Data Integrity Issue Haunts Again With Covid Vaccine?

Data Integrity Issue Haunts Again With Covid Vaccine? 

On March 22, 2021, by a media release, AstraZeneca announced that its ‘US Phase III trial of AZD1222 demonstrated statistically significant vaccine efficacy of 79% in preventing symptomatic COVID-19 and 100% efficacy at preventing severe disease and hospitalization.’

Quite unexpectedly, on March 23, 2021, the above claim on AstraZeneca’s Covid-19 vaccine, triggered a rare post-midnight statement by the National Institute of Allergy and Infectious Diseases (NIAID) of the United states. It rekindled a lurking fear of many, yet again, on the issue of questionable data integrity within the drug industry, in general.

This News Release articulated: “Late Monday, the Data and Safety Monitoring Board (DSMB) notified NIAID, BARDA, and AstraZeneca that it was concerned by information released by AstraZeneca on initial data from its COVID-19 vaccine clinical trial.”

The concern was on the possible inclusion of outdated information from that trial, ‘which may have provided an incomplete view of the efficacy data.’ It urged AstraZeneca to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as soon as possible.

Later on that very day, AstraZeneca released another statement saying: “The numbers published yesterday were based on a pre-specified interim analysis with a data cutoff of 17 February. We have reviewed the preliminary assessment of the primary analysis and the results were consistent with the interim analysis. We are now completing the validation of the statistical analysis.”

The company further emphasized, “We will immediately engage with the independent data safety monitoring board (DSMB) to share our primary analysis with the most up to date efficacy data.” And also added that AstraZeneca intends to issue the results of the primary analysis within 48 hours.

However, the impact of the NIAID’s announcement on the unfurling of AstraZeneca’s Covid-19 vaccine in the U.S, is yet to be ascertained. It’s also still unknown what this news could mean for the vaccine’s alleged efficacy. Be that as it may, it all happened at a time when millions of people, in many countries of the world, including India, have already taken, at least, the first dose of this vaccine.

In this article, I shall deliberate on broader aspects of this critical issue and its relevance in the present case. However, before doing so, let’s try to figure out, why data integrity still remains a major concern of many experts in this area.

Why data integrity is still a major issue:

There are many studies that raised serious concern in this area, over a period of time. For example – ‘Dozens of recent clinical trials may contain wrong or falsified data’ – was claimed by the research paper that was discussed in ‘The Guardian’ on June 05, 2017.

This study reviewed data from 5,087 clinical trials, published during the past 15 years, in two prestigious medical journals – JAMA and the New England Journal of Medicine, and six anesthesia journals. In total, 90 published trials had underlying statistical patterns that were unlikely to appear by chance (or be termed as ‘unforced error’) in a credible dataset, the paper concluded.

Even my own article of September 30, 2019 deliberated on various facets of ‘data integrity’ involving novel therapy, across the world. There, I quoted one of the top medical experts related to the above paper, saying: “It’s very scary that we may be treating patients based on false evidence.” He further added: “It may be the case that certain treatments may need to be withdrawn from use.”

The ghost of a recent example still haunts:

Not so long ago, much reported fallout from Novartis’ alleged data manipulation fiasco with its billion-dollar gene therapy Zolgensma, shook all concerned. So much so, that the Company CEO had to pledge during an investor conference that: ‘the company will be more proactive in reporting data integrity issues to the FDA.’

He also added, Novartis has responded to the FDA’s Form 483 and is making documents available as requested, while reiterating that the data manipulation uncovered at the San Diego site “does not impact the safety, efficacy or quality of Zolgensma.”

The key point to ponder, therefore, especially in AstraZeneca’s Covid-19 vaccine case – is the same ghost haunting us, yet again?

Is it happening again? 

One may, possibly, find some cue of the answer to this question while looking at what followed after ‘validation of the statistical analysis’ by AstraZeneca, as it was promised by the company. Interestingly, the following day, after apparently a thorough analysis,...continue reading at..Data Integrity Issue Haunts Again With Covid Vaccine?  

