Patients as research stakeholders Patient participation

patient participation can include broad spectrum of activities human subjects during clinical trials , has become associated several other words such “patient engagement” or “decision making.”

this includes agenda-setting, clinical guideline development , clinical trial design.

clinical trials

in us, trends in patient participation have been influenced variety of sources , previous political movements. 1 such source patient participation in clinical research aids epidemic in 1980s , 1990s. during epidemic, aids activists argued not new clinical trial models, importance of additional social service groups support wider range of potential human subjects. since then, fda has taken several steps include patients earlier in drug development process. authorization of prescription drug user fee act (pdufa) v in 2012 included patient-focused drug development (pfdd) initiative provide fda way of hearing patients’ perspectives , concerns. similarly, european medicine agency (ema) has been attempting incorporate patient perspectives during evaluation of medicinal products ema scientific committees.

there has been increased interest among healthcare providers, such nurses, in cultivating patient participation. due increased interest, studies have been done assess benefits , risks of patient participation , engagement in research. benefits, patient engagement improves patient outcomes clinical trial enrollment , retention. risks, has been proposed inclusion of patient participation may lead extended research times , increased funding clinical trials.

a few of tools used cultivate patient participation in clinical research have been growth of patient organizations along development of databases , concept of patient or disease registry. these tools allow mass collection , dissemination of data. registries, specifically, not allow patients access personal information, registries allow physicians review outcomes , experiences of several patients received treatment medicinal products . furthermore, registries , patient participation have been particularly important development of rare-disease medicines. in us, rare diseases clinical research network (rdcrn) created in 2003 includes registry patients afflicted rare-disease. registry provides information patients , allows physicians contact potential patients enrollment in clinical trials.

patients have new resource them navigate clinical trials landscape , find lay summaries of medital research in opentrials database launched alltrials campaign in 2016 part of open data in medicine.

precision medicine change conduct of clinical trials, , role of patients subjects. key making precision medicine mainstream ongoing shift in relationship between patients , physicians comments n.j. schork venter institute in nature. cites reasons development growing interest in omics assays , cheap , efficient devices collect health data.

a newer article in nature outlines conditions patent participation can optimized, , co-authored jennifer wagner et al.

with cancer being prime target precision medicine, dr. jennifer carter, founder of start-up n-of-one, recruits patients participate in clinical trials find cure it.