Featured Trial Design Editorial

  1. Clinical News Roundup: Why All The Love For Adaptive Trials?

    Clinical News Roundup for the week of April 10, 2017 with information on Scott Gottlieb and adaptive approaches, preparing for epidemic clinical trials, proposed tax law changes for clinical research, and using selfies to improve medicine adherence.  

  2. Finding The Right CRO For Rare Disease Trials

    CRO selection is a challenge for every company outsourcing clinical trials. When the trial you are about to launch is for a rare genetic disease and has 30 patients spread across multiple countries and continents, the challenges are multiplied. This was the situation for Cerenis Therapeutics, which recently launched a Phase 3 trial for patients having very low levels of high-density lipoprotein.

  3. Lilly Makes It Easier For Physicians To Become Investigators

    As the global head of clinical innovation for Eli Lilly and Company, Katherine Vandebelt knows there are many things pharma needs to do better. No drug can make it to market without first navigating the clinical trials process, which creates a burden on the physicians involved. Therefore, it should come as no surprise to anyone involved in the process that many physicians will oversee one trial and then opt to no longer take part in them.

  4. Are Outdated Pricing Models Hurting Clinical Research?

    Two issues that always seem to throw a wrench into sponsor/CROs relationships are changes to staffing and pricing. Protocol changes can disrupt trials for CROs and cause price increases for sponsors. Staffing changes can create new learning curves, delay trials, and cause sponsors to feel they were misled. Are penalties an easy way to fix both?

  5. PatientsLikeMe And Duke Bring Novel Approach To ALS Trial

    Can the peptide Lunasin help to reverse the debilitating effects of ALS? After one patient (and three experts) noted it could, PatientsLikeMe and the Duke ALS Clinic decided to get involved. Their novel trial will feature an unlimited number of patients, sharing of all patient data, and electronic patient reported outcomes. It also eliminated the use of a placebo.

  6. Eli Lilly Steps Up Focus On Autoimmune Diseases

    Managing patients having an autoimmune disease can present special challenges for researchers, from correctly diagnosing the disease to recruiting specific patients for clinical trials. I recently spoke with Chin Lee, global senior medical director in the immunology therapeutic area at Eli Lilly and Company. Lee discusses his decision to move from academia to pharma and the challenges inherent in performing clinical trials on autoimmune disease patients.

  7. How Nektar Therapeutics Improves The Transactional Outsourcing Model

    As pharma’s use of CROs continues to grow, so does the talk about outsourcing models. Today, one of the most popular models seems to be highly integrated strategic partnerships. Unfortunately, that model does not work for every company. Partnering agreements often seem to be built on a broad and sustainable pipeline, but for small- and mid-sized companies, that pipeline often does not exist.

  8. The High Price Of Failed Clinical Trials: Time To Rethink The Model

    Back in 2014, a study in Nature Biotech showed that only 32% of drugs have a probability of making it to Phase 3 trials, and only one in 10 drugs overall actually makes it to market. Things haven’t improved since then. BIO recently put out a study reporting that the average overall likelihood of approval (LOA) by FDA from Phase I was 9.6 percent – a 1 in 10 chance. The rate is even lower for major disease areas like oncology.

  9. Adaptive Trials: Complex But Advantageous

    When I speak with pharma executives on certain topics, it’s amazing to see the difference in where companies stand in terms of implementation. Adaptive trials is one of those topics. I will talk to one executive who will tell me it is one of the trends that will most impact the pharma industry in the coming year, and then talk to another who will tell me it’s old news and something they have been doing for years. Regardless of where you stand with adoption, one thing is clear: Adaptive trials have many advantages, but are also more complex.

  10. Patient Engagement: An Essential Strategy For Pharma

    For the pharma industry to improve clinical trials, as well as the entire drug discovery process, better links need to be forged with stakeholder groups. That’s the conclusion of a new report released by PwC Health Research Institute (HRI) titled, Patient Engagement: Pharma’s Strategy For Success In The New Health Economy. The report is based on an analysis of the state of patient engagement, including an analysis of 21 patient-engagement meetings and data from the FDA’s Orphan Drug Designations database.