subject recruitment

Recruitment usually begins with an enquiry via our website londontrials.com, which receives about 25,000 visits each month, yielding nearly 3,000 completed enquiry forms.  We advertise (with ethics committee approval) in London newspapers, on Google, and on social media, to target specific groups such as asthmatics. We benefit from London’s huge population, which enables us to recruit for trials that put high demands on the participants.

Our dedicated team of 30 recruitment staff are experienced telephone interviewers – several have more than 15 years’ experience.  They call potential volunteers and talk through the eligibility criteria for each trial, obtaining as much information as possible.  That prevents unnecessary screening appointments and speeds up recruitment, thereby helping to keep down costs for our sponsors.

• Dedicated team of 30 recruiters
• Databases of
  1. young
  2. elderly
  3. postmenopausal
  4. surgically sterilised
  5. smokers
  6. obese
  7. alcohol-dependent
  8. Japanese and other ethnic groups

We enter all subjects in a UK database called The Over-Volunteering Prevention System (TOPS), which helps prevent healthy subjects from taking part in Phase 1 trials too often. HMR set up TOPS in 2002; the Health Research Authority took responsibility for the system in 2013, and the use of TOPS is now a condition of ethics approval in the UK.

We have panels of patients with conditions such as asthma, COPD and obesity. We find most patients by advertising, using many types of media.  Also, we liaise with NHS hospitals, patient support groups, and London pharmacies.  Sometimes we liaise with local GPs or a GP consortium, or with a GDPR-compliant company that has access to GP patient records.

For each trial with patient cohorts, our dedicated specialist Patient Trial Coordinator makes a bespoke recruitment plan to identify suitable subjects.

Over the years, we’ve done proof-of-concept trials in over 30 different conditions, as listed below. In recent years we’ve studied patients with osteoarthritis, depression, schizophrenia, and cardiac amyloidosis. Patients with the last two conditions were referred by London teaching hospitals.

We’ve done proof-of-concept trials in patients with

• Asthma
• Allergic rhinitis
• Coronary artery disease
• Hormone replacement therapy
• Contraceptive patch
• Premenstrual syndrome
• Genital herpes
• Erectile dysfunction
• Pulmonary fibrosis
• Pulmonary hypertension
• Obesity
• Coeliac disease
• Down syndrome
• Amyloidosis
• Stretch marks
• Acne scars
• Benign prostatic hypertrophy
• GORD
• Diabetes type 2
• Parkinson’s disease
• Haemosiderosis
• Migraine
• Down syndrome
• Systemic lupus erythematosus (SLE)
• Alcohol dependence
• COPD
• Chronic heart failure
• Schizophrenia
• Depression
• Osteoarthritis
• Atopic dermatitis
• Psoriasis

We understand that patients take part in trials for a variety of reasons.  The trial must fit in with their lifestyle if they’re to decide to join the trial and remain in it until the last visit. Our experienced staff offer continuous support, from the recruitment phone call to the follow-up visit.  We’ve a dedicated Patient Trial Coordinator who’s a central part of our team.

We have ward bays and private rooms designated for patients, and can offer specialised menus, if required.  We have skilled, specialised nurses trained for several disease areas and procedures. We allocate patient liaison officers to ensure that we meet the needs of specific patients, and provide them with appropriate specialist care.

Our many years of experience enable us to give realistic assessments of the feasibility of a trial design and the likely patient recruitment rate.  Our contact with GP federations (see below) gives early feedback on any research proposal, which helps to ensure that the protocol and patient recruitment methods are in line with local clinical pathways. We advise on strategies to accelerate recruitment, and devise a bespoke recruitment strategy to target the required population.   We consider

• disease prevalence
• eligibility criteria for the trial
• our past experience of similar trials
• feedback from collaborators
• the number of patients needed
• the required rate of recruitment
• recruitment budget

We’ve successfully used the following approaches to recruit patients.

• Advertising in local and national newspapers, on the radio, and via social media – all effective in recruiting people with common diseases
• Private agencies that review anonymous medical records to identify specific patient populations; suitable patients are then approached by their GP. This method is efficient, because any patients approached will are very likely to meet the entry criteria
• We liaise with local NHS hospitals, such as Central Middlesex, Northwick Park, and Hammersmith Hospital, to set up patient identification centres (PICs)
• We recommend that trials be included on the NIHR Clinical Research Network (CRN) portfolio, which offers early engagement, site identification, and trial setup support to companies like us, and gives us access to NHS patients from both secondary and primary care
• We’ve a strong relationship with the Clinical Research Network in North West London  (NWL CRN).  NWL CRN works with GP federations rather than individual GP practices, allowing feasibility searches across whole Clinical Commissioning Group regions, to find research-active GP practices where the disease burden is greatest
• Collaboration with the West London Research Network, which connects us with GPs who help us to identify specific patient populations

Our trials follow the guidelines of the Association of the British Pharmaceutical Industry (ABPI) and compensate subjects in the unlikely event that they’re injured as a result of taking part in a trial. We also have a Privacy Committee to advise trial subjects on their data protection rights in accordance with the General Data Protection Regulation (GDPR).

Trials in healthy Japanese volunteers, often referred to as bridging trials, are very different from trials in natives of the UK. Since 2006, we’ve done over 30 trials in healthy Japanese volunteers; in the last 3 years, we’ve done 9. Some involved radiolabelled products or an opioid, and would have been difficult or impossible to do in Japan, for regulatory reasons. We’ve also done trials of biologicals with follow-up lasting up to 5 months. What’s more, some trials needed Chinese and Korean subjects as well as Japanese, making them even harder to do.

Bridging trials require

• an understanding of Japanese culture
• knowledge of the lifestyle of Japanese people living in the UK, and how to find them
• staff experienced in recruiting and carrying out trials in Japanese subjects
• translation of trial documents, eg information and consent form and health questionnaire
• special resources and facilities, eg Japanese meals cooked on site, Japanese comics, newspapers and board games

According to the Japanese Embassy in London (2017), 63,000 Japanese people (24,000 men and 39,000 women) live in the UK. We use only ethical and legal methods to recruit Japanese subjects, such as advertising on websites for Japanese people in the UK. Immigration laws don’t allow people to come to the UK just to do clinical trials, so we don’t advertise for or recruit Japanese volunteers outside the UK.  We don’t subcontract recruitment, as do some of our competitors, because the methods used are dubious and are favoured neither by ethics committees nor the UK regulatory agency.

When deciding whether to participate in a trial, Japanese subjects are influenced more by the timelines and the type of IMP than by the amount of payment. We meet their needs through

• Flexibility with group sizes in a trial (smaller cohort sizes)
• Flexibility with the dates of trial sessions

Japanese volunteers often have poor English language skills. We have a team of bilingual Japanese staff who recruit, inform and screen Japanese subjects. Compared with non-Japanese subjects, it takes twice as long to inform Japanese subjects over the phone, and 2–3 times longer to screen them.

While on our wards, Japanese subjects are looked after by a ward team dedicated to bridging trials – altogether, we have about 20 Japanese staff. A Japanese member of staff is available 24/7 while a bridging trial is in progress.

Find out more about bridging trials in Japanese subjects.