Rebuilding Pharma Begins with Patients
Successfully engaging patients in a clinical trial setting is a challenge. Hugo Stephenson MD, Executive Chairman, DrugDev looks at the key principles of patient engagement that work.
In January 2013, the UK based consultancy group PatientView surveyed 600 patient groups across Europe and the Americas to evaluate the corporate reputation of pharma in general and 29 leading pharma companies specifically. In terms of reputation, the pharma industry was 7th of the 8 healthcare sectors evaluated. Only 34% of respondents gave pharma a “good” or “excellent” rating for reputation. Pharma trailed retail pharmacists (62%), medical device companies (50%), private healthcare services (46%), biotechs (44%), not-for-profit health insures (39%) and generic drug makers (37%). Only for-profit health insurers trailed pharma with 24%. Given how easy it is to find unflattering articles about the pharmaceutical industry, these results are not surprising – yet, in order to bring about a new generation of medicines upon which we can rebuild this industry, we require hundreds of thousands of patients to give of themselves to participate in our clinical trials.
Succinctly put: we are living in the middle of a crisis of engagement with patients that cannot be fixed by simply directing more and more protocols to the developing world.
How Can We Fix This?
As we search for effective methods to engage patients better, it is helpful to consider successful experiences engaging other clinical groups (in our case, global investigators) to discover common challenges and potential solutions.
DrugDev was founded in 2007 with the aim of building greater engagement between industry and research doctors – including professional investigators and key opinion leaders, but also private clinicians and specialists interested in taking the temperature of the water, but not necessarily committed to the path. At the time, investigators and research sites faced the same challenges with engagement that we encounter with patients today:
Lack of Inclusion: Sites usually had no input into study design or direction and were frequently being asked to participate in protocols on a ‘take it or leave it’ basis. Not surprisingly, the protocols that pharma wanted to run were not always the ones that sites wanted.
Poor Communication: Sites were often asked to invest significant time up front by completing long study feasibility questionnaires with no payment, and almost no follow-up in the event they were not successful. In an internally run 2009 DrugDev survey of research sites, over 70% of sites sending back feasibility questionnaires to pharma or CRO never even received confirmation of receipt, let alone follow-up in the event they were not being considered.
Inadequate Transparency: Sites typically were given no visibility into upcoming clinical trials until the last minute, nor any feedback on the reasons why they were/were not selected for specific studies (or the criteria upon which these selections were based).
Non-existent Continuity: Those sites that ended up being chosen for a study were forced to log into multiple, disparate systems and interact with multiple points of contact simply to maintain their information, before even trying to enroll patients and capture data.
Haphazard Reimbursement: Unfortunately, investigators have traditionally been paid in a haphazard and error-prone manner. Many sites facing 90-day+ payment cycles were unable to manage their shrinking businesses – and were beginning to close down.
As an organization, we have made significant strides in addressing investigator engagement, resulting in over 70,000 research doctors today opting to register with the DrugDev network. This has been accomplished by operating with an almost exclusively investigator-centric view of the challenges at hand. Let’s look at our experiences as a case study.
Throughout consistent global outreach, we learned that specialist doctors rely heavily on assistants to interact with administrative systems –they didn’t log onto online platforms themselves (not Facebook, not LinkedIn, and certainly not a clinical trial management system). We also learned that they preferred to communicate by email, usually through mobile devices.
Equipped with this understanding, we hired DrugDev Research Assistants who speak and write in local languages to engage with these doctors and maintain their profiles for them. Where possible, we capture feasibility responses in email, and consolidate data on our end – rather than forcing doctors to log into lengthy survey systems. We introduced the not-so-novel concept of following up with each doctor from whom we had received an expression of study participation and – even when a site was not successful – provided some feedback on ways the site could improve their chances of success next time.
We then partnered with leading pharma companies to establish the Investigator Databank – a one-stop-shop for research doctors to maintain their research relevant information without having to complete the same information and training in different ways for different sponsors. Of course, we took a significant step forward towards integrating sites’ online experience through our acquisition of TrialNetworks, and their payment frequency and accuracy through our purchase of CFS Clinical, now DrugDev Payments.
We believe the industry can adopt a similar approach for patients and achieve the same success.
How Does This Apply to Patients?
For the last few years, we have all heard terms like “patient-centricity” and “patient engagement” being used more frequently in our industry. These words suggest different approaches for different people, so to make these words actionable we believe that the same principles DrugDev has successfully applied towards investigator engagement must now be applied to patients too.
