The average price tag for a new drugs approval is now $2.5 billion. 40% of that cost is related to study enrollment. If a drug company cannot afford the maintenance costs of a clinical trial, that drug may be killed. It is conceivable that recruitment costs alone are preventing life-saving medications from making it into the hands of sick patients.
In 2012, 28,000 unique Principal Investigators (“sites”) worldwide filed a form 1572 and began recruitment efforts to identify and enroll qualified volunteers. While the types of studies being offered range as wide as the number of treatable medical conditions, many of these sites are conducting studies in the same therapeutic areas and literally have offices right up the street from each other. Part of the solution to drug development costs may lie in collaboration. Is it within the realm of possibility that we can view “competitive sites” as “complimentary”, by establishing an efficient way to refer eligible study volunteers?Here is an example, lets say that Site A is advertising for a study seeking volunteers age 18-65 who are having symptoms of Major Depressive Disorder. They place a television advertisement and after phone screening 10 callers, 4 sounded like they may qualify for the MDD study. Out of the other 6, 2 were over the age of 65, 2 had insulin dependent diabetes (which was exclusionary for that specific study), and 2 were struggling with substance abuse/dependence. Ideally those 6 unqualified callers would be put into the sites database and that database is monitored and updated regularly by a staff member dedicated to cleaning, organizing and monitoring the database for upcoming studies.But, this doesn’t always happen. Sites rarely have a dedicated recruiter and CRC’s often get too busy with visits, queries, trainings, investigator meetings etc. to bother with database mining. Its easier to generate new calls through placing new advertising. Also, potential study volunteers change phone numbers, move, lose interest etc. Fast forward 6 months-1 year ahead and site A is awarded a study that those callers may be eligible for. What is the likelihood that those callers have the same phone number, have remaining symptoms, have a schedule that accommodates weekly study visits or are even still interested in the study they originally called about? The point is that volunteers who are ready and willing to immediately participate in a study and help advance modern medicine, fall through the cracks.
Lets consider a hypothetical scenario. What if, site A was willing to reach out to site B regarding a recruitment referral system. Site B is a mile from site A’s office and they are currently enrolling in a MDD study for volunteers ages 18-75. 2 of Site A’s non-qualified, overage callers could potentially be screened for site B’s study. Site B also has the benefit of the callers high interest level and up-to-date contact information. Just to keep things interesting, enter site C. This site just started enrolling in a study evaluating a new type of cognitive treatment for people with addictions. Site C can now benefit from site A’s non-qualified callers who met criteria for substance abuse.
In a perfectly harmonious world, this could work nicely. But, whats in it for site A? Would site A be better off just hording the callers contact info and hope they eventually secure a suitable study, while crossing their fingers that those callers don’t visit clinicaltrials.gov or Centerwatch? This may boil down to the question of karma. Do you think that what goes around comes around?
This sort of cooperation among researchers could result in shorter study timelines and ultimately get life-saving medicines approved faster. So here is the question: What is preventing your site from reaching out to competitive sites? Do you feel that by helping another site recruit efficiently, you’re giving up potential revenue? Have you tried reaching out to other sites? How was the experience? We could make this type of referral system easy. TrialSphere allows sites to create invite only groups with other research professionals, post updates to the group, communicate with other sites privately, upload documents etc. Do you think that this could be a valuable tool?