Of all the truisms that apply to clinical drug research, probably none is more universally accepted than this one: “There’s no substitute for experience.” But if you’re working in an indication that is not widely studied, selecting sites on the basis of experience can be difficult.
That’s one of many subjects we addressed in a recent Premier Research webcast, Neuropathic Pain Studies: Patient Selection, Study Design, and Clinical Trial Challenges.
Site selection and start-up
Working with less experienced sites requires a lot of training and interaction to achieve the required level of understanding and proficiency. Fortunately, most sites can use central institutional review boards to achieve fast start-up. In the absence of data relevant to the specific type of drug under development, we look at site performance information on data quality, patient enrollment, staff relationships, and assessment skills.
Currently, the technology exists to analyze performance metrics on sites we’ve used before and overlay that intelligence with input from vendors and other outside companies that have broader access to site performance data. That way, we can objectively evaluate sites on the basis of the most important criteria, such as data integrity and the ability to manage placebo response — a concern that is of particular (and growing) significance in pain trials.
The enrollment rates of pain studies are such that most sites are not accustomed to seeing large numbers of analgesia patients. A site might, for example, see these patients only every other month, so you need to continually interact with them to stay top of mind and avoid retraining the staff every time the patient makes a visit.
Additional factors for site selection
You also need to determine if the sites are handling competing trials — not just competing for an indication but also competing for staff time. The coordinator is critical to helping your trial progress, and if you aren’t first on his or her list, you risk falling by the wayside.
Evaluating sites for objectivity of research versus patient care is also essential. Every study is different, and the details really matter when it comes to inclusion/exclusion criteria. It’s easy to say, “We’ve worked with this site before, so we can skip a site qualification visit.” That site might have worked miracles for you in the past, but you still need a qualification screening — even if it’s done over the phone. All indications are different, and there is always a tremendous amount of turnover. Trust but verify: another well-worn truism that could hardly be truer here.
Current trends in analgesia trials
Our webcast also looked at some trends in the pain studies we’re working on:
- With the decline in opioid research, we’re seeing a more diverse range of trials, including more injectables and locally acting patches. Also, drugs like pregabalin and duloxetine are looking to expand their labels
- Recruiting for these trials has been aided by widespread pharmaceutical marketing (who hasn’t seen a TV commercial for Lyrica at least a hundred times?) and availability of research advertising
- In indications including painful diabetic neuropathy, gene-based therapies are now being researched. Analgesic research is still focused mostly on treating pain as a symptom of another affliction, and it’s gratifying to see disease-modifying agents begin to come into play
- Treatment of postherpetic neuralgia is advancing rapidly. In addition to TRPV1 antagonists, better and longer-lasting lidocaine and capsaicin patches have emerged recently
- In treatment of chemotherapy-induced neuropathic pain, naturally derived neurotoxins are showing promise, and we’ve seen sustainable TRPV1 nerve impedance in treating Morton’s neuroma. These newer treatments are lasting for three and even six months in some cases
Our webcast covered these and many other topics surrounding site selection and execution in neuropathic pain trials. Check it out!