Evaluating Barriers to Enrolment into Multiple Myeloma (MM) Clinical Trials: Results from Health Care Professionals and Patient Survey from the UK Myeloma Research Alliance Equity, Diversity and Inclusivity (EDI) Working Group

Background:

Under-representation in clinical trials from minority populations can lead to limited access to novel therapies as well as uncertain validity of trial data for these patients. We have previously demonstrated that patients from racial minorities and lower socio-economic classes were less likely to be represented in clinical trials for MM in the UK. Reported reasons are perceived stigma, cultural beliefs or distrust in clinicians. However, as each country has its own unique racial mix and Health and Social Care challenges, reasons for disparities may vary across countries. To evaluate further, we formed a National EDI group to understand barriers to clinical trials in MM and set recommendations to address these.

Methods:

In order to evaluate barriers to trial enrolment, the EDI group designed two surveys: one for Health Care Professionals (HCPs) and another for patients. Questions were designed by a core group of multi-disciplinary HCPs, validated by the UKMRA EDI group and distributed through the UK Myeloma Society (UKMS) and the British Oncology Pharmacy Association (BOPA). Here we report the results of the national HCP survey and a pilot of the patient survey from a single centre.

Results:

131 HCPs responded to the national survey: trials nurses/ practitioners 60%, physicians 37%, pharmacists 3.8%, data managers 1.5% and others 11%. 70% were white, 18% asian and 5% black. 62% were from large sites, and 33% from small to medium sites. 69% had treated patients from ethnic minorities. The commonest barriers to trial enrolment were resource issues such as staff shortages (74%), lack of staff resources (64%), time needed to discuss and introduce clinical trials to patients (60%), and the perceived burden of trial participation for patients (64%). Overall, perceptions of barriers were similar for minority groups and the whole group with age considered the greatest barrier (75%), although cultural barriers (44%), distrust in healthcare and clinical trials (49%) were also cited to be important. Physicians had more concerns with access to interpreters than non-physicians (43% vs 28%) as well as ability of patients to understand information (90% vs 59%). Physicians perceived that minority patients have distrust, mistrust, fear of discrimination whereas non-physicians were more likely to not know what the barriers were. More non-white HCPs reported that cultural reasons, distrust, fear of randomisation and being discriminated against were barriers than white HCPs.

161 MM patients of a median age range of 66-70 years responded to the survey. M:F was 1.5:1 and 78% were white, 8% Asian and 9% black. Overall, 57% were not in employment and 81% reported that their diagnosis affected employment. 45% had been offered participation in a clinical trial of which most (83%) agreed. Reasons for declining were: concerns regarding side effects, safety and efficacy of trial medications and treatment burden factors such as hospital visits, effects on lifestyle and mode of treatment delivery. There were no clear differences in reasons for declining between white and non-white patients. Overall, white patients were overrepresented in trial enrolment (87%).

Informal comparison of the HCP and patient survey highlighted the different racial mix of HCPs and patients, with fewer black HCPs compared to patients. Additionally, unlike physician perceptions, only 5% of minority patients reported cultural barriers including religious beliefs and mistrust in clinicians as main reasons for not participating. Both surveys were however limited by responder bias.

Conclusions:

The main barrier for HCPs to enrol patients into trials was a lack of resources and time highlighting the need for further investment and prioritisation of clinical research. Concerns regarding understanding information and cultural barriers were also raised. Patients however mainly reported potential side effects and safety as their main concerns. This highlights differing views between HCPs and patients which require further investigation with targeted minority populations.