would be interested in participating in the trial, enclosing a form on which he was to indicate his interest or disinterest, and a summary of the protocol. He completed and returned this form confirming his interest. He was visited two months later by a DAR clinical research associate to discuss the trial, following which he was confirmed as a suitable potential investigator.
An initiation meeting was held six months later, at which the study design was again discussed with a detailed review of the case record forms. At that meeting Dr Gonsai signed a formal agreement to participate in the trial, the protocol, an indemnity letter, and a receipt for the investigator brochure. These documents clearly stated that the trial was to be monitored by authorised individuals with respect to current guidelines on Good Clinical (Research) Practice. Clinical supplies and documentation were provided for five patients.
A routine monitoring telephone call to Dr Gonsai was made after one month, at which he confirmed he had recruited four patients, although he had not returned their enrolment cards. During this telephone call, an appointment was made for a monitoring visit the following week, but 24 hours before the appointment, when a call was made to confirm it, Dr Gonsai cancelled the appointment, and it did not prove possible to hold the first monitoring meeting until one full month later. At that meeting the data for the four patients were reviewed. For one patient, the documentation appeared satisfactory. The data for the other three patients revealed an anomaly regarding the dates of assessments: the third assessments for each of these three patients were all dated in advance of the monitoring visit.
Dr Gonsai explained that his wife, who helped with completion of the clinical report forms, had dated these assessment forms in advance, but that the appointments book confirmed that the patients had visited the surgery earlier, although verification with the NHS notes of these patients revealed no record of these visits having taken place.
Regarding the diary cards, required to be completed by each patient, further anomalies arose. The entries for two of the four patients were completed for up to two weeks in advance of the monitoring visit. Dr Gonsai could offer no explanation for this.
A further monitoring appointment was made so that the company might seek a written explanation from Dr Gonsai on the completion of diary cards by patients beyond the dates of their last visits, and to check the appointments book. This appointment was duly fulfilled early in September 1991, when it was noted that Dr Gonsai had recruited one further patient into the study.
A number of further issues were raised, which required clarification at a subsequent meeting.
1 For the fifth recruited patient no diary cards were available at all. Dr Gonsai stated that the patient had not returned them, and additionally that he had issued old cards to the patient, from a previous study.
2 The FEV and FVC values were identical for all three visits for three patients, and for two visits for the fourth and fifth patients. These results are beyond reasonable bounds of statistical coincidence.
3 The evening peak flow readings recorded by one patient were outside the range of the peak flow meter.
4 The morning and evening peak flow readings were identical for all patients on all the diary cards; there is usually a variation between morning and evening readings in real life, and the chances of finding this constant uniformity of data in practice are beyond belief.
5 The contract house queried further the state of the diary cards. They were in pristine condition, without any of the usual evidence of handling found on their return from patient use. It was also queried why two sets of the diary cards appeared to be in the same handwriting, and, again, why some of the data had been completed on diary cards beyond the date of the final visit of the patient to the doctor.
On the strong grounds of probability, it was concluded that the data submitted by Dr Gonsai to DAR included entries that were incompatible with the facts concerning the patients to whom they were supposed to refer, and that this constituted serious professional misconduct, justifying referral to the General Medical Council. At a hearing before the Professional Conduct Committee Dr Gonsai was indeed found guilty of serious professional misconduct, and his name was erased from the Medical Register.
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