Editorial
Comparisons are odious Doctors often ask companies which drug is better. This is because companies try to promote that their drug is better than competitor drugs. However quite often, among the so-called me too drugs within the same class there are no adequately powered, well-designed, head to head, clinical comparative studies. In the absence of such data, how fair is it to compare? Why will we not have such head to head studies with other members in the same class? Is it because the difference between these drugs is so small that one would need 1000’s of patients to show that one drug is better than the other? And even if one is able to show that the difference is statistically significant, can we always say that the difference is clinically significant? Plus one may end up spending a lot of time, money and effort and still run the risk of the competitor being better, or that the study may be prematurely terminated for reasons of futility? So then what do companies resort to? Indirect comparisons. Why? It’s because all the new kids on the block have been compared to the standard of care. However, such indirect comparisons have obvious limitations as study designs and patient populations may be different. Meta-analyses (regression/network) are done but are again fraught with the same limitations.[1]
and use this to help doctors to maximize the appropriate number of patients who should be on our product.
Plus the disease is heterogeneous, for example each patient can experience a stroke or diabetes differently. Number needed to treat (NNT) or number needed to harm (NNH) is sometimes calculated, but the same patient may experience benefit and harm. Hence, people have come up with NNT unqualified success (how many patients must I treat before one experiences benefit without experiencing harm) and NNH unmitigated failure (how many patients must I treat before one experiences harm without experiencing any benefit).[2] Still one is not able to compare. Don’t despair. Dare (to be different). Naturally, it makes sense, not to compare, but to focus on our own product, look into our own database, identify patient clinical characteristics that correlate with optimal safety and/or efficacy outcomes,
Even when we do a head to head parallel group study comparing two drugs, patients in one arm are not exposed to the other drug, and hence one does not know how these patients would have responded to the other drug.
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Klastersky wrote in an NEJM editorial, “the real issue is no longer the choice of the “best” agent, but rather the identification, on a rational basis, of the population of patients who will benefit from a given agent the most.”[3] In other words, it is not that one drug is better than another. It is about finding out, which patient responds best to which drug/regimen. Companies may find the former relevant. For doctors, the latter is relevant. In the spirit of competitive collaboration, companies can come together and facilitate practical or pragmatic investigator initiated trials that address clinically relevant questions. For example, companies marketing products for hormone responsive breast cancer could have facilitated pragmatic trials in women with hormone responsive breast cancer that are estrogen receptor and/or progesterone receptor positive, where investigators try and match a patient subset to the right treatment, in sequence or in combination, viz., tamoxifen, or aromatase inhibitors or inactivator or fulvestrant.
In other words, let us focus on our customer’s needs and help them match the right patient to the right drug, instead of comparing in the absence of appropriate data. This approach may apparently shrink the market, but ultimately one gains by having the right patient on the right drug for life (in chronic conditions), thus increasing the length of a prescription and ensuring customer life-time value. And one’s credibility is enhanced in the eyes of the customer and consumer. Remember we too can be patients 1 day. Viraj Suvarna Boehringer Ingelheim India Private Limited, Mumbai, Maharashtra, India
www.picronline.org DOI: 10.4103/2229-3485.140540
143
Address for correspondence: Dr. Viraj Suvarna, C-35, Rose Blossom, Sitladevi Temple Road, Mahim, Mumbai - 400 016, Maharashtra, India. E-mail: [email protected]
Perspectives in Clinical Research | October-December 2014 | Vol 5 | Issue 4
Suvarna: Editorial
REFERENCES 1.
2.
Ruff CT, Giugliano RP, Braunwald E, Hoffman EB, Deenadayalu N, Ezekowi MD, et al. Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: A meta-analysis of randomised trials. Lancet 2014;383:955-62. Schulzer M, Mancini GB. ‘Unqualified success’ and ‘unmitigated
3.
failure’: Number-needed-to-treat-related concepts for assessing treatment efficacy in the presence of treatment-induced adverse events. Int J Epidemiol 1996;25:704-12. Klastersky J. Antifungal therapy in patients with fever and neutropeniaMore rational and less empirical? N Engl J Med 2004;351:1445-7.
How to cite this article: Suvarna V. Comparisons are odious. Perspect Clin Res 2014;5:143-4.
“Quick Response Code” link for full text articles The journal issue has a unique new feature for reaching to the journal’s website without typing a single letter. Each article on its first page has a “Quick Response Code”. Using any mobile or other hand-held device with camera and GPRS/other internet source, one can reach to the full text of that particular article on the journal’s website. Start a QR-code reading software (see list of free applications from http://tinyurl.com/ yzlh2tc) and point the camera to the QR-code printed in the journal. It will automatically take you to the HTML full text of that article. One can also use a desktop or laptop with web camera for similar functionality. See http://tinyurl.com/2bw7fn3 or http://tinyurl.com/3ysr3me for the free applications.
