Dr. Robert Findling, Director of Johns Hopkins Division of Child and Adolescent Psychiatry and leading researcher in pediatric psychopharmacology, views being a principal investigator as “a privilege, not a right.” Dr. Findling has been noted as saying “with privilege comes great responsibility”. Principal investigators who subscribe to this philosophy can set themselves apart by leading the development of cutting-edge technology and novel treatments. According to 21 CFR 812.100, General Responsibilities of investigators, P.I.s are responsible for conducting research according to the federal regulations, agreements with the sponsor, the investigational plan, and the requirements set forth by the IRB.
However, some investigators go above and beyond their responsibilities outlined in the regulations. These physicians recognize the added responsibility associated with the privilege of conducting clinical trials. Investigators that are responsive to the study team, effectively communicate with site staff, have strong interpersonal skills, demonstrate familiarity with the regulations, and exhibit comprehensive oversight of the trial are the individuals that sponsors want to work with. Once a strong, positive relationship is established with an investigator, sponsors appreciate feedback on how to keep the relationship growing. Often investigators have constructive, useful feedback on how a trial was conducted or the way a protocol was written. Sponsors may find this insight helpful for future studies. Other times, investigators choose not to work with a sponsor again as the demands of the study or the sponsor requirements create an extra burden.
Read on to learn 5 tips for sponsors to keep great principal investigators for current or future trials.
- Case Report Forms- Keep it simple! Dr. Christopher O’Connor, professor of medicine at Duke University, as noted in CardioSource, suggests that a study not have case report forms with a greater number of pages
than numberof events. The sponsor can do a thorough review of the data collected in the case report forms to confirm that it is meaningful and relevant to the overall outcome measures of the trial.
- Protocol Development- When developing protocols, sponsors may wish to consult with thought leaders in the field to confirm that the data being collected is reasonable, meaningful, and within
standardprocedure. For example, collectionof concomitant medications; consider the therapeutic area, outcome measurements, and meaningfulness of collecting every single medication the subject has ever been on. Consider collecting only statins or blood pressure medications to decrease the unnecessary burden on the staff collecting the data.
- Publication Opportunities- Establishing publication opportunities at the start of the study when executing investigator agreements allows for the physicians to take ownership of the data collected as well as expand their CVs. Mentoring investigators may consider extending publication opportunities to junior staff for development experience.
- Effective Communication- Investigators are on a need to know basis! Sponsors are understandably excited to get the first subject enrolled into a trial. An email blast to all participating investigators gets the study team excited and updates the group on recruitment timelines. However, frequent updates on enrollment, for the 2nd, 3rd, 16th subjects may not be information that investigators need to know. Keep communications streamlined with information specifically pertaining to the investigators. These communications can be sent on a regular but not too frequent basis. Allow research coordinators to communicate less pressing information to the investigators.
- Enrollment Support- Dr. O’Connor, in CardioSource, notes that many studies will not finish due to recruitment problems. Physicians appreciate enrollment support from the sponsor, whether it is in the form of advertisements, marketing materials, or brainstorming at site initiation and monitoring visits. Quick reference guides, magnets, or inclusion/exclusion “cheat-sheets” help investigators manage their study load and triage their patient population for screening. Physicians cringe at the calls from the sponsor requesting why enrollment is low and what the physician is going to do about it. Support and collaborative efforts are almost always a welcome contribution from the sponsor.
Do you have tips to share to keep good investigators conducting your trials?
Can you add to the list of things that great investigators do that set them apart?
Are there ways that your study team has changed operations between projects as a result of investigator feedback?
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