Clinical Research Team brings phase one trials to patients in Lincolnshire

A patient says he feels lucky to still be here and able to take part in one of the first phase one clinical research trials at United Lincolnshire Hospitals NHS Trust (ULHT).

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The Trust is actively involved in clinical research and every year dozens of trials are underway at Lincoln, Boston and Grantham hospitals, with hundreds of patients offered the opportunity to be involved. A dedicated team supports the patients and colleagues taking part in the trials, as well as collecting all of the data.

Phase one clinical trials are the first phase of research studies used to test a new treatment on humans. The major goal of a phase one clinical trial is to determine whether a drug or procedure is safe for human use.

Phase two trials are aimed at determining the drug’s efficacy and optimal dosing regime, whilst the main focus of phase three trials is to demonstrate and confirm the preliminary evidence gathered in the previous trials that the drug is safe, beneficial and an effective treatment. It is the last phase of testing to be completed before the drug’s details and clinical trial results are submitted to the regulatory authorities for approval of the drug’s release and use on patients.

The Trust has recently been approved to take part in three phase one clinical research trials in Myeloid cancers, and this month, the first patient started on the first of the trials at ULHT. This trial is testing a potential new treatment for a rare type of blood cancer called Myelofibrosis that affects the bone marrow.

76-year-old Tony is among the first patients in the world to try the treatment, and the first in the UK.

Tony was first diagnosed with a different type of rare blood cancer 34 years ago. He underwent several rounds of chemotherapy and other treatments before starting his first clinical research trial in 2012 at Pilgrim Hospital, Boston. This was a phase three trial for a treatment that was later approved and is now used as routine treatment for certain forms of cancer.

At the end of last year Tony was then diagnosed with secondary Myelofibrosis. His doctor, Professor Ciro Rinaldi, asked if Tony would be willing to take part in another clinical trial.

Tony said: “I am so grateful for all of the care and support I have received from the haematology, cancer and research teams, as well as everyone else at the Trust who have helped me over the last 34 years. I feel I have been extremely lucky to have Professor Rinaldi as my clinician. I honestly believe he came when I needed him most.

“I know that without having the opportunities to take part in the clinical research trials I would not still be here today. I really am so grateful and will never be able to thank Professor Rinaldi and all of the teams enough for all of the extra time and wonderful memories I have been able to create.

“I never realised that these opportunities would be available to me at my local hospital. It really is amazing. I have had my first round of treatment of the new drug and I am feeling a little bit better than I did before I started. This is not about curing my cancer, but instead about giving me a longer and better quality of life.”

The plan is that Tony will come in for regular check-ups to see if the drugs are working. After a year he will have a full review and find out what will happen next.  “The whole time they are working and if I am happy then I will continue on the treatment,” he added.

Professor Rinaldi is the Trust’s Deputy Medical Director and Director of Research and Innovation. He is also the Trust’s Principal Investigator for the three phase one trials. He said: “I am so proud that we are able to bring treatments and opportunities to our hospitals for patients like Tony that would not be possible without our involvement in research.

“By working with our patients and our healthcare partners, we are learning so much more about many diseases and our involvement in research is helping to influence future treatments and will help to save lives.

“We have never had a phase one trial at the Trust and now we have three! It is a momentous occasion, but is only possible thanks to wonderful patients like Tony who are courageous in embracing research. It is also testament to our amazing team that are involved in research across the Trust.”