There’s a strong case to be made for making clinical trial results fully transparent to the public. Unpublished results of raw clinical data, whether positive or negative, would not only put patients in harm’s way but it would prevent independent scientists and physicians from drawing their own conclusions about the safety and efficacy of the drugs, and make appropriate determinations for prescribing these drugs to patients. The other issue is data integrity—skewing or biasing clinical trial data before it reaches peer-reviewed journal publications. However, the case against this idea is the potential competitive threats and financial liabilities that releasing proprietary clinical trial information could pose to the pharma industry.
A few major milestones took place over the last couple of months that suggest more is being done to enforce clinical trial transparency on clinicaltrials.gov and other registries. In September 2012, the Food and Drug Administration (FDA) was given authority by the Dept. of Health and Human Services to keep sponsors and contract research organizations honest in submitting and reporting accurate clinical trial data. In October, GlaxoSmithKline (GSK) announced its pledge to make all of its clinical trial data public on its website despite whether the results were positive or negative. This came after a regulatory breach and non-disclosure debacle for its diabetes drug Avandia, and the company later supported British Medical Journal’s (BMJ) plans to only publish scientific papers where authors can disclose patient-level data on request for independent analysis. Companies such as Astellas, Genentech, Pfizer and Shire have dedicated a section of their websites to fully disclosing data on the registries, but not all companies have put theory into practice.
So where is this all going? What does it mean for pharma marketing? We asked our scientific and pharma marketing experts as well as independent physicians to weigh in on the implications of this trend on pharma marketing to patients and healthcare providers (HCPs) and how it can be good or bad for the industry.
Transparency Builds Respect and Trust
“Genuine transparency of any kind by pharmaceutical companies is likely to increase trust between the company and its customers and stakeholders,” says Daniel Ghinn, Creation Healthcare’s CEO, a digital healthcare marketing/communications company that specializes in healthcare stakeholder engagement.
“I think it is good practice and good public relations to do this,” he says. “Making it more transparent will increase patients’ and doctors’ awareness of how much and what is collected, and openness will translate into greater respect for the pharmaceutical industry.”
Matthew Mintz, MD, FACP, Associate Professor of Medicine, Director, Practice of Medicine Course Director, Premier Access and Executive Services at The George Washington University School of Medicine also believes that clinical trial transparency will help forge respect and trust while also mitigating the concern that pharma puts profits over patients.
“Having clinical trial data be completely transparent will help this substantially,” Mintz says. “Physicians and the public will at a minimum be reassured that pharma isn’t trying to hide something. GSK should be commended for getting ahead of the game on this issue.”.
John Wes Green, Integrated Marketing Innovation Practice Lead, Advisory Services of Paragon Solutions says that transparency will help build acceptance and trust, but pharma must be disciplined and patient.
“Exhibiting gestures of good faith in the clinical trial process will eventually be met with a positive response,” Green says. “However, it will not happen overnight; trust has to be earned, which takes time and hard work. Organizations must demonstrate honesty and reliability over time in order to facilitate a shift in perception and trust.”
Transparency is Good for Drug Development and Discovery
Both Ghinn and Kevin D. Lustig, Ph.D., CEO & President of Assay Depot, an online marketplace for scientific research services and specialized products, agree that transparency opens the door to advancing the field.
“Pharma companies will benefit not only as a result of the openness and transparency inherent in the full release of data, but also from the synergistic increase in the ability of researchers to make new discoveries,” Lustig says. “Ultimately this will move the whole field of pharmaceutical research forward—the good clearly outweighing the bad. I also see this as part of a broader shift towards open science with its emphasis on open access, community collaboration and citizen science.”
Ghinn concurs: “Voluntary transparency of clinical trial data by GSK is in line with a growing trend towards openness that could also strengthen opportunities for collaboration and ultimately accelerate the advancement of medical science.”
Transparency is Good for Patient and HCP Marketing
“[Clinical transparency] is good from a marketing standpoint because trust and value is what gets you in the door,” Mintz claims. “If a drug company has done a good job pre-launch and at launch, then publically available trial data can only help. In other words, it’s one thing to say a drug’s safety record is stellar; it’s another thing to have this data available. If a clinician asks a question that’s not clearly spelled out in the sales aid, the rep is allowed to tell the physician to go online and look for themselves.”
Lustig agrees that transparency is a good thing for the patient, and ultimately pharma companies should be prepared to capitalize on it. Lustig also believes that by having large randomized controlled trial (RCT) data available for third-party study, pharma would be able to develop predictive models which would be useful for patient and HCP marketing,
“Predictive models [would] enable allocation of patients to different treatment regimens based on matching a patient’s clinical history to the RCT results,” he says. “From a HCP marketing perspective, the availability of predictive models to aid physicians in matching patients with the most appropriate therapy is definitely something the industry should be prepared to capitalize on. For many medications we are likely to see a shift from a broad ‘one size fits all’ model to a more segmented approach with different treatment regimes for each subclass of patients. From a patient marketing perspective, once a pharma company understands which group of patients its drug is suited to [based on the predictive model], they need to be prepared to aggressively pursue that group of patients either directly or through their HCP with the goal of converting as many as possible onto their product.”
