Seeding trial
Encyclopedia
A seeding trial or marketing trial is a form of marketing, conducted in the name of research, designed to target product sampling towards selected consumers. In medicine, seeding trials are clinical trial
s or research studies in which the primary objective is to introduce the concept of a particular medical intervention—such as a pharmaceutical drug or medical device—to physicians, rather than to test a scientific hypothesis. In software development, beta-testing may also be referred to as conducting seeding trials.
To create loyalty and advocacy towards a brand, seeding trials take advantage of opinion leadership
to enhance sales, capitalizing on the Hawthorne Effect
. In a seeding trial, the brand provides potential opinion leaders with the product for free, aiming to gain valuable pre-market feedback and also to build support among the testers, creating influential word-of-mouth advocates for the product. By involving the opinion leaders as testers, effectively inviting them to be an extension of the marketing department, companies can create "a powerful sense of ownership among the clients, customers or consumers that count" by offering engaging the testers in a research dialogue. Seeding trials in medicine are not illegal but are considered unethical because they "deceive investigators, clinicians, and patients, subverting the scientific process".
. In 1977, secretaries to senior management staff throughout the United States were sent packs of Post-its and invited to suggest possible uses for them. They soon found them to be extremely useful and became "brand champions" for the product, an early example of viral marketing
.
Companies that have used seeding trials include Procter & Gamble
, Microsoft
, Hasbro
, Google
, Unilever
, Pepsi
, Coke, Ford, Dreamworks SKG, EMI
, Sony
, and Siemens
.
. The article, whose authors included U.S. Food and Drug Administration commissioner David Aaron Kessler
, also described a number of characteristics common to seeding trials:
In a seeding trial, doctors and their patients are given free access to a drug and exclusive information and services to use the drug effectively. Additionally, participating physicians are often given financial remuneration and a chance to be a co-author on a resulting scientific publication. By triggering the Hawthorne effect
, physicians become "opinion-leading word-of-mouth advocates". This practice has been shown to be effective.
Seeding trials are not illegal, but such practices are considered unethical. The obfuscation of true trial objectives (primarily marketing) prevents the proper establishment of informed consent
for patient decisions. Additionally, trial physicians are not informed of the hidden trial objectives, which may include the physicians themselves being intended study subjects (such as in undisclosed evaluations of prescription practices). Seeding trials may also utilize inappropriate promotional rewards, which may exert undue influence or coerce desirable outcomes.
may have been a seeding trial, with the intention being to introduce the drug to physicians rather than test its efficacy. It appears Merck knew about the potential criticism they would face; an internal email suggested: "It may be a seeding study, but let's not call it that in our internal documents". The 2003 study was originally published in the Annals of Internal Medicine
but was strongly criticized for its deception by the journal's editors in a 2008 editorial, calling for greater responsibility in academia to end the practice of "marketing in the guise of science".
In another example, the Study of Neurontin: Titrate to Efficacy, Profile of Safety (STEPS) trial performed by Parke-Davis
to evaluate the anticonvulsant
Neurontin may have been a seeding trial. Detailed documents were released due to litigation against Parke-Davis and reviewed by several researchers in a 2011 Annals of Internal Medicine article. The STEPS trial was presented as a phase IV clinical trial with the stated objective to "study efficacy, safety, tolerability, and quality of life among gabapentin users", however the trial was actually completely uncontrolled
and unblinded and the scientific validity of the trial was considered dubious by independent external sources. Documents also revealed that the trial recruited 772 physician investigators, many with very limited research experience, provided inadequate training for investigators, and that company sales representatives were "directly involved in collecting and recording individual subject trial data".
Clinical trial
Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...
s or research studies in which the primary objective is to introduce the concept of a particular medical intervention—such as a pharmaceutical drug or medical device—to physicians, rather than to test a scientific hypothesis. In software development, beta-testing may also be referred to as conducting seeding trials.
To create loyalty and advocacy towards a brand, seeding trials take advantage of opinion leadership
Opinion leadership
Opinion leadership is a concept that arises out of the theory of two-step flow of communication propounded by Paul Lazarsfeld and Elihu Katz. This theory is one of several models that try to explain the diffusion of innovations, ideas, or commercial products....
to enhance sales, capitalizing on the Hawthorne Effect
Hawthorne effect
The Hawthorne effect is a form of reactivity whereby subjects improve or modify an aspect of their behavior being experimentally measured simply in response to the fact that they know they are being studied, not in response to any particular experimental manipulation.The term was coined in 1950 by...
