There is a vibrant field of clinical research into new approaches for tackling cancer, and the picture is particularly positive for patients with rare tumor types that have received limited attention in the past. As a proportion of the patients in phase 1 studies, the common cancer types are decreasing and the uncommon types are increasing. (Medical Xpress)
Target cancer stem cells and revolutionize cancer treatment
About 95-98% of new anti-cancer drugs fail phase III clinical trials. Most drugs are made to target “bulk” cancer cells, but not the root cause: the cancer stem cell. New therapies that specifically target and eradicate these cancer stem cells are needed to prevent tumors from growing and spreading, and we may then be able to turn cancer into a manageable chronic disease. (INDEPENDENT)
Profit motive and aversion to risk limit Alzheimer’s progress
Large pharmaceutical companies have been cutting back on their in-house Alzheimer’s research and development. The lack of progress in the fight against Alzheimer’s likely has more to do with the world of finance than the world of biology. Pharmaceutical companies are not able to pursue promising research directions due to business model considerations of profit potential and investment risk. (being patient)
Can Flatiron succeed in changing the clinical trial model?
Flatiron Health, a small tech company acquired by Roche, is trying to use real-world data from patient electronic medical records to replace more traditional clinical trial data. One of their major goals is to use data from health records to mimic a control group. However, FDA is not fully on board with the prospect of replacing control groups. (STAT)
The physician-sponsored IDE clinical trial
The Physician-Sponsored Investigational Device Exemption (PS-IDE) clinical trial is when a physician acts as a sponsor-investigator and both initiates and actually conducts, alone or with others, a drug or device study. It’s a challenge for the hospital or site to accommodate a physician who is conducting a PS-IDE trial because they have traditionally performed the site responsibilities and activities only. (ACRPnet.org)
‘The magic balance’: Diverse advisory boards guide clinical trial design
With the recent marriage between technology and science aimed at innovating aspects of clinical trials panels composed of experts from fields outside of pharma could prove to be impactful.(outsourcing-pharma.com)
Indian association seeks greater investment in clinical research ecosystem
The Indian Society for Clinical Research (ISCR) is seeking greater investment in research and urging stakeholders to strengthen the clinical research ecosystem in the country to address India’s growing disease burden. India has the second highest population and highest disease burden in the world, but only 1.2% of clinical trials are done in India. (The Times of India)
FDA guidance promises flexibility for stem cell trials
In a final guidance issued last week, “Expedited Programs for Regenerative Medicine Therapies for Serious Conditions”, regulators are promising flexibility in clinical trial design for stem cell therapies in rare diseases. The FDA is also promising to be flexible about fast-tracking some potential stem cell treatments. (CenterWatch)
Survey reveals patient perspective on clinical trials
www.appliedclinicaltrialsonline.com
A recent survey of 4,000 patients and care providers examined the patient perspective on clinical trials. The most important motivator to take part in a trial was safety- the clinical trial should do no harm. Institutional support from one’s physician was also important, as were health benefits– the potential to benefit their personal health. (Applied Clinical Trials)
Sites having trouble getting paid, affects trial success
A recent survey of more than 500 respondents from clinical trial sites across the globe by Greenphire, a global leader in financial software for clinical trials, and the Society for Clinical Research Sites (SCRS) found that sites still face challenges in payment processes. The biggest challenge is getting appropriate funding for the study. (CISION PR NewsWire)
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