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It's about time

How can marketers help get compelling clinical evidence into practice faster?

A blue clock showing the hand approaching 6 o'clockThe pharmaceutical industry commits considerable resources to clinical trial programmes to provide proof of efficacy and define the role of a candidate drug in patient management. But the evidence from these trials, even when positive, may not be effectively translated into timely changes in clinical practice.

In the rapidly evolving world of pharma, this begs the question: do pharma marketers have a greater role to play in closing what has come to be known as the 'clinical care gap' and what innovative solutions can be employed to help physicians recognise the suitability and benefit of key research findings within their individual clinical settings?

Expectations of the evidence
Overcoming the ever-increasing demands from regulatory authorities and reimbursement agencies, to ensure patients get access to appropriate treatments, remains one of the most significant pressures facing industry. To meet the challenge, those involved in product development and commercialisation need innovative ways of producing compelling clinical evidence and demonstrating product value. They also need to forward plan to ensure that timely implementation of the evidence will result in an improvement in patient outcomes.

The accumulation of evidence to establish the benefits of a given therapy is the cornerstone for regulatory submissions and Health Technology Assessment (HTA). Beyond ensuring appropriate trial design and the achievement of primary and secondary outcomes, complexities in extracting and communicating value from the evidence-base to payors, regulators and ultimately within a clinical setting, remain key challenges for industry.

Demands on the evidence source to support the high level of inquiry by all stakeholders can contribute to unrealistic expectations about what the evidence is able to demonstrate.

From an HTA perspective, the evidence assessment is primarily focused on three elements: who is most likely to benefit from the pharmacological intervention, at what cost, and how does it compare to alternative therapies and interventions currently available?

The HTA has become an important bridge between research and decision making, however, there is concern that the HTA process can be used to shift medical treatment decisions away from physicians to financial managers. The balance of enquiry is then skewed toward the cost of treatment, rather than towards a thorough understanding of the clinical implications for physicians and a patient's response to treatment within the clinical setting. The hiatus we are witnessing between drug evaluation and drug availability is further compounded by, what recent Canadian studies described as, the 'clinical care gap.'

The clinical care gap refers to the distance between available research and current practice, which has been memorably described as a "practice famine amidst an evidence glut."

Many practitioners recognise the need to put important new evidence into practice more quickly and thoroughly, but as Dave Davis, professor of medicine at the University of Toronto, puts it: "A large gulf remains between what we know and what we practise." This represents the difference between available published evidence and management recommendations, and actual clinical practice.

Clinical evaluation 
The evaluation and inclusion of evidence within clinical practice is often integrated into practice guidelines. Guidelines are generally systematically developed statements designed to assist physicians and patients make decisions about appropriate healthcare for specific clinical circumstances. They are intended to advise on therapeutic benefit, reduce unnecessary variation in healthcare delivery and minimise medical error. However, even when compelling, the evidence from large-scale trials is often not included into guidelines or effectively translated into timely changes in practice. Research that could, or should, change practice often has little real impact for several years. Even when best practices are well known, they are often poorly implemented, frequently for cost reasons.

Although randomised controlled trials (RCTs) are still considered to be the most credible sources of evidence, the most desirable evidence-base is the systematic review or meta-analysis of multiple RCTs.

The use of experimental designs alone to inform clinical decisions does, however, have limitations and implications for both the patient and the healthcare community as a whole. One of the most reported issues regarding RCTs – apart from being costly and sometimes underpowered – is that they may not be representative of the wider patient population in a 'real world' clinical situation. The existence of comorbidities or concomitant treatments different to those included in the study design make it difficult for physicians to evaluate the evidence within their own patient group, based on the reported findings alone.

The challenge of closing the clinical care gap creates an opportunity for pharma marketers. They can help practitioners put important evidence into practice, while assessing its usefulness more quickly and thoroughly, and in ways that support the appropriate use and promotion of quality medicines. Such an approach would also meet a number of commercial objectives, including product uptake, brand awareness and differentiation.

