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Ct-toolkit.ac.uk

Trial Scenarios for Monitoring

Pilot randomised trial of streptokinase, aspirin and heparin in acute myocardial infarction1
Background: Several small trials have been undertaken of IV streptokinase in acute MI,
often followed by an anticoagulant, but there was considerable heterogeneity of effect and use of these treatments is very variable. Design: 2x2x2 factorial RCT to gain experience with the treatments and to collect
information on common adverse effects prior to conducting a very large-scale trial Setting: 8 hospitals (7 in UK and one in Australia)
Study population: 600 patients with suspected MI
Eligibility criteria: Physician diagnosis of suspected MI; <24 hours of onset of symptoms; no
clear indication for or contra-indication to trial drugs and not other life-threatening condition Interventions: IV streptokinase infused over 1 hour or matching placebo
IV heparin infused over 48 hours or matching placebo Alternate day oral aspirin 325mg or matching placebo in 28 day calendar pack Randomisation: 4 hour central telephone randomisation service which allocated the
Trial supplies: Treatment pack containing allocated treatments
Outcomes: Adverse events during hospital stay – drug reactions, bleeding, stroke,
arrhythmias, heart block, cardiogenic shock, cardiac arrest, reinfarction, death Deaths for up to one year fol owing randomisation (from ONS flagging). Data management: Data collected on paper CRFs by investigators at each site.
Experience: Coordinating centre experienced in clinical trials.
Variable experience at the clinical sites. What are the particular hazards of the trial?
 Vulnerable population, some of which may not be capable of giving informed consent  Complex design and double blind trial, therefore it is particularly important to ensure that the patients receive the allocated treatment 1 This scenario was largely based on the ISIS pilot study (European Heart Journal, 1987; 8:634-642), but some of the details have been altered. Suggested Approaches to Monitoring:

1. Trial Oversight:
 An independent Data Monitoring Committee (essential)  A
2. Before the start
of
recruitment:
 Investigators meeting to review the trial procedures and discuss consent  Written assurance from each investigator that the setup was complete and  Most panel members would also consider a site visit to review setup and trial supply arrangements desirable, particularly for inexperienced sites
3. During the
trial
Depending on whether or not site visiting is undertaken, one of the following plans is suggested: Without site visiting
With site visiting
consent form at coordinating centre (with patient consent) over the telephone) prior to randomisation  Unique identifier on label in each treatment pack to be attached to CRF as a  Testing of drugs in some packs to ensure accuracy of pack assembly  Centralised
4. At
the
end of
the
trial
 Drug reconciliation by return of unused treatment packs to coordinating centre or  Written confirmation from each site regarding archiving Trial of prescribing strategies in managing sore throat2

Background: The management of sore throats in primary care is controversial
Design: Open randomised trial of 3 prescribing strategies
Setting: 11 general practices in one regional primary care research
Study population: Patients aged 4 years or more presenting with sore throat to GP
Eligibility criteria: ≥4 yrs. old; sore throat + local sign of infection (inflamed tonsils
or pharynx, exudate, or cervical adenopathy). Intervention: Group 1 - immediate prescription for 10 day course of standard
antibiotics - penicillin V (or erythromycin if allergic) Group 2 - no antibiotic prescription Group 3 – prescription (as in Group 1) to be collected if symptoms are not starting to settle in 3 days Randomisation: Sealed envelopes in GP surgery containing advice sheet for the
Trial supplies: Prescriptions dispensed by high street chemist
Outcomes: Patient assessed (duration of symptoms recorded by patient
diary) Duration of time off work/school Patient satisfaction Data management: Paper CRF - data entry at coordinating centre.
Experience: Coordinating centre and network practices have undertaken a
2 This scenario was based in part on a trial report by Little P, Williamson I, Warner G, Gould C, Gantley M, Kinmonth AL Open randomised trial of prescribing strategies in managing sore throat(BMJ, 1977; 314:722), but some of the details have been altered or invented. What are the particular hazards of the trial?
This is a very low-risk trial – a comparison of commonly-used treatment strategies in a
patient population that is not seriously ill undertaken by an experienced group of
investigators. The particular concerns are:
Randomisation process – use of sealed envelopes in an open trial makes the study vulnerable to the random allocation of treatment being compromised – either through ignorance or intentionally. Centralised process should be used if at all possible.  Although not a vulnerable population, the inclusion of children introduces the issue of providing information about the trial for different levels of capacity to understand.  An open trial with patient-assessed outcomes introduces the hazard of differential and biased outcome assessment. Complete fol ow-up and a robust data collection instrument for the primary outcome are important.
Suggested Approaches to Monitoring:

