Reflection and Reaction 712 www.thelancet.com/oncology Vol 11 August 2010 similar approach, with data from the National Oncologic PET Registry, to estimate the effect of PET on the management of 8240 patients who had 10 497 treatment- monitoring PET scans at 946 centres for a wide range of cancers. The intended post-PET management plan represented a change for 43·1% of patients. These and other studies indicate that PET changes the management of patients with common cancers. PET is likely to be cost effective and even cost saving in many clinical scenarios. We suggest that the evidence for PET should be carefully reviewed for each potential indication and where evidence is deficient, well-designed prospective trials should be done. However, the current lack of RCTs should not blind health-care providers from existing powerful evidence for the usefulness of PET. Michael P Mac Manus*, Rodney J Hicks Department of Radiation Oncology (MPMM), Centre for Molecular Imaging (RJH),Peter MacCallum Cancer Centre; University of Melbourne (MPMM, RJH), Melbourne, Victoria, Australia michael.macmanus@petermac.org The authors declared no conflicts of interest. 1 van Tinteren H, Hoekstra OS, Smit EF, et al. Effectiveness of positron emission tomography in the preoperative assessment of patients with suspected non-small-cell lung cancer: the PLUS multicentre randomised trial. Lancet 2002; 359: 1388–93. 2 Herder GJ, Kramer H, Hoekstra OS, et al. Traditional versus up-front [18F] fluorodeoxyglucose-positron emission tomography staging of non-small- cell lung cancer: a Dutch cooperative randomized study. J Clin Oncol 2006; 24: 1800–06. 3 Maziak DE, Darling GE, Inculet RI, et al. Positron emission tomography in staging early lung cancer: a randomized trial. Ann Intern Med 2009; 151: 221–28. 4 Fischer B, Lassen U, Mortensen J, et al. Preoperative staging of lung cancer with combined PET-CT. N Engl J Med 2009; 361: 32–39. 5 Viney RC, Boyer MJ, King MT, et al. Randomized controlled trial of the role of positron emission tomography in the management of stage I and II non-small-cell lung cancer. J Clin Oncol 2004; 22: 2357–62. 6 Ruers TJ, Wiering B, van der Sijp JR, et al. Improved selection of patients for hepatic surgery of colorectal liver metastases with 18F-FDG PET: a randomized study. J Nucl Med 2009; 50: 1036–41. 7 Cheson B. The case against heavy PETing. J Clin Oncol 2009; 27: 1742–43. 8 Mac Manus MP, Hicks RJ, Ball DL, et al. F-18 fluorodeoxyglucose positron emission tomography staging in radical radiotherapy candidates with non small cell lung carcinoma: powerful correlation with survival and high impact on treatment. Cancer 2001; 92: 886–95. 9 Kalff V, Hicks RJ, MacManus MP, et al. Clinical impact of (18)F fluorodeoxyglucose positron emission tomography in patients with non-small-cell lung cancer: a prospective study. J Clin Oncol 2001; 19: 111–18. 10 Hillner BE, Siegel BA, Shields AF, et al. The impact of positron emission tomography (PET) on expected management during cancer treatment: findings of the National Oncologic PET Registry. Cancer 2009; 115: 410–18. Building research capacity and clinical trials in developing countries Modern cancer therapies are designed to accurately target specific, and often restricted, populations by interfering with signalling receptors, transduction pathways, or other proteins that are correlated with the oncogenic phenotype. Clinical studies are now considering the mutation status of proto-oncogenes or specific translocations, and therefore, more specific genomic-based criteria are being used to improve selection of potential responders. This complex strategy, which needs the participation of multiple centres and well-trained research teams, strongly restricts accrual because large numbers of patients have to be screened to assemble a statistically relevant study group. Although most research participants continue to be recruited from the USA and Europe, Asia and South America are increasing their involvement—participants from low-income countries included in clinical trials increased from 8·9% in 2003 to 17·5% in 2007 1 —this globalisation of clinical studies is a crucial step for running clinical trials in the modern era. However, inequalities in financial resources and health-care priorities between high-income and low-income countries are still an issue. The international community is rightly concerned about the potential exploitation and vulnerability of patients in regions where appropriate medical care is scarce, and such discussions extend to ethical questions about the fairness of post-trial benefits for people who might not be able to access the new treatment. 2 Potential risks that underlie the organisation of trials in developing countries should be addressed, and the balance of advantages and disadvantages needs to be carefully analysed (webappendix). The involvement of key low-to-middle income countries (LMICs) including Brazil, Russia, India, and China in multinational trials is encouraged for several reasons. A benefit to the participant might include post-trial access to the study intervention, which would be particularly advantageous in the setting of advanced cancer (the most common presentation in LMICs), where the intervention could be continued for Volker Steger/Science Photo Library See Online for webappendix