. In a seeding trial, the brand provides potential opinion leaders with the product for free, aiming to gain valuable pre-market feedback and also to build support among the testers, creating influential word-of-mouth advocates for the product. By involving the opinion leaders as testers, effectively inviting them to be an extension of the marketing department, companies can create "a powerful sense of ownership among the clients, customers or consumers that count" by offering engaging the testers in a research dialogue. Seeding trials in medicine are not illegal but are considered unethical because they "deceive investigators, clinicians, and patients, subverting the scientific process".
In industry
An early example of a seeding trial was during the development of Post-it notes, produced by 3M3M
3M Company , formerly known as the Minnesota Mining and Manufacturing Company, is an American multinational conglomerate corporation based in Maplewood, Minnesota, United States....
. In 1977, secretaries to senior management staff throughout the United States were sent packs of Post-its and invited to suggest possible uses for them. They soon found them to be extremely useful and became "brand champions" for the product, an early example of viral marketing
Viral marketing
Viral marketing, viral advertising, or marketing buzz are buzzwords referring to marketing techniques that use pre-existing social networks to produce increases in brand awareness or to achieve other marketing objectives through self-replicating viral processes, analogous to the spread of viruses...
.
Companies that have used seeding trials include Procter & Gamble
Procter & Gamble
Procter & Gamble is a Fortune 500 American multinational corporation headquartered in downtown Cincinnati, Ohio and manufactures a wide range of consumer goods....
, Microsoft
Microsoft
Microsoft Corporation is an American public multinational corporation headquartered in Redmond, Washington, USA that develops, manufactures, licenses, and supports a wide range of products and services predominantly related to computing through its various product divisions...
, Hasbro
Hasbro
Hasbro is a multinational toy and boardgame company from the United States of America. It is one of the largest toy makers in the world. The corporate headquarters is located in Pawtucket, Rhode Island, United States...
Google
Google Inc. is an American multinational public corporation invested in Internet search, cloud computing, and advertising technologies. Google hosts and develops a number of Internet-based services and products, and generates profit primarily from advertising through its AdWords program...
, Unilever
Unilever
Unilever is a British-Dutch multinational corporation that owns many of the world's consumer product brands in foods, beverages, cleaning agents and personal care products....
, Pepsi
Pepsi
Pepsi is a carbonated soft drink that is produced and manufactured by PepsiCo...
, Coke, Ford, Dreamworks SKG, EMI
EMI
The EMI Group, also known as EMI Music or simply EMI, is a multinational music company headquartered in London, United Kingdom. It is the fourth-largest business group and family of record labels in the recording industry and one of the "big four" record companies. EMI Group also has a major...
, Sony
Sony
, commonly referred to as Sony, is a Japanese multinational conglomerate corporation headquartered in Minato, Tokyo, Japan and the world's fifth largest media conglomerate measured by revenues....
, and Siemens
Siemens
Siemens may refer toSiemens, a German family name carried by generations of telecommunications industrialists, including:* Werner von Siemens , inventor, founder of Siemens AG...
.
In medicine
Seeding trials to promote a medical intervention were described as "trials of approved drugs appear to serve little or no scientific purpose" and "thinly veiled attempts to entice doctors to prescribe a new drug being marketed by the company" in a special article in the New England Journal of MedicineNew England Journal of Medicine
The New England Journal of Medicine is an English-language peer-reviewed medical journal published by the Massachusetts Medical Society. It describes itself as the oldest continuously published medical journal in the world.-History:...
. The article, whose authors included U.S. Food and Drug Administration commissioner David Aaron Kessler
David Aaron Kessler
David Aaron Kessler is an American pediatrician, lawyer, author, and administrator...
, also described a number of characteristics common to seeding trials:
- The trial is of an intervention with many competitors
- Use of a trial design unlikely to achieve its stated scientific aims (e.g., un-blinded, no control group, no placeboPlaceboA placebo is a simulated or otherwise medically ineffectual treatment for a disease or other medical condition intended to deceive the recipient...