1. Trial Oversight:
A trial management group that includes the col aborators. An independent DMC is unnecessary
2. Before the start
of
recruitment:
Investigators’ meeting that includes all those who will be involved in obtaining patient consent, the randomisation procedure, and follow-up for discussion/training plus written assurance from each investigator that the practice is prepared and setup complete; or

3. During the
trial
Because the trial is being conducted in a small network of practices in the same region, site visiting may pose few logistical or financial difficulties, and in view of the concern over the randomisation process may be the best way to monitor the conduct of the trial. Depending on whether or not site visiting is undertaken, one of the following plans is suggested: Without site visiting
With site visiting
centre (with patient consent) Alternatively, ONS flagging would be possible but generally considered unnecessary Centralised classification of outcomes blind to treatment group is recommended.

4. At the end of the trial
 Local PCT arrangements for archiving of documents should be followed. Trial of preoperative chemotherapy in oesophageal cancer

Background: It has been reported that preoperative chemotherapy improves survival
in oesophageal cancer, but there is little randomised evidence. Design: Open simple pragmatic RCT
Setting: 42 hospitals across Europe
Study population: 800 patients with oesophageal cancer due to have surgery
Eligibility criteria: Microscopically confirmed oesophageal cancer without lymph node
involvement or metastatic disease; no other malignancy; normal renal function, white-cell count and platelets Intervention: Group 1 – immediate chemotherapy with 2 cycles of cisplatin and
fluorouracil (commonly used chemotherapies in long-standing use) followed by surgical resection Group 2 – immediate surgical resection Randomisation: Central telephone randomisation
Trial supplies: From routine hospital stock
Main outcomes: Survival time (primary) and dysphagia (secondary) recorded by
Follow-up: 3-monthly for first year, then 6-monthly until death
Data management: Paper CRFs
Experience: Coordinating centre and clinical sites all experienced in conducting

What are the particular hazards of the trial?
The main concern in this trial is whether pre-operative chemotherapy increases the peri-
3 This scenario was based on a trial report by the MRC Oesophageal Cancer Working Party, Surgical resection with or without preoperative chemotherapy in oesophageal cancer. (Lancet 2002;359:1727), but some of the details have been altered or invented.
Suggested Approaches to Monitoring

1. Trial Oversight:

2. Before the start
of
recruitment:
Minimum  Written assurance from each investigator that setup complete and ready to start.  Investigator questionnaire to check appropriate training and skills Optimal  Investigators’ meeting(s) to review trial and al procedures (it might be possible to organise a meeting in conjunction with a scientific conference)
3. During the
trial
Depending on whether or not site visiting is undertaken, one of the following plans is suggested: Without site visiting
With site visiting
 Collect pathology reports  Central registry (e.g. Centralised classification of outcomes blind to treatment group is recommended. 4. At
the
end of
the
trial
 Written confirmation from each site regarding archiving. Trial of aspirin and heparin in acute ischaemic stroke
Background: Anticoagulants are widely used in ischaemic stroke to facilitate clot
lysis and to inhibit clot propagation but there is little randomised evidence on the balance of risks and benefits. Design: Open 2x2 factorial RCT with an additional randomisation of dose
Setting: Multi-centre, international (467 hospitals in 36 countries)
Study population: 20,000 patients with acute stroke (some comatose)
Eligibility criteria: Onset of stroke <48hours previously; CT scan to confirm absence
of intracranial haemorrhage (unless severe delays and physician considered stroke very likely to be ischaemic); no contraindications to aspirin or heparin Interventions: Group 1: low dose subcutaneous heparin + 300mg aspirin daily
Group 2: medium dose subcutaneous heparin + 300mg aspirin daily for 14 days Group 3: low dose subcutaneous heparin + avoidance of aspirin daily for 14 days Group 4: medium dose subcutaneous heparin + avoidance of aspirin daily for 14 days Group 5: 300 mg aspirin daily + avoidance of heparin for 14 days Group 6: avoidance of aspirin and heparin for 14 days Randomisation: Central telephone randomisation
Trial supplies: From routine hospital stock
Main outcomes: Death from any cause within 14 days; death or dependency at 6
months (collected from patient or proxy) Data management: Paper CRFs. Data entry at coordinating centre.
Experience:
Experienced coordinators; some sites had participated in pilot; some were completely inexperienced in participating in clinical trials.
What are the particular hazards of the trial?