At a time when patients are both increasingly educated and empowered – yet have the lowest trust in our industry on record - only the sponsors and CROs that are committed to implementing these principles of patient engagement on every study (not just pilots) will be able to rebuild their pipelines - and ultimately product sales - on a solid foundation:
1. Inclusion. Running a trial in a manner that no patient would be interested in sounds like an obvious recipe for disaster, yet few medical teams take protocols out to potential patients to test their acceptability. Would a patient who is finally barely stable on a particular medication be willing to change their treatment regime? Are the frequencies and types of visit schedule and investigation convenient for patients? A trial cannot be patient-centric unless patients have input into the design process – and neither CROs nor sponsors can achieve this without access to appropriate patient groups in the right regions.
2. Communication. Patients should be kept in the loop regarding their responsibilities, risks, benefits and contribution during and after their trial without compromising their privacy. They are an integral part of the study team, and need to be offered the chance to be as educated as possible on the background to the trial, why it holds scientific potential and ongoing results from the trial even after it has finished in a manner they can understand. This means delivering informed consent through videos and cartoons, not 20+ pages of legalese. It involves ongoing communication every time major results are published, the drug is approved for mainstream use by a regulator, or a major news story breaks about the treatment that they helped make possible. A trial cannot be patient-centric unless the sponsor has a means to communicate important information with study participants in their own language during and after completion of the study.
3. Transparency. Too often, we act as though we have something to hide – from the very people who are so giving of themselves with us. Patients should have easy and immediate access to information regarding the study that may otherwise be obscure or difficult to obtain. This ranges from documents they’ve signed to the data we’ve captured about them. If they want a copy of the protocol, it should be at their fingertips. Ditto consent forms. They should be able to print whatever information they want so they can take it to their family doctor for review. Even if they don’t want it now, they might want it later. We must make this information easily accessible and ensure that its availability survives the life of the study or even the site.
4. Continuity. In trying to improve a patient’s experience, we run the risk of overloading them with many unrelated systems in the same way we, as an industry, had historically done with sites. Already we are seeing patients leave screening visits with instructions to login to an ePRO system, a separate video training system, a separate reminders system, a separate payments system, and what else? Then we provide them a telephone number for an unrelated call center. Individually these services may make things easier for the patient, but lined up together it makes the overall experience entirely cumbersome, time-consuming and frustrating. Without a commitment towards continuity, you could make an argument that patients had it easier when none of these systems existed and they had one phone number – that of their site – they could call with any question or concern. Unless we can encourage convergence of disparate systems into a unified patient interface, the reality of patient-centricity will keep slipping further away.
5. Reimbursement. Too many study teams provide little or no support towards patient reimbursement of time and travel. This means that reimbursement decisions are usually left entirely up to sites, resulting in large differences in payment policy for patients at different sites even amongst those in the same geographical area. For sites that experience problems with cashflow, it can even mean that patients are required to go out of pocket for many weeks before being reimbursed. Clearly a trial cannot be patient-centric without a consistent approach to patient reimbursement, and therefore a way that patients can receive timely payments in a manner that does not require them to bankroll their own participation.
With more products falling off patent every year, pharma must rebuild itself through its pipeline and its ability to bring new medicines to market to address unmet medical needs. This is only possible through the voluntary participation of hundreds of thousands of patients every year. At a time where patients have increased access to information, and are increasingly surrounded by unflattering representation of the pharmaceutical industry, it is clear that those organizations that successfully engage patients will fare much better than those who do not.
As a project manager, clinical research associate or even data manager you will soon be faced with the opportunity to choose between a traditional approach to clinical operations, and a commitment to patient-centricity through inclusion, communication, transparency, continuity and reimbursement – usually in conjunction with efforts involving the site. If done correctly, patient-centricity will create site advocates and it will increase patient satisfaction with your company. Perhaps most importantly, it will help us treat patients right – easing their burden and showing real gratitude for all that they give to us – while setting an optimistic tone for recruitment and retention rates for your future trials.
We’ve seen engagement strategies work for sites and investigators - now it is time for innovative technology providers to offer the same approaches for patients too.
About the Author
Hugo Stephenson MD is Executive Chairman of DrugDev, which provides technology-driven solutions that enable sponsors, CROs and sites to do more clinical trials together. He is a medical doctor and biotech services entrepreneur who is passionate about organizations that think out of the box to improve life. Dr. Stephenson can be reached at firstname.lastname@example.org
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