Creating A Unique Patient Experience By Listening To Patients Voice – An Imperative In The New Normal

Creating A Unique Patient Experience By Listening To Patients Voice – An Imperative In The New Normal 

Acquiring deeper insight on the patient journey through a disease treatment process to create and enhance end-to-end patient experience, never assumed such critical importance, ever in the past. Without this realization, I reckon, even digitalization of any scale in the pharmaceutical industry, is unlikely to yield desired results. The term ‘Patient experience’ is generally considered as ‘the summation of interactions that influence patient perceptions across the continuum of care, until now,’ as defined in an article, published by Aranca on February 28, 2020.

This isn’t a new concept. This subject was well-deliberated even before the pandemic crisis. For example, an article, published in the Pharma Voice on April 2014, had also highlighted this point. It wrote: “Too many companies continue to view the world as a physician-centric, and do not recognize the growing influence of the patient in treatment decisions. The evolution toward a fully integrated commercialization approach centering on the patient experience will continue to crystallize over the next five to 10 years. Within a few years the industry will universally have one goal that supports the patient experience, as there is a tremendous amount of attention being put on the patient today.”

Even thereafter, another paper, published in the Reuters Event Pharma, on August 17, 2017, also reiterated: ‘A greater understanding of the patient journey is rapidly becoming an essential tool for market access.’ It further elaborated that the use of patient journey data stands to benefit everyone:

• Patients: through empowerment programs,
• Pharma marketers and more widely, the Company: by targeting the right patient segment and the company more widely.

The paper concluded: ‘Given the potential benefits, pharmaceutical companies should develop a robust mechanism to design effective patient journeys, which could prove instrumental when it comes to bridging treatment gaps and improving quality of life for countless patients around the world.’

From this perspective, Covid-19 pandemic seems to have hastened the process with changing customer behavior and expectations in the new normal, thorough understanding of customer needs emerged as a key success requirement for pharma marketers. That said, customer experience has to be measured both qualitatively and quantitively through credible market research initiatives, capturing the patients’ views. Guessing the same, as was generally the common practice in the old normal, would no longer suffice. This article will dwell in this area.

The pandemic played a catalytic role:

That Covid-19 pandemic played a catalytic role to hasten the process of providing a unique patient experience during a patient’s journey through a disease treatment process in the digital world. This was vindicated by a ZS study, published on July 05, 2020. The analysis found – over the last three months several companies started looking at new ways to engage with patients. These include:

• Forming patient panels – to continually check and monitor the quality of patient experience that the company is providing,
• Connecting with patient advocacy groups – to get a pulse on critical needs
• Leveraging the field force – to hear from physicians where their patients need the most help.

These are laudable initiatives for dovetailing patients’ views in the drug marketing strategy to provide a unique experience to patients during their end-end-to journey through a disease treatment process.

Measuring patient-experience – an integral part of digital sales and marketing:

Measuring patient-experience has always been an integral part, virtually of all types of sales and marketing using digital platforms. We experience it almost every day, such as, while buying a product through Amazon, buying grocery items through D-Mart, scheduling a doctor appointment through Practo, buying medicines through PharmaEasy, or even for availing a service through Urban Company.

The November 15, 2020 research report of DT Consulting has also reiterated this need. It found, patients seeking and receiving care, depend on a complex system of health providers—an environment in which pharmaceutical companies play an important role. ‘When seeking care, patients gravitate to experiences that other patients rated well; when receiving care, they prefer experiences that consistently meet or exceed their expectations,’ it underscored.

Why then all pharma digital initiatives for its customers aren’t in sync with such practices? It’s about time that pharma players also follow a similar path, to continually improve company offerings, based on what the customers expect from a company’s brand and services – regardless of whether they are doctors, patients or any other key stakeholder.

I re-emphasize, this initiative has to cover end-to-end of a customer journey starting from clinical development, brand launch and expansion of market access. In each of these stages, loose knots, if any, require to be tightened, after thorough deliberations, to delight the customers – and consequently rewarded by them, appropriately. While some progress can be seen in this area, pan industry progress in this space, still falls much short of other industries. A pharma company may continue to ignore its importance, even in the new normal, at its own peril.

The way forward won’t be a bed of roses, expect thorns to overcome:

The above ZS study also brought out some interesting facts, as follows:

• 43% of participants cited difficulty identifying quantitative, measurable KPIs that fit within the organizational structure and practices,

• 29% indicated ..... continue reading at Creating A Unique Patient Experience By Listening To Patients Voice – An Imperative In The New Normal 

How Pharma To Stay Relevant To Customers In The New Digital World

How Pharma To Stay Relevant To Customers In The New Digital World 

Covid-19 vaccination has commenced in India on January 16, 2021, as in several other countries of the world. A few million Indians, across the country have already received their first shot, according to media reports. But, this isn’t the endgame of pandemic by any measure. Covid-19 will get over – only when it gets over.

