Turkey, by aiming to join the EU, is undergoing an extensive reform process and therefore will become an increasingly important pharmaceutical market
Turkey is transforming into an attractive place to conduct clinical trials.
That's the verdict of Christine Ott of independent CRO Chiltern International, which has shown the potential of running trials in less traditional countries worldwide.
Countries such as Turkey, which are negotiating to join the European Union (EU) in the future, are emerging as promising areas for clinical research.
Despite their good opportunities in terms of conducting clinical trials, Ott believes these countries have largely been overlooked until now. Turkey, by aiming to join the EU, is undergoing an extensive reform process and therefore will become an increasingly important pharmaceutical market.
In order to be successful companies are beginning to realise the importance of giving local physicians and healthcare professionals experience of working with new products that are being developed.
As no official list exists of all clinical studies that are ongoing globally it is difficult to say how many international multi-centre studies are really performed in Turkey but according to an internet search it can be assumed that the number of clinical trials is rather low in international terms.
Pharmaceutical companies are largely reluctant to perform clinical trials in Turkey due to several presumptions and concerns.
Non-acceptance of clinical trial data from Turkey at authorities is one major concern.
And its close proximity to potential trouble spots in the Middle East has given sponsors even less incentive to use the country as a base for their clinical research.
However, sponsors who approach the region in a strategic and open manner could reap major benefits that help them meet their overall drug development objectives. For a start they can take note that Turkey's population is increasing rapidly.
In 1963 it was around 40 million but by the end of 2003, an estimated 70 million.
Another important factor is that as a consequence of low screening efforts and the low public awareness there is a greater prevalence of certain disorders for which preventive action is well established in Western countries - such as cardiovascular diseases, hypercholesterolemia, chronic obstructive pulmonary disease, goiter, certain forms of cancer, such as lung and bladder cancer.
"This offers a clear opportunity for the conduct of clinical trials, particularly in rare diseases but also in indications such as cardiovascular diseases, hypercholesterolemia and certain forms of cancer," commented Ott.
"For certain clinical studies, especially for studies in treatment-naive patients, Turkey is a very interesting country because of the higher availability of treatment-naive patients compared with Western countries".
Turkey also has a remarkable number of universities and specialised hospitals concentrated in the bigger cities and giving access a large number of patients.
However, due to the currently ineffective referral system at Turkish primary care units, hospitals are overloaded with patients and time and resources are short. However, high recruitment figures can be achieved in state hospitals and the dual employment of many specialised physicians offers additional patient resources.
As Christine Ott points out, the absence of novel and effective drugs helps to identify investigators and patients that are interested in participating in a clinical trial.
"The possibility of receiving a new drug, good care and continuous control is usually of great interest to patients in Turkey - as in any other country," she states.
Compliance to Good Clinical Practice is the basic requirement to obtain marketing approval and in Turkey Good Clinical Practice has been implemented into the national regulations since 1993.
In addition, in 1998, the Ministry of Health published the Turkish translation of the ICH guideline for Good Clinical Practice.
German regulatory agency BfArM and other European agencies generally will also have no concerns regarding the acceptance of data from Turkey even for pivotal clinical trials if the study is conducted according to Good Clinical Practice.
As a venue for clinical trials Turkey has some similarities to central and eastern European countries.
One similarity is lower study costs in the sense of providing value for money.
Investigator compensation in Turkey is usually lower than in Europe and the USA as well.
The costs for ethical review are also relatively low compared to some Western countries and there are no costs for regulatory approval as there are no fees required for central ethics review.
"Even today, despite some disadvantages, Turkey offers good opportunities with regard to the high number of enthusiastic physicians interested in participating in clinical trials," concluded Ott.
"The high number of patients, especially in certain indications, offers the potential for rapid rates of patient recruitment - a great benefit for early phase trials where marketing considerations do play a minor role.
"However, there are also barriers that will be faced when conducting a clinical trial in Turkey and it is important for companies to be fully aware of these when looking at this region.
"The relatively low number of physicians per capita and the overload of the hospitals with patients will restrict the ability of the site staff to allocate sufficient time for a clinical trial.
"Inward investment by pharmaceutical companies is the next step and that will create a functioning network of partners for clinical trials in Turkey.
"If the reform process itself continues and the current political situation becomes more stabilised, with the accession of Turkey to the EU the prospects are very positive for the country to become more involved in international clinical trials in the near future.
"There's no doubt that those pharmaceutical companies that have proactively taken the right approach to the region will benefit from the results."
