Clinical research firm lauds Malta input

Malta formed part of a two-country team that was lauded for the recruitment levels and quality attained in clinical studies conducted by research organisation Quintiles.

Quintiles' clinical operations director for Malta, Jordanka Mircheva, said the team made up of Malta and Bulgaria was the one with the highest level of recruitment of people for clinical trials. Moreover, no errors were found in the findings of a major study, which has been finalised.

In view of the country's good performance, the company decided to hold its annual staff appreciation day in Malta.

As part of the appreciation day, the Malta Cancer Foundation was presented with a cheque which Dr Mircheva said aims to bring some "happiness and hope to cancer patients". Quintiles Central and Eastern region vice-president Heinz Carmann also presented a cheque to the foundation.

Quintiles started operating in Malta two years ago in conjunction with five local hospitals, both public and private. Its function is to implement and monitor clinical research on behalf of the pharmaceutical companies.

Dr Mircheva explained that before a medicinal product is made available on the market it needs to be tested intensively, a process that takes about a decade and costs hundreds of millions of dollars.

A trial for a medicine to treat dermatitis in children has been successfully completed with the participation of Malta, she said. Two other trials are underway - one for a medicine for osteoporosis and another for a medicine to treat advanced breast cancer. She said two more trials - on rheumatoid arthritis and on Parkinsons disease - were in the pipeline.

A total of 37 patients from Malta are taking part in clinical research through Quintiles.

"The clinical research is mainly in therapeutic areas where we are always seeking to improve medication. For example, we still have not managed to find the magic bullet to treat cancer, except for the well-known tumours that respond well to chemotherapy. We still have a long way to go, although literature is indicating we are close to discovering the best medication," she said.

The chairman of the Radiotherapy and Oncology Department at Sir Paul Boffa Hospital, Stephen Brincat stressed the importance of clinical research being available in Malta for patients here. Patients often tried to go abroad to take part in trials but this was not practical, he said. The department has been involved in clinical trials for over 15 years, initially through the European Organisation for Research and Treatment of Cancer but more recently working in collaboration with a number of international organisations.

"It is extremely important that patients have access to drugs that are not yet available on the market," he said.

Malta's small size and population is beneficial in clinical research. Dr Brincat said: "We tend not to lose touch with our patients, which is a problem in centres abroad when patients or doctors move to another part of the country."

Dr Mircheva explained that not every patient who applies to take part in a trial is accepted. "One will only be included if one meets strict criteria," she said.

Dr Brincat added that the criteria for selection were very restrictive, which meant that the number of patients who were suitable to take part in the trial was small.

The oncology department is presently working on three studies on breast cancer. One is aimed at decreasing the chance of relapse in early breast cancer patients, another involves patients with advanced breast cancer and a third is aimed at preventing the development of breast cancer in high risk women.

Dr Brincat reported that in the case of the study by Quintiles involving women with advanced breast cancer the uptake in Malta has been very good, with all the patients offered entry accepting to do so. So far nine women had joined the study.

Dr Mircheva explained that some of the patients participating in the clinical trial would be given the best known drug available on the market. These would represent the control group and the rest will be treated with the new medication. There are a number of diseases where one could not give patients just a placebo. Cancer was a case in point.

She complimented Malta's health care system, describing it as "excellently organised with very highly professional doctors, who have a realistic view of clinical research".