Clinical researchers are beginning to ask why pharmacists are not well-represented on clinical drug trial teams.
When most people think of clinical drug trials, they consider patients, doctors, and the people running computer models and analyzing all the information that the trial produces. Yet most people do not consider that a pharmacist – whose expertise, after all, is drugs – might be an important part of this team.
Yet it makes perfect sense to consider how pharmacists can improve clinical trials. They view drug administration and compliance through a different lens than other clinical researchers, and this could prove valuable to researchers and patients.
Indeed, a recent study in the journal Clinical Therapeutics found that pharmacists were valuable members of the research team for two non-insulin diabetes drugs, adding only marginally to trial costs, which were later recouped because of higher patient compliance and timely study completion. Here are five examples of how pharmacists can improve clinical trials.
1. By Lending Their Unique Pharmaceutical Expertise
Pharmacists are medication experts, with experienced pharmacists possessing extensive knowledge about drugs, side effects, and interactions. When clinical trials have a pharmacist on call for study participants, researchers and patients can get answers based on strong expertise. A pharmacist may, for example, quickly pick up that a patient’s over-the-counter medication would cause an unpleasant drug interaction with the study drug and advise against taking it.
2. By Intervening to Prevent Patient Protocol Violations
In the Clinical Therapeutics study referenced above, pharmacists were on hand to help patients understand their protocol and to stick to it. Patients could reach a pharmacist by phone at any time if they were unsure of how to proceed. Pharmacists were able to explain what the patients were supposed to do, when, and how, as well as what they might expect in terms of side effects and interactions. The result was a higher proportion of study participants sticking with the clinical protocol.
3. By Helping Patients Understand Instructions
Clinical drug trial protocols must be followed meticulously to prevent data artifacts and other mistakes. Sometimes drug protocols are more complex than what the average patient is accustomed to managing. Having a pharmacist available to help patients understand their protocol instructions helps ensure that the data produced by the study is of the highest integrity and quality. If unusual data is collected, the pharmacist can confirm whether or not the patient understood what he or she was supposed to do in terms of protocol.
Pharmacists are uniquely suited to helping clinical trial patients understand how they are supposed to take the medications they are prescribed.
4. By Answering Patient Questions and Noting Adverse Reactions
One of the most important aspects of a clinical drug trial is learning about adverse reactions and side effects, and pharmacists offer unique expertise based on their experience in dispensing drugs and answering patient and doctor questions. One of the most important instances of how pharmacists can improve clinical trials is when they are able to assess patient reactions and the seriousness of those reactions. They may reassure patients after minor reactions, or know when immediate medical intervention is indicated.
5. By Offering a Positive Return on Research Investment
Overall, pharmacists add to clinical drug trials by helping maximize the return on the research investment. Though adding pharmacists to the research team raises costs incrementally, if those pharmacists help ensure that more patients stay in the trials, comply with instructions, and make note of important side effects, they make the information collected in the trial more valuable and allow researchers to be more confident of the conclusions they draw.
Researchers are asking how pharmacists can improve clinical trials, and it makes sense that pharmaceutical investors should be asking those same questions. Validity of scientific results requires consistency of research conditions and extensive documentation of how the trial is administered. Clinical trials are expensive, and researchers want to be confident their data is genuine and of high quality. Adding one or more pharmacists to clinical trial teams can be a wise use of resources that can improve the integrity of clinical trials and help healthcare deliverers, patients, and pharmaceutical investors make the smartest choices surrounding pharmaceutical products.