When protocols are not followed, it can create serious issues that slow the study down or significantly increase costs. These best practices can help sponsors and CROs work together seamlessly to prevent and alleviate protocol deviations in their clinical studies keeping development on time and within budget.
I am currently participating in a clinical trial. I have neither seen a physician nor traveled to a site for a procedure. During my first 15 days of trial participation, my samples have been sent 43 times - and I never once had to leave my house for it.
Predictive analytics will help keep clinical trials in the world of actual data rather than succumbing to “alternative data.” No longer will we be stuck estimating enrollment rates, trial costs or other simple outputs of multi-factorial processes.
Clinical trials are incorporating data from so many more sources today: genomic sequencing, medical imaging data, lab data, wearable sensor and other mHealth data. Today’s clinical research requires a technology platform that can ingest and integrate data from any data source.
Med device breakfast: Designing & implementing effective clinical trials
Running efficient and effective clinical trials for medical device and diagnostic companies has become increasingly complex. The sheer volume of available genetic and epigenetic data on patients, outcomes data on different procedures and treatments, and the variety of data from personal health trackers can be overwhelming.
Indication assessment ensures a clear understanding of unmet medical needs, patient segmentation, and what the therapeutic profile—efficacy, safety, dosing, etc.—needs to look like to meet those needs.
Bid defenses can, when executed properly, be extremely valuable. We have some insights to share that we have learned from sitting through years of CRO bid defenses and seeing both the relationships and the conduct of the clinical study play out afterward.
3 Protocol Design Strategies to Enhance Patient Recruitment
How many of the clinical trials that your company has conducted have met the initial patient recruitment timelines? How often have you seen recruitment issues increase costs or cause delays in your company’s operational objectives? Nearly 80 percent of clinical trials experience delays or even early termination due to recruitment issues.
As the majority of clinical trials involve external collaborations, healthy vendor relationships cannot be overemphasized. In parallel, the market for CROs (contract research organizations) continue to consolidate, and these businesses become as large or larger than the companies they serve.