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Table 2 The four trials

From: Financial considerations in the conduct of multi-centre randomised controlled trials: evidence from a qualitative study

TRIAL

SPECIALTY

POPULATION

MANAGEMENT

RECRUITMENT SETTING

INTERVENTIONS

DESIGN

FUNDERS

HPS

(The H eart P rotection S tudy)

Cardiovascular health promotion

Patients at increased risk of coronary heart disease

Clinical Trials Unit

Hospital

- Statins (Simvastatin)

-Antioxidant vitamins

- Placebo

4 arm randomised trial (2 × 2 factorial)

MRC

BHF

Industry

FOCUS

(Trial of Chemotherapy for Bowel Cancer (F luorouracil, O xaliplatin and Irinotecan (C PT11), U se and S equencing)

Oncology

Patients with advanced metastatic colorectal cancer

Clinical Trials Unit

Hospital

Chemotherapeutic agents

- Modified de gramont with fluorouracil

- Irinotecan

- Oxaliplatin

5 arm randomised trial with cross-over

MRC

Industry

NHS Trusts

ELEVATE

(A pragmatic single-blind RCT and health economic evaluation of leukotriene receptor antagonists in primary care at steps two and three of the National Asthma Guidelines)

Asthma management

Primary care patients with asthma requiring regular preventative treatment or an increase in therapy

University Department

General Practice

- Leukotriene receptor antagonists

- Inhaled corticosteroids

- long-acting beta agonists

3 arm randomised trial (with option to switch treatments post-randomisation and parallel non-randomised 'naturalistic' cohort for patients refusing randomisation)

HTA

Industry

PCTs

TOuCAN

(T rial of O utcome for C hild &A dolescent Anorexia N ervosa)

Adolescent psychiatry

Adolescents (aged 12–18) with anorexia nervosa

Hospital/university

Hospital and out-patient service

- intensive inpatient treatment

- general local outpatient service

- specialist outpatient service

2 severity strata (steps) with 2 arms at each step

HTA