Practical Pointers for Drug Development and Medical Affairs

Written by Gerald L. Klein, MD & Roger Morgan, MD

Drug Development

  • Up to 50% of subjects have poor medication adherence in clinical trials. This can be a significant factor affecting the efficacy of the results. In order to prevent this, it may be worthwhile to do a placebo screening for 2-4 weeks to determine if the potential participant will demonstrate adequate medication adherence to be enrolled in the study.1

  • The constant change of regulations, introduction of new technology and the modifications of best clinical trial practices, makes the need for continuing staff education and training essential. This type of guidance will help maintain the highest clinical practice standard for your company and may also prevent staff turnover.

  • The signing of an Informed Consent Form is not totally adequate in obtaining a potential participants informed consent for a pharmaceutical clinical trial. The process should also involve a careful, meaningful explanation of potential risks and a commitment to attend all required patient visits and procedures. These procedures should be clearly defined so that the potential subject understands their actual commitment. This is not only a regulatory requirement but an ethical, moral, and medical obligation. If potential study participants better understand the risks and their obligations it should also aid with patient retention.3

    Medical Affairs

  • A practical method to demonstrate the application of a biopharmaceutical product may be to publish a case history or series about this topic. Through these articles, health care providers are able to identify the example with their own patients and how this product may fit in with their practice.4

  • The use of n-1 clinical studies is another cost-effective manner of conducting small pilot clinical studies.5 They are especially useful in patient-centric research and to re-evaluate chronic therapies.6

  • Medical Affairs teams frequently want to work with established experts, Key Opinion Leaders (KOLs), in specific therapeutic areas.7 These teams should have an ethical synergistic plan that provides benefits for both the clinical scientist’s research and/or patient care (as well as addressing their own needs) allowing for a prudent exchange of ideas. Rather than compensating a physician only for their time, a more useful activity will help establish a better relationship. An example is a medical liaison (working for a company that sells allergy products), contacting a prominent allergist to determine what pollens seem to cause nocturnal allergy symptoms in July in San Diego.

  1. Klein GL. The case for digital pill use in clinical trials. Clin Trial Pract Open J. 2021; 1(1): 89-94

  2. Butryn, Tracy, et al. “Keys to success in clinical trials: A practical review.” International Journal of Academic Medicine 2.2 (2016): 203.

  3. Yarborough, M. Rescuing Informed Consent: How the new “Key Information” and “Reasonable Person” Provisions in the Revised U.S. Common Rule open door to long Overdue Informed Consent Disclosure Improvements and why we need to walk Through that door. Sci Eng Ethics 26, 1423-1443 (2020).

  4. Riley, David s., et al. “CARE guidelines for case reports: explanation and elaboration document.” Journal of clinical epidemiology 89 (2017) 218-235.

  5. Duan N, Kravitz RL, Schmid CH. Single-patient (n-of-1) trials: a pragmatic clinical decision methodology for patient-centered comparative effectiveness research. J Clin Epidemiol. 2013 Aug;66(8Suppl):S21-8

  6. Vohra, S., Shamseer, L., Sampson, M., Bukutu, C., Schmid, C.H., Tate, R., …& Moher, D. (2015). CONSORT extension for reporting N-of-1 trials (CENT) 2015 Statement. bmj, 350.

  7. Scher, J.U., Schett, G. Key opion leaders - a critical perspective. Nat Rev Rheumato/17, 119-124 (2021).