Wendy White, Founder & President of Siren Interactive, a relationship marketing agency focused on rare disorder therapies, points out that “with the rise of empowered patients and the clinical trial information that is currently being shared via social media, there is already a certain level of transparency [taking place with patients], so it’s important for pharma companies to acknowledge this.”
Ghinn adds: “Since these customers will be searching for information, it makes sense for a pharmaceutical company to take the lead in the provision of that information, when practical and within the boundaries of regulatory compliance. Furthermore, from a corporate communications perspective, sharing details of the clinical trial process could serve to educate stakeholders about investment into product development, which could have a positive impact on the company’s corporate brand.”
Transparency Opens the Door to Educating HCPs
Lustig thinks that transparency not only opens the door to a greater sharing of data with clinicians for educational purposes, but it opens up the ability for pharma to provide more direct comparisons for their drug(s) with other drugs on the market, as they will have unrestricted access to data.
“This is certainly going to prove beneficial for HCPs where historically it has been quite difficult to compare a new compound to all of the existing treatments without undertaking a specially designed RCT (typically the Phase III trial is only going to compare against the current standard of care, not against all of the potential options),” Lustig adds.
Ghinn also believes that publicizing clinical trial data provides a relevant opportunity in today’s digital age, especially when healthcare professionals are increasingly using social media to learn, collaborate and share clinical information.
“Pharmaceutical companies seeking to engage healthcare professionals via their new and emerging channels of choice need relevant content,” Ghinn explains. “In our work at Creation Healthcare, we are seeing a trend towards companies supporting Key Opinion Leaders (KOLs) to engage effectively through digital channels, and also identifying ‘Digital Opinion Leaders’ who are already influential online. The availability of clinical trial data could provide a key component of a content marketing strategy targeted at healthcare professionals.”
Transparency Will Translate into Greater Collaboration
Green believes that clinical trial data transparency will positively impact the relationship between pharma and HCPs through a “trickle-down effect.”
“[It begins with] improved collaboration between clinical investigators, KOLs and pharma companies,” Green says. “Greater collaboration and interaction in clinical trials process [between these three groups] will translate into a greater level of openness, acceptance and understanding by HCPs of new information as it becomes available.”
How Could Transparency be Bad for Pharma?
Ghinn asserts that any communication by pharmaceutical companies can be made complex because of regulatory compliance issues. “The sharing of clinical trial information has the potential to impact other areas of communication and there are bound to be tough questions to ask about how this information is made available and to whom, especially when it comes to any two-way engagement,” he says.
Green believes that “providing access to a product’s proprietary information puts it at a competitive disadvantage regardless of the circumstances, in that, generic companies, who are not subjected to the same ‘rules of engagement,’ could leverage this to their strategic advantage to enhance their methodology to more effectively challenge and overturn patents.” The other potential challenge, according to Green is that “pharma’s litigation budget is likely to increase, and product lifecycle may be shortened.”
Lustig stresses that there are downsides that pharma will need to learn how to manage.
“There will be inevitable conflicts of interest with the researchers undertaking meta-studies using the RCT data,” he says. “In a publish or perish environment, even academic researchers cannot claim to be free of such conflicts. Given the amount of money at stake for blockbuster medications and the fierce level of competition between pharma companies for market share, the data sets are inevitably going to be reviewed to see if they provide one company with an advantage over their competition.”
Pharma Companies Should Follow GSK’s Lead
White agrees that pharma should follow GSK’s lead because scientific cooperation and sharing detailed clinical research data can only increase knowledge. She also points out that starting in January 2013, the BMJ will not publish academic papers on drugs/devices unless the relevant anonymized patient-level data is made available for third-party study.
Green believes that other pharma companies should follow GSK’s lead as a matter of sensitivity and trust, but suspects that many will be slow to comply because financial implications have not been fully quantified.
“I would look for signs of pharma companies shifting perspectives and begin to deploy dedicated resources that strategically and tactically map out effective management of this new paradigm within the business model,” he says.
Lustig thinks that since the publicity of clinical trial data is inevitable, pharma should fully embrace and support the initiative.
“I think pharma needs to embrace the change and look for the ways in which it can leverage this new availability of information to benefit themselves, as well as the patients and healthcare providers they serve,” Lustig says.
Ghinn thinks that pharma’s embrace of transparency depends on each company’s existing culture.
He commented, “Given the complex communications and compliance issues to consider for any company that does make its clinical trial data public, it is not a course that would be straightforward without a significant commitment.”