Interestingly, on March 07, 2021, the Union Health Minister claimed, ‘the country is in the end game of the COVID-19 pandemic. Curiously, the very next day – the Indian Medical Association IMA termed it as: ‘Unauthorized political statements on Covid-19 pandemic invokes a false sense of security.’ Moreover, vindicating the IMA statement, the Coronavirus trend report, updated as on March 05, 2021 clearly demonstrated that ‘The pandemic is far from over.’

As a fallout of this pandemic, alongside many other nations of the world, most industries in India are going through a recovery process of disruptive changes in the business processes, after a harrowing time. Pharma industry is no exception in this area. Recreating contemporary operational processes to excel in the new normal, would call for not only jettisoning many practices from the old normal by the new ones, but also the creative deployment of the precious resources, by each pharma players.

Accordingly, the need for avant-garde digital-based customer engagement services, is gathering winds on the sails of the ships of pharma marketers, signaling a ‘never before’ urgency to move in this direction. It’s a new business imperative to survive, perform, and excel in pharma. At the same time, the industry also should examine other critical changes required in its primary interfaces with customers, in today’s fast evolving scenario.

This process would involve redefining the new roles of some critical positions in the organization. Today’s article will explore how pharma will stay relevant to its customers, increasingly getting more and more involved in the new digital practices.

Some key challenges in pharma digital strategy:

One of the key challenges for a productive ‘company – physician engagement’, in the new normal, is to be available at any preferred time of customers’ choice and the way they want. This may include, both virtual and in-person F2F engagements, along with customized contents for the same. This need is universal and, by and large, remains the same for key stakeholders of all drug companies.

This point was further reinforced, in the February 22, 2021 article on capacity building in the digital space, published in Reuters Events, Pharma. It focused on demands in new era of ‘digital-first customer engagement’, where content creation and omnichannel engagement also play equally vital roles.

Besides, the paper emphasized, today’s need is investing in the type of contents that add clinical value, as opposed to overtly commercial marketing type material. The primary task for marketers is now, therefore, to use updated, high-quality, neutral content on customer engagement platforms that will offer value – the customers are looking for – and not just values from a company’s self-serving perspective. From this angle, the new content model prompts greater customer involvement for meaningful outcomes.

In tandem, company staff members – including medical representatives, need to acquire multi-tasking expertise, being equipped with – required digital knowledge, skills on using digital platforms and ascertaining individual key customers’ engagement needs. Whereas a company’s digital strategist will work on “digital initiatives, solutions, products and how those will be integrated locally.” Thus, this is not about making everyone a digital expert, as the article underscores.

Need to redefine work processes and realigning the staff members:

As the above article from Reuters Events reconfirms, the digital approach that several pharma players were taking even a year or two ago is redundant in the new normal. Amid rapid transformation in the drug business, ‘pharmaceutical industry can no longer act like ostriches. Digital is no longer a fancy add-on, it’s an integral part of everything we do,’ the study highlighted.

Thus, to move in this direction effectively, pharma companies would require redefining many work processes and realign the staff members in sync with their new roles, accordingly. Further elaborating this point, the Accenture study – ‘A digital booster dose for health care,’ identified a few such roles that will undergo a metamorphosis to meet with post Covid challenges. Following are some, where urgent transformations required are, as follows:

 A.   ‘Intelligent representatives’ – not just ‘medical representatives’: 

In the current scenario, rep’s engagement process with the medical profession calls for leveraging specific intelligence based on behavioral preferences. This is fast emerging as a key requirement. Thus, the paper underscores: “Armed with a closed-looped CRM, representatives can effectively use data insights to plan, deliver and report calls.” I also indicated earlier – to succeed in this effort, individual skill sets, such as digital awareness and analytics will be of great use. The core objective is, looking through physicians’ eyes to understand their needs and solve problems by ‘serving customers as individuals, not as numbers in a call roster,’ the study emphasized.

