CLTR5003 - Outline the Potential Impact of a Greater than Expected Number of Drop outs/Drop ins - Medical Science Assignment Help

Assignment Task

1. A study is being undertaken to examine whether testosterone supplementation substantially reduces the incidence of new diagnoses of Type 2 Diabetes Mellitus in cohort of men with ‘prediabetes’ who are at high risk for developing diabetes. The study is a double-blind placebocontrolled randomised trial in otherwise healthy individuals to establish whether 2 years supplementation with testosterone substantially reduces the risk of developing type 2 diabetes. A sample size of 560 is planned to detect an absolute reduction of at least 13.4% from a control rate of 60% with 90% power and 95% confidence. After 180 patients have been randomised (90 in each
treatment group), and exposed to treatment for at least 12 months, the pooled event rate was found to be 48%. Your advice on the future of this study is sought.
Outline your advice to the study chair with suggestions on how the trial should/should not proceed. Your response should include a clear overall recommendation. Discussion of relevant considerations at this point in the trial should be supported, where relevant, with summary statistics.

2. You are the Study Chair for the ASPIRE study (see protocol summary) which has reached its recruitment target and is now in follow-up. The planned limits for patients discontinuing study treatment (drop-outs) and commencing aspirin in the placebo arm (drop-ins) is 10%.
1) Outline the potential impact of a greater than expected number of drop outs/drop ins on the study objectives
2) Indicate what strategies you would consider to ensure that the number of patients dropping out/in remained within the planned study limit of 10%.
3) Explain how you would evaluate the success or otherwise of these strategies
4) Outline alternative actions you would consider if the strategies you have outlined were unsuccessful 

3. You are a lead investigator of a trial examining the impact of a combination of chemotherapy ( a platinum and gemcitabine) following surgery compared to surgery alone (control arm) in operable (early stage) biliary tract cancer. The study requires 1000 patients (500 patients to receive surgery only, and 500 to receive combination chemotherapy. This is a multi-national, phase III randomised study to be conducted in Australasia, South America, India and Africa and has currently accrued 100 patients.
At a recent scientific meeting the following results were presented on an almost identical study by a group of Korean & Japanese investigators comparing surgery alone to adjuvant treatment with TAS102 monotherapy. TAS-102 is an oral anti-neoplastic agent that is active in gastrointestinal cancers resistant to fluoropyrimidines. No direct comparison of the activity between TAS-102 and gemcitabine exists, and toxicity profiles of both compounds are similar in Japan. TAS-102 is not currently available or used in Australia, South America, India or Africa

The primary outcome of your study is the 3-year relapse free survival (RFS) rate where it is hypothesized that the chemotherapy combination will increase the rate by ~8.8%. Some of your colleagues raise the question of whether the study should still continue in its current form. Some suggest stopping the study while others suggest changing the control group.
Discuss the different options for the future of the study including any strategies for modifying the design, stopping the trial or continuing the study without change. Provide a detailed recommendation, with justification, to the trial management committee.

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