) - Recruitment of physicians as trial investigators because they commonly prescribe similar medical interventions rather than for their scientific merit
- Disproportionately high payments to trial investigators for relatively little work
- Sponsorship is from a company's sales or marketing budget rather than from research and development
- Little requirement for valid data collection
In a seeding trial, doctors and their patients are given free access to a drug and exclusive information and services to use the drug effectively. Additionally, participating physicians are often given financial remuneration and a chance to be a co-author on a resulting scientific publication. By triggering the Hawthorne effect
Hawthorne effect
The Hawthorne effect is a form of reactivity whereby subjects improve or modify an aspect of their behavior being experimentally measured simply in response to the fact that they know they are being studied, not in response to any particular experimental manipulation.The term was coined in 1950 by...
, physicians become "opinion-leading word-of-mouth advocates". This practice has been shown to be effective.
Seeding trials are not illegal, but such practices are considered unethical. The obfuscation of true trial objectives (primarily marketing) prevents the proper establishment of informed consent
Informed consent
Informed consent is a phrase often used in law to indicate that the consent a person gives meets certain minimum standards. As a literal matter, in the absence of fraud, it is redundant. An informed consent can be said to have been given based upon a clear appreciation and understanding of the...
for patient decisions. Additionally, trial physicians are not informed of the hidden trial objectives, which may include the physicians themselves being intended study subjects (such as in undisclosed evaluations of prescription practices). Seeding trials may also utilize inappropriate promotional rewards, which may exert undue influence or coerce desirable outcomes.
Examples
Documents released during a court case indicate that the Assessment of Differences between Vioxx and Naproxen To Ascertain Gastrointestinal Tolerability and Effectiveness (ADVANTAGE) trial of Vioxx conducted by MerckMerck & Co.
Merck & Co., Inc. , also known as Merck Sharp & Dohme or MSD outside the United States and Canada, is one of the largest pharmaceutical companies in the world. The Merck headquarters is located in Whitehouse Station, New Jersey, an unincorporated area in Readington Township...
may have been a seeding trial, with the intention being to introduce the drug to physicians rather than test its efficacy. It appears Merck knew about the potential criticism they would face; an internal email suggested: "It may be a seeding study, but let's not call it that in our internal documents". The 2003 study was originally published in the Annals of Internal Medicine
Annals of Internal Medicine
Annals of Internal Medicine is an academic medical journal published by the American College of Physicians . It publishes research articles and reviews in the area of internal medicine. Its current editor is Christine Laine...
but was strongly criticized for its deception by the journal's editors in a 2008 editorial, calling for greater responsibility in academia to end the practice of "marketing in the guise of science".
In another example, the Study of Neurontin: Titrate to Efficacy, Profile of Safety (STEPS) trial performed by Parke-Davis
Parke-Davis
Parke-Davis is a subsidiary of the pharmaceutical company Pfizer. Although no longer an independent corporation, it was once America's oldest and largest drug maker, and played an important role in medical history.- History :...
to evaluate the anticonvulsant
Anticonvulsant
The anticonvulsants are a diverse group of pharmaceuticals used in the treatment of epileptic seizures. Anticonvulsants are also increasingly being used in the treatment of bipolar disorder, since many seem to act as mood stabilizers, and in the treatment of neuropathic pain. The goal of an...
Neurontin may have been a seeding trial. Detailed documents were released due to litigation against Parke-Davis and reviewed by several researchers in a 2011 Annals of Internal Medicine article. The STEPS trial was presented as a phase IV clinical trial with the stated objective to "study efficacy, safety, tolerability, and quality of life among gabapentin users", however the trial was actually completely uncontrolled
Scientific control
Scientific control allows for comparisons of concepts. It is a part of the scientific method. Scientific control is often used in discussion of natural experiments. For instance, during drug testing, scientists will try to control two groups to keep them as identical and normal as possible, then...
and unblinded and the scientific validity of the trial was considered dubious by independent external sources. Documents also revealed that the trial recruited 772 physician investigators, many with very limited research experience, provided inadequate training for investigators, and that company sales representatives were "directly involved in collecting and recording individual subject trial data".