Pressreleases

When the results of a trial have been accepted for publication, it is worth considering whether a press release to the general laymedia, to coincide with their publication, would

Randomised phase III trial of surgery with or without pre-operative chemotherapy in resectable cancer of the oesophagus

PI Clark on behalf of the MRC Oesophageal Cancer Working Party

MRC Clinical Triali Unit

BACKGROUND

OE02

• A relatively common cancer of changing epidemiology

• Approximately 5000 deaths per year in the UK

> Outlook for surgery alone poor

> Evidence from non-randomised studies that chemotherapy may improve results of surgery and reduce subclinical metastases

= > Does pre-op chemotherapy

Prolong survival? Affect physical well-being?

TRIAL DESIGN

Resectable carcinoma of the oesophagus

Chemotherapy and then surgery

Resectable oesophageal cancer; any cell type No previous chemotherapy radiotherapy or surgery No other malignant disease

No indication for urgent resection

Renal function adequate for chemotherapy

MRC Clinical Triab Unit

CHEMOTHERAPY REGIMEN

1 Two 4-day pre-operative courses, 3 weeks apart

- Cisplatin

- Fluorouracil

80 mg/m2 by 4-hr infusion on day 1

lg/m2/day by infusion for 4 days

MRC Clinical Trial« I

STATISTICAL CONSIDERATIONS

• Primary outcome measure=survival 1 Intended intake 800 patients in 4 years ' Enabling an increase in 2-year survival rates from 20% to 30% to be detected with a 5% significance level and 90% power

MRC Clinical Triali Unit

ACCRUAL

March 1992 - June 1998 802 patients randomised CS = 400 S = 402

(from more than 40 European centres)

MRC Clinical Triali Unit

PATIENT

OE02

CHARACTERISTICS

CS

S

Age:

Median

63 years

62 years

Range

(36 - 84)

(30 - 80)

Sex:

Male

77%

74%

Histology:

Adenocarcinoma

66%

67%

Site of tumour:

Lower third

65%

63%

Level of physical activity:

Normal

58%

55%

MRC Clinical Triait Un*

CHEMOTHERAPY RECEIVED

2 cycles with no delay/modifications

294 (76%)

2 cycles with dose delay/modification

53(14%)

1 cycle only

22 (6%)

None given

17 (4%)

Total

386 (100%)

Details incomplete/form missing

14

Total allocated chemotherapy

400

MRC Clinical Trial* Unit

MRC Clinical Trial* Unit

Fig. 10.2 Example slides for a 10-15 min presentation

Fig. 10.2 (Continued)

be useful or appropriate. Some trials, particularly perhaps those relating to primary care and public health, will naturally capture the public imagination and the potential for interest in the lay press will be clear. In these situations, many journals will write their own press release, making it available to the media prior to publication, although they will apply embargoes preventing discussion of the results before the publication date. For others it will be less clear if the interests of the research, or its potential to impact on the clinical community, will really be enhanced by this approach. However, for publicly funded research, press releases can be a means of showing that public money has been well spent while for research charities, it can be an excellent means of raising awareness and thus generating income.

If the results of a trial are likely to have a major impact, then it may be useful to have prepared a press release in advance of the publication which explains the results and their implications clearly, and in your own words. As a rule, these should be no more than a page long, and be written in a series of short paragraphs. The first paragraph should provide a self-contained summary of the research results and implications, with subsequent paragraphs elaborating on aspects in decreasing order of importance. The reason for this 'inverted triangle' approach is that editors will rarely have space to use an entire press release, and will inevitably precis by cutting from the bottom up. Some trials will generate a lot of interest and dealing with media inquiries can take up a great deal of time. The media particularly like attributed quotes and so a useful tip is to include a direct quote from the lead researcher in the press release which can be lifted out. Box 10.2 gives an example from a press release reporting the results of a meta-analysis of chemotherapy for malignant glioma [12].

Press releases may lead to requests for interviews, and it is helpful if one or more of the lead investigators are prepared to be interviewed. If this is likely to be a regular occurrence, then it is well worth considering a short media training course. Some general guidance for media interviews includes:

♦ Never reveal findings that are still provisional or confidential or that have not yet been conveyed to collaborating centres or been subjected to independent peer review.

♦ Do not discuss results prior to publication.

♦ If given the option, it is usually better to choose a live broadcast rather than a recorded one. In this way potential editorial distortion is avoided, although the experience is likely to be more nerve-racking.

♦ If offered only a recorded interview, then ask to see or hear the edited version before it is broadcast.

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