Cross-border trials: ‘Not every patient is as lucky as me’
Patient story: travelling to Germany for a clinical trial offered Savo Pilipovic access to life-saving melanoma therapy. But his story is the exception, not the rule.
Savo considers himself fortunate. He was diagnosed with melanoma after a routine check-up by a doctor who took the time to connect him with a hospital in Germany. Savo signed up for two clinical trials which, despite some setbacks, have helped to keep him alive.
Along the way, he had to overcome the practical, linguistic and cost barriers associated with cross-border clinical trials. However, traveling to Germany gave him access to medicines which were unavailable in his home country. More than ten years since being diagnosed with metastatic melanoma ‒ a disease with a poor prognosis ‒ Savo is alive and well.
Sadly, as President of the Melanoma Patients Association of Serbia, he has seen many other patients die of their disease. In fact, his knowledge of the impact of melanoma began close to home.
‘My cousin died of melanoma at 33 years of age,’ Savo says. ‘After that, I began going to my doctor for regular check-ups.’
Over several years, he had operations to remove more than ten moles. The moles were tested for cancer and the results came back with good news: the samples were benign. Until 2012, when a small mole at the top of Savo’s head was removed as a precaution.
‘Unfortunately, it was malignant. In March 2012, I was diagnosed with melanoma. By December 2013, the doctor told me I had several metastases and the prognosis was very bad. There were no treatments in Serbia: I knew I would die within months.’
New treatments, new hope
Then Savo’s doctor threw him a lifeline. She connected him with experts in Tübingen, Germany, where trials of a new immunotherapy were under way. From there, everything moved quickly. On 27 December 2013 ‒ two days after Christmas ‒ he was in Germany receiving the first of four doses of a new treatment.
‘I felt better; my metastases had gone,’ he recalls. ‘I was given the all clear.’
However, one year later, the cancer was back. Fortunately, Savo had the opportunity to join a new trial in May 2015 at the same clinic in Germany.
‘Now, ten years after starting that second trial, I no longer have metastases,’ he says. ‘But I had a great deal of luck: I could afford to travel and I have a family member in Stuttgart who I could stay with when I began the first trial.’
Through his work as a patient advocate, Savo knows of up to forty melanoma patients from Serbia who have taken part in trials in Germany. Most were in a position to cover the costs of travel. One, a young patient who had just turned 18 years of age, was offered a fully-funded place on the trial on compassionate grounds.
Savo was also fortunate that, even after the second trial ended two years ago, the research sponsor continued to provide the treatment free of charge. ‘Some of these therapies were unavailable in Serbia despite being available in Germany,’ he says. ‘Many patients died waiting for access to innovative therapies.’
Barriers and borders
The reality of participating in a clinical study in another country can be challenging. For a start, there can be language barriers. And, travelling from Serbia to Germany, Savo was required to justify his trip and prove that his stay would be temporary.
‘Some treatments can be unpleasant, or a patient may become ill while they are abroad,’ he explains. ‘On one occasion, the doctors in Germany found a clot in my leg on a CT scan and they hesitated to allow me to travel home. Fortunately, through the trial, I was insured for any additional stay in the hospital.’
Communication is also a barrier ‒ not just between patients and health professionals, but between health systems: ‘One of the big problems is communication between doctors and the question of who will be responsible for the patient when they go back to their own country.’
For patients in Serbia, and those in neighbouring Montenegro and Bosnia & Herzegovina, Savo would like to see easier access to trials taking place in Croatia. This would bridge the language gap. More than that, it could lead to the region being viewed as a sizeable bloc, which could make Croatia a more attractive partner for large clinical trials. That, he says, would be good for the whole region and for Europe.
Looking to the future
Today, Savo is in good health and has been metastasis-free for ten years. He is dedicating his time to advocating for patients in his region.
‘The issue is that my experience in Tübingen is the exception not the rule,’ Savo says. ‘My doctor invests a lot of energy trying to attract trials to our country, and she has good contacts with the clinic in Germany which allowed me to go to Tübingen. There is still a lot of bureaucracy and issues with research ethics committees [approving cross-border participation] and other barriers. This really has to change.’
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Learn more about EU-X-CT, a multi-stakeholder initiative dedicated to improving cross-border access to clinical trials for patients in Europe.