The opportunity to partner
The effective implementation and uptake of clinical evidence by physicians presents an opportunity for industry to lead and partner the medical community at a local and global level. Focused efforts to evaluate key data through active and guided implementation also helps to establish effective translational models.

Although involvement in the delivery of care is somewhat unfamiliar territory for the traditional pharma marketer, industry has an opportunity to take the high ground and help the healthcare community identify and adopt best practices, not only to reduce inconsistencies in patient access to optimal treatment, but also to enhance the safety and effectiveness of their products.

This level of involvement will require that the pharma marketer takes an active role in driving and supporting strategies to ensure key data are bought to life and activated.

An appropriate response
Activation of evidence (AoE) is a translational concept previously published by Ware and colleagues, which aims to involve physician participation in the evaluation and implementation of clinical evidence more frequently than traditional and often passive dissemination strategies do.

'Activation of evidence' initiatives based on knowledge translation techniques could be a mutually beneficial way to address this challenge, ie a way for marketers to enhance the evidence they use to differentiate and communicate brand value in clinical settings. These programmes are active, focused mechanisms for behaviour change that bring key evidence to life and supplement the academic evaluation. They help healthcare providers implement the latest, most relevant knowledge derived from the most credible sources — including published guidelines and key clinical data with strong endpoints such as morbidity and mortality — to close care gaps in key areas and provide real benefits to patients.

The components
AoE initiatives cover a spectrum of activities and include tools and support programmes for clinical or bedside settings. Successful activation of evidence strategies could also include the following:

1. Active use of trial investigators and thought leaders to develop new treatment algorithms and drive practical, hands-on implementation of programmes in specific clinical settings.
2. Clinical audit and comparative feedback: mechanisms to identify, assess and improve practice by implementing current standards, guidelines or treatment algorithms.
3. Assessment and evaluation tools for healthcare professionals: electronic patient assessment and risk evaluation tools can use case histories to generate clear treatment recommendations for individual patients by applying appropriate guidelines or treatment algorithms.
4. Prompts and reminder systems: manual or computerised systems can provide doctors with a summary of each patient's relevant medical and personal history, follow-up actions from previous visits, and the latest evidence-based guidance on the best prevention and treatment protocols relevant to that patient.
5. Integrated educational outreach: dissemination of educational materials alone is not enough, but as part of a broader implementation programme, personal visits by specialists to healthcare providers in their own setting can gain acceptance of the strength of the evidence-base and help to change practice.
6. Patient-mediated interventions: support programmes that provide patients with targeted educational materials in language that can be easily understood.
7. Ongoing studies to track the effectiveness of the programme: these are key to the wider adoption of changes in practices and, over time, these studies will allow participants to evaluate their success and encourage adoption of new programmes.

AoE is not an attempt to pre-empt or replace formal guidelines from established bodies, rather it is a complement to those guidelines that will:

• Reduce the delay between publication of studies and review of guidelines, which may result in sub-optimal disease management protocols.
• Contribute constructively to the debate by measuring the effect of implementation of new evidence, thereby helping to develop definitive guidelines and determine clinical effectiveness.
• Assist trial investigators and expert opinion leaders in implementing trial evidence more widely and encourage them to drive beneficial programmes.

Of necessity, the AoE approach implies an expanded role for industry professionals in working closer with physicians and key stakeholders to demonstrate product value and the appropriate evaluation of the evidence-base within the clinical setting. By 'activating' the evidence and helping physicians recognise the clinical value and relevance of trial results, industry is able to report 'real world' impact of the evidence. This may prove to be beneficial as supportive argumentation for payors, regulators and guideline committees when evaluating overall value of a given pharmacological intervention.

The Authors
Carlyle Ware is client services director at Complete Medical Group, Basel, Switzerland, Charlie Buckwell is chief executive of Complete Medical Group and Ian Johnson is technical director of The Evidence Research Unit, the specialist market access division of Complete Medical Group.
To comment on this article, email pm@pmlive.com

20th November 2008

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