ICH Releases Draft Revision of E8 Guideline, General Considerations for Clinical Trials

Since the last update of ICH6 (R2) on 2017, ICH was working on a new release, a new revision of ICH E8 about General Considerations for Clinical Trials. The E8 last version was adopted in 1997, but changes to trial design and conduct in the last two decades have made much of the guideline out of date.

Currently, parties involved in clinical trials development have a draft version of ICH E8 available and ICH plans to release the final ICH E8(R1) by June 2020.

The new revision adds a new section about quality of clinical studies design which is focus on “critical to quality” factors adaptable to several types of clinical trials and the importance of patient centricity in clinical trial development.

Review complete draft version here: ICH E8(R1) Draft version


Acknowledgment for APICES collaboration in a clinical trial published in The Oncologist.

Many times the work of CROs is not totally acknowledged. But, fortunately, this is not always the case.

This month, we want to share the acknowledgment that APICES has received in a recent publication in The Oncologist. This means to all APICES team an extra motivation in order to give continuity to the implication we have in every project in which we collaborate. From APICES, we are pride because of the recognition of our work and we want to thank ONCOSUR and Dr Eva Ciruelos for the opportunity they have given to APICES to appear as author as well as in the publication acknowledgments, and congratulate them for their project success.

The paper analyzes the results of a phase II clinical trial about neurotoxicity caused by three dose regimens of nab-paclitaxel in comparison with solvent-based paclitaxel as first line therapy. The clinical trial NEURABRAX has showed that, regardless of the dose, nab-paclitaxel did not differ from solvent-based-paclitaxel in terms of neurotoxicity as evaluated with the TNS. However, results from NCI-CTCAE, dose delays and reductions, and functional tools consistently indicate that 150 mg/m2 of nab-paclitaxel administered on days 1, 8 and 15 in a 4-week cycles is associated with a greater risk of chemotherapy-induced neuropathy. Thus, these results question the superiority of the TNS over NCI-CTCAE for evaluating chemotherapy-induced neuropathy and guiding treatment decisions in this context.

For more detailed information: A Pilot, Phase II, Randomized, Open‐Label Clinical Trial Comparing the Neurotoxicity of Three Dose Regimens of Nab‐Paclitaxel to That of Solvent‐Based Paclitaxel as the First‐Line Treatment for Patients with Human Epidermal Growth Factor Receptor Type 2‐Negative Metastatic Breast Cancer Ciruelos, et al. The Oncologist



This month has been published a relevant article about a new therapeutic advance. A patient with spinal cord injury can walk again after being treated with NC1, a new cell therapy produced at Hospital Puerta de Hierro from Madrid, Spain.

The medical team from Hospital Puerta de Hierro started working in NC1 20 years ago. This therapy consists of expanded autologous mesenchymal stromal cells and autologous plasma as its excipient. APICES collaborated in project start-up and is proud of it. Congratulations to the Hospital Puerta de Hierro team and all the personnel involved who have made this possible.

For more information:




Next year is very close and is time to think about results of this year, time to celebrate successes and to be enthralled with the beginning of new projects and challenges for 2019.

Moreover, 2019 is really a very special year, APICES will be 10 years old, in which APICES has not stopped growing and improving its capabilities, quality and team. During last 10 years, APICES has met all our clients objectives & milestones, which are ours, and has overcame all challenges encountered along the way, but, this is not enough, and new clients, projects and challenges are waiting for us for next 10 years.

For all these reasons, APICES team wants to thank for this wonderful past 10 years to all involved stakeholders: clients, providers, investigators, patients, HHAA and for an awesome future:

The entire APICES team wishes you a Peaceful and Merry Christmas and a healthy and successful 2019.