Developments in Turkey and Worldwide Discussed at the Clinical Trials in Oncology Symposium

On 22 June 2018 in Istanbul, the Turkish Society of Medical Oncologyhosted the “Symposium on Industry-Supported Clinical Trials in Oncology.” Oncology and clinical research specialists from across the country discussed the importance of clinical trials and why and how they should be supported for both patient health and national development.

A clinical trialis a scientific study with volunteers intended to obtain medical knowledge. Before widespread use, new drugs, medical devices and other treatments must demonstrate safety and effectiveness to benefit people. Trials also provide knowledge for developing new treatments and identifying drugs’ and devices’ side effects. Patients or healthy individuals may participate with written consent from themselves or legal representatives. Trials require Ministry of Health permission and approval from institutionally authorized ethics committees.

The first speaker was the Clinical Research Association president, Prof. Dr. Hamdi Akan, who began by noting that 275 thousand trials were ongoing worldwide, 11 thousand in the Middle East and 3 thousand in Turkey.

Other Highlights of Dr. Hamdi Akan’s Talk:

Our country conducts %1 of all trials, ranking 31st worldwide and 55th per million population. Although we have approximately 3 thousand trials, no new drug has emerged from our country. Only a vaccine against Crimean-Congo hemorrhagic fever has reached phase-3. Most of our trials develop generic drugs rather than new medicines.

Although we are not where we wish to be in clinical trials and drug development, we rank 16th in drug use worldwide. We produce little and consume much.

Why are trials so important? They have many benefits. In 2016, global spending was 70 billion dollars, but only 55 million reached our country (appropriate policies could raise this to 900 million).

One reason we lag behind is the continuing perception of drug development as “experimenting on humans.” Another rumor is that “developed countries test new drugs on people in less developed countries.” This is completely incorrect: %60 of all trials come from 5 countries—the United States, China, Japan, India and Spain.

In recent years, India required Indian patients’ participation in the development of drugs entering its market to increase domestic trial numbers.

Serious efforts have also begun here. Our 10-year development plan envisaged annual growth of %25 in trial numbers, but current growth is approximately %12.

The most important factors in sponsors’ choice of country are cost, speed, quality and adequately trained personnel!

A trial costing 1 lira in the United States costs 0.47 lira here, an important cost advantage. But some developed countries, such as France, have even lower costs.

Speed is a disadvantage for us: we lag behind Europe. The interval between preparing an application and starting a study is unacceptable, despite being far better than 10 years ago. Applications go both to the Turkish Medicines and Medical Devices Agency (TİTCK) of the Ministry of Health and to ethics committees. The Ministry has accelerated processes considerably, but some committees still respond slowly.

Another important factor in choosing a country is study quality. Recently the FDA stated that, despite precautions, protocol compliance errors were found in %25 of worldwide inspections, followed by insufficient or incorrect records at %12.1. Our country does well in this respect, with no problems detected in inspections to date.

Our country is estimated to have 12 thousand people trained for clinical trials , an important advantage. We also do well in regulation and health policy: rules for medical research on humans were specified as early as laws published in the 1920s.

Beyond free new drugs for patients, trials bring significant extra income to centers, experience with new treatments and participation in scientific publications. Trials also develop health technologies, not just drugs, such as the epilepsy-predicting smartwatch Embrace .

The second speaker was the Ministry of Health’s Head of the Clinical Trials Department, Dr. Pharmacist Nihan Burul Bozkurt .

Highlights from Dr. Pharmacist Nihan Burul Bozkurt, who has contributed greatly to accelerating trials: Regulations protect volunteer safety and well-being while ensuring quality data recording. A major gap is the small number of early trials. Efforts continue to increase phase-1 trials, which require substantial scientific and technical infrastructure, and new phase-1 centers have begun opening. A promising drug’s chance of proceeding from phase-1 to approval is approximately %9. Since phase trials follow laboratory and animal studies, the difficulty of these investments is clear. Oncology has the most trials but the fewest approvals, because cancer’s complexity makes finding treatments harder than in other fields.

The Ministry’s initial application assessment time in 2016 was 120 days and is now 22. Projects support Ministry-affiliated training and research hospitals in trials. A system eliminating paper and postal submission, allowing online application and tracking, will enter service at the end of 2018.

Clinical trials also importantly shift patient treatment costs to pharmaceutical companies. The United Kingdom is a good example: legal changes in 2011 stimulated trials, and now %30 of patients entering oncology clinics join one, gaining free new medicines while removing this healthcare burden from government.

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