Time and resources spent recruiting qualified subjects for clinical trials
Sponsors understand a successful clinical trial does not mean that a few subjects respond positively to a treatment. For the treatment to be approved for marketing, regulators want to see that the treatment works for a statistically significant group.That does not mean the treatment must be effective in 90 percent of subjects with a specific disease state like NSCLC, but instead the treatment is effective (as an example) for patients in stage IIIa NSCLC, with surgical excision but not yet treated with radiation.
As more targeted treatments are developed for specific disease states, looking at a narrower patient population pool becomes more involved.
CROs and some sponsors may be able to identify key opinion leaders (KOLs) who could help with the marketing of the treatment but cannot be assured that the KOL will have a large enough patient population to make recruitment goals. Resources can be spent meeting with providers at oncology events and specialty society meetings, but that research can take time and money. Some clinical development leaders also know that there are some providers who say they can meet recruitment goals are conducting several trials at once, so your trial could be at the bottom of the recruitment pool.
Recruiting those patients does not mean they will meet all the criteria for your protocol. Increasingly specific eligibility criteria are raising rates of screen fails - from 1999 to 2002, 52 percent of patients who screened completed a trial, but by 2006, that number dropped to 28 percent.1
How can you identify those specific patients in a more cost-effective and timely way?
Community oncology providers see almost 55 percent of all U.S.-diagnosed cancer patients, according to the Community Oncology Alliance.2 That majority of patients seen by the community oncology provider makes the available subject pool larger for recruitment.
How IntrinsiQ Specialty Solutions can help: access to patient datasets from the specialty providers with specific patient populations, who can be targeted by practice to biomarker, age, gender, race for a specific disease state) – and 140+ practices already engaged in clinical research; and clinical development technology expertise offered by an experienced team. We can also help identify the right practices for a sponsor’s trial by conducting site feasibility studies and then, connect the clinical development team directly to the point of care to seek out specific patients who meet the trial criteria.
To learn more about how IntrinsiQ Specialty Solutions can help find those specific patient populations, and partner to learn the attributes and inclusion criteria most important to your protocol, contact advanceIQ@intrinsiq.com.