Pharma avoids risks. Industry plays it safe. Uncertainty is discouraged, even dangerous. Sound familiar? The clinical side of pharma is more black and white than its commercial counterparts, true. But risk-averse? It’s time to rethink what that means.
After all, what’s riskier than editing the human genome? Than developing a new vaccine? Than changing the way the immune system works, or reconfiguring brain chemistry? In risk management, the negative connotation often associated with risk is removed and chances are divided into either opportunities or threats.
Risk management, then, is more about having the confidence to know which risks you find acceptable and trusting that your partners have the experience to deliver balanced, thoughtful programs and services to leverage opportunities and address threats as they arise.
Avoiding risk all together means avoiding opportunities, too. Betting it all on a “risk-free” approach to business, whether that’s in clinical trials or elsewhere, means you are abandoning opportunities to succeed.
Risk management, then, is more about having the confidence to know which risks you find acceptable and trusting that your partners have the experience to deliver balanced, thoughtful programs and services to leverage opportunities and address threats as they arise.
Patient recruitment and retention is, in many ways, specialized risk management. From outreach to site management to retention and recruitability, threats and opportunities abound. Identifying them early (by conducting original research or drawing on experience) and developing a plan to mitigate threats and seize opportunities is how we find success for our sponsor partners.
Take advertising, for example. In clinical trials, outreach to patients through advertising is an opportunity to find the right patients for your trial, and to drive them to a site in their area. Investing in message refinement through a process that uses creative concept testing, as well as language based on patient insights means the ads will be more successful. But with this success comes a new risk—that sites may be overwhelmed with referrals. Overwhelmed sites are a threat—the resulting lack of follow-up means lost patients and frustrated healthcare practitioners. Managing this threat (and carefully balancing it against the opportunities it generates) is crucial to successful patient recruitment.
Avoiding the risk all together by foregoing advertising and relying on sites to recruit patients from their own database presents a different threat—more than half of clinical trial sites fail to meet their projected enrollment targets. The threat of low enrollment is surely a much less tolerable risk than the threat of abundant referrals. Having the experience to explore this balance and assess the threats and opportunities each new decision generates lets sponsors (and their partners) make smart decisions about risk management.
If clinical trials are to meet their milestones, pharma must prioritize relationships with partners who have the experience to thoughtfully manage the risks they will inevitably face. Using risk assessment to our advantage isn’t just smart, it’s essential to success.
One of the most expensive threats that sponsors face in clinical trials is losing already randomized patients. Retention strategy, then, is an important component of mitigating the risk of patient drop out. Gathering insights and experience data throughout the clinical trial, combined with predictions about patient satisfaction can inform a risk management strategy that enhances opportunities for learnings, while minimizing the threat of dropouts.
Leveraging what we know about a protocol puts us in a better position to both predict when patient satisfaction is likely to decline (is there a spinal tap during visit 7?), and preemptively put in place a communication strategy to mitigate the threat of dissatisfaction turning into noncompliance. Employing a recruitability™ approach allows us to identify threats and opens us up to gathering patient insights and experience data—an opportunity for improving patient centricity. Some threats are unavoidable, but almost all of them can be planned for in one way or another. Again, this is an opportunity for sponsors and partners to spend time understanding the entire landscape of the clinical trial and putting in place a risk management plan that sets the trial up for success.
Pharma isn’t risk-averse. It’s just been historically good at balancing equal and opposite risks—gathering the patient insights necessary to enroll the right people in the right study (a potential risk with investment of resources) versus enrolling patients you haven’t vetted or who have higher potential for dropping out of the study (a more certain threat). If clinical trials are to meet their milestones, pharma must prioritize relationships with partners who have the experience to thoughtfully manage the risks they will inevitably face. Using risk assessment to our advantage isn’t just smart, it’s essential to success.