Perspectives in Clinical Research | October-December 2014 | Vol 5 | Issue 4
144
Copyright of Perspectives in Clinical Research is the property of Medknow Publications & Media Pvt. Ltd. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
Comparisons are odious Doctors often ask companies which drug is better. This is because companies try to promote that their drug is better than competitor drugs. However quite often, among the so-called me too drugs within the same class there are no adequately powered, well-designed, head to head, clinical comparative studies. In the absence of such data, how fair is it to compare? Why will we not have such head to head studies with other members in the same class? Is it because the difference between these drugs is so small that one would need 1000’s of patients to show that one drug is better than the other? And even if one is able to show that the difference is statistically significant, can we always say that the difference is clinically significant? Plus one may end up spending a lot of time, money and effort and still run the risk of the competitor being better, or that the study may be prematurely terminated for reasons of futility? So then what do companies resort to? Indirect comparisons. Why? It’s because all the new kids on the block have been compared to the standard of care. However, such indirect comparisons have obvious limitations as study designs and patient populations may be different. Meta-analyses (regression/network) are done but are again fraught with the same limitations.[1]
and use this to help doctors to maximize the appropriate number of patients who should be on our product.
Plus the disease is heterogeneous, for example each patient can experience a stroke or diabetes differently. Number needed to treat (NNT) or number needed to harm (NNH) is sometimes calculated, but the same patient may experience benefit and harm. Hence, people have come up with NNT unqualified success (how many patients must I treat before one experiences benefit without experiencing harm) and NNH unmitigated failure (how many patients must I treat before one experiences harm without experiencing any benefit).[2] Still one is not able to compare. Don’t despair. Dare (to be different). Naturally, it makes sense, not to compare, but to focus on our own product, look into our own database, identify patient clinical characteristics that correlate with optimal safety and/or efficacy outcomes,
Even when we do a head to head parallel group study comparing two drugs, patients in one arm are not exposed to the other drug, and hence one does not know how these patients would have responded to the other drug.
Access this article online Quick Response Code:
Website:
Klastersky wrote in an NEJM editorial, “the real issue is no longer the choice of the “best” agent, but rather the identification, on a rational basis, of the population of patients who will benefit from a given agent the most.”[3] In other words, it is not that one drug is better than another. It is about finding out, which patient responds best to which drug/regimen. Companies may find the former relevant. For doctors, the latter is relevant. In the spirit of competitive collaboration, companies can come together and facilitate practical or pragmatic investigator initiated trials that address clinically relevant questions. For example, companies marketing products for hormone responsive breast cancer could have facilitated pragmatic trials in women with hormone responsive breast cancer that are estrogen receptor and/or progesterone receptor positive, where investigators try and match a patient subset to the right treatment, in sequence or in combination, viz., tamoxifen, or aromatase inhibitors or inactivator or fulvestrant.
In other words, let us focus on our customer’s needs and help them match the right patient to the right drug, instead of comparing in the absence of appropriate data. This approach may apparently shrink the market, but ultimately one gains by having the right patient on the right drug for life (in chronic conditions), thus increasing the length of a prescription and ensuring customer life-time value. And one’s credibility is enhanced in the eyes of the customer and consumer. Remember we too can be patients 1 day. Viraj Suvarna Boehringer Ingelheim India Private Limited, Mumbai, Maharashtra, India
www.picronline.org DOI: 10.4103/2229-3485.140540
143
Address for correspondence: Dr. Viraj Suvarna, C-35, Rose Blossom, Sitladevi Temple Road, Mahim, Mumbai - 400 016, Maharashtra, India. E-mail: [email protected]
Perspectives in Clinical Research | October-December 2014 | Vol 5 | Issue 4
Suvarna: Editorial
REFERENCES 1.
2.
Ruff CT, Giugliano RP, Braunwald E, Hoffman EB, Deenadayalu N, Ezekowi MD, et al. Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: A meta-analysis of randomised trials. Lancet 2014;383:955-62. Schulzer M, Mancini GB. ‘Unqualified success’ and ‘unmitigated
3.
failure’: Number-needed-to-treat-related concepts for assessing treatment efficacy in the presence of treatment-induced adverse events. Int J Epidemiol 1996;25:704-12. Klastersky J. Antifungal therapy in patients with fever and neutropeniaMore rational and less empirical? N Engl J Med 2004;351:1445-7.
How to cite this article: Suvarna V. Comparisons are odious. Perspect Clin Res 2014;5:143-4.
“Quick Response Code” link for full text articles The journal issue has a unique new feature for reaching to the journal’s website without typing a single letter. Each article on its first page has a “Quick Response Code”. Using any mobile or other hand-held device with camera and GPRS/other internet source, one can reach to the full text of that particular article on the journal’s website. Start a QR-code reading software (see list of free applications from http://tinyurl.com/ yzlh2tc) and point the camera to the QR-code printed in the journal. It will automatically take you to the HTML full text of that article. One can also use a desktop or laptop with web camera for similar functionality. See http://tinyurl.com/2bw7fn3 or http://tinyurl.com/3ysr3me for the free applications.
Perspectives in Clinical Research | October-December 2014 | Vol 5 | Issue 4
144
Copyright of Perspectives in Clinical Research is the property of Medknow Publications & Media Pvt. Ltd. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