B.  ‘Customer experience managers’ – not just ‘brand managers’: 

While using omnichannel digital platforms, doctor-patient interactions become more content dependent. Accordingly, brand managers’ role will be pivotal to facilitate a uniform interaction experience across all channels.

Therefore, for targeted communication, better understanding of doctors and patients and how they want to be engaged, is a key requirement. Which is why, brand managers will have to acquire skills, such as content management for continuous engagement across multiple channels. This is now absolutely necessary for effective branding in fostering a new genre of ‘customer-brand relationship’ model, across the company.

C. ‘Helping doctors manage their practice and patients better’ – not just ‘brand marketing’: 

‘Think beyond the patients’...continue reading at http://www.tapanray.in/how-pharma-to-stay-relevant-to-customers-in-the-new-digital-world/

Appears On Radar New L&D Needs For Pharma’s New e-Environment

Appears On Radar New L&D Needs For Pharma’s New e-Environment 

As drug companies were desperately trying to navigate through the operational disruptions due to Covid crisis, the Learning and Development (LD) plans of most organizations, considered so important for employees, got badly impacted. This was ably captured in the article – ‘Adapting workplace learning in the time of Coronavirus’, appeared in the March 2020 issue of McKinsey Accelerate.

It highlighted, as businesses around the world postpone and cancel in-person meetings in response to the COVID-19 pandemic, “workplace learning is emerging as one of the earliest and hardest-hit business activities.” The paper further elucidated: “Based on our observations as of early March, roughly one-half of in-person programs through June 30, 2020, have been postponed or canceled in North America. Whereas “in parts of Asia and Europe, the figure is closer to 100 percent.”

Interestingly, no one is talking much about it as much as the need for quick digitalization in the pharma industry, to respond to the challenge of disruptive changes. A quick return to employee L&D initiatives in the new normal, I reckon, would encourage, particularly the hands-on staff members on e-marketing to come out with more innovative digital solutions to reap a rich harvest from remote engagement with customers, on an ongoing basis.

In this article, I shall explore this area from the perspective of increasing employee productivity in the digital work environment of the new normal.

Why is L&D more relevant to pharma employees, now?

To effectively respond to post-Covid changes in customer behavior – aspirations – expectations – other market dynamics, alongside a different genre of competition, new learnings in the digital space, is critical for all employees. Which is why, it is so important for pharma players to quickly refocus on this process, just as digitalization. Without requisite digital skill development, corporate performance may look lackluster, eventually.

It is important for all to recognize that just digital transformation of business isn’t a panacea. For example, e-marketing is certainly a powerful contemporary marketing tool that a company must go for. But, it is no less important to know how making effective use of this versatile technology would appeal to individual customer emotions, with personalized content. Medical Representatives of pre-Covid days may not be generally well-versed in this area, at least, as much as they ought to – now.

Some pace-setting Indian examples in this area:

According to an article, published in leading Indian business daily on June 17, 2020, the Indian pharma major – Lupin, reportedly, used the lockdown as an opportunity to train its sales teams on medical acumen, soft skills, disease knowledge, effective communication etc. They conducted over 200 sessions using Microsoft Teams. In some sessions, the attendance count reached 8000 people.

As the article points out, using digital tools and platforms, the company reps were enabled to record a video of brand detailing and share it with the doctors who can view it as per his or her convenience. It also says, ‘Lupin team reached out to more than 1 lakh doctors through live webinars, ECMEs, e-mailers, webinars to update them with the latest medical and therapeutic advancements.’

The core idea of this initiative is undoubtedly worth imbibing, although, it is still not clear to many, how effective were those digital marketing strategies in the form as it has been described.

The new e-environment needs new sets of L&D models:

From the above perspective, the take home message, I reckon, is - in pharma’s new normal, digitalization isn’t just about a modern and contemporary technology. It is much more profound – signifies the criticality of credible data-based, novel decision-making process, offering high yield solutions to complex sets of disruptive problems in business.  Consequently, now appears on the radar a new set of L&D needs for the new e-environment of the pharma industry.

Ramifications of e-environment changes in pharma business: 

Many studies have pointed out to a number of changes in pharma industry’s e-environment, in the new normal. Just to give a sense of such mega changes, let me quote another recent paper in this regard....continue reading at http://www.tapanray.in/appears-on-radar-new-ld-needs-for-pharmas-new-e-environment/