This document summarizes the key components of successful primary care clinical trials. It outlines that great primary care trials require: 1) Clever and imaginative clinicians to design the trials. 2) A trials unit led by a leader with clever statisticians, strict data management, and governance of the trial. 3) A primary care research network with practices and patients across England to conduct the trials. Iconic past trials are summarized that examined self-management of oral anticoagulation, warfarin versus aspirin for stroke prevention, telemonitoring for hypertension control, and cytisine for smoking cessation. The future of trials should broaden subject matter, use innovative trial management methods, and develop new methodologies

1. Primary Care Clinical
Research & Trials Unit
Prof Richard Lilford
Outgoing Director PC-CRTU

2. What makes a great Primary Care Trial?
Clever &
Imaginative
Clinicians
Trials Unit
Network of
Collaborating
Practices

3. 1. Clever & Imaginative Clinicians

4. 2. Trials Unit
Clever statisticians
Leader of
the orchestra
Trial governance
Fastidious
data-management

5. 3. Primary Care Research Network
• Hub and spoke model
• Extending across England
• NIHR funded
• Local network
– 3 000 GPs
– 685 practices
– 4 000 000 patients

6. Iconic Studies
Self management of oral anticoagulation:
randomised trial
Fitzmaurice DA, Murray ET, McCahon D, Holder R, Raferty JP, Hussain S,
Sandhar H, Hobbs FDR.
Conclusion With appropriate training, self management is safe
and reliable for a sizeable proportion of patients receiving oral
anticoagulation treatment. It may improve the time spent the
therapeutic range for patients with initially poor control.
BMJ. 2005; 331: 1057.
Warfarin versus aspirin for stroke prevention
in an elderly community population with
atrial fibrillation (the Birmingham Atrial
Fibrillation Treatment of the Aged Study,
BAFTA): a randomised controlled trial.
Mant J, Hobbs FD, Fletcher K, Roalfe A, Fitzmaurice D, Lip GY, Murray E;
BAFTA investigators; Midland Research Practices Network.
Interpretation These data support the use of anticoagulation therapy
for people aged over 75 who have atrial fibrillation, unless there are
contraindications or the patient decides that the benefits are not
worth the inconvenience.
Lancet. 2007; 370: 493-503.
Telemonitoring and self-management in the
control of hypertension (TASMINH2): a
randomised controlled trial
McManus RJ, Mant J, Bray EP, Holder R, Jones MI, Greenfield S, Kaambwa
B, Banting M, Bryan S, Little P, Williams B, Hobbs FDR.
Interpretation Self-management of hypertension in combination with
telemonitoring of blood pressure measurements represents an
important new addition to control of hypertension in primary care.
Lancet. 2010 376: 163-172.
Placebo-Controlled Trial of Cytisine for
Smoking Cessation
West R, Zatonski W, Cedzynska M, Lewandowska D, Pazik J, Aveyard P,
Stapleton J.
Conclusions In this single-center study, cytisine was more effective
than placebo for smoking cessation. The lower price of cytisine as
compared with that of other pharmacotherapies for smoking
cessation may make it an affordable treatment to advance smoking
cessation globally.
NEJM. 2011; 365: 1193-1200.

7. The Future
Broaden
Subject
Matter
Methodological
Development
Innovative Trial
Management

8. Broaden Subject Matter
1. Consolidate Primary Care Studies;
2. Include Public Health Studies;
e.g. Peymane Adab’s HTA Cluster Trial of >100 schools.
3. Service delivery interventions;
e.g. Tom Marshall’s case-finding study,
Marshall et al. BMC Public Health. 2012; 12: 908.
4. Non-health care interventions:
–
–
–
–
–
Social services;
Criminal justice;
Education;
Agriculture;
International.

9. Innovative Trial Management
Patient sensed outcomes
Home
Clinical features
Suitability for study
Study data
(Randomisation)
Clinical outcomes
Study outcomes
Primary Care
Long-term outcomes
Out-patients
Admission

10. Methodological Development
1. Pre-implementation evaluations –
NIHR CLAHRC WM.
2. Cluster studies & step wedge
Marshall et al. BMC Public Health. 2012; 12:908.
Brown & Lilford. BMC Med Res Methodol. 2006; 6:54.
Brown et al. Qual Saf Health Care. 2008; 17:163-9.
Hemming & Marsh. STATA Journal. 2013; 13(1): 114-35.
3. Supply side health economics and
Value of Information
Girling et al. Health Econ. 2012; 21(12): 1502-7.
Hemming et al. BMC Med Res Methodol. 2011; 11: 102.
Girling et al. Int J Technol Assess Health Care. 2007; 23(2):269-77.
Girling et al. Clin Trials. 2007; 4(1): 15-24.
4. Service delivery interventions and
Bayesian methods
Yao et al. BMJ Qual Saf. 2012; 21(s1): i29-38.
Hemming et al. PLoS One. 2012; 7(6): e38306.
Lilford et al. BMJ. 2010; 341: c4413.

11. Systematic Reviews
2. Network meta-analysis
1. Panoramicmeta-analysis
Chen Y-F. Evaluating Evidence of Medical
Bowater et al. Ann Surg Oncol.
Devices – International Experiences.
2012; 19(11):3343-50.
ISPOR 5th Asia-Pacific Conference. 2012.

12. Managing Science