 Vulnerable population, many of whom may not be capable of giving informed  Very large number of centres in many different countries of very variable  Potentially hazardous interventions, although considerable clinical experience of 4 This scenario was based on the International Stroke Trial (Lancet 1997; 349:1569), but some of the details have been altered or invented. Suggested Approaches to Monitoring:
1. Trial Oversight:
2. Before the start
of
recruitment:
 Written assurance from each investigator that setup is complete and they are  Investigators meeting(s) to review the trial procedures and discuss consent 3. During the
trial
 The size of the trial and large number of sites makes it particularly suitable for central statistical monitoring, with targeted visits if indicated  Depending on whether or not site visiting is undertaken, one of the following Without site visiting
With site visiting
Annual investigator meetings Annual site visits adherence to protocol and trial procedures Verification of form at coordinating centre (with patient consent)  Collect CT scan  Central registry (e.g. chart to check what chart to check what patients were prescribed Outcome/adverse events Collect death certificates Check completeness and accuracy of adverse event reports against clinic records in sample Centralised classification of outcomes blind to treatment group 4. At
the
end of
the trial
 Written confirmation from each site regarding archiving. Trial of fish oil supplementation in normal pregnancy
Background: Gestational age and birth weight are strong predictors of a baby’s
survival. Observational evidence suggests that women with a high dietary intake of oily fish have long pregnancies and babies with high birth weights. Design: RCT
Setting: A single large antenatal clinic
Study population: 600 healthy pregnant women attending routine week 30
Eligibility criteria: Normal pregnancy at 30 weeks gestation based on ultrasound
or LMP Exclusions – multiple pregnancy, bleeding in pregnancy, previous placental abruption, allergy to fish, regular fish oil supplementation. Intervention:
Randomisation: Sealed opaque envelopes in antenatal clinic containing a number
corresponding to a treatment pack or indicating no supplementation. Trial supplies: Pre-numbered boxes of oil capsules given to women at each visit
Outcomes: Duration of pregnancy, birth weight and length
Other data: Participant interviews about lifestyle factors relevant to pregnancy
outcome, compliance, food frequency questionnaire Data management: Paper CRF. Data entry at coordinating centre.
Experience: Experienced coordinators; clinic staff little trial experience
What are the particular hazards of the trial?
This is a low-risk trial – a single-centre trial to assess of the impact of two different oils
present in a normal diet on the outcome of normal, low-risk pregnancies.
The particular concerns are:
 Randomisation process – use of sealed envelopes in an open trial makes the Study vulnerable to the random allocation of treatment being compromised – either through ignorance or intentionally. Centralised process should be used if at all possible.  Although the women are not a vulnerable population, their babies are and their safety is of particular concern – both the risks and benefits of treatment should be carefully monitored. 5 Scenario was based on a trial report by Olsen S, Sorensen N, Hedgaard M, Henriksen T, Hansen H, Grant A, Randomised controlled trial of effect of fish-oil supplementation on pregnancy duration. (Lancet 1992; 339:1003), but some of details have been altered or invented Suggested Approaches to Monitoring:
1. Trial Oversight:
 A Trial Management Group,  An independent Data Monitoring Committee (unless the recruitment phase will be so short that no information on pregnancy outcomes would be available on the first patients randomised in time to prevent some of the patients being recruited unnecessarily should a benefit be detected). 2. Before the start
of
recruitment:
As it is a large antenatal clinic a large number of midwives and obstetricians will be involved in the study and they may have little experience of trials. An investigators’ meeting or a site visit is recommended to ensure that all staff are clear about the trial procedures, in particular the randomisation process. 3. During the
trial
Because the trial is being conducted in a single hospital, visiting the clinics periodical y is likely to be an efficient way of monitoring the trial. The following could be checked  Signed consent forms  Adherence to randomisation process  Patient eligibility (most of the panel would do this in a small sample) Outcomes data could be checked either against the clinic records or by collecting a copy of the birth record. 4. At
the
end of
the trial
Record of destruction of unused treatment packs

Source: http://www.ct-toolkit.ac.uk/__data/assets/pdf_file/0006/35961/trial-scenarios-in-monitoring.pdf

Ch 30

CHAPTER 30 Pharmaceutical Products 1. This Chapter does not cover: (a) Foods or beverages (such as dietetic, diabetic or fortified foods, food supplements, tonic beverages and mineral waters)other than nutritional preparations for intravenous administration (Section IV); Plasters specially calcined or finely ground for use in dentistry (heading 2520); Aqueous distillates or aqueou

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