3. Mr Y complains about the delay in referring his late wife to a cancer trial in Newcastle, near to where she lived. He feels the consultant should have known about this trial.
4. Mr Y believes his wife may have survived with earlier access to this trial. He would like the Trust to apologise, explain why the consultant was not aware of this trial and improve its service.
5. On 7 June 2018, Mrs Y was told she had cancer. During this appointment, she and Mr Y asked if she would be able to access any clinical trials. The consultant said none were currently available in Newcastle.
6. Mrs Y was later referred to the GARNET trial in Newcastle in April 2019. This is a clinical trial for the treatment of advanced or recurrent endometrial cancer. In September 2019, Mr Y discovered this trial had been active since 2017.
Access to clinical trial
10. Before we decide whether we should conduct a detailed investigation of a complaint, we look at whether there are signs the organisation involved has got something wrong. We do this by comparing what should have happened with what did happen. We have done this and have not found any signs of something going wrong.
11. We are sorry to hear of the circumstances surrounding Mr Y’s complaint and wish to offer our condolences for Mrs Y’s death. We know this will have been an incredibly difficult time, and Mr Y now questions whether his wife could have survived. We know this complaint will have had a profound effect on him.
12. Mr Y complains the consultant who saw his wife on 7 June 2018 did not refer his wife to a clinical trial running in Newcastle (the GARNET trial) and that the doctor should have known about this trial.
13. We have taken clinical advice on this matter to establish what responsibilities a doctor would have relating to clinical trials. This included whether there is any requirement for them to have up-to-date knowledge of relevant clinical trials and what they should do when a patient shows interest in accessing a trial.
14. Our clinical adviser told us there is no specific guidance or standards related to this, so they relied on their own knowledge and experience of best practice when offering their advice.
15. Our adviser told us that, at any given time, there are hundreds of ongoing trials, and each oncology centre around the country will run trials. Due to this, it would not be possible to have an awareness of all available trials, and clinicians would mainly be aware of the clinical trials running in the centre where they are based. They do have access to databases with this information, but even with this resource, it would not be possible to know about every trial.
16. Mr and Mrs Y asked during an appointment on 7 June 2018 whether any clinical trials were available. When a patient suggests they would be interested in clinical trials, clinicians would generally offer information about the trials they are aware of that may be suitable and would screen patients against the trial’s eligibility criteria. If they are not aware of any suitable trials, they may search databases for this information, but this does not guarantee one will be found which the patient is suitable for.
17. Our adviser also told us each clinical trial will have inclusion and exclusion criteria, and it is only if a patient meets the relevant criteria that they would be able to access the trial.
18. Our adviser looked at Mrs Y’s case and told us she would not have initially been eligible for the GARNET trial due to its inclusion criteria. Participants selected for the GARNET trial would have shown disease progression (an increase in the size of the tumour) after receiving anti-cancer treatment (chemotherapy or immunotherapy) or would have been treated with platinum doublet therapy (a specific type of chemotherapy). At the time of her diagnosis, Mrs Y had not undergone these treatments, so she would not have been eligible for this trial. She later became eligible after undergoing treatment for her cancer, and a referral was made.
19. In Mrs Y’s records, we can see the doctor says he ‘knows there are none in Newcastle at present’. We cannot say whether this is in reference to there not being any Mrs Y would be eligible for or he meant he knew there were none at all. Although we now know the GARNET trial was running at the time, we consider the advice we received that it would not be possible to know about every trial available. We understand the consultant may not have been aware of this trial at the time. We also take into account there are no guidelines or standards that would require the consultant to know of available trials.
20. We can see Mrs Y would not have met the eligibility criteria for the GARNET trial at that time, so she would not have been able to access a referral to it. We also see Mrs Y was later able to access the trial, after becoming eligible. Due to this, we cannot see the Trust has failed by not referring Mrs Y to the GARNET trial earlier.
21. We know this decision may be upsetting for Mr Y. We hope our explanations of how we reached our decision will reassure him we have considered his complaint carefully and thoroughly.
1. We have carefully considered Mr Y’s complaint about South Tees Hospitals NHS Foundation Trust (the Trust). We are very sorry to learn of Mrs Y’s death and the circumstances surrounding this complaint. We know this must have been a difficult time for Mr Y.
2. We have taken clinical advice on this matter. Although consultants may have knowledge of ongoing clinical trials, there is no specific requirement for them to maintain an up-to-date knowledge of all trials. In addition, Mrs Y would not have initially been eligible for the trial in question at the time of the consultation complained about. She was later referred to this trial, by which point she had become eligible. We have seen no sign anything went seriously wrong. We explain in full the reason for our decision below.